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III. Information for Institutional Review Boards
1. Memorandum to Institutional Review Boards/Human Subjects Review Committees
MEMORANDUM
TO: Institutional Review Boards/Human Subjects Review Committees
FROM: David R. Weir, Principal Investigator, Health and Retirement Study
RE: Review of Proposals for Analysis of Health and Retirement Study Restricted Datasets
The Health and Retirement Study (HRS) is an ongoing longitudinal survey of Americans over the age of 50, sponsored by the National Institute on Aging (U01 AG09740) with support from the Social Security Administration. HRS makes available to researchers both unrestricted datasets, available to all researchers, and restricted datasets, available only under agreement to researchers who meet rigorous conditions. Unrestricted datasets have been sufficiently purged of identifying information that we believe they pose no significant threat to respondent anonymity. These files are public-use and are distributed via download from our website. Restricted datasets contain information that HRS, and/or the agencies (such as the Social Security Administration) that supplied us data with the permission of respondents, believes increases the potential risk of re-identification of study participants.
It is because of the potential risk of re-identification of participants that we request that you review portions of proposals to use restricted data from HRS, and to do so using the same standards you would use for surveys of live human subjects. Although researchers using HRS restricted datasets are conducting "secondary data analysis", the increased potential risk of re-identification of HRS study participants (who are, for HRS, live human subjects) makes inappropriate the usual "exemption" applied to "secondary analysis" of anonymized datasets.
We request that you review specifically the Restricted Data Protection Plan, and those aspects of the Research Plan that deal with issues of respondent anonymity and data security, if any. By the time they reach you, HRS will have approved these Plans. But we ask for your review because you will be better able to judge the extent to which, in your institution's physical and computing environment, whether the Plans are adequate to ensure participant anonymity and limitation of access to the restricted data to the persons specified in the agreement.
We are not asking that you review the entire Health and Retirement Study. That review has been done by the relevant committees at the University of Michigan and the National Institute on Aging, the primary sponsor of HRS.
If you have any questions about the nature and scope of what we are asking, please feel free to contact:
Cathy Liebowitz
Survey Research Center
Box 1248
Ann Arbor, Michigan 48106-1248
-or-
426 Thompson, Room 3050
Ann Arbor, Michigan 48104-2321phone: 734-763-4180
fax: 734-647-1186
email: catlieb@isr.umich.edu
2. Certification of Human Subjects Review
Certification of Human Subjects Review
Restricted Data Investigator:
________________________________________________
Title of Research Proposal:
________________________________________________
________________________________________________
As chairperson of the Institutional Review Board/Human Subjects
Review Committee of the Institution specified below, I certify
that:
1. our Institutional Review Board/Human Subjects Review
Committee meets requirements established by the Department
of Health and Human Services for Multiple Project Assurances
or Federal-Wide Assurances;
2. our Institutional Review Board/Human Subjects Review
Committee has reviewed, according to its standards and
procedures for live human subjects, and approved, the
Restricted Data Protection Plan (and those portions of
the Research Plan that deal with respondent anonymity
and data security, if any), approved by the Health and
Retirement Study, of the Restricted Data Investigator
above; and has approved those plans.
__________________________________
Signature Date
__________________________________
Typed name
__________________________________
Title
__________________________________
Institution
__________________________________
Building address
__________________________________
Street address
__________________________________
City State ZIPCode
__________________________________
Phone
__________________________________
Fax
__________________________________
email
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