If the archived data will be made publicly available then the research must be prospectively reviewed and approved by the IRB before the research project begins. The IRB requires that the researcher make provisions for obtaining informed consent from all participants and document the process. Participants in oral history projects should be allowed to review the material prior to public archive and decide if they wish any or all of the oral history archived.
Under the terms of 45 CFR 46, Subpart C, prisoners are considered to be members of a vulnerable population and therefore entitled to special protections if they participate in research activities. Subpart C defines both the types of permissible research with prisoners, and the safeguards that must be followed. For additional information, review the regulations.
Yes. As a result, investigators who propose to conduct research at an outside facility need to submit documentation to both Davenport IRB and the IRB for the outside facility.
A Certificate of Confidentiality is issued by a federal agency when protection against compelled disclosure of identifying information about subjects of biomedical, behavioral, clinical, and other research is necessary. For additional information, review the information posted by the federal Department of Health and Human Services (DHHS).
Investigators who are considering submitting an application for a Certificate of Confidentiality are advised to plan well in advance, as the process can be very lengthy. If participation in research is likely to place an individual at risk of criminal liability, the IRB may require that a Certificate be obtained.