Procedure for Recruiting Volunteers for Investigative Studies

Procedure for Recruiting Volunteers for Investigative Studies from the NIOSH Deepwater Horizon Roster

To facilitate efforts by the many stakeholders interested in meeting the surveillance and research needs of Deepwater Horizon oil spill clean-up workers, NIOSH is establishing a policy that allows qualified researchers to recruit individuals included in the roster for participation in investigative studies. This procedure balances the need for transparency and data utility against NIOSH’s responsibility to protect the privacy of the individuals on the roster.

In order to recruit volunteers for participation in research studies from the roster, investigators must follow these steps:

1. Research Proposal: Submit a research proposal outlining the objectives of the research study or surveillance activity along with documentation of approval from an Institutional Review Board (IRB). The submitted proposal should include its IRB-approved plan for protecting the confidentiality of study participants’ data. The submission should also include an IRB-approved recruitment letter addressed to individuals on the roster that describes the study and provides contact information for the requesting investigator to individuals wishing to participate. The reviewing IRB’s current approved assurance number on file with the Department of Health and Human Services Office of Human Research Protections (OHRP) should be provided. In addition, the submission should contain a letter from the investigator’s University or other organizational entity that demonstrates institutional commitment and adequate allocation of funding.
2. NIOSH Review: Proposals will be reviewed by NIOSH to verify that IRB and other necessary approvals for research (e.g., Office of Management and Budget (OMB) approvals, institutional commitment and funding) have been obtained and that the proposal provides a framework to identify potential disclosure risk.
3. Distribution of Recruitment Letter to Individuals on Roster: If approved, NIOSH will coordinate with the requester for NIOSH to mail a hard copy of the letter, along with a postage paid response card and/or email an electronic copy of the letter to all individuals on the roster. Subjects would respond directly to the researcher if they are willing to participate If a researcher wishes to send subsequent mailings, the same process for letter distribution would be followed.
4. Study Enrollment and Participation: Enrollment and participation of contacted individuals from the Deepwater Horizon Roster who respond to the requester will occur as specified in the project’s IRB-approved protocol.

Requests for use of the roster can be sent to the following NIOSH e-mail address: cdcnioshgulfworker@cdc.gov. Please put “Roster Research Request” in the subject line of the e-mail.