Human Subject Protection
All who request NHLBI's data sets must
comply with the Distribution Agreement for ensuring study subject
confidentiality. The IRB at the institution of each requester is responsible
for determining whether the project satisfies the requirements for protection
of human subjects. The NHLBI cannot accept an IRB letter stating that the
proposed study is exempt from review as there still exists a possibility an
individual could be identified given the large amount of data, and as access to
this data is not available unconditionally to the public but restricted to
those agreeing to the terms of the Distribution Agreements. The IRB, whether
within or outside of the U.S., must operate under the Office of Human Research
Protections (OHRP)approved assurance. The Web Site for OHRP provides
information regarding the process to obtain project assurances (http://www.hhs.gov/ohrp/). Investigators who do not agree to
sign the Distribution Agreement or do not submit an IRB approval will not be
sent the data set.
The requester should inform the IRB to review each of
the following items in considering approval of the request:
- Does the Study's informed consent permit use of
these data for research purposes by investigators who were not part of the
original study?
- If the answer to (1) is no, is the protection of
privacy so great, and the risk to the participants so low, as to merit waiver
of informed consent?
- Have all reasonable personal identifying items
been removed from the data set, or modified appropriately?
- Will the recipient investigators provide
appropriate safeguards for protection of participant privacy?
- Has the recipient investigator signed the data
distribution agreement with the NHLBI pledging to protect confidentiality, not
to contact individuals in any way, and to use the data in the manner specified
in the agreement?
A copy of the IRB approval document, including the
OHRP assurance number, should be sent to the NHLBI along with the signed Data
Distribution Agreement.
These requests are stated below in the form of a memo
to the Institutional Review Board to assist in the IRB's review process.
To: Institutional Review Boards
Re: Considerations for Approval of Studies Involving
Data Provided by the National Heart, Lung, and Blood Institute
The National Heart, Lung, and Blood Institute (NHLBI)
provides data from their epidemiology studies and clinical trials to
researchers interested in further analysis of the data. All obvious and
inadvertent identifiers have been removed from the data sets. However, because
of the comprehensiveness of the data which is provided, there is a potential,
though small, for identification of participants in these studies. Prior to
release of these data the NHLBI requires that the recipient and the recipient's
institution sign a Data Distribution Agreement in which the recipient agrees to
protect the privacy of the individuals, agrees not to contact any individual in
the study, agrees to inform the NHLBI of any breech of privacy, and is informed
of the legal consequences of any violation in the agreement. The NHLBI also
requires that the recipient obtain a review by the recipient's Institutional
Review Board. Because there is the potential for participant identification the
review is NOT exempt. However, an expedited review is permissible.
Yes |
No |
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|
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1. |
Does the
Study's informed consent permit use of these data for research purposes by
investigators who were not part of the original study? |
|
|
2. |
If the
answer to (1) is no, is the protection of privacy so great, and the risk to the
participants so low, as to merit waiver of informed consent? |
|
|
3. |
Have all
reasonable personal identifying items been removed from the data set, or
modified appropriately? |
|
|
4. |
Will
recipient investigator provide appropriate safeguards for protection of
participant privacy? |
|
|
5. |
Has the
recipient investigator signed the data distribution agreement with the NHLBI
pledging to protect confidentiality, not to contact individuals in any way, and
to use the data in the manner specified in the agreement? |
|
|
|