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Appendices

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192 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH conclucted in accordance with the IRB's requirements or that has been associates! with unexpected serious harm to subjects" (45 CFR 46.1 13). The purpose of lodging ultimate approval authority with an IRB was to insulate IRBs from pressures from institutional officials to approve research that might be important to the institution but that the IRB determined would! not adequately protect participants. FincI- ing ways to enable IRBs to resist pressures that could potentially compromise ethical judgments was anct is a legitimate goal. How- ever, some researchers believe that the lack of an appeals process gives IRBs too much power over the conduct of research. Further study is needed to finct better ways to maintain IRB integrity and yet also allow researchers greater access to the decision process. The panel discussed the desirability of recommencling that a for- mal appeals process be adcled to the human participant protection process. Such a provision would provide a recourse to an investi- gator who believed that IRB-required changes woulc! harm the sci- entific integrity of the proposed research ant! but not provide adcled participant protection. Some panel members wantec! to recommence an appeals procedure, but other panel members feared that such a procedure could alit! another layer of bureaucratic oversight to the IRB system. These members hope that implementation of rec- ommenciation 7.1 to improve IRB-research interaction and other stepssuch as clearer guidance from IRBs to researchers and more explicit guidance from OHRP to IRBsconic! go a long way to alle- viate the possible need for a formal appeals process. ORGANIZATION OF AND Al\IONG IRBS . . Organization and Staffing of IRBs The Common Rule requires that IRBs have at least five mem- bers with varying backgrounds, including at least one scientist ant! one nonscientist, and at least one member not affiliated with the research institution, but it does not otherwise specify IRB compo- sition, size, staffing, or other organizational features. The several thousand IRBs in the United States differ in their size, disciplines and expertise of members, level of staffing, ant! other resources for their operations. As one wouicI expect, high-volume IRBs have more members, are supporter! by more hours of administrative staff, and make greater use of consultants, on average, compared with low- 6

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- A Tracing Changes in Regulatory Language As an aid to following the changes in federal regulations for human research participant protection from 1974 through 1998, this appendix excerpts text from regulations and proposed regulations for human re- search participant protection on the following topics: Box A-1, applicability of regulations; Box A-2, definition of research; Box A-3, definition of human subject; Box A-4, research eligible for exemption; Box A-5, expedited review (SBES-related categories); Box A-6, criteria for IRB review; Box A-7, basic elements of informed consent; Box A-8, additional elements of informed consent; Box A-9, conditions for waiver of informed consent; Box A-10, documentation of informed consent and waiver condi- tions; and Box A-11, definition of minimal risk. As applicable, language is excerpted from 45 CFR 46, May 30, 1974; proposed regulations amending basic policy of the U.S. Department of Health, Education, and Welfare (HEW) (predecessor to the U.S. De- partment of Health and Human Services tHHS]), August 14, 1979; 45 CFR 46, January 26, 1981; 45 CFR 46, June 18, 1991; suggested revi- sions to the IRB expedited review list, November 10, 1997; expedited review list, November 9, 1998. Italics are added to note key differences from preceding or succeeding text. 193

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194 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH BOX A-1 Applicability of IRB Regulations May 30, 1974: 45 CFR 46, Protection of Human Subjects 46.1 (a) The regulations in this part are applicable to all Department of Health, Education, and Welfare grants and contracts supporting research, development, and related activities in which human subjects are involved. Aug. 1 4, 1 9 79: Proposed Regulations Amending Basic H EW Policy for Protection of Human Research Subjects 46.101(a) Except as provided in paragraph (c), this subpart applies to all research involving human subjects conducted or supported by the Department of Health, Education, and Welfare. 46.122 Except for the categories of research exempted under 46.101(c), prior and continuing review and approval by an Institu- tional Review Board is required for the conduct of all research involv- ing human subjects not funded by the Department, if the research is conducted at or supported by any institution receiving funds from the Department for the conduct of research involving human subjects. Jan. 26, 1981: 45 CFR 46, Subpart A Basic HHS Policy for Protection of Human Research Subjects 46.101(a) Except as provided in paragraph (b) of this section, this subpart applies to all research involving human subjects conducted by the Department of Health and Human Services or funded in whole or in part by a Department grant, contract, cooperative agreement or fellowship. [proposed 46.122 dropped] June 18, 1991: 45 CFR 46, Subpart A Federal Policy for the Protection of Human Sub jects 46.101(a) Except as provided in paragraph (b) of this section, this policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal Department or Agency which takes appropriate administrative action to make the policy applicable to all such research.

