Generally, any research project on a sensitive health-related topic that collects names or other identifying characteristics of subjects, and that has been approved by an IRB operating under either an approved Federal-Wide Assurance issued by the Office of Human Research Protections or the approval of the Food and Drug Administration may beeligible for a Certificate. Federal funding is not a prerequisite for an NIH-issued Certificate, but the subject matter of the study must fall within a mission area of the National Institutes of Health or the Department of Health and Human Services. Issuance of Certificates is discretionary.
The following is an illustrative but not exhaustive list of sensitive research topic areas:
- Research on HIV, AIDS, and other STDs;
- Studies that collect information on sexual attitudes, preferences, or practices;
- Studies on the use of alcohol, drugs, or other addictive products;
- Studies that collect information on illegal conduct;
- Studies that gather information that if released could be damaging to a participant's financial standing, employability, or reputation within the community;
- Research involving information that might lead to social stigmatization or discrimination if it were disclosed;
- Research on participants' psychological well being or mental health;
- Genetic studies, including those that collect and store biological samples for future use;
- Research on behavioral interventions and epidemiologic studies.