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Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
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References

AAHRPP (Association for the Accreditation of Human Research Protection Programs, Inc.). 2003. Statement to the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine. [Online]. Available: http://www.iom.edu/includes/DBFile.asp?id=14404 [accessed March 11, 2004].

AANMA (Allergy & Asthma Network/Mothers of Asthmatics). 2003. Statement to the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine. [Online]. Available: http://www.iom.edu/includes/DBFile.asp?id=13796 [accessed March 11, 2004].

AAP (American Academy of Pediatrics). 1977. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 60(1):91–101.

AAP. 1988. Policy statement: Age limits of pediatrics (RE8116). Pediatrics 81(5):736. [Online]. Available: http://www.aap.org/policy/02031.html [accessed March 11, 2004].

AAP. 1995. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 95(2):286–294.

AAP. 2001. Corporal punishment in schools. In: 2001 State Legislation Report. Elk Grove Village, IL: AAP. Pp. 49–52. [Online]. Available: http://www.aap.org/advocacy/01statelegrpt.pdf [accessed March 11, 2004].

AAP. 2003 (July 9). Participation and Protection of Children in Clinical Research. Statement to the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine.

AAPS (Association of American Physicians & Surgeons, Inc.) v. FDA. 2002. 226 F. Supp. 2d 204, 19689, (D.D.C.). [Online]. Available: http://www.dcd.uscourts.gov/00-02898.pdf [accessed March 11, 2004].

Abramovitch R, Freedman JL, Thoden K, Nikolich C. 1991. Children’s capacity to consent to participation in psychological research: Empirical findings. Child Development 62(5): 1100–1109.

Aby JS, Pheley AM, Steinberg P. 1996. Motivation for participation in clinical trials of drugs for the treatment of asthma, seasonal allergic rhinitis, and perennial nonallergic rhinitis. Annals of Allergy, Asthma & Immunology 76:348–354.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

ACHRE (Advisory Committee on Human Radiation Experiments). 1995. Final Report of the Advisory Committee on Human Radiation Experiments. Washington, DC: U.S. Government Printing Office. Reprint: 1996. New York, NY: Oxford University Press. [Online]. Available: http://tis.eh.doe.gov/ohre/roadmap/achre/report.html [accessed March 11, 2004].

ACS (American Cancer Society). 2003. Cancer Facts and Figures, 2003. Atlanta, GA: ACS. [Online]. Available: http://www.cancer.org/downloads/STT/CAFF2003PWSecured.pdf [accessed March 11, 2004].

Ahmadieh H, Javadi MA. 2001. Intra-ocular lens implantation in children. Current Opinion in Ophthalmology 12(1):30–34.

Albert T. 2002 (November 18). Federal court overturns FDA pediatric drug testing rule: Bill before the House and Senate would require drug testing in children, but passage is uncertain. AMedNews. [Online]. Available: http://www.ama-assn.org/amednews/2002/11/18/gvsc1118.htm [accessed March 11, 2004].

Alderson P. 1993. Children’s Consent to Surgery. Buckingham, England: Open University Press.

Allmark P, Mason S, Gill AB, Megone C. 2003. Obtaining consent for neonatal research. Archives of Disease in Childhood. Fetal and Neonatal Edition 88(3):F166–F167.

Altman LK. 2001 (June 15). Volunteer in asthma study dies after inhaling drug. New York Times. P. A16.

AMA (American Medical Association). 1994. Finder’s Fees: Payment for the Referral of Patients to Clinical Research Studies. Chicago, IL: AMA.

AMA. 1999. Fees splitting: Referrals to health care facilities. Current Opinions of the Council on Ethical and Judicial Affairs E-6.03(A-99).

Ambuel B, Rappaport J. 1992. Developmental trends in adolescents’ psychological and legal competence to consent to abortion. Law & Human Behavior 16(2):129–154.

Amdur RJ, Bankert L. 2003. Adverse Event Reports. In: Amdur RJ. Institutional Review Board Member Handbook. Sudbury, MA: Jones & Bartlett Publishers, Inc.

American Heritage. 1992. American Heritage Dictionary of the English Language. 3rd ed. Boston, MA: Houghton Mifflin Company.

Angold A, Costello EJ, Erkanli A, Worthman CM. 1999. Pubertal changes in hormone levels and depression in girls. Psychological Medicine 29(5):1043–1053.

Annas GJ, Grodin MA, eds. 1992. The Nazi Doctors and the Nuremburg Code: Human Rights in Human Experimentation. New York, NY: Oxford University Press.

Annas GJ, Glantz LH, Katz BF. 1977. Informed Consent to Human Experimentation: The Subject’s Dilemma. New York, NY: HarperInformation. [Online]. Available: http://www.bumc.bu.edu/www/sph/lw/pvl/book/book_content.html [accessed March 11, 2004].

Appelbaum PS, Roth LH, Lidz C. 1982. The therapeutic misconception: Informed consent in psychiatric research. International Journal of Law and Psychiatry 5(3–4):319–329.

Arias E, Smith BL. 2003. Deaths: Preliminary data for 2001. In: National Vital Statistics Reports. Vol. 51. No. 5. Hyattsville, MD: National Center for Health Statistics. [Online]. Available: http://www.cdc.gov/nchs/data/nvsr/nvsr51/nvsr51_05.pdf [accessed March 11, 2004].

Arrillaga P. 2001 (April 15). Stuck between two worlds: Tribal youth ravaged by violence, drug abuse, depression. The Los Angeles Times. P. B1.

ASCP (American Society of Consultant Pharmacists). 1991. Statement on Drug and Related Research in the Elderly. Alexandria, VA: ASCP. [Online]. Available: http://www.ascp.com/public/pr/policy/drug.shtml [accessed March 11, 2004].

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Baker E, Atwood E, Duffy T. 1988. Cognitive approaches to assessing the readability of text. In: Davison A, Green G, eds. Linguistic Complexity and Text Comprehension. Hillsdale, NJ: Lawrence Erlbaum. Pp. 55–83.

Ballentine C. 1981. Taste of raspberries, taste of death: The 1937 elixir sulfanilamide incident. FDA Consumer Magazine. [Online]. Available: http://www.fda.gov/oc/history/elixir.html [accessed March 11, 2004].

Bartholomew T. 1996. Challenging Assumptions About Young People’s Competence—Clearing the Pathway to Policy? Paper presented at the Australian Institute of Family Studies’ Fifth Australian Family Research Conference, Brisbane, Australia. Australian Institute of Family Studies. [Online]. Available: http://www.aifs.org.au/institute/afrcpapers/barthol.html [accessed March 11, 2004].

Batalden PB, Nelson EC, Roberts JS. 1994. Linking outcomes measurement to continual improvement: the serial “V” way of thinking about improving clinical care. Joint Commission Journal on Quality Improvement 20(4):167–180.

Bayley N. 1993. Bayley Scales of Infant Development: Birth to Two Years. 2nd ed. New York, NY: The Psychological Corporation.

Beauchamp TL, Childress JF. 1994. Principles of Biomedical Ethics. 4th ed. New York, NY: Oxford University Press.

Beecher HK. 1966. Ethics and clinical research. New England Journal of Medicine 274(24): 1354–1360. [Online]. Available: http://www.who.int/bulletin/pdf/2001/issue4/vol79.no.4.365-372.pdf [accessed March 11, 2004].

Beecher HK. 1970. Research and the Individual: Human Studies. Boston, MA: Little, Brown and Co.

Behrman RE, Kliegman RM, Jenson HB, eds. 2004. Nelson Textbook of Pediatrics. 17th ed. Philadelphia, PA: WB Sanders.

Bell J, Whiton J, Connelly S. 1998. Final Report: Evaluation of NIH Implementation of Section 491 of the Public Health Service Act, Mandating a Program of Protection for Research Subjects. Arlington, VA: James Bell Associates. [Online]. Available: http://www.washingtonfax.com/samples/docs/bioethics/patients/hsp_final_rpt.pdf [accessed March 11, 2004].

Bellin E, Dubler NN. 2001. The quality improvement—research divide and the need for external oversight. American Journal of Public Health 91(9):1512–1517.

Belter RW, Grisso T. 1984. Children’s recognition of rights violations in counseling. Professional Psychology: Research and Practice 15(6):899–910.

Bernhardt BA, Tambor ES, Fraser G, Wissow LS, Geller G. 2003. Parents’ and children’s attitudes toward the enrollment of minors in genetic susceptibility research: Implications for informed consent. American Journal of Medical Genetics 116A:315–323.

Berwick DM. 1989. Continuous quality improvement as an ideal in health care. New England Journal of Medicine 320(1):53–56.

Berwick DM, Godfrey AB, Roessner J. 1990. Curing Health Care: New Strategies for Quality Improvement. San Francisco, CA: Jossey-Bass.

Bevan EG, Chee LC, McGhee SM, McInnes GT. 1993. Parents’ attitudes to participation in clinical trials. British Journal of Clinical Pharmacology 35(2):204–207.

Bleyer WA, Tejeda HA, Murphy SB, Brawley OW, Smith MA, Ungerleider RS. 1997. Equal participation of minority patients in U.S. national pediatric cancer clinical trials. Journal of Pediatric Hematology and Oncology 19(5):423–427.

Bluebond-Langner M. 1978. The Private Worlds of Dying Children. Princeton, NJ: Princeton University Press.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
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Bluebond-Langner M, DeCicco A, Belasco J. In press. Involving children in decisions about research and treatment for life shortening illnesses: A proposal for shuttle diplomacy and negotiation. In: Kodish E, ed. Ethics and Research with Children: A Case-Based Approach. New York, NY: Oxford University Press.

Blustein J, Levine C, Dubler NN, eds. 1999. The Adolescent Alone: Decision Making in Health Care in the United States. Cambridge, United Kingdom: Cambridge University Press .

Bonner GJ, Miles TP. 1997. Participation of African Americans in clinical research. Neuroepidemiology 16(6):281–284.

Borzekowski DLG, Rickert VI, Ipp L, Fortenberry JD. 2003. At what price? The current state of subject payment in adolescent research. Journal of Adolescent Health 33(5):378–384.

Boseley S. 2003 (June 11). Mood drug Seroxat banned for under-18s. The Guardian. [Online]. Available: http://www.guardian.co.uk/uk_news/story/0,3604,974901,00.html [accessed March 11, 2004].

Botkin JR. 2001. Informed consent for the collection of biological samples in household surveys. In: National Research Council. Cells and Surveys: Should Biological Measures Be Included in Social Science Research? Washington, DC: National Academy Press. Pp. 276–302.

Bradlyn AS, Varni JW, Hinds PS. 2003. Assessing health-related quality of life in end-of-life care for children and adolescents. In: Institute of Medicine. When Children Die: Improving Palliative and End-of-Life Care for Children and Their Families. Washington, DC: The National Academies Press. [Online]. Available: http://books.nap.edu/html/children_die/AppC.pdf [accessed March 11, 2004].

Brainard J. 2003 (October 21). Federal agency says oral history is not subject to rules on human research volunteers. The Chronicle of Higher Education. P. A25.

Brazelton TB, Nugent JK, Lester BM. 1987. Neonatal Behavioral Assessment Scale. 2nd ed. New York, NY: Wiley.

Brett A, Grodin M. 1991. Ethical aspects of human experimentation in health services research. Journal of the American Medical Association 265(14):1854–1857.

Britner PA, LaFleur SJ, Whitehead AJ. 1998. Evaluating juveniles’ competence to make abortion decisions: How social science can inform the law. University of Chicago Law School Roundtable 5(1):35–62.

Brock DW. 1994. Ethical issues in exposing children to risks in research. In: Grodin MA, Glantz LH, eds. Children as Research Subjects: Science, Ethics & Law. New York, NY: Oxford University Press. Pp. 81–102.

Brody JL, Scherer DG, Annett RD, Pearson-Bish M. 2003. Voluntary assent in biomedical research with adolescents: A comparison of parent and adolescent views. Ethics & Behavior 13(1):79–95.

Brokowski C. 2003 (July 11). Testimony before the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine.

Broome ME. 1999. Consent (assent) for research with pediatric patients. Seminars in Oncology Nursing 15(2):96–103.

Broome ME, Richards DJ. 2003. The influence of relationships on children’s and adolescents’ participation in research. Nursing Research 52(3):191–197.

Broome ME, Bates T, Lillis P, McGahee T. 1990. Children’s medical fears, coping behaviors, and pain perceptions during a lumbar puncture. Oncology Nursing Forum 17(3):361–367.

Broome ME, Richards DJ, Hall JM. 2001. Children in research: The experience of ill children and adolescents. Journal of Family Nursing 7(1):32–49.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Broome ME, Kodish E, Geller G, Siminoff LA. 2003. Children in research: New perspectives and practices for informed consent. IRB: Ethics & Human Research 25(Supp 5):S20– S25.

Bruzzese JM, Fisher CB. 2003. Assessing and enhancing the research consent capacity of children and youth. Applied Developmental Science 7(1):13–26.

Bullinger M, Petersen C, Schmidt S, Baars R, Hatziagorou E, Koopman H, Vidalis A, Tsanakas J, Karagianni P, Hoare P, Atherton C, Phillips K, Simeoni MC, Clement A, Chaplin JE, Quittan M, Schuhfried O, Hachemian N, Thyen U, Muller-Godeffroy E, Ravens-Sieberer U. 2002. European paediatric health-related quality of life assessment: The DISABKIDS Group. MAPI Research Institute Quality of Life Newsletter 29:5–6. [Online]. Available: http://www.mapi-research-inst.com/pdf/art/QOL29_Bullinger%20.pdf [accessed March 11, 2004].

Burgess E, Singhal N, Amin H, McMillan DD, Devrome H. 2003. Consent for clinical research in the neonatal intensive care unit: A retrospective survey and a prospective study. Archives of Disease in Childhood Fetal Neonatal Edition 88(4):F280–F285.

Burman WJ, Reves RR, Cohn DL, Schooley RT. 2001. Breaking the camel’s back: Multicenter clinical trials and local institutional review boards. Annals of Internal Medicine 134(2): 152–157.

Burman W, Breese P, Weis S, Bock N, Bernardo J, Vernon A, the Tuberculosis Trials Consortium. 2003. The effects of local review on informed consent documents from a multicenter clinical trials consortium. Controlled Clinical Trials 24(3):245–255.


