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Broad Consent
What is Broad Consent?
Broad consent enables the research team to retain, manage, and reuse identifiable or re-identifiable private information or biospecimens for future research projects that are not specifically defined at the time of the initial study, with the participants' agreement.
Requirements for Obtaining Broad Consent
- Broad consent is an additional process beyond the informed consent process and form.
- Broad consent cannot be required to participate in a research study.
- If a participant or their legally authorized representative is asked to provide broad consent, the following must be provided to them:
- A description of the identifiable private information or identifiable biospecimens that might be used in research
- Whether sharing of identifiable private information or identifiable biospecimens might occur
- The types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimen
- A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research to be conducted.
- A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which period of time could be indefinite).
- Unless the participant or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the subject's identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies.
- Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the participant in all circumstances, a statement that such results may not be disclosed to the subject.
- An explanation of whom to contact for answers to questions about the participant’s rights and about storage and use of their identifiable private information or identifiable biospecimens, and whom to contact in the event of research-related harm.
- When a researcher implements Broad Consent, they must track which participants provided Broad Consent and which did not as participant may revoke their Broad Consent in the future (if possible).
- For Broad Consent that involves biospecimens:
- A statement that the participant’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit
- Whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).