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eliminate apparent inmediate hazards to the Subject. (5) Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department Or agency head of (i) any unanticipated problems involving risks to subjectS or others or any serious or Continuing noncompliance with this policy or the requirements or determinations of the IRB and (ii) any suspenSiOn Or termination of IRB approval. (c) The assurance shall be executed by an individual authorized to act for the institution and to assume on behalf of the institution the obligations inposed by this policy and shall be filed in Such form and manner as the department or agency head prescribes. (d) The department or agency head will evaluate all assurances Submitted in accordance with this policy through such officers and employees of the department Or agency and such experts or consultants engaged for this purpose as the department Or agency head determines to be appropriate. The department or agency head’s evaluation will take into consideration the adequacy Of the proposed IRB in light. Of the anticipated Scope of the institution’s reSearch activities and the types of Subject populations likely to be involved, the appropriateness of the proposed initial and COntinuing review procedures in light of the probable risks, and the size and complexity of the institution. (e) On the basis of this evaluation, the department or agency head may approve or disapprove the assurance, or enter into negotiations to develop an approvable one. The department or agency head may limit the period during which any particular approved asSurance or class of approved assurances shall remain effective or otherwise Condition Or restrict approval. (f) Certification is required when the research is supported by a federal department or agency and not otherwise exempted or waived under $27.101 (b) or (i). An institution with an approved assurance shall certify that each application or proposal for research covered by the assurance and by $27.103 of this Policy has been reviewed and approved by the IRB. Such certification must be submitted with the application or pro

posal or by such later date as may be prescribed by the department or agency to which the application or proposal is Submitted. Under no condition shall research covered by $27.103 of the Policy be Supported prior to receipt of the Certification that the research has been reviewed and approved by the IRB. Institutions without an approved assurance covering the research shall certify within 30 days after receipt of a request for such a Certification from the department or agency, that the application or proposal has been approved by the IRB. If the Certification is not submitted within these time limits, the application or proposal may be returned to the institution.

(Approved by the Office of Management and Budget under Control Number 9999–0020)

[56 FR 28012 and 28019, June 18, 1991, 56 FR 29756, June 28, 1991]

§§ 27.104–27.106 [Reserved]

$27.107 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 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 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 area.S. (d) Each IRB shall include at least One member who is not. Otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. (e) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. (f) An IRB may, in its discretion, invite individuals with Competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.

$27.108 IRB functions and operations.

In Order to fulfill the requirementS Of this policy each IRB Shall:

(a) Follow written procedures in the Same detail as described in § 27.103(b)(4) and, to the extent required by, $27.103(b)(5).

(b) Except when an expedited review procedure is used (see $27.110), 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.

$27.109 IRB review of research.

(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or dis

approve all research activities covered by this policy. (b) An IRB shall require that information given to Subjects as part of informed consent is in accordance with $27.116. The IRB may require that information, in addition to that specifically mentioned in $27.116, 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 or may waive documentation in accordance with $27.117. (d) An IRB shall notify investigators and the institution in Writing Of its decision to approve or disapprove the proposed research activity, or of modifications required to Secure IRB approval Of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. (e) An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to obServe Or have a third party observe the consent process and the research.

(Approved by the Office of Management and Budget under Control Number 9999–0020)

$27.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

(a) The Secretary, HHS, has established, and published as a Notice 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 after consultation with other departments and agencies, through periodic republication by the Secretary, HHS, in the FEDERAL REGISTER. A copy of the list is available from the Office for Protection from Research Risks, National Institutes of Health, HHS, Bethesda, Maryland 20892.

(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 one 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 non-expedited procedure Set forth in § 27.108(b).

(c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of reSearch proposals which have been approved under the procedure.

(d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an institution’s or IRB's use of the expedited review procedure.

$27.111 Criteria for IRB approval of research.

(a) In order to approve research COVered by this policy the IRB shall determine that all of the following requirements are Satisfied:

(1) Risks to subjects are minimized: (i) By using procedures which are Consistent with sound research design and which do not unnecessarily expose Subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if

not participating in the research). The IRB should not consider possible longrange effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. (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. (4) Informed Consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by $27.116. (5) Informed consent will be appropriately documented, in accordance with, and to the extent required by $27.117. (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the Confidentiality of data. (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.

$27.112 Review by institution.

Research covered by this policy 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.

$27.113 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 requirement.S 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 department or agency head.

(Approved by the Office of Management and Budget, under Control Number 9999–0020)

$27.114 Cooperative research.

Cooperative research projects are those projects covered by this policy which involve more than one institution. In the conduct of Cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human Subjects and for complying with this policy. With the approval of the department Or agency head, an institution participating in a COOperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort.

$27.115 IRB records.

(a) An institution, Or when 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, progress reports Submitted by investigators, and reports of injuries to Subjects.

(2) Minutes Of IRB meetings which Shall be in Sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.

(3) Records of Continuing review activities.

(4) Copies of all correspondence between the IRB and the investigators. (5) A list of IRB members in the same detail as described is $27.103(b)(3). (6) Written procedures for the IRB in the Same detail as described in $27.103(b)(4) and $27.103(b)(5). (7) Statements of significant new findings provided to subjects, as required by $27.116(b)(5). (b) The records required by this policy shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records shall be accesSible for inspection and copying by authorized representatives of the department Or agency at reasonable times and in a reasonable manner.

(Approved by the Office of Management and Budget under Control Number 9999–0020)

§ 27.116 General requirements for informed consent.

Except as provided elsewhere in this policy, no investigator may involve a human being as a Subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the Subject’s legally authorized representative. An investigator Shall seek Such Consent only under Circumstances that provide the prospective subject or the 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 representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive Or appear to waive any of the Subject’s legal rights, or releases or appears to release the investigator, the Sponsor, the institution or its agents from liability for negligence.

(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: (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) A description of any benefits to the subject or to others which may reasonably be expected from the research; (4) A disclosure of appropriate alternative procedures Or Courses of treatment, if any, that might be advantageous to the subject; (5) A Statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury OCcurs and, if so, what they COnsist Of, or where further information may be Obtained; (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 (8) 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. (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) Anticipated circumstances under which the Subject’s participation may be terminated by the investigator

without regard to the subject’s conSent; (3) Any additional costs to the subject that may result from participation in the research; (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject; (5) A statement that Significant new findings developed during the Course of the research which may relate to the subject’s willingness to continue participation will be provided to the Subject; and (6) The approximate number of subjects involved in the Study. (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 of service programs; (ii) procedures for obtaining benefits or Services under those 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. (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: (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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