Caldwell PHY, Butow PN, Craig JC. 2003. Parents’ attitudes to children’s participation in randomized controlled trials. Journal of Pediatrics 142(5):554–559.

Callahan D. 2003. The Research Imperative: What Price Better Health? Berkeley, CA: University of California Press.

Campbell H, Surry SAM, Royle EM. 1998. A review of randomized controlled trials published in Archives of Disease in Childhood from 1982-1996. Archives of Disease in Childhood 79(2):192–197.

Capon N, Kuhn D. 1982. Can consumers calculate best buys? Journal of Consumer Research 8:449–453.

Carome MA. 2000 (November 3). Letter to Michael M. Gottesman re: Human research subject protections under Multiple Project Assurance (MPA) M-1000. Research project: Population differences in the insulin sensitivity, resting energy expenditure, and body composition of overweight children and children of overweight parents. [Online]. Available: http://ohrp.osophs.dhhs.gov/detrm_letrs/nov00a.pdf [accessed March 11, 2004].

Carome MA. 2003 (January 9). Overview of OHRP Research Ethics Compliance Activities and Data Resources . Presentation to the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine.

Casarett D, Karlawish JHT, Sugarman J. 2000. Determining when quality improvement initiatives should be considered research: Proposed criteria and potential implications. Journal of the American Medical Association 283(17):2275–2280.

Cassileth BR, Lusk EJ, Miller DS, Hurwitz S. 1982. Attitudes toward clinical trials among patients and the public. Journal of the American Medical Association 248:968–970.

Castile R, Filbrun D, Flucke R, Franklin W, McCoy K. 2000. Adult-type pulmonary function tests in infants without respiratory disease. Pediatric Pulmonology 30(3):215–227.

CDC (Centers for Disease Control). 1982. Neonatal deaths associated with use of benzyl alcohol—United States. Morbidity and Mortality Weekly Report 31(22):290–291. [Online]. Available: http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm [accessed March 11, 2004].

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

CDC. 1999. Achievements in public health, 1900-1999. Impact of vaccines universally recommended for children—United States, 1990-1998. Morbidity and Mortality Weekly Report 48(12):243–248. [Online]. Available: http://www.cdc.gov/mmwr/preview/mmwrhtml/00056803.htm [accessed March 11, 2004].

CFF (Cystic Fibrosis Foundation). 2002. Cystic Fibrosis Foundation Patient Registry 2002 Annual Data Report to the Center Directors. Bethesda, MD: Cystic Fibrosis Foundation.

Charrow V. 1988. Readability vs. comprehensibility: A case study in improving a real document. In: Davison A, Green G, eds. Linguistic Complexity and Text Comprehension. Hillsdale, NJ: Lawrence Erlbaum. Pp. 85–114.

Cheng JD, Hitt J, Koczwara B, Schulman KA, Burnett CB, Gaskin DJ, Rowland JH, Meropol NJ. 2000. Impact of quality of life on patient expectations regarding phase I clinical trials. Journal of Clinical Oncology 18(2):421–428.

Chi MTH, Ceci SJ. 1987. Content knowledge: Its role, representation, and restructuring in memory development. In: Reese H, ed. Advances in Child Development and Behavior. New York, NY: Academic Press. Pp. 93–141.

Chien YC, Lin C, Worthley J. 1996. Effect of framing on adolescents’ decision making. Perceptual and Motor Skills 83(3 Pt 1):811–819.

Children’s Hospital Boston. No date. A Family’s Guide to Clinical Research. Boston, MA: Children’s Hospital Boston.

Children’s Hospital Boston. 2003. Policies and Procedures for the Protection of Human Research Subjects. Boston, MA: Children’s Hospital Boston.

Children’s Hospital of Philadelphia. 2002. An Introduction to Pediatric Clinical Research: Help Lead the Way. Philadelphia, PA: Children’s Hospital of Philadelphia.

Choonara I, Conroy S. 2002. Unlicensed and off-label drug use in children: Implications for safety. Drug Safety 25(1):1–5.

Churchill LR, Collins ML, King NM, Pemberton SG, Wailoo KA. 1998. Genetic research as therapy: Implications of “gene therapy” for informed consent. Journal of Law and Medical Ethics 26(1):38–47.

Churchill LR, Nelson DK, Henderson NMP, Davis AM, Leahey E, Wilfond BS. 2003. Assessing benefits in clinical research: Why diversity in benefit assessment can be risky. IRB: A Review of Human Subjects Research 25(3):1.

CIOMS. 2002. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, Switzerland: CIOMS. [Online]. Available: http://www.cioms.ch/frame_guidelines_nov_2002.htm [accessed March 11, 2004].

COG (Children’s Oncology Group). No date. Children’s Oncology Group Home Page. [Online]. Available: http://www.childrensoncologygroup.org [accessed March 11, 2004].

COG. 2003 (July 9). Statement on Clinical Research Involving Children. Statement to the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine.

Cohn LD, Schydlower M, Foley J, Copeland RL. 1995. Adolescents’ misinterpretation of health risk probability expressions. Pediatrics 95(5):713–716.

Collins F. 2001. The Human Genome Project. Presentation at the National Human Research Protections Advisory Committee Meeting, Bethesda, MD. Department of Health and Human Services. [Online]. Available: http://ohrp.osophs.dhhs.gov/nhrpac/mtg04-01/franciscollins.pdf [accessed March 11, 2004].

Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, Knoeppel C, Seyberth H, Pandolfini C, Raffaelli MP, Rocchi F, Bonati M, Jong G, de Hoog M, van den Anker J, on behalf of the European Network for Drug Investigation in Children. 2000. Survey of unlicensed and off-label drug use in paediatric wards in European countries. British Medical Journal 320(7227):79–82.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Corey M, Edwards L, Levison H, Knowles M. 1997. Longitudinal analysis of pulmonary function decline in patients with cystic fibrosis. Journal of Pediatrics 131(6):809–814.

Cousens P, Waters B, Said J, Stevens M. 1988. Cognitive effects of cranial irradiation in leukaemia: A survey and meta-analysis. Journal of Child Psychology and Psychiatry, and Allied Disciplines 29:839–852.

Cowdry R. 1997. Presentation at the Human Subjects Subcommittee Meeting, National Bioethics Advisory Commission. [Online]. Available: http://www.georgetown.edu/research/nrcbl/nbac/transcripts/1997/7-15-97.pdf [accessed March 11, 2004].

Coyne CA, Xu R, Raich P, Plomer K, Dignan M, Wenzel LB, Fairclough D, Habermann T, Schnell L, Quella S, Cella D. 2003. Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: A study of the Eastern Cooperative Oncology Group. Journal of Clinical Oncology 21(5):836–842.


Dahan E. 2000. Intraocular lens implantation in children. Current Opinion in Ophthalmology 11(1):51–55.

Daugherty CK, Ratain MJ, Grochowski E, Stocking C, Kodish E, Mick R, Siegler M. 1995. Perceptions of cancer patients and their physicians involved in phase I trials. Journal of Clinical Oncology 13(5):1062–1072.

Davis TC, Crouch MA, Wills G, Miller S, Abdehou DM. 1990. The gap between patient reading comprehension and the readability of patient education materials. Journal of Family Practice 31(5):533–538.

Davis TC, Mayeaux EJ, Fredrickson D, Bocchini JA, Jackson RH, Murphy PW. 1994. Reading ability of parents compared with reading level of pediatric patient education materials. Pediatrics 93(3):460–468.

Davis TC, Holcombe RF, Berkel HJ, Pramanik S, Divers SG. 1998. Informed consent for clinical trials: A comparative study of standard versus simplified forms. Journal of National Cancer Institute 90(9):668–674.

de Vane PJ. 2001 (March 21). Letter to Health Care Professional re: two recent changes to the Cordarone I.V. (amiodarone HCI) prescribing information. [Online]. Available: http://www.fda.gov/medwatch/safety/2001/cordarone_deardoc.pdf [accessed March 11, 2004].

Deatrick JA, Angst DB, Moore C. 2002. Parents’ views of their children’s participation in phase I oncology clinical trials. Journal of Pediatric Oncology Nursing 19(4):114-121.

Dembner A. 2001 (February 18). Drug research on children raises concerns. Boston Globe. P. 1.

Deyo RA, Cherkin DC, Weinstein J, Howe J, Ciol M, Mulley Jr AG. 2000. Involving patients in clinical decisions: Impact of an interactive video program on use of back surgery. Medical Care 38(9):959-969.

DHEW (Department of Health Education and Welfare). 1973a. Final Report of the Tuskegee Syphilis Study Ad Hoc Advisory Panel. Washington, DC: U.S. Government Printing Office. [Online]. Available: http://biotech.law.lsu.edu/cphl/history/reports/tuskegee/tuskegee.htm [March 11, 2004].

DHEW. 1973b. H.E.W. draft working document on experimentation with children. Federal Register 38:31746. [Online]. Available: http://www.bumc.bu.edu/www/sph/lw/pvl/book/Ch9.pdf [accessed March 11, 2004].

DHEW. 1974. H.E.W. proposed rules on experimentation with the institutionalized mentally disabled. Federal Register 39:30655–30656. [Online]. Available: http://www.bumc.bu.edu/www/sph/lw/pvl/book/Ch9.pdf [accessed March 11, 2004].

DHHS (Department of Health and Human Services). 1981. Final regulations amending basic HHS policy for the protection of human research subjects. Federal Register 46:8366.

DHHS. 1998. Protection of human subjects: Categories of research that may be reviewed by the institutional review board (IRB) through an expedited review procedure. Federal Register 63:60353.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

DHHS. 2000. Office of Public Health and Science, and National Institutes of Health, Office of the Director. Statement of organization, functions, and delegations of authority. Federal Register 65:37136–37137. [Online]. Available: http://ohrp.osophs.dhhs.gov/references/fr.pdf [accessed March 11, 2004].

DHHS. 2001. Protections for Children in Research: A Report to Congress in Accord with Section 1003 of P.L. 106310, Children’s Health Act of 2000. Washington, DC: DHHS. [Online]. Available: http://ohrp.osophs.dhhs.gov/reports/ohrp5-02.pdf [March 11, 2004].

DHHS. 2002a. Proposed research protocol: Precursors to diabetes in Japanese American youth. Federal Register 67:77495.

DHHS. 2002b. Solicitation of public review and comment on research protocol: A multicenter, randomized dose response study of the safety, clinical and immune response of Dryvax administered to children 2 to 5 years of age. Federal Register 67:66403.

DHHS. 2003a. HHS Identifies Drugs for Pediatric Testing and Announces FY 2003 and FY 2004 Funding. [Online]. Available: http://www.hhs.gov/news/press/2003pres/20030121.html [accessed March 11, 2004].

DHHS. 2003b. Solicitation of public review and comment on research protocol: Sleep mechanism in children: Role of metabolism. Federal Register 68:35415–35416.

Dickert N, Grady C. 1999. What’s the price of a research subject? Approaches to payment for research participation. New England Journal of Medicine 341(3):198–203.

Dickert N, Emanuel E, Grady C. 2002. Paying research subjects: An analysis of current policies. Annals of Internal Medicine 136(5):368–373.

Doolittle P. 1997. Vygotsky’s zone of proximal development as a theoretical foundation for cooperative learning. Journal on Excellence in College Teaching 8(1):83–103.

Dorn LD, Susman EJ, Fletcher JC. 1995. Informed consent in children and adolescents: Age, maturation and psychological state. Journal of Adolescent Health 16(3):185–190.

Dresser R. 2001. When Science Offers Salvation: Patient Advocacy and Research Ethics. Oxford, United Kingdom: Oxford University Press.

Dresser R. 2003. Patient advocates in research: New possibilities, new problems. Washington University Journal of Law and Policy 11:237–248.

Driscoll DA. 2003. Polycystic ovary syndrome in adolescence. Annals of the New York Academy of Sciences 997:49–55.

Duffy TM. 1985. Readability formulas: What’s the use? In: Duffy T, Waller R, eds. Designing Usable Texts. New York, NY: Academic Press. Pp. 113–143.

Duffy TM, Kabance P. 1982. Testing a readable writing approach to text revision. Journal of Educational Psychology 74(5):733–747.


ECRI. 2002. Should I Enter a Clinical Trial. A Patient Reference Guide for Adults with Serious or Life-Threatening Illness. Washington, DC: American Association of Heath Plans.

Edejer TT. 1999. North-South research partnerships: The ethics of carrying out research in developing countries. British Medical Journal 319(7207):438–441.

Edsall G. 1971. Experiments at Willowbrook. Lancet 298(7715):95.

Edwards A, Elwyn G, Covey J, Matthews E, Pill R. 2001. Presenting risk information—a review of the effects of “framing” and other manipulations on patient outcomes. Journal of Health Communication 6(1):61–82.

Edwards SJL, Lilford RJ, Hewison J. 1998. The ethics of randomised controlled trials from the perspectives of patients, the public, and healthcare professionals. British Medical Journal 317(7167):1209–1212.

Eisenberg N, Guthrie IK, Cumberland A, Murphy BC, Shepard SA, Zhou Q, Carlo G. 2002. Prosocial development in early adulthood: A longitudinal study. Journal of Personality and Social Psychology 82(6):993–1006.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Ellenberg SS, Braun MM. 2002. Monitoring the safety of vaccines: Assessing the risks. Drug Safety 25(3):145–152.

Ellenberg SS, Temple R. 2000. Placebo-controlled trials and active-control trials in the evaluation of new treatments: Part 2: Practical issues and specific cases. Annals of Internal Medicine 133(6):464–470.

Ellis GB, Lin MH. 1996 (October 31). Letter to Institutional Officials and Institutional Review Board (IRB) Chairs re: Informed Consent Requirements in Emergency Research. [Online]. Available: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/hsdc97-01.htm [accessed March 11, 2004].

Emanuel EJ, Miller FG. 2001. The ethics of placebo-controlled trials—a middle ground. New England Journal of Medicine 345(12):915–919.

Emerson J, Rosenfeld M, McNamara S, Ramsey B, Gibson RL. 2002. Pseudomonas aeruginosa and other predictors of mortality and morbidity in young children with cystic fibrosis. Pediatric Pulmonology 34(2):91–100.

English A, Kenney KE. 2003. State Minor Consent Laws: A Summary. 2nd ed. Chapel Hill, NC: Center for Adolescent Health & the Law.


