Source: http://history.nih.gov/about/timelines/21cfr56.html
Timestamp: 2014-10-25 13:21:17
Document Index: 32345803

Matched Legal Cases: ['ART 56', 'arts 812', 'art 58', 'arts 312', 'art 16', 'art 20']

[CITE: 21CFR56] [Page 294-302]
PART 56--INSTITUTIONAL REVIEW BOARDS Subpart A--General Provisions Sec.
56.105 Waiver of IRB requirement. Subpart B--Organization and Personnel 56.107 IRB membership. Subpart C--IRB Functions and Operations 56.108 IRB functions and operations.
56.114 Cooperative research. Subpart D--Records and Reports 56.115 IRB records. Subpart E--Administrative Actions for Noncompliance 56.120 Lesser administrative actions.
56.124 Actions alternative or additional to disqualification. Authority: 21 U.S.C. 321, 346, 346a, 348, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-
263n. Source: 46 FR 8975, Jan. 27, 1981, unless otherwise noted. top of page
Subpart A--General Provisions Sec. 56.101 Scope. (a) This part contains the general standards for the composition, operation, and responsibility of an Institutional Review Board (IRB) that reviews clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. Compliance with this part is intended to protect the rights and welfare of human subjects involved in such investigations.
(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. [46 FR 8975, Jan. 27, 1981, as amended at 64 FR 399, Jan. 5, 1999] Sec. 56.102 Definitions. As used in this part:
(a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-392)). [[Page 295]] (b) Application for research or marketing permit includes:
(2) Data and information regarding a substance submitted as part of the procedures for establishing that a substance is generally recognized as safe for a use which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, described in Sec. 170.35.
(4) Data and information regarding a food additive submitted as part of the procedures regarding food additives permitted to be used on an interim basis pending additional study, described in Sec. 180.1.
(12) An Application for an Investigational Device Exemption, described in parts 812 and 813.
(18) Data and information regarding an electronic product submitted as part of the procedures for obtaining a variance from any electronic product performance standard, as described in Sec. 1010.4.
(19) Data and information regarding an electronic product submitted as part of the procedures for granting, amending, or extending an exemption from a radiation safety performance standard, as described in Sec. 1010.5.
(c) Clinical investigation means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58, regarding nonclinical laboratory studies. [[Page 296]] The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for purposes of this part.
(m) IRB approval means the determination of the IRB that the clinical investigation 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. [46 FR 8975, Jan. 27, 1981, as amended at 54 FR 9038, Mar. 3, 1989; 56 FR 28028, June 18, 1991; 64 FR 399, Jan. 5, 1999; 64 FR 56448, Oct. 20, 1999; 65 FR 52302, Aug. 29, 2000] Sec. 56.103 Circumstances in which IRB review is required. (a) Except as provided in Secs. 56.104 and 56.105, any clinical investigation which must meet the requirements for prior submission (as required in parts 312, 812, and 813) to the Food and Drug Administration shall not be initiated unless that investigation has been reviewed and approved by, and remains subject to continuing review by, an IRB meeting the requirements of this part.
(b) Except as provided in Secs. 56.104 and 56.105, the Food and Drug Administration may decide not to consider in support of an application for a research or [[Page 297]] marketing permit any data or information that has been derived from a clinical investigation that has not been approved by, and that was not subject to initial and continuing review by, an IRB meeting the requirements of this part. The determination that a clinical investigation may not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any other applicable regulations to submit the results of the investigation to the Food and Drug Administration.
(c) Compliance with these regulations will in no way render inapplicable pertinent Federal, State, or local laws or regulations. [46 FR 8975, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981] Sec. 56.104 Exemptions from IRB requirement. The following categories of clinical investigations are exempt from the requirements of this part for IRB review:
(d) Taste and food quality evaluations 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. [46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28028, June 18, 1991] Sec. 56.105 Waiver of IRB requirement. On the application of a sponsor or sponsor-investigator, the Food and Drug Administration may waive any of the requirements contained in these regulations, including the requirements for IRB review, for specific research activities or for classes of research activities, otherwise covered by these regulations. top of page
Subpart B--Organization and Personnel Sec. 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, 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 the 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 or professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable catgory of subjects, such as children, prisoners, pregnant women, or handicapped 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 those subjects.
(b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the instituton's consideration of qualified persons of both [[Page 298]] 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.
(f) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB. [46 FR 8975, Jan 27, 1981, as amended at 56 FR 28028, June 18, 1991; 56 FR 29756, June 28, 1991] top of page
Subpart C--IRB Functions and Operations Sec. 56.108 IRB functions and operations. In order to fulfill the requirements of these regulations, each IRB shall:
(c) Except when an expedited review procedure is used (see Sec. 56.110), review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting. (Information collection requirements in this section were approved by the Office of Management and Budget (OMB) and assigned OMB control number 0910-0130) [46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28028, June 18, 1991] Sec. 56.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by these regulations.
