Funding and Regulatory Agencies

Depending upon the nature of your research and the agency that funds your research there are a number of other regulations, policies and procedures that may need to be considered. Below is a brief description of selected regulations, regulatory bodies, and funding agencies that may oversee your research. Funding agencies and /or your local IRB offices can also provide guidance on whether any additional requirements apply to a research activity. Hyperlinks will open in a new browser window. Close the new browser window to return here.

Funding Agency / Regulatory Agencies

General Regulations

DHHS

The Department of Health and Human Services (DHHS) is responsible for one group of human subjects federal regulations.

The DHHS 45 Code of Federal Regulations (CFR) Part 46 applies to all human research submitted to or funded by Department of Health and Human Services and is applied to all human research by most large institutions. Subparts include:

  • Subpart A: Basic Federal Policy for the Protection of Human Subjects
  • Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
  • Subpart C: Additional Protections for Prisoners
  • Subpart D: Additional Protections for Children

NIH

The National Institutes of Health include funding agencies that provide federal funding for biomedical research. NIH requires grantees conducting certain types of clinical research studies to have either data safety monitoring plans and/or data safety and monitoring boards. In general NIH policy requires that a Data and Safety Monitoring Board be established for all phase III randomized clinical trials.

(1) NIH Policy for Data and Safety Monitoring .

(2) Policy for the National Cancer Institute for Data and Safety Monitoring of Clinical Trials.

(3) Essential Elements of a Data and Safety Monitoring Plan for Clinical Trials Funded by the National Cancer Institute.

(4) Further Guidance on Data and Safety Monitoring for Phase I and Phase II Trials.

OHRP

The Office for Human Research Protections is the DHHS oversight body that provides guidance to IRBs and investigators conducting human subject research.

OHRP Policy and Assurances guidelines, regulations, ethical principles, IRB Guide Book, OHRP/OPRR Reports, FAQs, and other materials relevant to the protection of human research subjects are available from the Office for Human Research Protections Website.

FDA

The Food and Drug Administration oversees the use of all drugs, devices, biologics, etc. including their use in research with human subjects.

The Food and Drug Administration ( FDA) has numerous regulations directly impacting informed consent. See Guidance documents , information sheets and regulations indirectly impacting IRBs and investigators .

ICH/GCP.
International Conference on Harmonization / Good Clinical Practices.

Human subject research that is conducted in international settings may have additional requirements that must be met such as, International Conference on Harmonization / Good Clinical Practices

Department of Education.

Research that is funded by the Federal Department of Education may have additional requirements that must be met.

Department of Veterans Affairs.

Research involving human subjects recruited from or conducted in a Veterans Affairs facility must also meet the requirements as set forth in the VA Manual 1200.5

Other Federal Agencies.

Each federal agency may have additional policies, procedures, requirements, etc. that must be applied to research involving human subjects. Examples are the Department of Defense , Department of Energy , and National Science Foundation .

Search Kenyon

Website
Directory
Join our path forward.
Give To Kenyon
Loading