Faden R, Beauchamp T. 1986. A History and Theory of Informed Consent. New York, NY: Oxford University Press.

Fallowfield LJ, Jenkins V, Brennan C, Sawtell M, Moynihan C, Souhami RL. 1998. Attitudes of patients to randomised clinical trials of cancer therapy. European Journal of Cancer 34(10):1554–1559.

Fazzi E, Orcesi S, Telesca C, Ometto A, Rondini G , Lanzi G. 1997. Neurodevelopmental outcome in very low birth weight infants at 24 months and 5 to 7 years of age: Changing diagnosis. Pediatric Neurology 17(3):240–248.

FDA (Food and Drug Administration). 1979a. Prescription drug products: Patient labeling requirements. Federal Register 44:37434-37467.

FDA. 1979b. Protection of human subjects; proposed establishment of regulations. Federal Register 44:24106–24111.

FDA. 1991a. Protection of human subjects; informed consent; standards for institutional review boards for clinical investigations. Federal Register 56:28025. [Online]. Available: http://ohrp.osophs.dhhs.gov/references/comrulp4.pdf [accessed March 11, 2004].

FDA. 1991b. Withdrawal of certain pre-1986 proposed rules: Final action. Federal Register 56:67440.

FDA. 1994a. Specific requirements on content and format of labeling for human prescription drugs: Revision of “Pediatric Use” subsection in the labeling; final rule. Federal Register 59:64240. [Online]. Available: http://frwebgate3.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=4062924610+1+0+0&WAISaction=retrieve [accessed March 11, 2004].

FDA. 1994b. Studies in Support of Special Populations: Geriatrics [ICH E7]. Rockville, MD: FDA. [Online]. Available: http://www.fda.gov/cder/guidance/iche7.pdf [accessed March 11, 2004].

FDA. 1996a. E6 Good Clinical Practice: Consolidated Guidance. Rockville, MD: FDA. [Online]. Available: http://www.fda.gov/cder/guidance/959fnl.pdf [accessed March 11, 2004].

FDA. 1996b. Protection of human subjects. Informed consent. Federal Register 61:51498.

FDA. 1997. International conference on harmonisation: Good clinical practice: Consolidated guideline; Availability, Part II. Federal Register 62:25692–25709.

FDA. 1998a. Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update: Continuing Review after Study Approval. Rockville, MD: FDA. [Online]. Available: http://www.fda.gov/oc/ohrt/irbs/review.html [accessed March 11, 2004].

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

FDA. 1998b. Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update: Cooperative Research. Rockville, MD: FDA. [Online]. Available: http://www.fda.gov/oc/ohrt/irbs/research.html [accessed March 11, 2004].

FDA. 1998c. Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update: Non-Local IRB Review. Rockville, MD: FDA. [Online]. Available: http://www.fda.gov/oc/ohrt/irbs/nonlocalreview.html [accessed March 11, 2004].

FDA. 1998d. Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update: Payment to Research Subjects. Rockville, MD: FDA. [Online]. Available: http://www.fda.gov/oc/ohrt/irbs/toc4.html#payment [accessed March 11, 2004].

FDA. 1998e. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients; final rule. Federal Register 63:66631–66672. [Online]. Available: http://www.fda.gov/ohrms/dockets/ac/03/briefing/3927B1_05_1998%20Pediatric%20Rule.pdf [accessed March 11, 2004].

FDA. 2000a. Draft guidance for institutional review boards, clinical investigators, and sponsors: Exception from informed consent requirements for emergency research. Federal Register 65:16923. [Online]. Available: http://www.fda.gov/ora/compliance_ref/bimo/emrfinal.pdf [accessed March 11, 2004].

FDA. 2000b. E11 Clinical Investigation of Medicinal Products in the Pediatric Population. Rockville, MD: FDA. [Online]. Available: http://www.fda.gov/cber/gdlns/ichclinped.pdf [accessed March 11, 2004].

FDA. 2000c (March 7). New Initiatives to Protect Participants in Gene Therapy Trials. [Online]. Available: http://www.fda.gov/bbs/topics/NEWS/NEW00717.html [accessed March 11, 2004].

FDA. 2001a. Acceptance of Foreign Clinical Studies. Rockville, MD: FDA. [Online]. Available: http://www.fda.gov/cder/guidance/fstud.pdf [accessed March 11, 2004].

FDA. 2001b. Additional safeguards for children in clinical investigations of FDA-regulated products. Federal Register 66:20589-20600. [Online]. Available: http://www.fda.gov/OHRMS/DOCKETS/98fr/042401a.htm [accessed March 11, 2004].

FDA. 2001c. Draft Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees. Rockville, MD: FDA. [Online]. Available: http://www.fda.gov/cber/gdlns/clindatmon.pdf [accessed March 11, 2004].

FDA. 2001d. E10 Choice of Control Group and Related Issues in Clinical Trials. Rockville, MD: FDA. [Online]. Available: http://www.fda.gov/cder/guidance/4155fnl.pdf [accessed March 11, 2004].

FDA. 2002a (August 5). FDA Backgrounder: Milestones in U.S. Food and Drug Law History. [Online]. Available: http://www.fda.gov/opacom/backgrounders/miles.html [accessed March 11, 2004].

FDA. 2002b. Institutional review boards: Requiring sponsors and investigators to inform IRBs of any prior IRB reviews (proposed rules). Federal Register 67:10115–10116. [Online]. Available: http://www.fda.gov/OHRMS/DOCKETS/98fr/030602a.pdf [accessed March 11, 2004].

FDA. 2003a. Draft financial relationships and interests in research involving human subjects: Guidance for human subject protection. Federal Register 68:15456–15460.

FDA. 2003b. Draft Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices. Rockville, MD: FDA. [Online]. Available: http://www.fda.gov/cdrh/mdufma/guidance/1220.pdf [accessed March 11, 2004].

FDA. 2003c. Questions and Answers on Paxil (Paroxentine Hydrochloride). [Online]. Available: http://www.fda.gov/cder/drug/infopage/paxil/paxilQ&A.htm#q3 [accessed March 11, 2004].

FDA. 2004 (February 6). Pediatric Rule Labeling Changes. [Online]. Available: http://www.fda.gov/cder/pediatric/labelchange.htm [accessed March 11, 2004].

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Findling RL, McNamara NK, Gracious BL. 2000. Paediatric uses of atypical antipsychotics. Expert Opinion on Pharmacotherapy 1:935–945.

Fisher CB. 2003. A goodness-of-fit ethic for child assent to non-beneficial research. American Journal of Bioethics 3(4):27–28.

Fisher CB, Hoagwood K, Boyce C, Duster T, Frank DA, Grisso T, Levine RJ, Macklin R, Spencer MB, Takanishi R, Trimble JE, Zayas LH. 2002. Research ethics for mental health science involving ethnic minority children and youths. American Psychologist 57(12):1024–1040.

Flegel KM. 1997. Physicians, finder’s fees and free, informed consent. Canadian Medical Association Journal 157(10):1373–1374.

FOPO (Federation of Pediatric Organizations). 1991. Statement on pediatric fellowship training. Pediatrics 87(2):265.

Forrow L, Taylor WC, Arnold RM. 1992. Absolutely relative: How research results are summarized can affect treatment decisions. American Journal of Medicine 92:121–124.

Frankenburg WK, Dodds J, Archer P, Shapiro H, Bresnick B. 1992. The Denver II: A major revision and restandardization of the Denver Developmental Screening Test. Pediatrics 89(1):91–97.

Freedman B. 1987. Equipoise and the ethics of clinical research. New England Journal of Medicine 317(3):141–145.

Freedman B, Weijer C, Glass KC. 1996. Placebo orthodoxy in clinical research, I: Empirical and methodological myths. Journal of Law, Medicine & Ethics 24(3):243–251.

Freiman JA, Chalmers TC, Smith H, Kuebler RR. 1986. The importance of beta, the type II error, and sample size in the design and interpretation of the randomized controlled trial: Survey of 71 “negative” trials. In: Bailar JCI, Mosteller F, eds. Medical Uses of Statistics. Boston, MA: New England Journal of Medicine Books. Pp. 357–374.

Fuchs HJ, Borowitz DS, Christiansen DH, Morris EM, Nash ML, Ramsey BW, Rosenstein BJ, Smith AL, Wohl ME, for the Pulmozyme Study Group. 1994. Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. New England Journal of Medicine 331(10): 637–642.


Gallin JI, Alling DW, Malech HL, Wesley R, Koziol D, Marciano B, Eisenstein EM, Turner ML, DeCarlo ES, Starling JM, Holland SM. 2003. Intraconazole to prevent fungal infections in chronic granulomatous disease. New England Journal of Medicine 348(24): 2416–2422.

Gallo AM. 2003. The fifth vital sign: Implementation of the Neonatal Infant Pain Scale. The Journal of Obstetrics and Gynecology Neonatal Nursing 32(3):199–206.

GAO (General Accounting Office). 1996. Scientific Research: Continued Vigilance Critical to Protecting Human Subjects. Washington, DC: GAO. [Online]. Available: http://frwebgate.access.gpo.gov/cgi-bin/useftp.cgi?IPaddress=162.140.64.21&filename=he96072.pdf&directory=/diskb/wais/data/gao [accessed March 11, 2004].

GAO. 2001. Biomedical Research: HHS Direction Needed to Address Financial Conflicts of Interest. Report to the Ranking Minority Member, Subcommittee on Public Health, Committee on Health, Education, Labor, and Pensions, U.S. Senate. [Online]. Available: http://www.gao.gov/new.items/d0289.pdf [accessed March 11, 2004].

GAO. 2003. Pediatric Drug Research. Food and Drug Administration Should More Efficiently Monitor Inclusion of Minority Children. Report to the Committee on Health, Education, Labor, and Pensions, U.S. Senate, and the Committee on Energy and Commerce, House of Representatives. Washington, DC: GAO.

Gappa M, Ranganathan SC, Stocks J. 2001. Lung function testing in infants with cystic fibrosis: Lessons from the past and future directions. Pediatric Pulmonology 32(3):228–245.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Garrison EG. 1991. Children’s competence to participate in divorce custody decisionmaking. Journal of Clinical Child Psychology 20(1):78–87.

Gee L, Abbott SP, Conway JP, Etherington C, Webb AK. 2000. Development of a disease specific health related quality of life measure for adults and adolescents with cystic fibrosis. Thorax 55(11):946–954.

Geller G, Tambor ES, Bernhardt BA, Fraser G, Wissow LS. 2003. Informed consent for enrolling minors in genetic susceptibility research: A qualitative study of at-risk children’s and parents’ views about children’s role in decision-making. Journal of Adolescent Health 32(4):260–271.

Gerteis M, Edgman-Levitan S, Daley J, Delbanco TL, eds. 1993. Through the Patient’s Eyes: Understanding and Promoting Patient-Centered Care. San Francisco, CA: Jossey-Bass.

Gibson RL, Emerson J, McNamara S, Burns J, Rosenfeld M, Yunker A, Hamblett N, Accurso F, Dovey M, Hiatt P, Konstan MW, Moss R, Retsch-Bogart G, Wagener J, Waltz D, Wilmott R, Zeitlin PL, Ramsey B, Cystic Fibrosis Therapeutics Development Network Study Group. 2003. Significant microbiological effect of inhaled tobramycin in young children with cystic fibrosis. American Journal of Respiratory Critical Care Medicine 67(6):841–849.

Gigerenzer G. 1996. The psychology of good judgment: Frequency formats and simple algorithms. Journal of Medical Decision Making 16(3):273–280.

Gilman JT, Gal P. 1992. Pharmacokinetic and pharmacodynamic data collection in children and neonates. Clinical Pharmacokinetics 23(1):1–9.

Glantz LH. 1992. Influence of the Nuremberg Code on U.S. Statutes. In: Annas GL, Grodin MA, eds. The Nazi Doctors and the Nuremburg Code: Human Rights in Human Experimentation. New York, NY: Oxford University Press.

Glantz LH. 1994. The law of human experimentation with children. In: Grodin M, Glantz L, eds. Children as Research Subjects: Science, Ethics, and Law. New York, NY: Oxford University Press.

Goldby S. 1971. Experiments at the Willowbrook state school. Lancet 297(7702):749.

Goldman L. 1971. Was Dr. Krugman justified in giving children hepatitis? Medical World News 15:20–31.

Goldman L. 1973. The Willowbrook debate: Concluded? World Medicine 9(2):79–90.

Goldner JA. 2000. Dealing with conflicts of interest in biomedical research: IRB oversight as the next best solution to the abolitionist approach. Journal of Law, Medicine & Ethics 28(4):379–404.

Goldstein AO, Frasier P, Curtis P, Reid A, Kreher NE. 1996. Consent form readability in university-sponsored research. Journal of Family Practice 42(6):606–611.

Good WV. 2001. Cataract surgery in young children. British Journal of Ophthalmology 85(3):254.

Goodman LS, Gilman AG, Limbird LE, Hardman JG, eds. 2001. Goodman & Gilman’s the Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill Professional.

Goold G, ed. 1923. Hippocrates. Epidemics I, section XI . In: Hippocrates, Volume 1. W.H.S. Jones translation. Cambridge, MA: Harvard University Press. P. 165.

Goss CH, Mayer-Hamblett N, Kronmal RA, Ramsey BW. 2002. The Cystic Fibrosis Therapeutics Development Network (CFTDN): A paradigm of a clinical trials network for genetic and orphan diseases. Advanced Drug Delivery Reviews 54(11):1505–1528.

Grisso T, Vierling L. 1978. Minors’ consent to treatment: A developmental perspective. Professional Psychology 9:412–426.

Grodin MA. 1992. Historical origins of the Nuremberg Code. In: Annas GJ, Grodin MA, eds. The Nazi Doctors and the Nuremburg Code: Human Rights in Human Experimentation. New York, NY: Oxford University Press.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Grodin MA, Glantz LH. 1994. Children as Research Subjects: Science, Ethics and Law. New York, NY: Oxford University Press.

Grossman SA, Piantadosi S, Covahey C. 1994. Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? Journal of Clinical Oncology 12(10):2211–2215.

Grunbaum JA, LaBarthe D, Ayars C, Harrist R, Nichaman MZ. 1996. Recruitment and enrollment for Project Heartbeat: Achieving the goals of minority inclusion. Ethnicity and Disease 6:203–212.


