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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 g 690.108(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.

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 $690.116.

(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by $690.117.

(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.

8690.111 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

$690.112 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.

8 690.113 Suspension or termination of

IRB approval of research. An IRB shall have authority to sus pend or terminate approval of research that is not being conducted in accord ance 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 department or agency head. (Approved by the Office of Management and Budget under control number 9999–0020)

mary 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 8 690.103(b)(3).

(6) Written procedures for the IRB in the same detail as described in $690.103(b)(4) and 8690.103(b)(5).

(7) Statements of significant new findings provided to subjects, as required by $690.116(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)

8690.114 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. $690.115 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 sum

$690.116 General requirements for in

formed 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 in- (2) Anticipated circumstances under formed consent the following informa- which the subject's participation may tion shall be provided to each subject: be terminated by the investigator

(1) A statement that the study in- without regard to the subject's convolves research, an explanation of the sent; purposes of the research and the ex- (3) Any additional costs to the subpected duration of the subject's partici- ject that may result from participation pation, a description of the procedures in the research; to be followed, and identification of (4) The consequences of a subject's any procedures which are experi- decision to withdraw from the research mental;

and procedures for orderly termination (2) A description of any reasonably of participation by the subject; foreseeable risks or discomforts to the (5) A statement that significant new subject;

findings developed during the course of (3) A description of any benefits to the research which may relate to the the subject or to others which may rea- subject's willingness to continue parsonably be expected from the research; ticipation will be provided to the sub

(4) A disclosure of appropriate alter- ject; and native procedures or courses of treat (6) The approximate number of subment, if any, that might be advan- jects involved in the study. tageous to the subject;

(c) An IRB may approve a consent (5) A statement describing the ex- procedure which does not include, or tent, if any, to which confidentiality of which alters, some or all of the elerecords identifying the subject will be ments of informed consent set forth maintained;

above, or waive the requirement to ob(6) For research involving more than

tain informed consent provided the IRB minimal risk, an explanation as to finds and documents that: whether any compensation and an ex (1) The research or demonstration planation as to whether any medical project is to be conducted by or subject treatments are available if injury oc to the approval of state or local govcurs and, if so, what they consist of, or ernment officials and is designed to where further information may be ob study, evaluate, or otherwise examine: tained;

(i) Public benefit of service programs; (7) An explanation of whom to con

(ii) procedures for obtaining benefits or tact for answers to pertinent questions services under those programs; (iii) about the research and research sub possible changes in or alternatives to jects' rights, and whom to contact in those programs or procedures; or (iv) the event of a research-related injury possible changes in methods or levels to the subject; and

of payment for benefits or services (8) A statement that participation is under those programs; and voluntary, refusal to participate will

(2) The research could not pracinvolve no penalty or loss of benefits to ticably be carried out without the which the subject is otherwise entitled, waiver or alteration. and the subject may discontinue par

(d) An IRB may approve a consent ticipation at any time without penalty procedure which does not include, or or loss of benefits to which the subject which alters, some or all of the eleis otherwise entitled.

ments of informed consent set forth in (b) Additional elements of informed this section, or waive the requirements consent. When appropriate, one or to obtain informed consent provided more of the following elements of in the IRB finds and documents that: formation shall also be provided to (1) The research involves no more each subject:

than minimal risk to the subjects; (1) A statement that the particular (2) The waiver or alteration will not treatment or procedure may involve adversely affect the rights and welfare risks to the subject (or to the embryo of the subjects; or fetus, if the subject is or may be (3) The research could not praccome pregnant) which are currently ticably be carried out without the unforeseeable;

waiver or alteration; and

(4) Whenever appropriate, the sub- summary shall be given to the subject jects will be provided with additional or the representative, in addition to a pertinent information after participa- copy of the short form. tion.

(c) An IRB may waive the require(e) The informed consent require ment for the investigator to obtain a ments in this policy are not intended signed consent form for some or all to preempt any applicable federal,

subjects if it finds either: state, or local laws which require addi

(1) That the only record linking the tional information to be disclosed in

subject and the research would be the order for informed consent to be le

consent document and the principal gally effective.

risk would be potential harm resulting (f) Nothing in this policy is intended

from a breach of confidentiality. Each to limit the authority of a physician to

subject will be asked whether the subprovide emergency medical care, to the

ject wants documentation linking the extent the physician is permitted to do

subject with the research, and the subso under applicable federal, state, or

ject's wishes will govern; or local law.

