Consent Requirements

The revised Common Rule specifies two types of consent to be obtained from research subjects, informed consent and broad consent. However, most research only need to obtain informed consent. To see how they are different, read below. To get detailed information on each, click the links.

Informed Consent

All researchers who collect information or biospecimens from human subjects must provide prospective research subjects with enough information to make an informed decision about whether to participate in a research study. If participants cannot give informed consent, it must be obtained from their legal representatives.

Obtain information on and templates for informed consent

Broad Consent

Broad consent is a new type of consent required under the revised Common Rule (implemented in January 2019) tailored for biomedical researchers. It is only required for researchers who apply under Exempt categories #7 and #8.

Broad consent means that a researcher obtains prospective consent from research subjects for the use of identified private information or identified biospecimens in unspecified future research. If a researcher plans to store or maintain identifiable data or biospecimens for possible secondary research, they must obtain broad consent. If a researcher plans to use identifiable data or biospecimens in secondary research, they must provide proof that broad consent was already obtained.

Obtain information on broad consent