Halim NS. 2000. Gene therapy institute faces uphill battle: Investigations may lead to better gene therapy trials. The Scientist 14(3):1.

Halpern-Felsher BL, Cauffman E. 2001. Costs and benefits of a decision: Decision-making competence in adolescents and adults. Journal of Applied Developmental Psychology 22:257–273.

Halsey NA. 2002. Letter to Office for Human Research Protections re: a multicenter, randomizes dose response study of the safety clinical and immune responses of Dryvax administered to children 2 to 5 years of age. [Online]. Available: http://ohrp.osophs.dhhs.gov/dpanel/halsey.pdf [accessed March 11, 2004].

Hammerschmidt DE. 2002 (October). Letter to the Office for Human Research Protections re: a multicenter, randomizes dose response study of the safety clinical and immune responses of Dryvax administered to children 2 to 5 years of age. [Online]. Available: http://ohrp.osophs.dhhs.gov/dpanel/hammerschmidt.pdf [accessed March 11, 2004].

Hammerschmidt DE, Keane MA. 1992. Institutional review board (IRB) review lacks impact on the readability of consent forms for research. American Journal of the Medical Sciences 304(6):348–351.

Hanif M, Mobarak MR, Ronan A, Rahman D, Donovan Jr JJ, Bennish ML. 1995. Fatal renal failure caused by diethylene glycol in paracetamol elixir: The Bangladesh epidemic. British Medical Journal 311(6997):88–91.

Harmon WE. 2003 (July 9). Statement on behalf of the American Society of Transplantation, Children’s Hospital Boston, and the North American Pediatric Renal Transplant Cooperative Study to the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine.

Harth SC, Thong YH. 1995. Parental perceptions and attitudes about informed consent in clinical research involving children. Social Science and Medicine 41(12):1647–1651.

Hayman RM, Taylor BJ, Peart NS, Galland BC, Sayers RM. 2001. Participation in research: Informed consent, motivation and influence. Journal of Paediatrics and Child Health 37(1):51–54.

Heinrich J. 2001. Human Subjects Research: HHS Takes Steps to Strengthen Protections, But Concerns Remain. Hearing before the Senate Committee on Health, Education, Labor, and Pensions, Subcommittee on Public Health. Washington, DC: Government Accounting Office. [Online]. Available: http://www.gao.gov/new.items/d01775t.pdf [accessed March 11, 2004].

Heller J. 1972. Syphilis victims in the U.S. study went untreated for 40 Years. New York Times. P. A8.

Henry B, Grosskopf C, Aussage P, de Fontbrune S, Goehrs J, the French CFQOL Study Group. 1997. Measuring quality of life in children with cystic fibrosis: The cystic fibrosis questionnaires. Pediatric Pulmonolgy 14:331.

Hillabrant W. 2002. Research in Indian country: Challenges and changes. Paper presented at the Symposium on Research and Evaluation Methodology. In: Davis J, Erickson J, Johnson S, Marshall C, Running Wolf P, Santiago R, eds. Work Group on American Indian Research and Program Evaluation Methodology (AIRPEM), Symposium on Research and Evaluation Methodology: Lifespan Issues Related to American Indians/Alaska

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Natives With Disabilities. Flagstaff: Northern Arizona University, Institute for Human Development, Arizona University Center on Disabilities, American Indian Rehabilitation Research and Training Cent|er. Pp. 19–31. [Online]. Available: http://www.nau.edu/~ihd/airrtc/pdfs/monograph.pdf [accessed March 11, 2004].

Hilts PJ. 2003. Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation. New York, NY: Alfred A. Knopf.

Hinds PS, Birenbaum LK, Clarke-Steffen L, Quargnenti A, Kreissman S, Kazak A, Meyer W, Mulhern R, Pratt C, Wilimas J. 1996. Coming to terms: Parents’ response to a first cancer recurrence in their child. Nursing Research 45(3):148-153.

Hirshon JM, Krugman SD, Witting MD, Furuno JP, Limcangco MR, Perisse AR, Rasch EK. 2002. Variability in institutional review board assessment of minimal-risk research. Academic Emergency Medicine 9(12):1417–1420.

Hockenberry-Eaton M, Barrera P, Brown M, Bottomley SJ, O’Neill JB. 1999. Pain Management in Children with Cancer. Houston, TX: Texas Cancer Council. [Online]. Available: http://www.childcancerpain.org/contents/childpainmgmt.pdf [accessed March 11, 2004].

Hoffman ML. 1990. Empathy and justice motivation. Motivation & Emotion 14:151–172.

Hohmann E. No date. What Does the IRB Really Want? Part 2. Inservices Given by the PHRC and HRO Staff: Partners Human Research Committee. [Online]. Available: http://healthcare.partners.org/hrcedweb/inserv.htm [accessed March 11, 2004].

Hopper KD, TenHave TR, Hartzel J. 1995. Informed consent forms for clinical and research imaging procedures: How much do patients understand? American Journal of Roentgenology 164(2):493–496.

Hopper KD, TenHave TR, Tully DA, Hall TE. 1998. The readability of currently used surgical/procedure consent forms in the United States. Surgery 123(5):496–503.

Hoppu K, Koskimies O, Holmberg C, Hirvisalo E. 1991. Pharmacokinetically determined cyclosporine dosage in young children. Pediatric Nephrology 5(1):1–4.

Hurley JC, Underwood MK. 2002. Children’s understanding of their research rights before and after debriefing: Informed assent, confidentiality, and stopping participation. Child Development 73(1):132–143.

Hutchison C. 1998. Phase I trials in cancer patients: Participants’ perceptions. European Journal of Cancer Care 7(1):15–22.


ICH (International Conference on Harmonisation). 1996. Guideline for Good Clinical Practice: E6. Geneva, Switzerland: ICH. [Online]. Available: http://www.ich.org/MediaServer.jser?@_ID=487&@_TYPE=MULTIMEDIA&@_TEMPLATE=616&@_MODE=GLB [accessed March 11, 2004].

ICH. 2000a. Choice of Control Group and Related Issues in Clinical Trials: E10. Geneva, Switzerland: ICH. [Online]. Available: http://www.ich.org/MediaServer.jser?@_ID=486&@_TYPE=MULTIMEDIA&@_TEMPLATE=616&@_MODE=GLB [accessed March 11, 2004].

ICH. 2000b. Clinical Investigation of Medicinal Products in the Pediatric Population: E11. Geneva, Switzerland: ICH. [Online]. Available: http://www.ich.org/MediaServer.jser?@_ID=487&@_TYPE=MULTIMEDIA&@_TEMPLATE=616&@_MODE=GLB [accessed March 11, 2004].

IHS (Indian Health Services). 2002 (February 19). Indian Health Service Research Program: Area/Tribal IRB Chair. [Online]. Available: http://www.ihs.gov/MedicalPrograms/Research/areairb.htm [accessed March 11, 2004].

Ingelfinger FJ. 1973. Ethics of experiments on children. New England Journal of Medicine 288(15):791–792.

Inhelder B, Piaget J. 1958. The Growth of Logical Thinking from Childhood to Adolescence. New York, NY: Basic Books.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

IOM (Institute of Medicine). 1989. The Responsible Conduct of Research in the Health Sciences . Washington, DC: National Academy Press.

IOM. 1990. Clinical Practice Guidelines: Directions for a New Program. Washington, DC: National Academy Press.

IOM. 1994a. Careers in Clinical Research: Obstacles and Opportunities. Washington, DC: National Academy Press.

IOM. 1994b. Justice in Clinical Studies: Guiding Principles. In: Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Vol. I. Washington, DC: National Academy Press.

IOM. 2000a. Protecting Data Privacy in Health Services Research: Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection. Washington, DC: National Academy Press.

IOM. 2000b. Rational Therapeutics for Infants and Children: Workshop Summary. Washington, DC: National Academy Press.

IOM. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: National Academy Press.

IOM. 2003a. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press.

IOM. 2003b. When Children Die: Improving Palliative and End-of-Life Care for Children and Their Families. Washington, DC: The National Academies Press.

IOM/NRC (National Research Council). 2002. Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct. Washington, DC: National Academy Press.

IRBnet. 2003. About the IRBnet. [Online]. Available: https://www.irbnet.org/beta/public/about.jsp [accessed March 11, 2004].

Iyasu S. 2003. One Year Post-Pediatric Exclusivity Postmarketing Adverse Event Review SERTRALINE (Zoloft). Presentation to the Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee, Gaithersburg, MD. Food and Drug Administration. [Online]. Available: http://www.fda.gov/cder/pediatric/presentation/ac6-03si/ped_files/frame.htm [accessed March 11, 2004].


James S, Lanman JT. 1976. History of oxygen therapy and retrolental fibroplasia. Prepared by the American Academy of Pediatrics, Committee on Fetus and Newborn with the collaboration of special consultants. Pediatrics 57(Suppl 2):591–642.

Janner M, Knill SE, Diem P, Zuppinger KA, Mullis PE. 1994. Persistent microalbuminuria in adolescents with type I (insulin-dependent) diabetes mellitus is associated to early rather than late puberty. Results of a prospective longitudinal study. European Journal of Pediatrics 153(6):403–408.

Janofsky J, Starfield B. 1981. Assessment of risk in research on children. Journal of Pediatrics 98(5):842–846.

JCAHO (Joint Commission on the Accreditation of Healthcare Organizations). 2003. Root Cause Analysis in Health Care. 2nd ed. Oak Brook Terrace, IL: Joint Commission Resources.

Jobe AH. 1993. Pulmonary surfactant therapy. New England Journal of Medicine 328:861–868.

Johnson BH, Jeppson ES, Redburn L. 1992. Caring for Children and Families. Guidelines for Hospitals. Bethesda, MD: Association for the Care of Children’s Health.

Jones JH. 1992. Bad Blood: The Tuskegee Experiment. New York, NY: Free Press.

Jonsen AR. 1998a. The Birth of Bioethics. New York, NY: Oxford University Press.

Jonsen, AR. 1998b (July 14). The Birth of the Belmont Report. Presentation at the National Bioethics Advisory Committee meeting, Portland, OR. NBAC. [Online]. Available: http://www.georgetown.edu/research/nrcbl/nbac/transcripts/jul98/belmont.html [accessed March 11, 2004].

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Jonsen AR, Siegler M, Winslade WJ. 1998. Clinical Ethics: A Practical Approach to Ethical Decisions in Clinical Medicine. 4th ed. New York, NY: McGraw-Hill Companies.


Kaitin KI, ed. 2003. Post-approval R&D raises total drug development costs to $897 million. Tufts Center for the Study of Drug Development Impact Report 2003 5(3). [Online]. Available: http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=29 [accessed March 11, 2004].

Karlawish JHT, Lantos J. 1997. Community equipoise and the architecture of clinical research. Cambridge Quarterly of Healthcare Ethics 6:385–396.

Kaser-Boyd N, Adelman HS, Turner L. 1985. Minor’s ability to identify risks and benefits of therapy. Professional Psychology: Research and Practice 16(3):411–417.

Kearns GL, Winter HS. 2003. Proton pump inhibitors in pediatrics: Relevant pharmacokinetic and pharmacodynamics. Journal of Pediatric Gastroenterology and Nutrition 37(Supp 1):S52–S59.

Kerem E, Reisman J, Corey M, Canny GJ, Levison H. 1992. Prediction of mortality in patients with cystic fibrosis. New England Journal of Medicine 326(18):1187–1191.

King NMP. 2000. Defining and describing benefit appropriately in clinical trials. The Journal of Law, Medicine & Ethics. 28(4):332–343.

Kirsch I, Jungeblut A, Jenkins L, Kolstad A. 1993. Adult Literacy in America: A First Look at the Results of the National Adult Literacy Survey. Washington, DC: U.S. Department of Education.

Klaczynski PA, Gordon DH. 1996. Everyday statistical reasoning during adolescence and young adulthood: Motivational, general ability, and developmental influences. Child Development 67(6):2873–2891.

Klaczynski PA, Narasimham G. 1998. Development of scientific reasoning biases: Cognitive versus ego-protective explanations. Developmental Psychology 43(1):175–187.

Klaczynski PA, Robinson B. 2000. Personal theories, intellectual ability, and epistemological beliefs: Adult age differences in everyday reasoning biases. Psychology and Aging 15(3): 400–416.

Kodish E. 2003a. Assent and Informed Parental Permission: Insights from the PIC. Presentation to the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine.

Kodish E. 2003b. Informed consent for pediatric research: Is it really possible? Journal of Pediatrics 142(2):89–90.

Kodish E. 2003c. Pediatric ethics and early-phase childhood cancer research: Conflicted goals and the prospect of benefit. Accountability in Research 10:17–25.

Kodish E, Pentz RD, Noll RB, Ruccione K, Buckley J, Lange BL. 1998. Informed consent in the Children Cancer Group: Results of preliminary research. Cancer 82(12):2467–2481.

Kodish E, Eder M, Noll RB, Ruccione K, Lange B, Angiolillo A, Pentz R, Zyzanski S, Siminoff LA, Drotar D. 2004. Communication of randomization in childhood leukemia trials. Journal of the American Medical Association 291(4):470–475.

Kopelman LM. 1989. When is the risk minimal enough for children to be research subjects? In: Kopelman L, Moskop J, eds. Children and Health Care: Moral and Social Issues. Moskop, Dordrecht, The Netherlands: Kluwer Academic Publishers. Pp. 89–99.

Kopelman LM. 2000. Children as research subjects: A dilemma. The Journal of Medicine and Philosophy 25(6):745–764.

Kopelman LM. In press. Minimal risk as an international ethical standard in research. The Journal of Medicine and Philosophy.

Kopelman LM, Murphy TF. In press. Ethical concerns about federal approval of risky pediatrics studies. Pediatrics.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Koski G. 2000 (December 4). Letter to OHRP Staff re: Compliance Oversight Procedures. [Online]. Available: http://ohrp.osophs.dhhs.gov/references/ohrpcomp.pdf [accessed March 11, 2004].

Koski G. 2001 (May 2). Biomedical Research Progress: In Whose Interest? Presentation at the Institute of Medicine Southern California Regional Meeting, University of Southern California Keck School of Medicine. Los Angeles: Institute of Medicine. Quoted in: Oliwenstein L. 2002. Media, public scrutinize clinical trials. HSC Weekly 8(13):1.

