Informed consent shows respect for personal autonomy and is an important ethical requirement in research. Even if consent is not legally required in a specific circumstance, researchers should consider the best way to engage participants in order to respect their autonomy.
With limited exceptions, the Common Rule mandates that researchers obtain informed consent for federally funded research involving "a living individual about whom an investigator conducting research obtains data through direct intervention or interaction with the individual, or identifiable private information." Research funded by the United States Department of Health and Human Services (HHS) is also subject to the remaining portions of 45 CFR 46, which pertain to pregnant women, fetuses and neonates (Subpart B), prisoners (Subpart C), children (Subpart D) and Institutional Review Boards (IRBs) (Subpart E).
In addition, the Food and Drug Administration (FDA) regulations require informed consent for private and federally funded clinical research involving drugs, biological products, and devices. FDA regulations and requirements regarding informed consent closely align to the Common Rule regulations with a few differences, including specific situations under which consent may be waived. Some of these situations include research involving military personnel or involving data that would be identifiable only by linking data to the consent form. The FDA provides a comparison chart of the FDA and current HHS human subject protection regulations.
The Health Information Portability and Accountability Act (HIPAA) Privacy Rule mandates that researchers working within HIPAA 'covered entities' obtain patient/participant authorization to use or disclose individually identifiable health information for purposes other than clinical care or billing. Some human subjects research is conducted at institutions that are not subject to HIPAA (including federal labs), but there are portions of the Privacy Rule that may apply; to understand how the Privacy Rule might apply, researchers should check with institutional officials.
Not all research that involves human samples or data requires informed consent. According to the current definition of "human subject" in the Common Rule, informed consent for use of de-identified samples and data (such as those that are often stored in biobanks and data repositories for unspecified future research use), or for stored samples and data from people who are deceased is not required. Also, in some cases, the requirement for informed consent for research using samples and data from human subjects may be waived. IRBs can grant waivers when certain conditions are met, including that the research poses minimal risks or seeking consent is impractical. The HHS Office for Human Research Protections (OHRP) has developed useful decision trees for determining whether consent requirements may be waived.
For some research, while informed consent is not required by federal regulations, it may still be appropriate. Institutions, IRBs, federal funding agencies, or other governance bodies may require or expect consent in some of these cases. In particular, NIH, under the NIH Genomic Data Sharing (GDS) policy, expects that researchers generating large-scale human genomic data use specimens or cell lines for which consent was obtained for future research purposes and broad sharing.
Additionally, research on information from deceased individuals who did not provide consent before death is legally permissible under HIPAA and the Common Rule. However, the Privacy Rule requires authorization by a legally defined personal representative for disclosure of individual health information, including individual research results. It is generally viewed as ethically appropriate to continue to respect any known preferences of a research participant (e.g., as articulated in an advance directive) and/or conditions that were described in a consent form, even after that research participant has died. It is important to consider whether prior consent or consent from surrogates can and should be sought, even if not explicitly required by regulations, and how the interests of participants and surviving relatives will be protected if informed consent cannot be obtained.
Often, samples, genomic data, and health information collected during routine clinical care are stored and used for research, consistent with the current requirements of the Common Rule. Typically, research requires participants to choose to participate actively ("opt-in"). However, "opt-out" approaches assume a default of inclusion, whereby people must actively decline in order to not be included. In some opt-out structures, patients are actively given the option to decline to have their de-identified clinical samples used in research, though this is not required by regulations. Education and notification serves to promote participant autonomy. Whether the consent process is opt-in or opt-out, the plans for future use, and governance over research use of clinical specimens should be transparent.
Before proceeding with your research, you should confirm the relevant expectations for informed consent with your local institutional review board.
