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tion's or IRB's use of the expedited review procedure.

gree 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)

$690.110 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 ap pearing 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 8690.108(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 ap proved under the procedure.

(d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an institu

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: (1) 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 extive, in accordance with, and to tent 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.

8 690.112 Review by institution. Research covered by this policy that

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.

8690.115 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, ap proved 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 8690.103(b)(3).

(6) Written procedures for the IRB in the same detail as described in 8690.103(b)(4) and 8 690.103(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)

8690.113 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 department or agency head. (Approved by the Office of Management and Budget under control number 9999-0020)

§ 690.114 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.

8690.116 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 rep resentative. An investigator shall seek such consent only under circumstances

that provide the prospective subject or (8) A statement that participation is the representative sufficient oppor- voluntary, refusal to participate will tunity to consider whether or not to involve no penalty or loss of benefits to participate and that minimize the pos which the subject is otherwise entitled, sibility of coercion or undue influence. and the subject may discontinue parThe information that is given to the ticipation at any time without penalty subject or the representative shall be or loss of benefits to which the subject in language understandable to the sub is otherwise entitled. ject or the representative. No informed (b) Additional elements of informed consent, whether oral or written, may consent. When appropriate, one or include any exculpatory language more of the following elements of inthrough which the subject or the rep- formation shall also be provided to resentative is made to waive or appear each subject: to waive any of the subject's legal (1) A statement that the particular rights, or releases or appears to release treatment or procedure may involve the investigator, the sponsor, the insti risks to the subject (or to the embryo tution or its agents from liability for or fetus, if the subject is or may benegligence.

come pregnant) which are currently (a) Basic elements of informed con unforeseeable; sent. Except as provided in paragraph (2) Anticipated circumstances under (c) or (d) of this section, in seeking in which the subject's participation may formed consent the following informa be terminated by the investigator tion shall be provided to each subject: without regard to the subject's con

(1) A statement that the study in- sent; volves research, an explanation of the (3) Any additional costs to the subpurposes of the research and the ex ject that may result from participation pected duration of the subject's partici- in the research; pation, a description of the procedures (4) The consequences of a subject's to be followed, and identification of decision to withdraw from the research any procedures which are experi and procedures for orderly termination mental;

of participation by the subject; (2) A description of any reasonably (5) A statement that significant new foreseeable risks or discomforts to the findings developed during the course of subiect:

the research which may relate to the (3) A description of any benefits to subject's willingness to continue parthe subject or to others which may rea ticipation will be provided to the subsonably be expected from the research; ject; and

(4) A disclosure of appropriate alter (6) The approximate number of subnative procedures or courses of treat jects involved in the study. ment, if any, that might be advan (c) An IRB may approve a consent tageous to the subject;

procedure which does not include, or (5) A statement describing the ex which alters, some or all of the eletent, if any, to which confidentiality of ments of informed consent set forth records identifying the subject will be above, or waive the requirement to obmaintained;

tain informed consent provided the IRB (6) For research involving more than finds and documents that: minimal risk, an explanation as to (1) The research or demonstration whether any compensation and an ex- project is to be conducted by or subject planation as to whether any medical to the approval of state or local govtreatments are available if injury Oc- ernment officials and is designed to curs and, if so, what they consist of, or study, evaluate, or otherwise examine: where further information may be ob- (1) Public benefit of service programs; tained;

(ii) procedures for obtaining benefits or (7) An explanation of whom to con services under those programs; (iii) tact for answers to pertinent questions possible changes in or alternatives to about the research and research sub- those programs or procedures; or (iv) jects' rights, and whom to contact in possible changes in methods or levels the event of a research-related injury of payment for benefits or services to the subject; and

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.

(e) The informed consent requirements in this policy are not intended to preempt any applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be legally effective.

(1) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do So under applicable federal, state, or local law.

resentative adequate opportunity to read it before it is signed; or

(2) A short form written consent document stating that the elements of informed consent required by $690.116 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.

(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

(1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

(2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research. (Approved by the Office of Management and Budget under control number 9999 0020)

(Approved by the Office of Management and Budget under control number 9999-0020)

8690.117 Documentation of informed

consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.

(b) Except as provided in paragraph (c) of this section, the consent form may be either of the following:

(1) A written consent document that embodies the elements of informed consent required by $690.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the rep

8 690.118 Applications and proposals

lacking definite plans for involvement of human subjects. Certain types of applications for grants, cooperative agreements, or contracts are submitted to departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activi

approve or disapprove the application or proposal, or enter into negotiations to develop an approvable one.

$690.121 (Reserved)

$690.122 Use of Federal funds.

Federal funds administered by a department or agency may not be expended for research involving human subjects unless the requirements of this policy have been satisfied.

8690.123 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.

ties such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. These applications need not be reviewed by an IRB before an award may be made. However, except for research exempted or waived under 8690.101 (b) or (i), no human subjects may be involved in any project sup ported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the department or agency. 8690.119 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 subjects 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

(b) In making decisions about sup porting 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 ap plicant 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).

8690.124 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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