Koski G. 2002 (October 9). Letter to Honorable Tommy Thompson Secretary, United States Department of Health and Human Services. [Online]. Available: http://irb.mc.duke.edu/PDF/koskiLetter.pdf [accessed March 11, 2004].

Kowaleski J. 1997. State Definitions and Reporting Requirements for Live Births, Fetal Deaths, and Induced Terminations of Pregnancy (1997 Revision). Hyattsville, MD: National Center for Health Statistics. [Online]. Available: http://www.cdc.gov/nchs/data/itop97.pdf [accessed March 11, 2004].

Krechel SW, Bildner J. 1995. CRIES: A new neonatal postoperative pain measurement score. Initial testing of validity and reliability. Paediatric Anaesthesia 5(1):53–61.

Krugman S, Shapiro S. 1971. Letters to the Editor: Experiments at the Willowbrook State School. Lancet 297(7706):966–967.

Kupst MJ, Patenaude AF, Walco GA, Sterling C. 2003. Clinical trials in pediatric cancer: Parental perspectives on informed consent. Journal of Pediatric Hematology/Oncology 25(10):787–790.


Lambert GH, Kotake AN, Schoeller D. 1983. The CO2 breath tests as monitors of the cytochrome P450 dependent mixed function monooxygenase system. Progress in Clinical and Biological Research 135:119–145.

Lambert GH, Schoeller DA, Kotake AN, Flores C, Hay D. 1986. The effect of age, gender, and sexual maturation on the caffeine breath test. Developmental Pharmacology and Therapeutics 9(6):375–388.

Langley JM, Halperin SA, Mills EL, Eastwood B. 1998. Parental willingness to enter a child in a controlled vaccine trial. Medecine Clinique et Experimentale (Clinical and Investigative Medicine) 21(1):12–16.

Lasagna L. 1994. Interview by Susan White-Junod and Jon Harkness (ACHRE), Transcript of Audio Recording (ACHRE Research Project Series, Interview Program Files, Ethics Oral History Project). Pp. 37–38. [Online]. Available: http://tis.eh.doe.gov/ohre/roadmap/achre/chap3_fn.html [accessed March 11, 2004].

Lascari AD. 1981. Editorial: Risk of research in children. Journal of Pediatrics 98:759–760.

Le Guennec JC, Billon B. 1987. Delay in caffeine elimination in breast-fed infants. Pediatrics 79(2):264–268.

Lederer SE. 1992. Orphans as guinea pigs: American children and medical experimenters, 1890-1930 . In: Cooter R, ed. The Name of the Child: Health and Welfare, 1880-1940. London: Routledge. Pp. 96–123.

Lederer SE. 1995. Subjected to Science: Human Experimentation in America Before the Second World War. Baltimore, MD: Johns Hopkins University Press.

Lederer SE, Grodin MA. 1994. Historical overview: Pediatric experimentation. In: Grodin MA, Glantz LH, eds. Children as Research Subjects: Science, Ethics and Law. New York, NY: Oxford University Press.

Leiken S. 1993. The role of adolescents in decisions concerning their cancer treatment. Cancer Supplement 71(10):3342–3346.

Lepay D. 2003 (January 9). Overview of FDA Research Ethics Compliance Activities and Data Resources. Presentation to the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Levi R, Marsick R, Drotar D, Kodish E. 2000. Diagnosis, disclosure, and informed consent: Learning from parents of children with cancer. Journal of Pediatric Hematology and Oncology 22(1):3–12.

Levine RJ. 1999. The need to revise the Declaration of Helsinki. New England Journal of Medicine 341(7):531–534.

Levinsky N. 2002. Nonfinancial conflicts of interest in research. New England Journal of Medicine 347(10):759–761.

Lewis CC. 1981. How adolescents approach decisions: Changes over grades seven to twelve and policy implications. Child Development 52:538–544.

Lewis CE, Lewis MA, Ifekwunigue M. 1978. Informed consent by children and participation in an influenza trial. American Journal of Public Health 68(11):1079–1082.

Lidz CW, Appelbaum PS. 2002. The therapeutic misconception: Problems and solutions. Medical Care 40(9):V55–V63.

Lilly J. 2003 (July 11). Testimony before the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine.

Lilly MT. 2000 (February 29). Statement at Congressional Policy Briefing on Quality Cancer Care, Washington, DC. American Society for Clinical Oncology. [Online]. Available: http://www.asco.org/ac/1,1003,_12-002166-00_18-0010746-00_19001074900_20002,00.asp?ArticleId=10746&ArticleBodyId=10749&ShowHead=&PageNo=1&cancer_type_id=&state= [accessed March 11, 2004].

Liou TG, Adler FR, Fitzsimmons SC, Cahill BC, Hibbs JR, Marshall BC. 2001. Predictive 5-year survivorship model of cystic fibrosis. American Journal of Epidemiology 153(4): 345–352.

Lippincott S. 2003 (July 11). Testimony before the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine.

Liu L, Krailo M, Reaman GH, Bernstein L, Surveillance, Epidemiology and End Results Childhood Cancer Linkage Group. 2003. Childhood cancer patients’ access to cooperative group cancer programs: A population-based study. Cancer 97(5):1339–1345.

Llewellyn-Thomas HA, McGreal MJ, Thiel EC. 1995. Cancer patients’ decision making and trial-entry preferences: The effects of “framing” information about short-term toxicity and long-term survival. Medical Decision Making 15(1):4–12.

Lo B, Wolf LE, Berkeley A. 2000. Conflict-of-interest policies for investigators in clinical trials. New England Journal of Medicine 343(22):1616–1620.

Lowen R. 1995. Letter to ACHRE (Advisory Committee on Human Radiation Experiments) re: Discussion of the Ethics of Human Experimentation in the Medical and Scientific Literature. [Online]. Available: http://www.gwu.edu/~nsarchiv/radiation/dir/mstreet/commeet/meet13/brief13/tab_d/br13d3a.txt [accessed March 11, 2004].

Ludmerer KM. 1999. Instilling professionalism in medical education. Journal of the American Medical Association 282(9):881–882.

Lysaught MT. 1998. Commentary: Reconstruing genetic research as research. Journal of Law, Medicine and Ethics 26(1):48–54, 4.


Madsen SM, Holm S, Davidsen B, Munkholm P, Schlichting P, Riis P. 2000. Ethical aspects of clinical trials: The attitudes of participants in two non-cancer trials. Journal of Internal Medicine 248(6):463–474.

Malenka DJ, Baron JA, Johansen S, Wahrenberger JW, Ross JM. 1993. The framing effect of relative and absolute risk. Journal of General Internal Medicine 8(10):543–548.

Mammel KA, Kaplan DW. 1995. Research consent by adolescent minors and institutional review boards. Journal of Adolescent Health 17(5):323–330.

Man-Son-Hing M, O’Connor AM, Drake E, Biggs J, Hum V, Laupacis A. 2002. The effect of qualitative vs. quantitative presentation of probability estimates on patient decisionmaking: A randomized trial. Health Expectations 5(3):246–255.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Mann H, Djulbegovic B. 2003. Choosing a control intervention for a randomised clinical trial. BMC Medical Research Methodology 3(1):7–11.

Manworren RCB, Hynan LS. 2003. Clinical validation of FLACC: Preverbal patient pain scale. Pediatric Nursing 29(2):140–146.

Marshall MF. 2001 (August 13). Letter to Food and Drug Administration re: Comment on: Docket 00N-0074 April 24, 2001. Interim Rule: Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products. [Online]. Available: http://ohrp.osophs.dhhs.gov/nhrpac/mtg07-01/fda.pdf [accessed March 11, 2004].

Martin JA, Hamilton BE, Ventura SJ, Menacker F, Park MM, Sutton PD. 2002. Births: Final data for 2001. National Vital Statistics Report 51(2):1–3. [Online]. Available: http://www.cdc.gov/nchs/data/nvsr/nvsr51/nvsr51_02.pdf [accessed March 11, 2004].

Mason SA, Allmark PJ. 2000. Obtaining informed consent to neonatal randomized controlled trials: Interviews with parents and clinicians in the Euricon study. Lancet 356(9247): 2045–2051.

Mattson ME, Curb JD, McArdle R. 1985. Participation in a clinical trial: The patients’ point of view. Control Clinical Trials 6(2):156–167.

Mazur DJ, Hickam DH. 1991. Patients’ interpretations of probability terms. Journal of General Internal Medicine 6(3):237–240.

Mazur DJ, Merz JF. 1994. Patients’ interpretations of verbal expressions of probability: Implications for securing informed consent to medical interventions. Behavioral Sciences and the Law 12(4):417–426.

McGettigan P, Sly K, O’Connell D, Hill S, Henry D. 1999. The effects of information framing on the practices of physicians. Journal of General Internal Medicine 14(10):633–642.

McGrath P. 2002. Beginning treatment for childhood acute lymphoblastic leukemia: Insights from the parents’ perspective. Oncology Nursing Forum 29(6):988–996.

MCHB (Maternal and Child Health Bureau). 2003 (December). Strategic Plan: FY 2003-2007. [Online]. Available: http://mchb.hrsa.gov/about/stratplan03-07.htm [accessed January 27, 2004].

McIntyre MO. 2002 (September 10). Promise you’ll tell me if it will hurt: A 7-year-old patient offers some rules for the grown-ups who work in hospitals. Washington Post. P. HE7.

McNeilly PJ. 2001 (October 3). Letter to Vice Dean for Research, Johns Hopkins University re: Human research subject protection under multiple project assurance. [Online]. Available: http://ohrp.osophs.dhhs.gov/detrm_letrs/oct01a.pdf [accessed March 11, 2004].

McWilliams R, Hoover-Fong J, Hamosh A, Beck S, Beaty T, Cutting G. 2003. Problematic variation in local institutional review of a multicenter genetic epidemiology study. Journal of the American Medical Association 290(3):360–366.

Meadows M. 2003. Drug research and children. FDA Consumer Magazine 37(12-17). [Online]. Available: http://www.fda.gov/fdac/features/2003/103_drugs.html [accessed January 27, 2004].

Meropol NJ, Weinfurt KP, Burnett CB, Balshem A, Benson AB III, Castel L, Corbett S, Diefenbach M, Gaskin D, Li Y, Manne S, Marshall J, Rowland JH, Slater E, Sulmasy DP, Van Echo D, Washington S, Schulman KA. 2003. Perceptions of patients and physicians regarding phase I cancer clinical trials: Implications for physician-patient communication. Journal of Clinical Oncology 21(13):2589–2596.

Merriam-Webster. 2003. Merriam-Webster’s Collegiate Dictionary. 11th ed. Springfield, MA: Merriam-Webster, Inc.

Miller FG, Brody H. 2002. What makes placebo-controlled trials unethical? American Journal of Bioethics 2(2):3–9.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Millstein SG, Halpern-Felsher BL. 2001. Perceptions of risk and vulnerability in adolescent risk and vulnerability: Concepts and measurement. In: Institute of Medicine, National Research Council, eds. Adolescent Risk and Vulnerability: Concepts and Measurement. Washington, DC: National Academy Press.

Milne C. 2002. How Have Pediatric Clinical Trials Influenced Practice: Past and Future. Presentation at the Pediatric Anesthesiology Meeting, Society for Pediatric Anesthesia and American Academy of Pediatrics. [Online]. Available: http://www.pedsanesthesia.org/meetings/2002winter/syllabus/friday.pdf [accessed March 11, 2004].

Mofenson L. 2000. Perinatal exposure to zidovudine—Benefits and risks. New England Journal of Medicine 343(11):803–805.

Moher D, Dulberg CS, Wells GA. 1994. Statistical power, sample size, and their reporting in randomized controlled trials. Journal of the American Medical Association 272(2):122–124.

Morris AK, Sloutsky VM. 1998. Understanding of logical necessity: Developmental antecedents and cognitive consequences. Child Development 69(3):721–741.


Naar-King S, Ellis DA, Frey MA. 2004. Assessing Children’s Well-Being: A Handbook of Measures. Mahwah, NJ: Erlbaum.

Nahata MC. 1992. Advances in paediatric pharmacotherapy. Journal of Clinical Pharmacy and Therapeutics 17(3):141–146.

Nahata MC. 1999. Lack of pediatric drug formulations. Pediatrics 104(3 Pt 2):607–609.

Nannis ED. 1991. Children’s understanding of their participation in psychological research: Implication for issues of assent consent. Canadian Journal of Behavioural Science 23(2): 133–141.

NAS (National Academy of Sciences). 1992. Responsible Science, Volume I: Ensuring the Integrity of the Research Process. Washington, DC: National Academy Press.

NAS. 1995. On Being a Scientist: Responsible Conduct in Research. 2nd ed. Washington, DC: National Academy Press.

National Commission (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research). 1975. Report and Recommendations: Research on the Fetus. Washington, DC: U.S. Department of Commerce.

National Commission. 1976. Report and Recommendations: Research Involving Prisoners. Washington, DC: U.S. Department of Commerce. [Online]. Available: http://www.reb.ca/assets/documents/NATCOM/doc4.pdf [accessed March 11, 2004].

National Commission. 1977. Report and Recommendations: Research Involving Children. Washington, DC: U.S. Government Printing Office.

National Commission. 1978a. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: U.S. Government Printing Office.

National Commission. 1978b. Research Involving Those Institutionalized As Mentally Infirm: Report and Recommendations. Washington, DC: U.S. Government Printing Office.

NBAC (National Bioethics Advisory Commission). 1998. Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. Bethesda, MD: NBAC. [Online]. Available: http://www.georgetown.edu/research/nrcbl/nbac/capacity/TOC.htm [accessed March 11, 2004].

NBAC. 1999. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance. Bethesda, MD: NBAC.

NBAC. 2001a. Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, Volume I. Bethesda, MD: NBAC. [Online]. Available: http://www.georgetown.edu/research/nrcbl/nbac/clinical/Vol1.pdf [accessed March 11, 2004].

 

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

NBAC. 2001b. Ethical and Policy Issues in Research Involving Human Participants. Bethesda, MD: NBAC. [Online]. Available: http://www.georgetown.edu/research/nrcbl/nbac/human/overvol1.pdf [accessed March 11, 2004].

NCHS (National Center for Human Statistics). 2000. Health, United States, 2000 with Adolescent Health Chartbook. Hyattsville, MD: NCHS. [Online]. Available: http://www.cdc.gov/nchs/data/hus/hus00.pdf [accessed March 11, 2004].