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TRACING CHANGES IN REGULATORYI~GUAGE 195 BOX A-2 Definition of Research May 30, 1974: 45 CFR 46, Protection of Human Subjects No definition provided. Aug. 1 4, 1 979: Proposed Regulations Amending Basic H EW Policy. . . 46.102(e) "Research" means a formal investigation designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute "research" for purposes of this part, whether or not they are supported or conducted under a program which is considered research for other purposes. For example, some "demonstration" and "service" programs may include research activities. Jan. 26, 1981: 45 CFR 46, Subpart ABasic HHS Policy. . . 46.102(e) "research" means a systematic investigation designed to de- velop or contribute to generalizable knowledge. Activities which meet this definition constitute "research" for purposes of these regulations, whether or not they are supported or funded under a program which is considered research for other purposes. For example, some "demonstration" and "service" programs may include research activities. June 18, 1991: 45 CFR 46, Subpart A Federal Policy for the Protection of Human Sub jects 46.1 02(e) "Research" means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

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196 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH BOX A-3 Definition of Human Subject May 30, 1974: 45 CFR 46, Protection of Human Subjects No definition provided. Aug. 14, 1979: Proposed Regulations Amending Basic HEW Policy. . . 46.102(fl "Human subject" means an individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the person, or (2) identifiable information. Jan. 26, 1 981: 45 CFR 46, Subpart A Basic HHS Policy. . . 46.102(fl "human subject" means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. [definitions of intervention, interaction, and private information follow] June 18, 1991: 45 CFR 46, Subpart A Federal Policy for the Protection of Human Sub jects [Same as Jan. 26, 1 981 ]

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TRACING CHANGES IN REGULATORYLANGUAGE 197 BOX A-4 Research Eligible for Exemption May 30, 1974: 45 CFR 46, Protection of Human Subjects No provision to exempt any covered research. Aug. 14, 1979: Proposed Regulations Amending Basic HEW Policy. . . 46.101 tc) These regulations do not apply to: Alternative A (1 ) Research designed to study on a large scale: (A) the effects of proposed social or economic change, or (B) methods or systems for the delivery of or payment for social or health services. (2) Research conducted in established or commonly accepted educa- tional settings, involving normal educational practices, such as (A) research on regular and special education instructional strategies, or (B) research on the effectiveness of or the comparison among instructional techniques, curriculum, or classroom management. (3) Research involving solely the use of standard educational diag- nostic, aptitude, or achievement tests, if information taken from these sources is recorded in such a manner that subjects cannot be reasonably identified, directly or through identifiers linked to the subjects. (4) Research involving solely the use of survey instruments if: (A) results are recorded in such a manner that subjects cannot be reasonably identified, directly or through identifiers linked to the subjects, or (B) the research (although not exempted under clause (A)) does not deal with sensitive topics, such as sexual behavior, drug or alcohol use, illegal conduct, or family planning. (5) Research involving solely the observation (including observation by participants) of public behavior, if observations are recorded in such a manner that subjects cannot be reasonably identified, directly or through identifiers linked to the subjects. (6) Research involving solely the study of documents, records, or pathological or diagnostic specimens, if information taken from these sources is recorded in such a manner that subjects cannot be reasonably identified, directly or through identifiers linked to the subjects. (7) Research involving solely a combination of any of the activities described above. Alternative B ( 1 ) [same as Alternative A] (2) [same as Alternative A] (3) [same as Alternative A] (4) Survey activities involving solely product or marketing research, journalistic research, historical research, studies of organizations, public opinion polls, or management evaluations, in which the potential for invasion of privacy is absent or minimal.

