Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 277
Ethical Conduct of Clinical Research Involving Children 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.
OCR for page 278
Ethical Conduct of Clinical Research Involving Children 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].
OCR for page 279
Ethical Conduct of Clinical Research Involving Children 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.
OCR for page 280
Ethical Conduct of Clinical Research Involving Children 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.
OCR for page 281
Ethical Conduct of Clinical Research Involving Children 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].
OCR for page 282
Ethical Conduct of Clinical Research Involving Children 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.
OCR for page 283
Ethical Conduct of Clinical Research Involving Children 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.
OCR for page 284
Ethical Conduct of Clinical Research Involving Children 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. 106–310, 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.
OCR for page 285
Ethical Conduct of Clinical Research Involving Children 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].
OCR for page 286
Ethical Conduct of Clinical Research Involving Children 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].
OCR for page 287
Ethical Conduct of Clinical Research Involving Children 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=18.104.22.168&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.
OCR for page 298
Ethical Conduct of Clinical Research Involving Children 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].
OCR for page 299
Ethical Conduct of Clinical Research Involving Children 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].
OCR for page 300
Ethical Conduct of Clinical Research Involving Children 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.
OCR for page 301
Ethical Conduct of Clinical Research Involving Children 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.
OCR for page 302
Ethical Conduct of Clinical Research Involving Children 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.
OCR for page 303
Ethical Conduct of Clinical Research Involving Children 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.
OCR for page 304
Ethical Conduct of Clinical Research Involving Children 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].
OCR for page 305
Ethical Conduct of Clinical Research Involving Children 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.
OCR for page 306
Ethical Conduct of Clinical Research Involving Children 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.
OCR for page 307
Ethical Conduct of Clinical Research Involving Children 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.
OCR for page 308
Ethical Conduct of Clinical Research Involving Children 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].
Representative terms from entire chapter: