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  1. Clinical Trials and Human Subject Protection

Protection of Human Subjects; Informed Consent; Standards for Institutional Review Boards for Clinical Investigations - [Docket No. 87N-0032]

November 10, 1988

AGENCY: Food and Drug Administration.

ACTION: Proposed rule.

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend (1) its regulations that contain the general standards for any institutional review board (IRB) that reviews clinical investigations regulated by the agency and (2) its regulations that establish general requirements for informed consent of human subjects that participate in such research. The agency intends to conform its regulations to the extent possible to the "Federal Policy for the Protection of Human Research Subjects" (Model Policy) published elsewhere in this issue of the Federal Register. Existing FDA regulations governing protection of human subjects share a common core with the Model Policy and implement the fundamental principles embodied in that policy. The purpose of these proposed amendments is to eliminate certain inconsistencies with the Model Policy.

DATE: Comments by January 9, 1989.

ADDRESS: Written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, Rm. 4-62, 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Bonnie M. Lee, Office of Health Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-1382.

TEXT: SUPPLEMENTARY INFORMATION:

Background

Development of Model Policy

FDA is charged by statute with the obligation of ensuring the protection of the rights, safety, and welfare of human subjects who participate in clinical investigations involving articles subject to section 505(i), 507(d), or 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i), 357(d), or 360j(g)), as well as clinical investigations that support applications for research or marketing permits for products regulated by FDA, including food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. In performance of that obligation, FDA, in the Federal Register, of January 27, 1981, adopted regulations governing informed consent of human subjects (21 CFR Part 50; 46 FR 8942) and regulations establishing standards for the composition, operation, and responsibilities of any IRB that reviews clinical investigations involving human subjects (21 CFR Part 56; 46 FR 8958). At the same time, the Department of Health and Human Services (HHS) also adopted regulations on the protection of human research subjects (45 CFR Part 46). The regulations adopted by FDA in 21 CFR Parts 50 and 56 and by HHS in 45 CFR Part 46 have provided a common framework for clinical investigators, any IRB, and institutions that have been involved in research that is subject to FDA's regulatory requirements or that is funded by HHS.

In December 1981, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research issued its "First Biennial Report on the Adequacy and Uniformity of Federal Rules and Policies, and Their Implementation, for the Protection of Human Subjects in Biomedical and Behavioral Research, Protecting Human Subjects." Included in this report was a recommendation that the regulations issued by HHS (45 CFR Part 46) be adopted as a common core by all Federal departments and agencies, while permitting additions needed by any department or agency that were not inconsistent with these core provisions.

In May 1982, The President's Science Advisor, Office of Science and Technology Policy (OSTP), appointed an Ad Hoc Committee for the Protection of Human Research Subjects, under the auspices of the Federal Coordinating Council for Science, Engineering, and Technology (FCCSET), to respond to the recommendations of the President's Commission. The Committee was composed of representatives and ex-officio members from departments and agencies that conduct, support, or regulate research involving human subjects. The Ad Hoc Committee developed responses to the recommendations of the President's Commission in consultation with OSTP and the Office of Management and Budget (OMB).

The Ad Hoc Committee agreed that uniformity of Federal regulations is desirable to eliminate unnecessary regulations and to promote increased understanding by institutions that conduct federally supported or regulated research involving human subjects. The Ad Hoc Committee developed a model policy which OSTP later modified and, with the concurrence of all affected Federal departments and agencies, published as a proposal in the Federal Register of June 3, 1986 (51 FR 20204). More than 200 written comments were submitted in response to the proposal. These comments were considered by the Interagency Human Subjects Coordinating Committee, a second committee chartered by FCCSET in 1983. This committee is composed of representatives of all Federal departments and agencies that conduct, support, or regulate research involving human subjects. Published elsewhere in this issue of the Federal Register is the final Model Policy.

FDA concurs with the final Model Policy. However, FDA must diverge from § XXXX .101(h) of the final Model Policy with regard to those clinical investigations that take place in a foreign country and are conducted under a research permit granted by FDA. Such investigations must be carried out in accordance with the act, which establishes certain requirements for the conduct of such investigations (see, e.g., 21 U.S.C. 355(i), 357(d)(3), and 360j(g)). For these investigations, FDA does not have the authority to accept the procedures followed in a foreign country in lieu of the procedures required by the act. FDA must also depart from § XXXX .116(d) of the final Model Policy (see 21 CFR 50.20). The act requires that informed consent be obtained from all subjects of clinical investigations except in very limited circumstances (see, e.g., 21 U.S.C. 355(i), 357(d)(3), and 360j(g)(3)(D), which establish requirements for the conduct of clinical investigations for drugs, antibiotic drugs, and medical devices, respectively). FDA does not have the authority under the act to waive this requirement.

Accordingly, the agency is committed to being as consistent with the final Model Policy as it can be, given the unique situation created by the act and the fact that FDA only regulates, and does not support or conduct, research under its regulations. For all these reasons, the agency proposes the following amendments to its regulations in Parts 50 and 56 to conform them to the final Model Policy to the extent permitted by the act. The proposed changes are minor, and FDA believes that they would not require significant modifications in current IRB procedures or operations or in how informed consent is obtained from human subjects who participate in clinical investigations.

Proposed Revisions of FDA's Regulations

Definitions

1. FDA proposes to revise the definition of "minimal risk" in §§ 50.3(l) and 56.102(i) to conform it to the definition in the Model Policy. The current definition in §§ 50.3(l) and 56.102(i) of FDA's regulations states:

"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.

The wording of the definition of "minimal risk" in § -- -- .102(i) of the final Model Policy is slightly different. To make its regulations as consistent as possible with the Model Policy, FDA is proposing to adopt that policy's definition of "minimal risk." Accordingly, FDA is proposing to revise §§ 50.3(l) and 56.102(i) to state:

"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.

FDA believes that the proposed change in wording does not substantively change the current definition of "minimal risk" as it pertains to research regulated by the agency. Rather, it clarifies FDA's current definition.

2. FDA proposes to add to the IRB regulations a definition of "IRB approval," which is included in § -- -- .102(h) of the final Model Policy. The definition of "IRB approval" in proposed new § 56.102(m) is provided to conform FDA's regulations with the Model Policy and for clarification. It is consistent with the agency's policy respecting IRB approval under current Part 56.

Exemptions from IRB Requirement

3. In new § 56.104(d), FDA proposes to add to the list of categories of clinical investigations that are exempt from the requirements for IRB review certain taste and food quality evaluation studies. This exemption is provided in the final Model Policy at § -- -- .101(b)(6), in response to a request from the U.S. Departmen tof Agriculture (USDA), but it is also appropriate for FDA. The exemption would apply only to taste tests and quality evaluation studies of foods that are not adulterated and that contain ingredients that are (1) generally recognized as safe (GRAS) (see 21 CFR Parts 170, 182, 184, and 186), (2) used in accordance with FDA's food additive regulations, or (3) used in accordance with an approval issued by USDA or the Environmental Protection Agency.

IRB Membership

4. FDA is proposing to amend § 56.107(a) in several respects to conform it to the language contained in § -- -- .107(a) of the final Model Policy. First, instead of the current provision in FDA's regulations that specifies that an IRB shall be sufficiently qualified through, among other factors, "* * * the diversity of the members' backgrounds including consideration of the racial and cultural backgrounds of members * * *," the agency proposes to substitute "* * * the diversity of the members, including consideration of race, gender, and cultural backgrounds * * *."

This proposed change would add gender to the considerations of diversity. The addition of gender emphasizes the importance of including both men and women as members of any IRB. FDA considers this change to be necessary in light of the change that it is proposing to make in § 56.107(b), which is discussed in paragraph 5 of this preamble.

In addition, to conform to the language contained in § -- -- .107(a) of the final Model Policy, FDA is proposing to modify the requirement in § 56.107(a) that an IRB that regularly reviews research that involves a vulnerable category of subjects include one or more individuals who are primarily concerned with the welfare of those subjects. FDA is proposing to require only that the institution (or other authority) that establishes the IRB consider including such an individual as a member of such an IRB. FDA expects that, even if it makes this change in its regulations, institutions will continue to appoint individuals to the IRB who are primarily concerned with the welfare of vulnerable subject populations in appropriate situations.

Finally, FDA proposes to add the following examples of vulnerable populations to § 56.107(a): Children, prisoners, pregnant women, or mentally disabled persons. FDA is proposing this change in the regulation to conform it to the final Model Policy and to make clear the types of human subjects that the agency considers to be "vulnerable populations."

5. In current § 56.107(b), FDA provides that an IRB may not consist entirely of men or entirely of women, or entirely of members of one profession. FDA proposes to revise § 56.107(b) to require that:

Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.

This language was developed by OSTP in consultation with the U.S. Department of Justice and is included in § XXXX .107(b) of the final Model Policy to make clear that an individual should not be appointed to an IRB solely because of gender. FDA proposes to revise § 56.107(b) accordingly.

As provided in § 56.107(a), however, in seeking diverse membership on the IRB, the institution must consider both men and women who can contribute to the work of the IRB. Given the ready availability of well-qualified persons of both genders, FDA expects that only rarely, if ever, will an IRB consist solely of men or solely of women.

6. FDA proposes to revise § 56.107(c), which currently requires each IRB to include at least one member whose primary concerns are in nonscientific areas, to conform to the language contained in final § XXXX .107(c) of the Model Policy. As revised, § 56.107(c) would require that each IRB include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. These changes should not affect any IRB that reviews research regulated by FDA. As described in the preamble to the 1981 IRB regulations (46 FR 8966), FDA's current regulations assume that an IRB will include at least one qualified scientist:

* * * FDA emphasizes that § 56.107(a) requires that IRBs have as members persons with the professional competence necessary to review the proposed research. For example, FDA would expect that an IRB that reviews investigational new drug studies will include at least one physician.

FDA expects that institutions will continue to use good judgment and diligence in selecting as IRB members persons who can fulfill the requirements of § 56.107(a), so that persons of varying backgrounds will be included on any IRB to ensure complete and adequate review of the research activities.

Should FDA adopt the proposed amendment, in inspecting any IRB, the agency will continue to review an IRB's composition to ensure that its membership is appropriate for the research it is charged to review and may request that member ship be supplemented if complete and adequate review of the research does not appear possible.

IRB Functions and Operations

To be consistent with the language contained in § XXXX .103(b) (4) and (5) of the final Model Policy, FDA is proposing to remove § 56.108(a) (5) and (c), redesignate current § 56.108(b) as § 56.108(c), and add new § 56.108(b) that would state:

Follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Food and Drug Administration of: (1) Any unanticipated problems or scientific misconduct involving risks to human subjects or others; (2) any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB; and (3) any suspension or termination of IRB approval.

New § 56.108(b) would incorporate the requirements currently included in § 56.108(a) (5) and (c) of FDA's regulations, conform them to the final Model Policy, and respond to recommendations 7 and 8 of the President's Commission concerning scientific misconduct in research involving human subjects, as described in the preamble to the proposed Model Policy (51 FR 20209, 20210). New § 56.108(b) would effect three changes in FDA's regulations.

a. The major change is to require prompt reporting of scientific misconduct involving risks to human subjects or others while allowing institutions the flexibility to develop their own procedures. These procedures must assure that instances of scientific misconduct are promptly reported to the IRB, to appropriate institutional officials, and to FDA. Institutions will, therefore, be afforded flexibility in meeting the requirements of the regulations.

b. The current regulations require that an IRB follow written procedures that ensure prompt reporting to the IRB of unanticipated problems involving risks to subjects or others. Proposed § 56.108(b) would require that an IRB follow written procedures that ensure prompt reporting of unanticipated problems not only to the IRB but also to appropriate institutional officials and FDA.

c. Finally, FDA's current regulations provide that the IRB is responsible for reporting any instance of serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB, and any suspension or termination of IRB approval, to appropriate institutional officials and to FDA. FDA is proposing to require that these responsibilities be reflected in the written procedures of the IRB.

These proposed changes would ensure that the IRB, the institution, and FDA are informed of problems and misconduct based on noncompliance with the regulations. Because of the importance that FDA attaches to ensuring that the IRB, the institution, and FDA are so informed, the agency has tentatively determined that the obligation to notify these bodies should be reflected in the IRB's written procedures.

Expedited Review Procedures for Certain Kinds of Research Involving No More Than Minimal Risk and for Minor Changes in Approved Research

8. FDA proposes to revise § 56.110(b) to conform it to the language contained in § 2.110(b) of the final Model Policy. The first and second sentences of § 56.110(b) currently provide that:

An IRB may review some or all of the research appearing on [a list published in the Federal Register of January 27, 1981; 46 FR 8980] 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.

FDA proposes to revise this language to state:

An IRB may use the expedited review procedure to review either or both of the following: (1) Some or all of the research appearing on the list and found by the reviewers to involve no more than minimal risk, (2) minor changes in previously approved research during the period (of 1 year or less) for which approval is authorized.

FDA believes that this change would not in any way change the substance of the regulation or the circumstances in which expedited review may be used.

Criteria for IRB Approval of Research

9. FDA proposes to revise § 56.111(a)(3) and (b) to conform its regulations to the language contained in § XXXX .111(a)(3) and (b) of the final Model Policy. As discussed below, these proposed revisions would both clarify and reinforce current regulatory requirements.

FDA would retain the current wording in § 56.111(a)(3), but at the end of the provision would add the phrase "and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons."

This proposed addition would conform § 56.111(a)(3) to the language contained in § -- -- .111(a)(3) of the final Model Policy and would reinforce the protections in § 56.107 for vulnerable populations.

FDA is proposing three changes in § 56.111(b) to conform it to the language contained in the Model Policy. The first proposed change would delete the phrase "such as persons with acute or severe physical or mental illness" from the examples given of subjects likely to be vulnerable to coercion or undue influence. Although this category of subjects would no longer be explicitly included in § 56.111(b), FDA would continue to regard these persons as being likely to be vulnerable to coercion or undue influence and would expect an IRB to ensure that appropriate additional safeguards have been included in a study to protect the rights and welfare of such subjects. The second proposed change would clarify which groups of subjects are likely to be vulnerable to coercion or undue influence, by giving examples from § -- -- .111(b) of the final Model Policy. The groups mentioned are children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. The third change that the agency is proposing is to delete the word "appropriate" from the requirement that, where necessary "* * * additional safeguards have been included in the study to protect the rights and welfare of these subjects." FDA expect that any additional safeguards that are recommended in a study would be appropriate to protect the rights and welfare of subjects included in the study, and, therefore, inclusion of the word "appropriate" is unnecessary.

IRB Records

10. FDA is proposing to revise § 56.115(a)(6) to cross-reference proposed § 56.108(b), which would require the IRB to follow written procedures for certain reporting requirements. The agency proposes this change for consistency with the Model Policy and, therefore, considers it to be minor.

Environmental Impact

The agency has determined under 21 CFR 25.24(a)(8) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

Paperwork Reduction Act of 1980

Sections 56.108(b) and 56.115 of this proposed rule contain collection of information requirements subject to approval by the Office of Management and Budget under the terms of the Paperwork Reduction Act. Comments on these requirements should be submitted to FDA's Dockets Management Branch (address above) and to Mr. Richard Eisinger, Office of Management and Budget, Executive Office of the President, Room 3002, New Executive Office Building, Washington, DC 20503.

Economic and Regulatory Assessments

FDA has examined the economic consequences of the proposed amendments to its regulations pertaining to any IRB and to informed consent in accordance with the criteria in section 1(b) of Executive Order 12291 and found that these amendments, if promulgated, would not be a major rule under the Executive Order. The agency also has considered the effect that the proposed rule would have on small entities including small businesses in accordance with the Regulatory Flexibility Act (Pub. L. 96-354). The agency certifies that there will not be a significant economic impact on a substantial number of small entities.

The proposed amendments are intended to being FDA's regulations on informed consent of human subjects that participate in clinical research (21 CFR Part 50) and on general standards for any IRB that reviews clinical investigations regulated by the agency (21 CFR Part 56) into conformance with the Model Policy to the extent possible. The proposed amendments have three kinds of impact.

First, there are nomenclature, definitional, and clarifying changes that do not alter the current usage or meaning of the terms in the regulations. These changes have no impact on IRB functions or operations.

Second, there are two changes that clearly benefit an IRB and the research community in general. One exempts certain taste and food quality evaluation studies from IRB review. The other allows for greater flexibility in determining the composition of any IRB.

Third, there is the change, responding to recommendations in the preamble to the Model Policy, which necessitates adding "unanticipated problems or scientific misconduct" to a list of items that are to be reported to the IRB, the institution, and to the agency, and requires the IRB to adopt and follow written procedures for two responsibilities held under the current regulations. Incorporating these requirements into existing IRB written procedures should require at most a paragraph. The agency does not consider this to be a material burden on any IRB, regardless of size.

Thus, these proposed amendments are considered to have no significant effect, either positive or negative, on the institutions overseeing clinical research.