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198 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH BOX A-4 (continued) (5) Research involving the study of documents, records, data sets or human materials, when the sources or materials do not contain identifiers or cannot reasonably be linked to individuals. [similar to A.6] (6) [same as Alternative A.7] Jan. 26, 1 981: 45 CFR 46, Subpart ABasic HHS Policy. . . 46.101(b) Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from these regulations unless the research is covered by other subparts of this part: (l ) Research conducted in established or commonly accepted educa- tional settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. (2) Research involving the use of educational tests (cognitive, diagnos- tic, aptitude, achievement), if information taken from these sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. (3) Research involving survey or interview procedures, except where all of the following conditions exist: (i) Responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, (ii) the subject's responses, if they become known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, and (iii) the research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol. All research involving survey or interview procedures is exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office. (4) Research involving the observation (including observation by participants) of public behavior, except where all of the following conditions exist: (i) Observations are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, (ii) the observations recorded about the individual, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, and (iii) the research deals with sensitive aspects of the subject's own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol. (5) Research involving the collection or study of existing data, docu- ments, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

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TRACING CHANGES INREGULATORYLANGUAGE 199 BOX A-4 (continued) June 18, 1991: 45 CFR 46, Subpart AFederal Policy for the Protection of Human Sub jects 46.101 (b) Unless otherwise required by Deparlment or Agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy: ( 1 ) [so me as Jan. 26, 198 1, regulations] (2) Research involving the use of educational tests (cognitive, di- agnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) informa- tion obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (iiJ any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of crimi- nal or civil liability or can be damaging to the subjects' financial standing, employability, or reputation. (3) Research involving the use of educational tests (cognitive, di- agnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (id Federal statute(sJ require(sJ without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. (4) [same as Jan. 26, 1981, regulations, item 5] (5) Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (iJ Public benefit or service programs; (iiJ procedures for obtaining benefits or services under these programs; (iiiJ possible changes in or alternatives to those programs or procedures; or (ivJ pos- sible changes in methods or levels of payment for benefits or services under those programs. (6) Taste and food quality evaluation and consumer acceptance studies, (iJ if wholesome foods without additives are consumed or (iiJ if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricul- tural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agricul- ture.

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200 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH BOX A-5 Expedited Review (SBES-Related Categories) May 30, 1974: 45 CFR 46, Protection of Human Subjects No provision for expedited review. Aug. 14, 1 979: Proposed Regulations Amending Basic HEW Policy. . . 46.111 (a) The Secretary will publish in the Federal Register a list of categories of research, involving no more than minimal risk, that may be reviewed by the Institutional Review Board through an expedited review procedure. The Secretary will amend this list, as appropriate, through republication in the Federal Register. The Department proposes to include the following procedures in the list to be promulgated under this section: [SBES related categories only] (6) Voice recordings made for research purposes such as investigations of speech defects. (8) Program evaluation activities that entail no deviation for subjects from the normal requirements of their involvement in the program being evaluated or benefits related to their participation in such program. Note. The Department would add the following procedures to the above list if Alternative B under 46.101 (c) is adopted: [see Box A-4 above] (9) Survey activities to which responses are recorded in such a manner that individuals cannot reasonably be identified or in which the records will not contain sensitive information about the individuals. (10) Research activities involving the observation of human subjects carrying out their normal day-to-day activities, where observations are recorded in such a manner that individuals cannot reasonably be identified. (1 1 ) Research involving the study of documents, records, data sets, or human materials where the sources contain identifiers, but the researcher will take information from them in such a way as to prevent future identification of any individual. Jan. 26, 1981: 45 CFR 46, Subpart A Basic HHS Policy. . . 46.110(a) The Secretary has established, and published in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The list will be amended, as appropriate, through periodic republication in the Federal Register. 46.110(b) An IRB may review some or all of the research appearing on the list through an expedited review procedure, if the research involves no more than minimal risk. The IRB may also use the expedited review procedure to review minor changes in previously approved research during the period for which approval is authorized. . .

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TRACING CHANGES IN REGULATORYLANGUAGE 201 BOX A-5 (continued) Jan. 26, 1981: Research Activities Which May Be Reviewed Through Expedited Review Procedures. . . [SBES-related categories only] (6) Voice recordings made for research purposes such as investigations of speech defects. (8) The study of existing data, documents, records, pathological specimens, or diagnostic specimens. (9) Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects. June 18, 1991: 45 CFR 46, Subpart AFederal Policy for the Protection of Human Subjects 46.1 1 0(a) [essentially the same as Jan. 26, 1 981 ] 46.1 1 0(b) [essentially the same as Jan. 26, 1981 ] Nov. 10, 1997: Suggested Revisions to the IRB Expedited Review List [SBES-related categories only] (4) Research involving existing identifiable data, documents, records, or biological specimens (including pathological or diagnostic specimens) where these mate- rials, in their entirety, have been collected prior to the research, for a purpose other than the proposed research. (5) Research involving solely (a) prospectively collected identifiable residual or discarded specimens, or (b) prospectively collected identifiable data, documents or records, where (a) or (b) has been generated for nonresearch purposes. (7) Collection of data from voice, video, or image recordings made for research purposes where identification of the subjects and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to the subjects'financial standing, employability, or reputation. (8) Research on individual or group characteristics or behavior (including but not limited to research involving perception, cognition, surveys, interviews, and focus groups) as follows: (a) Involving adults, where (i) the research does not involve stress to subjects, and (ii) identification of the subjects and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to the subjects'financial standing, employability, or reputation. (b) Involving children, where (i) the research involves neither stress to subjects nor sensitive information about themselves, or their family; (ii) no alteration or waiver of regulatory requirements for parental permission has been proposed; and (iii) identification of the subjects and/or their responses would not reasonably place them or their family members at risk of criminal or civil liability or be damaging to the financial standing, employability, or reputation of themselves or their family members.