(2) That the research presents no (Approved by the Office of Management and more than minimal risk of harm to Budget under control number 9999-0020)

subjects and involves no procedures for 8690.117 Documentation of informed

which written consent is normally reconsent.

quired outside of the research context.

In cases in which the documentation (a) Except as provided in paragraph

requirement is waived, the IRB may re(c) of this section, informed consent

quire the investigator to provide subshall be documented by the use of a

jects with a written statement regardwritten consent form approved by the

ing the research. IRB and signed by the subject or the subject's legally authorized representa- (Approved by the Office of Management and tive. A copy shall be given to the per Budget under control number 9999-0020) son signing the form. (b) Except as provided in paragraph

8 690.118 Applications and proposals (c) of this section, the consent form

lacking definite plans for involvemay be either of the following:

ment of human subjects. (1) A written consent document that Certain types of applications for embodies the elements of informed grants, cooperative agreements, or conconsent required by $690.116. This form tracts are submitted to departments or may be read to the subject or the sub- agencies with the knowledge that subject's legally authorized representa jects may be involved within the period tive, but in any event, the investigator of support, but definite plans would not shall give either the subject or the rep normally be set forth in the applicaresentative adequate opportunity to tion or proposal. These include activiread it before it is signed; or

ties such as institutional type grants (2) A short form written consent doc when selection of specific projects is ument stating that the elements of in the institution's responsibility; reformed consent required by $690.116 search training grants in which the achave been presented orally to the sub- tivities involving subjects remain to be ject or the subject's legally authorized selected; and projects in which human representative. When this method is subjects' involvement will depend upon used, there shall be a witness to the completion of instruments, prior anioral presentation. Also, the IRB shall mal studies, or purification of comapprove a written summary of what is pounds. These applications need not be to be said to the subject or the rep reviewed by an IRB before an award resentative. Only the short form itself may be made. However, except for reis to be signed by the subject or the search exempted or waived under representative. However, the witness 8690.101 (b) or (i), no human subjects shall sign both the short form and a may be involved in any project supcopy of the summary, and the person ported by these awards until the actually obtaining consent shall sign a project has been reviewed and approved copy of the summary. A copy of the by the IRB, as provided in this policy,

pended for research involving human subjects unless the requirements of this policy have been satisfied.

and certification submitted, by the institution, to the department or agency. 8 690.119 Research undertaken with

out the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first be reviewed and approved by an IRB, as provided in this policy, a certification submitted, by the institution, to the department or agency, and final approval given to the proposed change by the department or agency.

$690.120 Evaluation and disposition of

applications and proposals for research to be conducted or supported by a Federal department or agency. The department or agency head will evaluate all applications and proposals involving human subiects submitted to the department or agency through such officers and employees of the department or agency and such experts and consultants as the department or agency head determines to be appropriate. This evaluation will take into consideration the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.

(b) On the basis of this evaluation, the department or agency head may approve or disapprove the application or proposal, or enter into negotiations to develop an approvable one.

$690.123 Early termination of re

search support: Evaluation of appli

cations and proposals. (a) The department or agency head may require that department or agency support for any project be terminated or suspended in the manner prescribed in applicable program requirements, when the department or agency head finds an institution has materially failed to comply with the terms of this policy.

(b) In making decisions about supporting or approving applications or proposals covered by this policy the department or agency head may take into account, in addition to all other eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termination or suspension under paragarph (a) of this section and whether the applicant or the person or persons who would direct or has have directed the scientific and technical aspects of an activity has have, in the judgment of the department or agency head, materially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to federal regulation).

$690.121 [Reserved]
$690.122 Use of Federal funds.

Federal funds administered by a department or agency may not be ex

$ 690.124 Conditions.

With respect to any research project or any class of research projects the department or agency head may impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head additional conditions are necessary for the protection of human subjects.

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