(b) An IRB shall require that information given to subjects as part of informed consent is in accordance with Sec. 50.25. The IRB may require that information, in addition to that specifically mentioned in Sec. 50.25, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
(c) An IRB shall require documentation of informed consent in accordance with Sec. 50.27 of this chapter, except as follows:
(1) The IRB may, for some or all subjects, waive the requirement that the subject, or the subject's legally authorized representative, sign a written consent form if it finds that the research presents no more than minimal risk of [[Page 299]] harm to subjects and involves no procedures for which written consent is normally required outside the research context; or
(g) An IRB shall provide in writing to the sponsor of research involving an exception to informed consent under Sec. 50.24 of this chapter a copy of information that has been publicly disclosed under Sec. 50.24(a)(7)(ii) and (a)(7)(iii) of this chapter. The IRB shall provide this information to the sponsor promptly so that the sponsor is aware that such disclosure has occurred. Upon receipt, the sponsor shall provide copies of the information disclosed to FDA. [46 FR 8975, Jan. 27, 1981, as amended at 61 FR 51529, Oct. 2, 1996] Sec. 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. (a) The Food and Drug Administration 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.
(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 reviewer(s) 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 IRB chairperson from among the 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 review procedure set forth in Sec. 56.108(c).
(d) The Food and Drug Administration may restrict, suspend, or terminate an institution's or IRB's use of the expedited review procedure when necessary to protect the rights or welfare of subjects. [46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991] Sec. 56.111 Criteria for IRB approval of research. (a) In order to approve research covered by these regulations the IRB shall [[Page 300]] determine that all of the following requirements are satisfied:
(5) Informed consent will be appropriately documented, in accordance with and to the extent required by Sec. 50.27.
(b) When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons, are likely to be vulnerable to coercion or undue influence additional safeguards have been included in the study to protect the rights and welfare of these subjects. [46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991] Sec. 56.112 Review by institution. Research covered by these regulations that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB. Sec. 56.113 Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the Food and Drug Administration. Sec. 56.114 Cooperative research. In complying with these regulations, institutions involved in multi-
institutional studies may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed at avoidance of duplication of effort. top of page
Subpart D--Records and Reports Sec. 56.115 IRB records. (a) An institution, or where appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:
(1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, [[Page 301]] progress reports submitted by investigators, and reports of injuries to subjects.
(6) Written procedures for the IRB as required by Sec. 56.108 (a) and (b).
(7) Statements of significant new findings provided to subjects, as required by Sec. 50.25.
(c) The Food and Drug Administration may refuse to consider a clinical investigation in support of an application for a research or marketing permit if the institution or the IRB that reviewed the investigation refuses to allow an inspection under this section. (Information collection requirements in this section were approved by the Office of Management and Budget (OMB) and assigned OMB control number 0910-0130) [46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991] top of page
Subpart E--Administrative Actions for Noncompliance Sec. 56.120 Lesser administrative actions. (a) If apparent noncompliance with these regulations in the operation of an IRB is observed by an FDA investigator during an inspection, the inspector will present an oral or written summary of observations to an appropriate representative of the IRB. The Food and Drug Administration may subsequently send a letter describing the noncompliance to the IRB and to the parent institution. The agency will require that the IRB or the parent institution respond to this letter within a time period specified by FDA and describe the corrective actions that will be taken by the IRB, the institution, or both to achieve compliance with these regulations.
(c) The parent institution is presumed to be responsible for the operation of an IRB, and the Food and Drug Administration will ordinarily direct any administrative action under this subpart against the institution. However, depending on the evidence of responsibility for deficiencies, determined during the investigation, the Food and Drug Administration may restrict its administrative actions to the IRB or to a component of the parent [[Page 302]] institution determined to be responsible for formal designation of the IRB. Sec. 56.121 Disqualification of an IRB or an institution. (a) Whenever the IRB or the institution has failed to take adequate steps to correct the noncompliance stated in the letter sent by the agency under Sec. 56.120(a), and the Commissioner of Food and Drugs determines that this noncompliance may justify the disqualification of the IRB or of the parent institution, the Commissioner will institute proceedings in accordance with the requirements for a regulatory hearing set forth in part 16.
(d) The Food and Drug Administration will not approve an application for a research permit for a clinical investigation that is to be under the review of a disqualified IRB or that is to be conducted at a disqualified institution, and it may refuse to consider in support of a marketing permit the data from a clinical investigation that was reviewed by a disqualified IRB as conducted at a disqualified institution, unless the IRB or the parent institution is reinstated as provided in Sec. 56.123. Sec. 56.122 Public disclosure of information regarding revocation. A determination that the Food and Drug Administration has disqualified an institution and the administrative record regarding that determination are disclosable to the public under part 20. Sec. 56.123 Reinstatement of an IRB or an institution. An IRB or an institution may be reinstated if the Commissioner determines, upon an evaluation of a written submission from the IRB or institution that explains the corrective action that the institution or IRB plans to take, that the IRB or institution has provided adequate assurance that it will operate in compliance with the standards set forth in this part. Notification of reinstatement shall be provided to all persons notified under Sec. 56.121(c). Sec. 56.124 Actions alternative or additional to disqualification. Disqualification of an IRB or of an institution is independent of, and neither in lieu of nor a precondition to, other proceedings or actions authorized by the act. The Food and Drug Administration may, at any time, through the Department of Justice institute any appropriate judicial proceedings (civil or criminal) and any other appropriate regulatory action, in addition to or in lieu of, and before, at the time of, or after, disqualification. The agency may also refer pertinent matters to another Federal, State, or local government agency for any action that that agency determines to be appropriate. ABOUT