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206 PROTECTING PARTICIPLE ED FACILITATING SOCIAL ED BEHAVIOR SCIENCES SEARCH BOX A-7 Basic Elements of Informed Consent May 30, 1974: 45 CFR 46, Protection of Human Subjects 46.3(c) "Informed consent" means the knowing consent of an individual or his legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion. The basic elements of information necessary to such consent include: (1) A fair explanation of the procedures to be followed, and their purposes, including identification of any procedures which are experimental; (2) a description of any attendant discomforts and risks reasonably to be expected; (3) a description of any benefits reasonably to be expected; (4) a disclosure of any appropriate alternative procedures that might be advantageous for the subject; (5) an offer to answer any inquiries concerning the procedures; and (6) an instruction that the person is free to withdraw his consent and to discontinue participation in the project or activity at any time without prejudice to the subject. 46.9...No such informed consent...shall include any exculpatory language through which the sub ject is made to waive, or appear to waive, any of his legal rights, including any release of the organization or its agents from liability for negligence. Aug. 14, 1979: Proposed Regulations Amending Basic HEW Policy. . . 46.1 1 2(a). . . consent shall be sought under circumstances that provide the subject (or the subject's legally authorized representative) sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the subject's legally authorized representative must be in a language understandable to the subject.... No informed consent, whether oral or written, may include any exculpatory language through which the subject. . . is made to waive, or to appear to waive, the subject's legal rights, including any release of the institution or its agents from liability for negligence. 46.1 1 2(a)(1 ). . . In seeking informed consent, the following information shall be provided: (A) A statement that the activity involves research, and that the Insti- tutional Review Board has approved the solicitation of subjects to participate in the research; (B) An explanation of the scope, aims, and purposes of the research, and the procedures to be followed (including identification of any treatments or procedures which are experimental), and the expected duration of the subject's participation; (C) A description of any reasonably foreseeable risks or discomforts to the subject (including likely results if an experimental treatment should prove ineffective);

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TRACING CHANGES IN REGULATORYLANGUAGE 207 BOX A-7 (continued) (D) A description of any benefits to the subject or to others which may reasonably be expected from the research; (E) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (F) A statement that new information developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; (G) A statement describing the extent to which confidentiality of records identifying the subject will be maintained; (H) An offer to answer any questions the subject (or the subject's representative) may have about the research[,] the subject's rights, or related matters; (1) For research involving more than minimal risk, an explanation as to whether compensation and medical treatment are available if injury occurs and, if so, what they consist of or where further information may be obtained; (J) Who should be contacted if harm occurs or there are questions or problems; and (K) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. Jan. 26, 1981: 45 CFR 46, Subpart A Basic HHS Policy. . . 46.1 1 6 [Essentially the same as Aug. 14, 1 979, 46.1 1 2(a)] 46.1 16 (a) Basic elements of informed consent. Except as provided in paragraph (c) of this section, in seeking informed consent the following information shall be provided to each subject: (1 ) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental. (2) A description of any reasonably foreseeable risks or discomforts to the subject. (3) [same as item D in Aug. 14, 1979, proposed regulations] (4) [same as item E in Aug. 14, 1979, proposed regulations] (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. (6) [essentially the same as item I in Aug. 14, 1979, proposed regulations] (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and