NCI (National Cancer Institute). 1999. Policy of the National Cancer Institute for Data and Safety Monitoring of Clinical Trials. Bethesda, MD: National Institutes of Health. [Online]. Available: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm [accessed March 11, 2004].

NCI. 2001. Simplification of Informed Consent Documents: Recommendations. [Online]. Available: http://www.cancer.gov/clinical_trials/doc_header.aspx?viewid=5fca4dc5-b6a7-4272-be96-b489f23022e5&docid=61f9435e-c529-42fa-81a5-fc6ecd30d42e [accessed March 11, 2004].

NCI. 2002a (July 8). Data and Safety Monitoring Example Plans. [Online]. Available: http://www.cancer.gov/ClinicalTrials/conducting/dsm-example-plans [accessed March 11,2004].

NCI. 2002b (December 18). Facts and Figures About Cancer Clinical Trials. [Online]. Available: http://www.nci.nih.gov/clinicaltrials/facts-and-figures [accessed March 11, 2004].

NCI. 2003. How Does the CIRB Process Work? (Detailed Version). [Online]. Available: http://www.ncicirb.org/CIRB_HowWorks_Detailed.asp [accessed March 11, 2004].

Neergaard L. 2003 (June 19). FDA cites possible suicide link in Paxil. AP Online. [Online]. Available: http://www.intelihealth.com/IH/ihtPrint/EMIHC270/333/21291/365913.html?hide=t&k=basePrint [accessed March 11, 2004].

Nelson EC, Batalden PB, Ryer JC, eds. 1998. Joint Commission Clinical Improvement Action Guide. Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations.

Nelson RM. 1999. Unpublished interview. Supported in part by grant K01 NS02151-06 from the National Institute of Neurological Disorders and Stroke.

Nelson RM. 2002 (June 4). Letter to Food and Drug Administration re: Docket No. 01N-0322. [Online]. Available: http://216.239.41.104/search?q=cache:PrcwZmrrZ0AJ: www.fda.gov/ohrms/dockets/dailys/02/Jun02/060602/01N-0322_emc-000018-01.doc+%22irb+shopping%22+nelson&hl=en&ie=UTF-8 [accessed February 6, 2004].

Nelson RM. 2003. Algorithm for Subpart D Analysis (45 CFR 46 and 21 CFR 50). Presentation to the Pediatric Advisory Subcommittee Meeting on Current Epidemiology and Therapeutic Interventions Relevant to Hyperbilirubinemia in the Term and Near-Term Newborn, Food and Drug Administration. [Online]. Available: http://www.fda.gov/ohrms/dockets/ac/cder03.html#Anti-Infective [accessed March 11, 2004].

NHRPAC (National Human Research Protections Advisory Committee). 2001. Children’s Workgroup Report (Draft). [Online]. Available: http://ohrp.osophs.dhhs.gov/nhrpac/mtg04-01/child-workgroup4-5-01.pdf [accessed March 11, 2004].

NHRPAC. 2002. Clarifying Specific Portion of 45 CFR 46 Subpart D That Governs Children’s Research. [Online]. Available: http://ohrp.osophs.dhhs.gov/nhrpac/documents/nhrpac16.pdf [accessed March 11, 2004].

NICHD (National Institute of Child Health and Human Development). No date. Pediatric AIDS Clinical Trials Group Interview: History/Background. [Online]. Available: http://pactg.s-3.com/pinfo_history.htm [accessed March 11, 2004].

NICHD. 2002. What Does the NICHD Do? [Online]. Available: http://www.nichd.nih.gov/about/nichd_does.cfm [accessed March 11, 2004].

NICHD. 2003 (April 30). Research Panels. [Online]. Available: http://www.nichd.nih.gov/crmc/pp/research_programs.htm [accessed March 11, 2004].

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Nicoletti A. 2003. Teens, confidentiality, and HIPPA. Journal of Pediatric and Adolescent Gynecology 16(2):113–114.

NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases). 2001. Research needs in pediatric kidney disease: 2000 and beyond. Research Updates in Kidney and Urologic Health. [Online]. Available: http://www.niddk.nih.gov/health/kidney/Research_Updates/win00-01/needs.htm [accessed March 11, 2004].

NIH (National Institutes of Health). 1994. NIH Guidelines on the inclusion of women and minorities as subjects in clinical research. Federal Register 59:11146–11151.

NIH. 1998a. NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects, March 6, 1998. Bethesda, MD: NIH. [Online]. Available: http://grants.nih.gov/grants/guide/notice-files/not98-024.html [accessed March 11, 2004].

NIH. 1998b. Policy for Data and Safety Monitoring. Bethesda, MD: NIH. [Online]. Available: http://grants1.nih.gov/grants/guide/notice-files/not98-084.html [accessed January 13, 2004].

NIH. 2000a. Figure 6: NIH-2514-1- Consent to participate in a clinical research study. In: Khuu M, ed. Protomechanics: A Guide to Preparing and Conducting a Clinical Research Study. Bethesda, MD: NIH. [Online]. Available: http://www.cc.nih.gov/ccc/protomechanics/pdfs/figure_6.pdf [accessed March 11, 2004].

NIH. 2000b. Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications. Bethesda, MD: NIH. [Online]. Available: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-031.html [accessed March 11, 2004].

NIH. 2001. NIH Grants Policy Statement (Rev. 03/01). Bethesda, MD: NIH. [Online]. Available: http://grants2.nih.gov/grants/policy/nihgps_2001/nihgps_2001.pdf [accessed March 11, 2004].

NIH. 2002 (July 18). Financial Conflict of Interest: Objectivity in Research. [Online]. Available: http://grants1.nih.gov/grants/policy/coi/nih_review.htm [accessed March 11, 2004].

NIH. 2003a (July 21). Certificates of Confidentiality: Background Information. [Online]. Available: http://grants1.nih.gov/grants/policy/coc/background.htm [accessed March 11, 2004].

NIH. 2003b. Multidisciplinary Clinical Research Career Development Programs. [Online]. Available: http://grants2.nih.gov/grants/guide/rfa-files/RFA-RM-04-006.html [accessed March 11, 2004].

NIH. 2003c. Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule . Bethesda, MD: NIH. [Online]. Available: http://privacyruleandresearch.nih.gov/pdf/HIPAA_Privacy_Rule_Booklet.pdf [accessed March 11, 2004].

NINR (National Institute of Nursing Research). 1993. Priority Expert Panel Report: Vol 5 Health Promotion for Older Children and Adolescents 1993. Bethesda, MD: National Institutes of Health.

Nisbett RE, Fong GT, Lehman DR, Cheng PW. 1987. Teaching reasoning. Science 238:623–631.

NLM (U.S. National Library of Medicine). 2002. Smallpox: A Great and Terrible Scourge. [Online]. Available: http://www.nlm.nih.gov/exhibition/smallpox/sp_vaccination.html [accessed March 11, 2004].

NRC (National Research Council). 2003. Protecting Participants and Facilitating Social and Behavioral Sciences Research. Washington, DC: The National Academies Press.

NRC/IOM (Institute of Medicine). 1999. Forum on adolescence. In: Adolescent Development and the Biology of Puberty: Summary of a Workshop on New Research. Washington, DC: The National Academies Press. [Online]. Available: http://books.nap.edu/catalog/9634.html [accessed March 11, 2004].

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Nuremberg Code: Directives for human experimentation. 1949. In: Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10, Vol. 2. Washington, DC: U.S. Governmental Printing Office. Pp. 181–182. [Online]. Available: http://ohsr.od.nih.gov/nuremberg.php3 [accessed March 11, 2004].


O’Brien KL, Selanikio JD, Hecdivert C, Placide M, Louis M, Barr DB, Barr JR, Hospedales CJ, Lewis MJ, Schwartz B, Philen RM, St. Victor S, Espindola J, Needham LL, Denerville K, for the Acute Renal Failure Investigation Team. 1998. Epidemic of pediatric deaths from acute renal failure caused by diethylene glycol poisoning. Journal of the American Medical Association 279(15):1175–1180.

O’Connor AM, Rostom A, Fiset V, Tetroe J, Entwistle V, Llewellyn-Thomas H, Holmes-Rovner M, Barry M, Jones J. 1999. Decision aids for patients facing health treatment or screening decisions: Systematic review. British Medical Journal 319(7212):731–734.

OCR (Office of Civil Rights). 2000. Policy Guidance on the Title VI Prohibition Against National Origin Discrimination as It Affects Persons with Limited English Proficiency. Washington, DC: U.S. Department of Health and Human Services. [Online]. Available: http://cms.hhs.gov/states/letters/lepguide.pdf [accessed March 11, 2004].

Oglaff FR, Otto RK. 1991. Are research participants truly informed? Readability of informed consent forms used in research. Ethics & Behavior 1(4):239–252.

OHRP (Office for Human Research Protections). 2001. Draft Interim Guidance: Financial Relationships in Clinical Research: Issues for Institutions, Clinical Investigators, and IRBs to Consider When Dealing With Issues or Financial Interest and Human Subject Protection . Washington, DC: U.S. Department of Health and Human Services. [Online]. Available: http://ohrp.osophs.dhhs.gov/humansubjects/finreltn/finguid.htm [accessed March 11, 2004].

OHRP. 2002a. Federalwide Assurance of Protection for Human Subjects. Washington, DC: U.S. Department of Health and Human Services. [Online]. Available: http://ohrp.osophs.dhhs.gov/humansubjects/assurance/filasurt.htm [accessed March 11, 2004].

OHRP. 2002b. Objectives and Overview of the OHRP Quality Improvement Program. Washington, DC: U.S. Department of Health and Human Services. [Online]. Available: http://ohrp.osophs.dhhs.gov/humansubjects/qip/qipdesc.pdf [accessed March 11, 2004].

OHRP. 2002c. OHRP Compliance Activities: Common Findings and Guidance Clickable Index. [Online]. Available: http://ohrp.osophs.dhhs.gov/references/findings.pdf [accessed March 11, 2004].

OHRP. 2002d. Quality Assurance Self-Assessment Tool. [Online]. Available: http://ohrp.osophs.dhhs.gov/humansubjects/qip/qatoold.htm [accessed March 11, 2004].

OHRP. 2003. Amendment of statement of organization functions and delegations of authority for the Office for Human Research Protections. Federal Register 68:60392–60393. [Online]. Available: http://ohrp.osophs.dhhs.gov/references/reorgfr.pdf [accessed March 11, 2004].

OIG (Office of Inspector General). 1998a. Institutional Review Boards: A Time for Reform. Washington, DC: U.S. Department of Health and Human Services. [Online]. Available: http://www.researchroundtable.com/pdfiles/time_reform.pdf [accessed March 11, 2004].

OIG. 1998b. Institutional Review Boards: The Emergence of Independent Boards. Washington, DC: U.S. Department of Health and Human Services. [Online]. Available: http://www.researchroundtable.com/pdfiles/irbemergence.pdf [accessed March 11, 2004].

OIG. 1998c. Institutional Review Boards: Their Role in Reviewing Approved Research. Washington, DC: U.S. Department of Health and Human Services. [Online]. Available: http://oig.hhs.gov/oei/reports/oei-01-97-00190.pdf [accessed March 11, 2004].

OIG. 2000a. Protecting Human Research Subjects: Status of Recommendations. Washington, DC: U.S. Department of Health and Human Services. [Online]. Available: http://www.researchroundtable.com/pdfiles/protecting_human.pdf [accessed March 11, 2004].

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

OIG. 2000b. Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research. Washington, DC: U.S. Department of Health and Human Services. [Online]. Available: http://www.researchroundtable.com/pdfiles/a459.pdf [accessed March 11, 2004].

OIG. 2001. The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects. Washington, DC: U.S. Department of Health and Human Services. [Online]. Available: http://oig.hhs.gov/oei/reports/oei-01-00-00190.pdf [accessed March 11, 2004].

Olechnowicz JQ, Eder M, Simon C, Zyzanski S, Kodish E. 2002. Assent observed: Children’s involvement in leukemia treatment and research discussions. Pediatrics 109(5):806–814.

Ondrusek N, Abramovitch R, Pencharz P, Koren G. 1998. Empirical examination of the ability of children to consent to clinical research. Journal of Medical Ethics (London) 24(3):158–165.

OPRR (Office for Protection from Research Risk). 1993. Protecting Human Research Subjects: Institutional Review Board Guidebook. Washington, DC: U.S. Government Printing Office. [Online]. Available: http://ohrp.osophs.dhhs.gov/irb/irb_chapter3.htm [accessed March 11, 2004].


Paasche-Orlow MK, Taylor HA, Brancati FL. 2003. Readability standards for informed-consent forms as compared with actual readability. New England Journal of Medicine 348(8):721–726.

Pandey SK, Wilson ME, Trivedi RH, Izak AM, Macky TA, Werner LM, Apple DJ. 2001. Pediatric cataract surgery and intraocular lens implantation: Current techniques, complications, and management. International Ophthalmology Clinics 41(3):175–196.

Pattee S. 2003. Testimony on behalf of the Cystic Fibrosis Foundation before the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine.

Pattishall EN. 1990. Negative clinical trials in cystic fibrosis research. Pediatrics 85(3):277–281.

Pellegrino ED. 1992. Character and the ethical conduct of research. Accountability in Research 2(1):1–11.

Peppercorn JM, Weeks JC, Cook EF, Joffe S. 2004. Comparison of outcomes in cancer patients treated within and outside clinical trials: Conceptual framework and structured review. Lancet 363:263–270.

Perkins J, Simon H, Cheng F, Olson K, Vera Y. 1998. Ensuring Linguistic Access in Health Care Settings: Legal Rights and Responsibilities. Los Angeles, CA: National Health Law Program.

Peterson JW, Sterling YM. 1999. Research involving African Americans: Implications for family nursing research. Journal of Child and Family Nursing 2(3):162–170.

PHRP (Partnership for Human Research Protection). 2003. Statement to the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine.

Piaget J, Inhelder B. 1969. The Psychology of the Child. New York, NY: Basic Books.

Pina LM. 1997. Center IDs top 10 drugs used off-label in out-patient setting. The Pike 3(1):6–7. [Online]. Available: http://www.fda.gov/cder/pike/jan97.pdf [accessed March 11, 2004].

