Other U.S. Agencies

There may be additional federal requirements based on the activities’ funding source, including projects funded by:

U.S. Department of Defense

While all units of the Department of Defense (DoD) abide by the Common Rule, including subparts B-D (protections for vulnerable populations of pregnant women, prisoners, and children), some components have unique policies and procedures that reflect the characteristics of the agency (e.g., leadership, culture, risk tolerance, mission) for approving institutions and assuring compliance for their sponsored research.

U.S. Department of Education

There are additional requirements provided by the U.S Department of Education Family Educational Rights and Privacy Act, the Protection or Pupil Rights Amendment, and 34 CFR 356 applicable to human subject research.

U.S. Department of Energy

There are additional requirements that apply to human subject research supported by the U.S. Department of Energy. DOE policy regarding the Protection of Human Subjects is established in the Federal Policy for the Protection of Human Subjects, adopted by DOE June 18, 1991 as Title 10 Code of Federal Regulations (CFR) 745, Protection of Human Subjects and expressed in DOE Policy 443.1A, Protection of Human Subjects, dated December 20, 2007.

U.S. Department of Health and Human Services

Several NIH policy notices provide additional requirements applicable to clinical trials, including registration with clinicaltrials.gov.

All NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials must be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).

The Final NIH Policy on Use of a Single IRB for Multi-Site Research establishes the expectation that all domestic sites participating in multi-site studies involving non-exempt human subjects research funded by NIH will use a single Institutional Review Board

U.S. Department of Justice – National Institute of Justice

The U.S. Department of Justice provides additional requirements when research is conducted within the Bureau of Prisons (BOP). There are also additional requirements codified in 28 CFR 512, such as requirements to obtain approval to conduct research within the BOP and responsibilities of the BOP staff.

There are also additional requirements applicable to research that is funded by the National Institute of Justice (NIJ).

U.S. Environmental Protection Agency

The U.S. Environmental Protection Agency (EPA) provides additional requirements for research conducted or supported by the EPA or if the intention of the research is submission to the EPA.

In addition to Basic EPA Policy for Protection of Subjects in Human Research (40 CFR 26 subpart A), the EPA has promulgated additional requirements in subparts B – Q. These subparts address intentional exposure and observational research of human subjects who are children or pregnant or nursing women and third party human research for pesticides involving intentional exposure.