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208 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH BOX A-7 (continued) (8) [same as item K in Aug. 14, 1979, proposed regulations] June 18, 1991: 45 CFR 46, Subpart A Federal Policy for the Protection of Human Sub jects 46.1 16 [same as Jan. 26, 1981 ] 46.1 16 (a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject: [same as list in Jan. 26, 1991, regulations]

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TMCING CHANGES IN REGULATORYI~NGUAGE 209 BOX A-8 Additional Elements of Informed Consent May 30, 1974: 45 CFR 46, Protection of Human Subjects No additional elements specified. Aug. 14, 1979: Proposed Regulations Amending Basic HEW Policy. . . 46.11 2(a)(2): Additional elements. When appropriate, the Institutional Review Board shall require that some or all of the following elements of information also be provided: (A) A statement that the particular treatment or procedure being tested may involve risks to the subject (or fetus, if the subject is pregnant or becomes pregnant) which are currently unforeseeable. This statement will often be appropriate in connection with tests of experimental drugs, or where the subjects are children, pregnant women, or women of childbearing age. (B) Foreseeable circumstances under which the subject's participation may be terminated by the investigator without regard to the sub ject's consent. (C) Any additional costs to the subject or others that may result from their participation in the research. (D) Who is conducting the study, the approximate number of subjects involved, the institution responsible for the study, and who is funding it. (E) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject. Jan. 26, 1981: 45 CFR 46, Subpart ABasic HHS Policy. . . 46.1 1 6(b): Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject: (1 ) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable. (2) [essentially the same as 46.1 1 2(a)(2) (B), Aug. 14, 1979, proposed regulations] (3) Any additional costs to the subject that may result from their participation in the research. (4) [same as 46.1 1 2(a)(2) (E), Aug. 14, 1 979, proposed regulations] (5) A statement that significant new findings developed during the course of the research which may relate to the subject's willing- ness to continue to participate will be provided to the subject; and (6) The approximate number of subjects involved in the study.

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210 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH BOX A-8 (continued) June 18, 1991: 45 CFR 46, Subpart A Federal Policy for the Protection of Human Sub jects 46.11 6(b): Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject: [essentially the same as in 46.11 6(b), Jan. 26, 1981, Basic HHS Policy]

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TRACING CHANGES IN REGULATORYLANGUAGE 211 BOX A-9 Conditions for Waiver of Informed Consent May 30, 1974: 45 CFR 46, Protection of Human Subjects No conditions specified. Aug. 1 4, 1 979: Proposed Regulations Amending Basic H EW Policy. . . 46.1 1 2(b): The Board may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in paragraph (a), provided the Board finds (and documents) the following: (1 ) The withholding or altering will not materially affect the ability of the subject to assess the harm or discomfort of the research to the subject or others; (2) Sufficient information will be disclosed to give the subject a fair opportunity to decide whether or not to participate; (3) The research could not reasonably be carried out without the withholding or alteration; (4) Information is not withheld or altered for the purpose of eliciting participation; and (5) Whenever feasible the subject will be debriefed after his or her participation. Jan. 26, 1981: 45 CFR 46, Subpart ABasic HHS Policy. . . 46.116(c): An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that: (1) The research is to be conducted for the purpose of demonstrat- ing or evaluating: (i) Federal, state, or local benefit or service programs which are not themselves research programs, (ii) pro- cedures for obtaining benefits or services under these programs, or (iiiJ possible changes in or alternatives to these programs or procedures; and (2) The research could not practicably be carried out without the waiver or alteration. 46.1 1 6(d): An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirements to obtain informed consent provided the IRB finds and documents that: (1) The research involves no more than minimal risk to the subjects) (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects; (3) The research could not practicably be carried out without the waiver or alteration; and (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

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212 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH BOX A-9 (continued) - 46.1 76(eJ The informed consent requirements in these regulations are not intended to preempt any applicable federal, state, or local laws which require additional information to be disclosed in order for in- formed consent to be legally effective. June 18, 1991: 45 CFR 46, Subpart A Federal Policy for the Protection of Human Sub jects 46.116(c): An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that: (1 ) the research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit service programs; (ii) procedures for obtaining benefits or services under these programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and (2) the research could not practicably be carried out without the waiver or alteration. 46.1 1 6(d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that: [same four conditions as 46.1 1 6(d), Jan. 26, 1 981, Basic HHS Policy] 46.116 (e) [same as 46.116(e), Jan. 26, 1981, Basic HHS Policy]

