What is the Common Rule, and how does it affect my research?

The RCCommon RuleFederal policy for the protection of human subjects RC Common Rule is a federal policy that outlines the basic ethical principles and regulatory requirements for research involving human subjects in the United States. Formally known as the Federal Policy for the Protection of Human Subjects, it was initially published in 1991 and underwent significant revisions in 2018 to reflect changes in research practices and technology. The Common Rule applies to research funded or regulated by any federal agency that has adopted it.

For researchers at IU, the Common Rule is central to how the RCInstitutional Review Board (IRB)Compliance policies for human subjects research RC Institutional Review Board (IRB) evaluates research proposals. It affects nearly every aspect of a study involving human subjects, including how participants are recruited, how consent is obtained, how privacy and confidentiality are protected, and how data are collected and shared. For example, the Common Rule requires researchers to obtain informed consent in a manner that is both understandable and voluntary, and to inform participants about how their information will be used, stored, and potentially shared.

The revised Common Rule also introduced new provisions to enhance transparency and reduce administrative burden. These include the use of broad consent for secondary use of identifiable private information and biospecimens, limited IRB review for certain categories of exempt research, and the requirement to post consent forms for certain federally funded clinical trials.  Researchers must ensure that their data management plans, consent forms, and data sharing strategies align with the requirements of the Common Rule, particularly in terms of protecting identifiable information and adhering to ethical standards.

At IU, the IRB, in collaboration with offices such as the RCOffice for Research Compliance RC Office for Research Compliance and RCSecureMyResearchFree resources & consulting to help researchers protect data RC SecureMyResearch , assists researchers in interpreting and applying the Common Rule to their specific projects. Researchers should consult with these offices early in the planning phase to ensure their study protocols are fully compliant. Ultimately, the Common Rule exists to uphold the rights, safety, and welfare of research participants while facilitating responsible and ethical research practices.