Department of Health and Human Services (45 CFR 46)
Federal Policy for the Protection of Human Subjects (aka “Common Rule”)
Except for Department of Defense and Federal Drug Administration studies, this federal law applies to all institutions receiving federal funds. This law governs the way in which institutions and researchers (funded and unfunded) conduct and manage human subject studies. Institutions may certify their commitment to the Common Rule’s principles of ethical research conduct by seeking a Federal-wide Assurance (FWA) from the Office of Human Research Protections (DHHS). Our Federal-wide Assurance Number is FWA00013541.
Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
The HIPAA Privacy Rule establishes conditions under which a covered entity may use or disclose protected health information. This includes defining the means covered entities pursue to inform individuals of the uses and disclosures of their medical information for research purposes, and their rights to access information held by the covered entities.
Department of Defense (32 CFR 319)
Human Subjects Protections (aka “DOD Common Rule”)
This policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any Department of Defense department or agency. This includes research conducted by contractors, federal civilian employees or military personnel. The “DOD Common Rule” also regulates human subject research conducted, supported, or otherwise subject to regulation by the federal government outside the United States.
Unique Human Subject Protection Requirements
The Department of Defense has strict requirements an investigator must adhere to before engaging in sponsored research involving members of the American Armed Forces. This handout, created by the Children’s Hospital of Philadelphia, outlines the requirements researchers should consider before pursuing studies involving American military personnel.
Food and Drug Administration
Protection of Human Subjects (21 CFR 50)
This regulation applies to clinical investigations regulated by the Food and Drug Administration under sections of the Federal Food, Drug and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration. These include foods, dietary supplements, ingredients that bear a nutrient content claim, infant formulas, food and color additives, drugs for human use, medical devices, biological products for human use, and electronic products.
Institutional Review Boards (21 CFR 56)
This regulation contains the general standard for the composition, operation and responsibility of the Institutional Review Board (IRB) that reviews clinical investigations regulated by the Food and Drug Administration, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for humans and electronic products.
Resources
An essential document that articulates the fundamental ethical principles which provide the foundation for the DHHS and FDA regulations. This is an essential document to read for all who conduct human subjects research.
The first consensus statement articulating ethical principles to guide the conduct of human subjects research. The World Medical Association updated the Declaration numerous times, most recently in October 2008.
Ethical Considerations for Children
The European Union/European Medicines Agency (EMEA) guidance on ethical conduct of clinical research involving children in pharmaceutical trials.
European Union General Data Protection Regulations
The regulation is an essential step to strengthen individuals’ fundamental rights in the digital age and facilitate business by clarifying rules for companies and public bodies in the digital single market. A single law will also do away with the current fragmentation in different national systems and unnecessary administrative burdens.
International Ethical Guidelines for Biomedical Research involving Human Subjects
The Council for International Organizations of Medical Sciences (CIOMS) Guidelines. This is the link to the pre-publication version of the November 2016 guidelines which cover the conduct of international research. Major changes include an added emphasis on scientific validity and social value, updates to research in low resource environments, changes to the sections addressing the collection, storage and future use of biological specimens, and the sections dealing with pregnant and lactating women.