Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program

Informed Consent in Research


Respect for persons is a fundamental tenet of ethical human research, as established in the Belmont Report and elsewhere. It is largely operationalized by the informed consent process, which begins with study advertisement and recruitment and typically involves an ongoing dialogue throughout a subject's participation in a research study to help ensure participants' rights and welfare are respected. In many instances, this process involves signing an informed consent form to document that participation is voluntary and required information has been communicated.

Due to research variability (i.e., biomedical; social, behavioral, education (SBE)) and the ever-increasing complexity of human research, challenges related to informed consent have long existed and remain today. Another dimension was introduced on January 19, 2017, when the Office for Human Research Protections, Department of Health and Human Services, and other federal agencies published final amendments ("Final Rule") to the Federal Policy for the Protection of Human Subjects ("Common Rule"). The Final Rule enacts new consent-related requirements in an effort to enhance human subject protections.

Harvard Catalyst Consent Subcommittee

The Harvard Catalyst Regulatory, Ethics, and Law Program Consent Subcommittee is charged with evaluating and recommending best practices and procedures related to the informed consent process. In order to fulfill this charge, the subcommittee will examine common challenges encountered by biomedical and SBE researchers as it pertains to obtaining and documenting informed consent and will develop tools and resources to more efficiently and effectively communicate study information to participants and optimize communication techniques to enhance comprehension among study populations. The subcommittee is intentionally comprised of content experts from a number of member institutions, so that their collective knowledge and experiences will allow the subcommittee to realize this mission and to disseminate this information to the community.


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