OPRR Requests for Assurances to Comply with
45 CFR 46
To safeguard the rights and welfare of all human research subjects regardless of
location, applicable federal policy requires that each entity involving
human subjects in research must enter into a binding commitment to minimum standards for
protection of human subjects, before such research is begun. The document
containing this binding commitment is called an Assurance. A Single Project
Assurance or SPA is used for an institution and an Agreement for an
Independent Investigator (AII) for an individual without institutional
affiliation.
No federal research that involves human subjects may take place at any site prior
to approval by OPRR of required Assurance documents. As Principal Investigator, it is your
responsibility to ensure that each performance site obtains OPRR approval prior to its
involvement of human subjects. Failure to comply with the requirement for prior approval
may result in fiscal sanctions by the awarding unit.
OPRR identifies those sites that it considers engaged in the research and seeks the
assistance of the PI in identifying others. Each engaged site is in need of an SPA or IIA
for the project. Collaborating institutions that have OPRR-approved Multiple
Project Assurances (MPAs) do not need to provide additional Assurance documents.
However, OPRR strongly recommends that the PI obtain certification of prior IRB review
from each MPA site.
The PI receives a written request from OPRR upon which to act. A copy is forwarded by the
PI to each collaborating site without an applicable MPA, whether identified by
OPRR or not. Each required site prepares its assurance to comply by submission of
the following to the PI who then forwards it to OPRR for approval prior to involvement of
any human subjects in research:
A. Single Project Assurance (SPA) or Agreement for an Independent
Investigator (AII)
B. Institutional Review Board (IRB) membership list (avoid conflicts
with research team)
C. Informed consent document (English translation) -waived
if the designated IRB is of an MPA institution
(MPA institutions can elect to perform IRB
review for others upon request).
Should additional protocols be undertaken subsequent to OPRR approval of the SPA
or AII for this project, OPRR must approve each such protocol for proposed use by the
awardee and all other sites prior to involvement of subjects. Accordingly, for each
protocol (unless reviewed and approved by an MPA IRB), you will be expected to
provide OPRR the following: (1) a copy of each subsequently proposed protocol after IRB
review, (2) an Optional Form 310 (use RTF equivalent of /humansubjects/assurance/as-fm310.htm),
and 3) IRB-approved consent text. Distribution of IRB-approved consent language by the
awardee to other sites for review and use should be subsequent to OPRR approval.
The following OPRR reference materials and preparation aids, amongst others, are
available from the Policy and Assurances Page/polasur.htm
):
1. 45
CFR 46 (regulatory standards)
2. The
Belmont Report (research ethics)
3. Sample
SPA
(use download format from library)
4. Preparation
Aid
5. Pitfalls
to Avoid (SPA prep)
6. Tips on Informed Consent (text
prep)
Additional Page materials are available, as needed, under Guidance
and Educational Materials. The IRB Guidebook covers numerous
general topics. OPRR Reports and OPRR Guidance
cover specific topics which may apply to your project. OPRR Guidance
includes the following:
7. Engagement
(SPA or
AII may be needed)
8. Certificate of Confidentiality
Contacts
9. Use of Another's IRB (review
efficiencies)
Use of Another's IRB
(local issues)
10. Informed
Consent from Non-English
11. HIV Status (two separate
documents)
HIV Status
(two separate
documents)
12. Repositories
Please note that the sample SPA and AII are periodically revised. Please do not
use earlier versions that you may have in your possession. The current SPA sample
may be used by an institution that has its own Institutional Review Board (IRB), as well
as by an institution which uses the IRB of another institution. AIIs are expected to
designate the IRB of another entity.
Basic policy on protection of human subjects is given at Title 45 CFR Part 46, Subpart A.
Subparts B, C and D cover policy regarding human subjects in special categories. IRB
composition is discussed on page 7 under Section 46.107. Performance
sites that do not already possess an IRB may wish to approach a collaborating institution
or other nearby institution with an MPA on file with OPRR (/humansubjects/assurance/cfed-a-c.htm)
to explore reliance upon an existing IRB. The process of informed consent
is discussed on page 9 under Section 46.116.
The SPA must be submitted on organizational letterhead, and must be signed by
the IRB Chair and by institutional official(s) who is (are) empowered to enter into
binding agreements on behalf of the institution(s). The signatory official should not be a voting
member of the IRB. Original signatures and
original documents are required by OPRR. No investigator who is involved in the
project should appear as a voting IRB member without appropriate disqualification from
participation in IRB events which would constitute a conflict of interest.
All blank spaces shown in the SPA sample must be filled in with
appropriate information, such as date of IRB approval. All documents should be identified
with the name of the Principal Investigator and the project/protocol number. Any
deviations from the sample's language should be highlighted for quick identification.
Assurances should be received by OPRR within 30 days of receipt of OPRR's
request letter. The
signatory official should not be a voting member of the IRB. OPRR
Assurance Coordinators are available to provide guidance to applicants and awardees who
reside in states and foreign countries for which they are responsible (/ab-staff.htm). This is
especially important if a project is a multi-site clinical trial.
(05-17-00)
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Updated June 19, 2001