Pletsch PK, Stevens PE. 2001. Children in research: Informed consent and critical factors affecting mothers. Journal of Family Nursing 7(1):50–70.

PPRU (Pediatric Pharmacy Research Unit Network). No date. Sites: 13 Pioneer Pediatric Sites Throughout the U.S. [Online]. Available: http://www.ppru.org [accessed March 11, 2004].

President’s Commission (President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research). 1981. Protecting Human Subjects: The Adequacy and Uniformity of Federal Rules and Their Implementation. Washington, DC: U.S. Government Printing Office.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Pui C, Sandlund JT, Pei D, Rivera GK, Howard SC, Ribeiro RC, Rubnitz JE, Razzouk BI, Hudson MM, Cheng C, Raimondi SC, Behm FG, Downing JR, Relling MV, Evans WE. 2003. Results of therapy for acute lymphoblastic leukemia in black and white children. Journal of the American Medical Association 290(15):2001–2007.

Pyke-Grimm KA, Degner L, Small A, Mueller B. 1999. Preferences for participation in treatment decision making and information needs of parents of children with cancer: A pilot study. Journal of Pediatric Oncology Nursing 16(1):13–24.


Quintana H, Keshavan M. 1995. Case study: Risperidone in children and adolescents with schizophrenia. Journal of the American Academy of Child and Adolescent Psychiatry 34(10):1292–1296.

Quittner AL, Sweeny SH, Watrous M, Munzenberger P, Bearss K, Gibson Nitza A, Fisher L, Henry B. 2000. Translation and linguistic validation of a disease-specific quality of life measure for cystic fibrosis. Journal of Pediatric Physiology 25(6):403–414.


Ramsey BW. 2003. Unpublished paper. Examples of Multicenter Phase I Clinical Trials Conducted Through the Cystic Fibrosis Therapeutics Development Network Between 2001 and 2003. Seattle, WA: Cystic Fibrosis Research Center, University of Washington.

Ramsey BW, Boat TF. 1994. Outcome measures for clinical trials in cystic fibrosis; summary of a Cystic Fibrosis Foundation Consensus Conference. Journal of Pediatrics 124:177–192.

Ramsey BW, Pepe MS, Quan JM, Otto KL, Montgomery AB, Williams-Warren J, Vasiljev-K M, Borowitz D, Bowman CM, Marshall BC, Marshall S, Smith AL, for the Cystic Fibrosis Inhaled Tobramyacin Study Group. 1999. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. New England Journal of Medicine 340(1):23–30.

Ramsey P. 1970. The Patient as Person: Explorations in Medical Ethics. New Haven, CT: Yale University Press.

Ramsey P. 1977. Children as research subjects: A reply. Hastings Center Report 7(2):40–42.

Ransohoff DF, Harris RP. 1997. Lessons from the mammography screening controversy: Can we improve the debate? Annals of Internal Medicine 127(11):1029–1034.

Reed MD, Gal P. 2004. Principles of drug therapy. In: Berhman R, Kliegman R, Jenson H, eds. Nelson Textbook of Pediatrics. 17th ed. Philadelphia, PA: WB Sanders.

Ries LAG, Smith MA, Gurney JG, Linet M, Tamra T, Young JL, Bunin GR, eds. 1999. Cancer Incidence and Survival among Children and Adolescents: United States SEER Program 1975-1995, National Cancer Institute, SEER Program. Bethesda, MD: National Institutes of Health. [Online]. Available: http://seer.cancer.gov/publications/childhood/ [accessed March 11, 2004].

Ries LAG, Eisner MP, Kosary CL, Hankey BF, Miller BA, Clegg L, Mariotto A, Fay MP, Feuer E J, Edwards BK, eds. 2003. Childhood cancer by site incidence, survival and mortality. In: SEER Cancer Statistics Review, 1975-2000. Bethesda, MD: National Cancer Institute. [Online]. Available: http://seer.cancer.gov/csr/1975_2000 [accessed March 11, 2004].

Rivera R, Reed JS, Menius D. 1992. Evaluating the readability of informed consent forms used in contraceptive clinical trials. International Journal of Gynaecology and Obstetrics 38(3):227–230.

Roberts R, Rodriguez W, Murphy D, Crescenzi T. 2003. Pediatric drug labeling: Improving the safety and efficacy of pediatric therapies. Journal of American Medical Association 290(7):905–911.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Rogers AS, Schwartz DF, Weissman G, English A, Adolescent Medicine HIV/AIDS Research Network. 1999. A case study in adolescent participation in clinical research: Eleven clinical sites, one common protocol, and eleven IRBs. IRB: A Review of Human Subjects Research 21(1):6–10.

Roman DD, Sperduto PW. 1995. Neuropsychological effects of cranial radiation: Current knowledge and future directions. International Journal of Radiation, Oncology, Biology, and Physics 31:983–998.

Rosella JD. 1994. Review of adolescent coping research: Representation of key demographic variables and methodological approaches to assessment. Issues in Mental Health Nursing 15(5):483–485.

Ross LF. 1998. Children, Families and Health Care Decision Making. New York, NY: Oxford University Press.

Rossi WC, Reynolds W, Nelson RM. 2003. Child assent and parental permission in pediatric research. Theoretical Medicine 24(2):131–148.

Rothman KJ, Michels KB. 1994. The continuing unethical use of placebo controls. New England Journal of Medicine 331(6):394–398.

Rothman AJ, Salovey P. 1997. Shaping perceptions to motivate healthy behavior: The role of message framing. Psychological Bulletin 121:3–19.

Rothman AJ, Salovey P, Antone C, Keough K, Martin CD. 1993. The influence of message framing on intentions to perform health behaviors. Journal of Experimental Social Psychology 29:408–433.

Rothmier JD, Lasley MV, Shapiro GG. 2003. Factors influencing parental consent in pediatric clinical research. Pediatrics 111(5):1037–1041.

Ruccione K, Kramer RF, Moore IK, Perin G. 1991. Informed consent for treatment of childhood cancer: Factors affecting parents’ decision making. Journal of Pediatric Oncology Nursing 8(3):112–121.

Rutkow IM. 1998. Beaumont and St. Martin: A blast from the past. Archives of Surgery 133:1259.


Sackett DL. 2000. Equipoise, a term whose time (if it ever came) has surely gone. Canadian Medical Association Journal 163(7):835–836. [Online]. Available: http://www.cmaj.ca/cgi/content/full/163/7/835?ijkey=4b1a3c08c63ec062b261aab49e49482f7abc9830&keytype2=tf_ipsecsha [accessed March 11, 2004].

Sagan L. 1994 (November 17). Interview by Javitt G, White-Junod S, Thomas S, and Kruger J (ACHRE Research Project Series, Interview Program File, Ethics Oral History Project), transcript of audio recording. P. 13–14.

Salgo v. Stanford Jr. (Olga Salgo, as Administratrix etc. Respondent v. Leland Stanford Jr. University Board of Trustees et al.). 1957. 154 Cal., App. 2d 560 (Cal. Dist. Ct. App. 57).

SAM (Society for Adolescent Medicine). 1995. Guidelines for adolescent health research. Journal of Adolescent Health 17(5): 264–269.

Sander N. 2003 (July 9). Statement on Behalf of the Allergy & Asthma Network/Mothers of Asthmatics to the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine.

Sarnblad S, Kroon M, Aman J. 2003. Metformin as additional therapy in adolescents with poorly controlled type 1 diabetes: Randomised placebo-controlled trial with aspects on insulin sensitivity. European Journal of Endocrinology 149(4):323–329.

Sateren W, Trimble E, Abrams J, Brawley O, Breen N, Ford L, McCabe M, Kaplan R, Smith M, Ungerleider R, Christian M. 2002. How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. Journal of Clinical Oncology 20(8):2109–2117.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Schachter AD, Meyers KE, Spaneas LD, Palmer JA, Salmanullah M, Baluarte J, Brayman KL, Harmon WE. 2004. Short Sirolimus half-life in pediatric renal transplant recipients on a calcineurin inhibitor-free protocol. Pediatric Transplantation 8(2):171–177.

Scherer DG. 1991. The capacities of minors to exercise voluntariness in medical treatment decisions. Law and Human Behavior 15:431–449.

Scherer DG, Reppucci ND. 1988. Adolescents’ capacities to provide voluntary informed consent: The effect of parental influence and medical dilemmas. Law and Human Behaviour 12(2):123–141.

Schultz CJ, Konopelska-Bahu T, Dalton RN, Carroll TA, Stratton I, Gale EA, Neil A, Dunger DB. 1999. Microalbuminuria prevalence varies with age, sex, and puberty in children with type 1 diabetes followed from diagnosis in a longitudinal study. Oxford Regional Prospective Study Group. Diabetes Care 22(3):495–502.

Schuster M. 2000. Well child care. In: McGlynn E, Damberg C, Kerr E, Schuster M, eds. Quality of Care for Children and Adolescents: A Review of Selected Clinical Conditions and Quality Indicators. Santa Monica, CA: Rand Corporation. [Online]. Available: http://www.rand.org/publications/MR/MR1283/mr1283.ch22.pdf [accessed March 11, 2004].

Schutta KM, Burnett CB. 2000. Factors that influence a patient’s decision to participate in a phase I cancer clinical trial. Oncology Nursing Forum 27(9):1435–1438.

Scott ES, Reppucci ND, Woolard JL. 1995. Evaluating adolescent decision making in legal contexts. Law and Human Behavior 19:221–244.

Segall MH, Dasen PR, Berry JW, Poartinga GH. 1999. Human Development in Global Perspective. Boston, MA: Allyn & Bacon.

Shah S, Whittle A, Wilfond B, Gensler G, Wendler D. 2004. How do institutional review boards apply the federal risk and benefit standards for pediatric research? Journal of the American Medical Association 291(4):476–482.

Sharav VH. 2003. Children in clinical research: A conflict of moral values. American Journal of Bioethics 3(1): InFocus. [Online]. Available: http://bioethics.net/in_focus/sharav.pdf [accessed March 11, 2004].

Shelton TL, Jeppson ES, Johnson BH. 1987. Family-Centered Care for Children with Special Health Care Needs. Bethesda, MD: Association for the Care of Children’s Health.

Shirkey HC. 1968. Editorial comment: Therapeutic orphans. Journal of Pediatrics 72(1):119–120.

Shochat SJ, Fremgen AM, Murphy SB, Hutchinson C, Donaldson SS, Haase GM, Provisor AJ, Clive-Bumpus RE, Winchester DP. 2001. Childhood cancer: Patterns of protocol participation in a national survey. American Cancer Journal for Clinicians 51(2):119–130. [Online]. Available: http://caonline.amcancersoc.org/cgi/reprint/51/2/119.pdf [accessed March 11, 2004].

Shore RE, Woodard E, Hildreth N, Dvoretsky P, Hempelmann L, Pasternack B. 1985. Thyroid tumors following thymus irradiation. Journal of the National Cancer Institute 74(6):1177–1184.

Shore RE, Hildreth N, Dvoretsky P, Andresen E, Moseson M, Pasternack B. 1993. Thyroid cancer among persons given X-ray treatment in infancy for an enlarged thymus gland. American Journal of Epidemiology 137(10):1068–1080.

Shrier I. 2001. Uncertainty about clinical equipoise. Canadian Medical Association Journal 164(13):1831.

Siegler M. 2002. Training doctors for professionalism: Some lessons from teaching clinical medical ethics. The Mount Sinai Journal of Medicine 69(6):404–409. [Online]. Available: http://www.mssm.edu/msjournal/69/v69_6_page404_409.pdf [accessed January 27, 2004].

Siegler RS. 1991. Children’s Thinking. Englewood Cliffs, NJ: Prentice Hall.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Sikand A, Schubiner H, Simpson PM. 1997. Parent and adolescent perceived need for parental consent involving research with minors. Archives of Pediatrics and Adolescent Medicine 151(6):603–607.

Silverman H, Hull SC, Sugarman J. 2001. Variability among institutional review boards’ decisions within the context of a multicenter trial. Critical Care Medicine 29(2):235–241.

Silverman WA. 1977. The lesson of retrolental fibroplasias. Scientific America 236:100–107.

Simon C, Eder M, Raiz P, Zyzanski S, Pentz R, Kodish ED. 2001. Informed consent for pediatric leukemia research: Clinician perspectives. Cancer 92(3):691–700.

Simon C, Zyzanski SJ, Eder M, Raiz P, Kodish ED, Siminoff LA. 2003. Groups potentially at risk for making poorly informed decisions about entry into clinical trials for childhood cancer. Journal of Clinical Oncology 21(11):2173–2178.

Simone JV. 2003. Childhood leukemia—successes and challenges for survivors. New England Journal of Medicine 349(7):627–628.

Singhal N, Oberle K, Burgess E, Huber-Okrainec J. 2002. Parents’ perceptions of research with newborns. Journal of Perinatology 22(1):57–63.

Smith KW, Avis NE, Assmann SF. 1999. Distinguishing between quality of life and health status in quality of life research: A meta-analysis. Quality of Life Research 8:447–459.

Snowdon C, Garcia J, Elbourne D. 1997. Making sense of randomization: Responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Social Science Medicine 45(9):1337–1355.

Somers S. 2003. Q & A: Interpreters for Home Health Care. [Online]. Available: http://www.healthlaw.org/pubs/200307.qanda.html [accessed March 11, 2004].

Sourkes BM. 1995. Armfuls of Time: The Psychological Experience of the Child with a Life-Threatening Illness. Pittsburgh, PA: University of Pittsburgh Press.

SPR and APS (Society for Pediatric Research and American Pediatric Society). 2003. Participation and Protection of Children in Clinical Research. Paper presented to the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine.

Stair TO, Reed CR, Radeos MS, Koski G, Camargo CA, on behalf of the Multicenter Airway Research Collaboration (MARC) Investigators. 2001. Variation in institutional review board responses to a standard protocol for a multicenter clinical trial. Academic Emergency Medicine 8(6):636–641. [Online]. Available: http://healthcare.partners.org/marc/articles/Stair_2001.pdf [accessed March 11, 2004].

Stanovich KE, West RF. 2000. Individual differences in reasoning: Implications for the rationality debate? Behavioral and Brain Sciences 23(5):645–665, discussion 665–726.

Stedman T. 2000. Stedman’s Medical Dictionary. 27th ed. Baltimore, MD: Lippincott Williams & Wilkins.

