(5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payments for benefits or services under those programs.
This category applies to:
- the projects conducted pursuant to specific federal statutory authority such as programs under the Social Security Act, or other federal statutory public benefit or services programs;
- procedures for obtaining benefits or services under those programs;
- possible changes in or alternatives to those programs or procedures; or
- possible changes in methods or levels of payment for benefits or services under those programs.
- projects for which there is no statutory requirement for IRB review;
- projects that do not involve significant physical invasions or intrusions upon the privacy interests of participants;
- authorization or concurrence by funding agencies that exemption from IRB review is acceptable.
This category of research is narrowly defined and only applies to Social Security Act programs and other public benefit programs that are specifically designated by the Department of Health and Human Services or the Secretary of one of the 19 other Federal Departments which have adopted the Common Rule.
Research and demonstration projects in general (e.g. state funded public service programs) do not fit in this category. Only projects which are conducted under federal statutory authority or the Social Security Act fit under this exemption criterion. OHRP recommends that institutions consult with the investigator's Department of Health & Human Services (HHS) funding agency before determining that a research project meets research category 5.
This category does not apply to FDA regulated research.