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TRACING CHANGES INREGULATORYLANGUAGE 213 BOXA-10 Documentation of Informed Consent and Waiver Conditions May 30, 1974: 45 CFR 46, Protection of Human Subjects 46.10. . . The documentation of consent will employ one of the following three forms: (a) Provision of a written consent document embodying all of the basic elements of informed consent. This may be read to the subject or to his legally authorized representative, but in any event he or his legally authorized representative must be given adequate opportunity to read it. This document is to be signed by the subject or his legally authorized representative. Sample copies of the consent form as approved by the committee are to be retained in its records. (b) Provision of a "short form" written consent document indicating that the basic elements of informed consent have been presented orally to the subject or his legally authorized representative. Written summaries of what is to be said to the patient are to be approved by the committee. The short form is to be signed by the subject or his legally authorized representative and by an auditor witness to the oral presentation and to the subject's signature. A copy of the approved summary, annotated to show any additions, is to be signed by the persons officially obtaining the consent and by the auditor witness. Sample copies of the consent form and of the summaries as approved by the committee are to be retained in its records. (c) [to modify procedures (a) or (b) the review committee must establish]: (1 ) that the risk to any subject is minimal, (2) that use of either of the primary procedures for obtaining informed consent would surely invalidate objectives of considerable immediate importance, and (3) that any reasonable alternative means for attaining these objectives would be less advantageous to the subjects. Aug. 14, 1 979: Proposed Regulations Amending Basic HEW Policy. . . 46.1 1 3: Documentation of informed consent. (a) Except as provided in paragraph (b), informed consent shall be documented in writing (and a copy provided to the subject or the subject's authorized representative) through either of the following methods: [essentially the same as in 46.10 (a, b), May 30, 1974, Protection of Human Subjects] (b) The Board may waive the requirement for the researcher to obtain documentation of consent for some or all subjects if it finds (and documents) either:

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214 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH BOX A-10 (continued) (1 ) That the only record linking the subject and the research would be the consent document, the only significant risk would be potential harm resulting from a breach of con- fidentialily, each subject will be asked whether he or she wants there to be documentation linking the subject with the research, and the subject's wishes will govern; or (2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which writ- ten consent is normally required outside of the research context. In many cases covered by this paragraph it may be appro- priate for the Board to require the investigator to provide subjects with a written statement regarding the research, but not to request their signature, or to require that oral consent be witnessed. Jan. 26, 1981: 45 CFR 46, Subpart ABasic HHS Policy. . . 46.1 1 7 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form. (b) Except as provided in paragraph (c) of this section, the consent form may be either of the following: (1 ) A written consent document that embodies the elements of informed consent required by 46.1 16. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it . . IS signec ; or (2) A "short form" written consent document stating that the elements of informed consent required by 46.1 16 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the "short form." (c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: [essentially the same as 46.1 1 2(c), Aug. 14, 1 979, Proposed Regulations Amending HEW Policy]

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TRACING CHANGES INREGULATORYLANGUAGE 215 BOX A-10 (continued) June 18, 1991: 45 CFR 46, Subpart A Federal Policy for the Protection of Human Sub Sects 46.1 1 7 Documentation of informed consent. [same as 46.1 1 7, Jan. 26, 1981, 45 CFR 46, Subpart A Basic HHS Policy]

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216 PROTECTING PARTICIP~ ED FACILITATING SOCIAL ED BEHAVIOR SCIENCES SEARCH BOXA-11 Definition of Minimal Risk May 30, 1974: 45 CFR 46, Protection of Human Subjects 46.3(b) "Subject at risk" means any individual who may be exposed to the possibility of injury, including physical, psychological, or social injury, as a consequence of participation as a subject in any research, development, or related activity which departs from the application of those established and accepted methods necessary to meet his needs, or which increases the ordinary risks of daily life, including the recognized risks inherent in a chosen occupation or field of service. Aug. 14, 1979: Proposed Regulations Amending Basic HEW Policy. . . 46.102(9) "Minimal" risk is the probability and magnitude of harm that is normally encountered in the daily lives of healthy individuals, or in the routine medical, dental or psychological examination of healthy individuals. Jan. 26, 1981: 45 CFR 46, Subpart ABasic HHS Policy. . . 46.102 (9) "Minimal risk" means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. June 18, 1991: 45 CFR 46, Subpart A Federal Policy for the Protection of Human Sub jects 46.102 (i) "Minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.