Steinberg L, Cauffman E. 1996. Maturity of judgment in adolescence: Psychosocial factors in adolescent decision making. Law and Human Behavior 20(3):249–272.

Steinbrook R. 2002. Testing medications in children. New England Journal of Medicine 110(2):364–370.

Stiffman AR, Striley CW, Brown E, Limb G, Ostmann E. 2002. American Indian Adolescents, Addictions, Trauma, and HIV Risk. Paper presented at the 130th Annual Meeting and Exposition of the American Public Health Association, San Francisco, CA. American Public Health Association. [Online]. Available: http://apha.confex.com/apha/130am/techprogram/paper_43748.htm [accessed March 11, 2004].

Stith-Coleman I. 1994. Protection of Human Subjects in Research. CRS Report to Congress. Washington, DC: U.S. Government Printing Office. [Online]. Available: http://www.gwu.edu/~nsarchiv/radiation/dir/mstreet/commeet/meet2/brief2/tab_i/br2i1d.txt [accessed March 11, 2004].

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Stolberg SG. 1999 (December 9). F.D.A. officials fault Penn team in gene therapy death. New York Times. P. A22. [Online]. Available: http://www.nytimes.com/library/national/science/health/120999hth-gene-therapy.html [accessed March 11, 2004].

Susman EJ, Dorn LD, Fletcher JC. 1992. Participation in biomedical research: The consent process as viewed by children, adolescents, young adults, and physicians. Journal of Pediatrics 121(4):547–552.

Sutherland HJ, Lockwood GA, Tritchler DL, Sem F, Brooks L, Till JE. 1991. Communicating probabilistic information to cancer patients: Is there “noise” on the line? Social Science and Medicine 32(6):725–731.


Tait AR, Voepel-Lewis T, Siewert M, Malviya S. 1998. Factors that influence parents’ decisions to consent to their child’s participation in clinical anesthesia research. Anesthesia and Analgesia 86(1):50–53.

Tait AR, Voepel-Lewis T, Munro HM, Malviya S. 2001. Parents’ preferences for participation in decisions made regarding their child’s anaesthetic care. Paediatric Anaesthesia 11(3):283–290.

Tait AR, Voepel-Lewis T, Robinson A, Malviya S. 2002. Priorities for disclosure of the elements of informed consent for research: A comparison between parents and investigators. Paediatric Anaesthesia 12(4):332–336.

Tait AR, Voepel-Lewis T, Malviya S. 2003a. Do they understand? (part I): Parental consent for children participating in clinical anesthesia and surgery research. Anesthesiology 98(3):603–608.

Tait AR, Voepel-Lewis T, Malviya S. 2003b. Do they understand? (part II): Assent of children participating in clinical anesthesia and surgery research. Anesthesiology 98(3):609–614.

Tanner JM. 1962. Growth of Adolescents. Oxford, United Kingdom: Blackwell Scientific Publications.

Tarnowski KJ, Allen DM, Mayhall C, Kelly PA. 1990. Readability of pediatric biomedical research informed consent forms. Pediatrics 85(1):58–62.

Taylor KM, Bezjak A, Hunter R, Fraser S. 1998. Informed consent for clinical trials: Is simpler better? Journal of the National Cancer Institute 90(9):644–645.

TDN (Therapeutics Development Network). 2003. Guidelines for reimbursement to study subjects. In: Manual of Operations. Bethesda, MD: Cystic Fibrosis Foundation. P. F-2.

Tejeda HA, Green SB, Trimble EL, Ford L, High JL, Ungerleider RS, Friedman MA, Brawley OW. 1996. Representation of African-Americans, Hispanics, and Whites in National Cancer Institute cancer treatment trials. Journal of the National Cancer Institute 88(12): 812–816. [Online]. Available: http://jncicancerspectrum.oupjournals.org/cgi/reprint/jnci;88/12/812.pdf [accessed March 11, 2004].

Thompson L. 2000a. Human gene therapy: Harsh lessons, high hopes. FDA Consumer 34(5). [Online]. Available: http://www.fda.gov/fdac/features/2000/500_gene. html [accessed March 11, 2004].

Thompson RA. 2000b. Appendix C: Protecting the health services research data of minors. In: Institute of Medicine. Protecting Data Privacy in Health Services Research. Washington, DC: National Academy Press. [Online]. Available: http://www.nap.edu/html/data_privacy/appC.html [accessed March 11, 2004].

Thorndike RL, Hagen EP, Sattler JM. 1986. Stanford-Binet Intelligence Scale. 4th ed. Chicago, IL: Riverside Publishing.

Travers SH, Jeffers BW, Bloch CA, Hill JO, Eckel RH. 1995. Gender and Tanner stage differences in body composition and insulin sensitivity in early pubertal children. Journal of Clinical Endocrinology and Metabolism 80(1):172–178.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Tri-Council (Medical Research Council of Canada, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada). 1998. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Ottawa, Ontario, Canada: Minister of Supply and Services.

Truog RD, Robinson W, Randolph A, Morris A. 1999. Is informed consent always necessary for randomized, controlled trials? New England Journal of Medicine 340(10):804–807.

Turner S, Nunn AJ, Fielding K, Choonara I. 1999. Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: A prospective study. Acta Paediatrica 88(9):965–968.


Ubel PA. 2002. Is information always a good thing? Helping patients make “good” decisions. Medical Care 40(9 Supp):V39–V44.

UCLA (University of California Los Angeles). 1997. Investigator’s Manual for the Protection of Human Subjects. Los Angeles, CA: UCLA. [Online]. Available: http://www.oprs.ucla.edu/human/hspcmanual/hspc497c.pdf [accessed March 11, 2004].

UNC (University of North Carolina, Chapel Hill). 2003. About UNC CERTs. [Online]. Available: http://www.sph.unc.edu/health-outcomes/certs/about2.htm [accessed March 11, 2004].

UNCHR (United Nations Commission on Human Rights). 1976. International Covenant on Civil and Political Right, G.A. Res. 2200A (XXI), 21 U.N. GAOR Supp. (No. 16) at 52, U.N. Doc. A/6316 (1966), 999 U.N.T.S. 171. [Online]. Available: http://www.unhchr.ch/html/menu3/b/a_ccpr.htm [accessed March 11, 2004].

U.S. Congress. 1995. Department of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Bill, 1996. H.R. Report No. 209. Washington, DC: U.S. Congress. [Online]. Available: http://thomas.loc.gov/cgi-bin/cpquery/T?&report=hr209&dbname=cp104& [accessed March 11, 2004].

USDA (Department of Agriculture, Department of Energy, National Aeronautics and Space Administration, Department of Commerce, Consumer Product Safety Commission, International Development Cooperation Agency, Agency for International Development, Department of Housing and Urban Development, Department of Justice, Department of Defense, Department of Education, Department of Veterans Affairs, Environmental Protection Agency, Department of Health and Human Services, National Science Foundation, Department of Transportation). 1991. Federal policy for the protection of human subjects. Federal Register 56:28003.

USPSTF (U.S. Preventive Services Task Force). 1995. Guide to Clinical Preventive Services. 2nd ed. Baltimore, MD: Lippincott Williams & Wilkins.

U.S. Surgeon General. 1966. U.S. Surgeon General Policy Statement: “Clinical Research and Investigation Involving Human Beings,” Surgeon General, Public Health Service to the Heads of the Institutions Conducting Research With Public Health Service Grants. Washington, DC: U.S. Surgeon General (Public Health Service).


Van Stuijvenberg M, Suur MJ, de Vos S, Tjiang GCH, Steyerberg EW, Derksen-Lusen G, Moll HA. 1998. Informed consent, parental awareness, and reasons for participating in a randomized controlled study. Archives of Disease in Childhood 79:120–125.

Varni, JW. 2003. The PedsQL 4.0 Measurement Model for the Pediatric Quality of Life Inventory version 4.0. [Online]. Available: http://www.pedsql.org/pedsql2. html [accessed March 11, 2004].

Vaughn A. 2003. Testimony before the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine.

Vedantam S. 2004 (January 29). Antidepressant makers withhold data on children. Washington Post. P. A1.

Villarrruel A. 1999. Culturally competent nursing research: Are we there yet? Journal of Child and Family Nursing 2(2):82–91.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Volk RJ, Spann SJ, Cass AR, Hawley ST. 2003. Patient education for informed decision making about prostate cancer screening: A randomized controlled trial with 1-year follow-up. Annals of Family Medicine 1(1):22–28.

Vollman J, Winau R. 1996. Informed consent in human experimentation before the Nuremburg Code. British Medical Journal 313(7070):1445–1447.

Vygotsky LS. 1978. Mind in Society: The Development of Higher Psychological Processes. Cambridge, MA: Harvard University Press.


Wax PM. 1995. Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act. Annals of Internal Medicine 122(6):456–461. [Online]. Available: http://www.annals.org/cgi/content/full/122/6/456 [accessed March 4, 2004].

Wechsler D. 1989. Wechsler Preschool and Primary Scale of Intelligence Revised. New York, NY: The Psychological Corporation.

Wechsler D. 1991. Wechsler Intelligence Scale for Children. 3rd ed. New York, NY: The Psychological Corporation.

Weijer C. 2001. The ethical analysis of risks and potential benefits in human subjects research: History, theory, and implications for U.S. regulation. In: National Bioethics Advisory Commission. Ethical and Policy Issues in Research Involving Human Participants, Vol. II. Besthesda, MD: NBAC.

Weijer C, Shapiro SH, Glass KC. 2000. Clinical equipoise and not the uncertainty principle is the moral underpinning of the randomised controlled trial. British Medical Journal 321(7263):756–758.

Weinfurt KP, Castel LD, Li Y, Sulmasy DP, Balshem AM, Benson 3rd A, Burnett CB, Gaskin DJ, Marshall JL, Slater EF, Schulman KA, Meropol NJ. 2003. The correlation between patient characteristics and expectations of benefit from phase I clinical trials. Cancer 98(1):166–175.

Weir RF. 2000. The ongoing debate about stored tissue samples. In: National Bioethics Advisory Commission. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Vol. II. Commissioned Papers. Rockville, MD: National Bioethics Advisory Commitssion. [Online]. Available: http://www.georgetown.edu/research/nrcbl/nbac/hbmII.pdf [accessed March 11, 2004].

Weir RF, Horton JR. 1995. Genetic research, adolescents, and informed consent. Theoretical Medicine 16(4):347–373.

Weir RF, Peters C. 1997. Affirming the decisions adolescents make about life and death. Hastings Center Report 27(6):29–40.

Weise KL, Smith ML, Maschke KJ, Copeland HL. 2002. National practices regarding payment to research subjects for participating in pediatric research. Pediatrics 110(3):577–582.

Weiss CF, Glazko AJ, Weston JK. 1960. Chloramphenicol in the newborn infant: A physiologic explanation of its toxicity when given in excessive doses. New England Journal of Medicine 262:787–794.

Weiss R, Nelson D. 2000 (March 4). FDA lists violations by gene therapy director at U-Penn. Washington Post. P. A4.

Weithorn LA, Campbell SB. 1982. The competency of children and adolescents to make informed treatment decisions. Child Development 53(6):1589–1598.

Welton AJ, Vickers MR, Cooper JA, Meade TW, Marteau TM. 1999. Is recruitment more difficult with a placebo arm in randomized controlled trials? A quasirandomised, interview based study. British Medical Journal 318(7191):1114–1117.

Wendler D. 2003 (January 9). The Ethics of Pediatric Research. Presentation to the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine.

Wendler D, Rackoff JE, Emanuel EJ, Grady C. 2002. The ethics of paying for children’s participation in research. Journal of Pediatrics 141(2):166–171.

Suggested Citation:"References." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Wertz DC, Fanos JH, Reilly PR. 1994. Genetic testing for children and adolescents. Who decides? Journal of the American Medical Association 272(11):875–881.

White LJ, Jones JS, Felton CW, Pool LC. 1996. Informed consent for medical research: Common discrepancies and readability. Academic Emergency Medicine 3(8):745–750.

White M. 2003 (July 9). Statement on behalf of the Asthma and Allergy Network/Mothers of Asthmatics to the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine.

White MT, Gamm J. 2002. Informed consent for research on stored blood and tissue samples: A survey of institutional review board practices. Accountability in Research 9(1):1–16.

Wilcox M, Schroer S. 1994. The perspective of patients with vascular disease on participation in clinical trials. Journal of Vascular Nursing 12(4):112–116.

Wilson JT. 1975. Pragmatic assessment of medicines available for young children and pregnant or breast-feeding women. In: Morselli P, Garattini S, Sereni F, eds. Basic and Therapeutic Aspects of Perinatal Pharmacology. New York, NY: Raven Press. Pp. 411–421.

WMA (World Medical Association). 1964. Declaration of Helsinki. In: Annas G, Glantz L, Katz B. Informed Consent to Human Experimentation: The Subject’s Dilemma. Appendix II. New York, NY: Harper Information. P. 281. [Online]. Available: http://www.bumc.bu.edu/www/sph/lw/pvl/book/Ch9.pdf [accessed March 11, 2004].

WMA. 2002. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Document 17.C. Washington, DC: WMA. [Online]. Available: http://www.wma.net/e/policy/pdf/17c.pdf [accessed March 11, 2004].

Wong D, Baker C. 1988. Pain in children: Comparison of assessment scales. Pediatric Nursing 14(4):9–17.


Yasui L. 2003 (July 11). Testimony before the Committee on Clinical Research Involving Children. Washington, DC: Institute of Medicine.

Yoder LH, O’Rourke TJ, Etnyre A, Spears DT, Brown T. 1997. Expectations and experiences of patients with cancer participating in phase I clinical trials. Oncology Nursing Forum 24(5):891–896.

Yuval R, Halon DA, Merdler A, Khader N, Karkabi B, Uziel K, Lewis B. 2000. Patient comprehension and reaction to participating in a double blind randomized clinical trial (ISIS-4) in acute myocardial infarction. Archives of Internal Medicine 160(8):1142–1146.


Zupancic JAF, Gillie P, Streiner DL, Watts JL, Schmidt B. 1997. Determinants of parental authorization for involvement of newborn infants in clinical trials. Pediatrics 99(1):1–6. [Online]. Available: http://pediatrics.aappublications.org/cgi/reprint/99/1/e6.pdf [accessed March 11, 2004].

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In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies.

Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

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