September 2020

As applicable, the Organization will comply with the regulatory requirements of federal departments or agencies if research activity is either funded by or conducted in conjunction with them. Several federal agencies have human subjects regulatory requirements in addition to those set forth by DHHS and FDA. Among the federal entities with such additional requirements for research are the Department of Defense, and the Department of Justice.

It is the responsibility of investigators on human subjects research protocols to conduct federally funded research activities in accord with the requirements of the funding source. JHM IRB review of research will consider the applicable regulations during the review process. Guidance on research funded by or conducted with federal entities is available to researchers.

Guidance regarding the regulatory requirements for these departments may be found at the following links:

• Department of Defense (DoD) Requirements for the Conduct of Human Subjects Research
• Requirements for Conducting Research Funded by the United States Department of Justice

For studies funded by federal departments with additional requirements for research, the JHM IRB staff will confirm that the requirements have been met.