August 27, 1998 [Updated July 21, 2000]
TO: |
Division of Human Subject Protections, OPRR |
FROM: |
Director, Division of Human Subject Protections, OPRR |
SUBJECT: | IRB Knowledge of Local Research Context |
(A) |
OPRR considers the following standards when evaluating the adequacy
of IRBs designated under an institutional Assurance, particularly
when the IRBs are geographically removed from the local research
context. These standards reflect minimum levels of adequacy.
More stringent standards may be required, depending upon the
nature of the proposed research or the relevant research context. |
(1) |
Where the research involves minimal risk to subjects, the IRB
should demonstrate that it has obtained necessary information
about the local research context through written materials or
discussions with appropriate consultants. |
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(2) |
Where the research involves greater than minimal risk to subjects
but (i) the local research context involves no intervention or
interaction with subjects and (ii) the principal risk associated
with the local research context is limited to the potential harm
resulting from a breach of confidentiality, the IRB should (i)
demonstrate that it has obtained necessary information1 about
the local research context through written materials or discussions
with appropriate consultants; and (ii) determine and specifically
document that provisions to protect the privacy of subjects and
maintain the confidentiality of data are adequate. |
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(3) | Where the research involves greater than minimal risk to subjects and item (A)(2) does not apply, the IRB should demonstrate that it has obtained necessary information1 about the local research context through one or more of the following mechanisms, or through other mechanisms deemed appropriate by OPRR for the proposed research and the local research context. |
1 | Necessary information under DHHS regulations includes all of the following: |
(a) |
Personal knowledge of the local research context on the part
of one or more IRB members, such knowledge having been obtained
through extended, direct experience with the research institution,
its subject populations, and its surrounding community. |
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(b) |
Participation (either physically or through audiovisual or telephone conference)
by one or more appropriate consultants in convened meetings of
the IRB. Such consultant(s) should have personal knowledge of
the local research context, such knowledge having been obtained
through extended, direct experience with the research institution,
its subject populations, and its surrounding community. |
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(c) |
Prior written review of the proposed research by one or more
appropriate consultants (see (b) above), in conjunction with
participation (either physically or through audiovisual or telephone conference)
by the consultant(s) in convened meetings of the IRB, when such
participation is deemed warranted either by the consultant(s)
or by any member of the IRB. |
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(d) |
Systematic, reciprocal, and documented interchange between the
IRB and elements of the local research context. Such interchange
should include (i) periodic visits to the research site, occurring
several times per year, by one or more IRB members in order to
obtain and maintain knowledge of the local research context,
including the research institution, its subject populations,
and its surrounding community; (ii) periodic discussion with
appropriate consultants knowledgeable about the local research
context; (iii) regular interaction with one or more designated
institutional liaisons; and (iv) review of relevant written materials. |
(B) | The following standards apply where an institution holding an OPRR-approved Assurance wishes to avoid duplication of effort, in accordance with DHHS regulations at 45 CFR 46.114, by relying upon the IRB review of another Assurance-holding institution: |
(1) |
The review arrangement must be approved in writing by OPRR and
by appropriate officials of the institutions involved. |
|
(2) | The institution relying upon another institution's IRB has a responsibility to ensure that the particular characteristics of its local research context are considered, either (i) through knowledge of its local research context by the reviewing IRB (see (A) above); or (ii) through subsequent review by appropriate designated institutional officials, such as the Chairperson and/or other members of its local IRB. |
(C) |
Regardless of the IRB's geographic location, each institution
holding an OPRR-approved Assurance is expected to maintain a
unified system of protections applicable to all human subjects
research covered under the Assurance. |
(1) |
Each institution remains responsible for safeguarding the rights
and welfare of human subjects within its local research context. |
|
(2) |
Each institution remains responsible for educating the members
of its research community in order to establish and maintain
a culture of compliance with Federal regulations and institutional
policies relevant to the protection of human subjects. |
|
(3) |
Each institution remains responsible for implementation, within
its local research context, of appropriate oversight mechanisms
in order to ensure compliance with the determinations of the
reviewing IRB. |
|
(4) | Where institutions holding an OPRR-approved Assurance engage a separate entity to perform human subject protection activities, OPRR must review and approve those portions of the contract and/or other clarifying documentation detailing responsibilities and implementation mechanisms relevant to such activities. |
(a) |
Such documentation must specify mechanisms to ensure that all
institutional responsibilities under the Assurance are fulfilled
(e.g., procedures for retention and accessibility of records
in accordance with DHHS regulations at 45 CFR 46.115; procedures
for prompt reporting to the IRB of proposed changes in approved
research and for prompt reporting to OPRR of unanticipated problems
in accordance with DHHS regulations at 45 CFR 46.103(b)(4), (5)). |
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(b) | No arrangement may contain disincentives, impediments, or conflicts of interest that may hamper the exercise of the IRB's function or objectivity (e.g., procedures or fee schedules that could discourage prompt reporting to the IRB of proposed changes or unanticipated problems or that could impede the IRB's flexibility to take prompt, objective action where necessary to protect human subjects). |
(c) | In order to avoid real or perceived conflicts of interest, (i) no IRB member may hold an equity interest (e.g., partnership, stock, or profit-sharing) in the organization providing IRB review; (ii) no IRB member may be paid more than reasonable compensation or receive more than reasonable benefits for IRB-related activities; and (iii) no IRB member may receive compensation or benefits under arrangements that could impede or discourage objective decision-making on behalf of human subjects. |
cc: | Dr. Gary Ellis |
Dr. Melody Lin | |
Ms. Michele Russell-Einhorn |