Request for Comments

Interested persons may, on or before January 9, 1989, submit to the Dockets Management Branch (address above) written comments regarding this proposal. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects

8321 CFR Part 50
Prisoners, Reporting and recordkeeping requirements, Research, Safety.

8321 CFR Part 56
Reporting and recordkeeping requirements, Research, Safety.

Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, it is proposed that Parts 50 and 56 be amended as follows:

PART 50 -- PROTECTION OF HUMAN SUBJECTS

1. The authority citation for 21 CFR Part 50 is revised to read as follows:

Authority: Secs. 201, 406, 409, 502, 503, 505, 506, 507, 510, 513-516, 518-520, 701(a), 706, and 801, Pub. L. 717, 52 Stat. 1040-1042 as amended, 1049-1054 as amended, 1055, 1058 as amended, 55 Stat. 851 as amended, 59 Stat. 463 as amended, 72 Stat. 1785-1788 as amended, 74 Stat. 399-407 as amended, 76 Stat. 794-795 as amended, 90 Stat. 540-560, 562-574 (21 U.S.C. 321, 346, 348, 352, 353, 355, 356, 357, 360, 360c-360f, 360h-360j, 371(a), 376, and 381); secs. 215, 351, 354-360F, Pub. L. 410, 58 Stat. 690, 702 as amended, 82 Stat. 1173-1186 as amended (42 U.S.C. 216, 262, 263b-263n); 21 CFR 5.10.

2. In § 50.3 by revising paragraph (l) to read as follows:

§ 50.3 Definitions.

* * * * *

(l) "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.

* * * * *

PART 56 -- INSTITUTIONAL REVIEW BOARDS

3. The authority citation for 21 CFR Part 56 is revised to read as follows:

Authority: Secs. 201, 406, 408, 409, 501, 502, 503, 505, 506, 507, 510, 513-516, 518-520, 701(a), 706, and 801, Pub. L. 717, 52 Stat. 1040-1042 as amended, 1049-1054 as amended, 1055, 1058 as amended, 55 Stat. 851 as amended, 59 Stat. 463 as amended, 68 Stat. 511-518 as amended, 72 Stat. 1785-1788 as amended, 74 Stat. 399-407 as amended, 76 Stat. 794-795 as amended, 90 Stat. 540-546, 560, 562-574 (21 U.S.C. 321, 346, 346a, 348, 351, 352, 353, 355, 356, 357, 360, 360c-360f, 360h-360j, 371(a), 376, and 381) secs. 215, 301, 351, 354-360F, Pub. L. 410, 58 Stat. 690, 702 as amended, 82 Stat. 1173-1186 as amended (42 U.S.C. 216, 241, 262, 263-263n); 21 CFR 5.10.

4. In § 56.102 by revising paragraph (i) and adding new paragraph (m) to read as follows:

§ 56.102 Definitions.

* * * * *

(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.

* * * * *

(m) "IRB approval" means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements.

5. In § 56.104 by adding paragraph (d) to read as follows:

§ 56.104 Exemptions from IRB requirement.

* * * * *

(d) Taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural 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 Agriculture.

6. In § 56.107 by revising paragraphs (a), (b), and (c) to read as follows:

§ 56.107 IRB membership.

(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.

(b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.

(c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.

* * * * *

7. In § 56.108 by removing paragraph (c), redesignating paragraph (b) as paragraph (c), revising paragraph (a), and adding paragraph (b) to read as follows:

§ 56.108 IRB functions and operations.

* * * * *

(a) Follow written procedures (1) for conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; (2) for determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review; (3) for ensuring prompt reporting to the IRB of changes in a research activity; and (4) for ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects.

(b) Follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Food and Drug Administration of (1) any unanticipated problems or scientific misconduct involving risks to human subjects or others; (2) any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB; and (3) any suspension or termination of IRB approval.

* * * * *

8. In § 56.110 by revising paragraph (b) to read as follows:

§ 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk and for minor changes in approved research.

* * * * *

(b) An IRB may use the expedited review procedure to review either or both of the following: (1) some or all of the research appearing on the list and found by the reviewers to involve no more than minimal risk, (2) minor changes in previously approved research during the period (of 1 year or less) for which approval is authorized. Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the nonexpedited procedure set forth in § 56.108(c).

* * * * *

9. In § 56.111 by revising paragraphs (a)(3) and (b) to read as follows:

§ 56.111 Criteria for IRB approval of research.

(a) * * *

(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

* * * * *

(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.

10. In § 56.115 by revising paragraph (a)(6) to read as follows:

§ 56.115 IRB records.

(a) * * *

(6) Written procedures for the IRB as required by § 56.108 (a) and (b).

* * * * *

James S. Benson,
Acting Commissioner of Food and Drugs.

Otis R. Bowen,
Secretary of Health and Human Services.

Dated: August 9, 1988.

[FR Doc. 88-25553 Filed 11-9-88; 8:45 am]

BILLING CODE 4140-01-M

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