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Appendix A: Tracing Changes in Regulatory Language
Pages 191-216

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From page 191...
... Appendices
From page 192...
... The panel discussed the desirability of recommencling that a formal appeals process be adcled to the human participant protection process. Such a provision would provide a recourse to an investigator who believed that IRB-required changes woulc!
From page 193...
... ) , August 14, 1979; 45 CFR 46, January 26, 1981; 45 CFR 46, June 18, 1991; suggested revisions to the IRB expedited review list, November 10, 1997; expedited review list, November 9, 1998.
From page 194...
... 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.
From page 195...
... 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.
From page 196...
... June 18, 1991: 45 CFR 46, Subpart A Federal Policy for the Protection of Human Sub jects [Same as Jan.
From page 197...
... (3) Research involving solely the use of standard educational diagnostic, 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.
From page 198...
... 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.
From page 199...
... , survey procedures, interview procedures or observation of public behavior, unless: (i) information 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 criminal or civil liability or can be damaging to the subjects' financial standing, employability, or reputation.
From page 200...
... (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.
From page 201...
... June 18, 1991: 45 CFR 46, Subpart A—Federal Policy for the Protection of Human Subjects 46.1 1 0(a) [essentially the same as Jan.
From page 202...
... (D) The expedited review procedure may not be used for classified research involving human subjects.
From page 203...
... (5) Informed consent will be sought from each prospective subject or his or her legally authorized representative, in accordance with and to the extent required by 46.1 12.
From page 204...
... June 18, 1991: 45 CFR 46, Subpart A Federal Policy for the Protection of Human Sub jects 46.111 (a) [essentially same as Jan.
From page 205...
... 46.11 1 (b) When some or all of the subjects are likely to be vulnerable to coercion or undue, influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
From page 206...
... 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....
From page 207...
... 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)
From page 208...
... 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.
From page 209...
... Aug. 14, 1979: Proposed Regulations Amending Basic HEW Policy.
From page 210...
... : 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)
From page 211...
... 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)
From page 212...
... 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 )
From page 213...
... 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.
From page 214...
... 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.
From page 215...
... [same as 46.1 1 7, Jan. 26, 1981, 45 CFR 46, Subpart A Basic HHS Policy]
From page 216...
... 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.


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