Human Subject Protection

All who request the limited access data set 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 limited access data set.

The requester should inform the IRB to review each of the following items in considering approval of the request:

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 the recipient investigators 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?

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.