What is Broad Consent?
Broad consent is a new type of informed consent provided under the revised Common Rule (implemented in January 2019) that is tailored for biomedical researchers. It is only required for researchers who apply under Exempt categories #7 and #8.
Broad consent entails a researcher obtaining prospective consent from research subjects for the use of identifiable private information or identifiable biospecimens in unspeci¿ed 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.
Key definitions:
secondary research: re-using identi¿able information and identi¿able biospecimens that are collected for some other ‘‘primary’’ or ‘‘initial’’ activity. For example, medical records, leftover tissue/samples from a hospital’s pathology specimen repository, or excess blood drawn for clinical purposes.
identi¿able biospecimen: a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen”
Some Things to Keep in Mind about Broad Consent
- Researchers can simultaneously obtain informed consent for participation in a current project and broad consent for participation in a secondary, future project. However, they must submit two separate IRB proposals and they must use different consent forms with each research subject, so that research subjects do not confuse the two distinct types of consent.
- Broad consent is not required if the researcher plans to maintain deidentified, anonymous information or biospecimens for possible secondary research.
- The researcher must maintain records of which research subjects gave broad consent and which ones declined, and must submit these records to the IRB so that they can reference them when other researchers apply, in the future, to use the data or biospecimens.
- Broad consent must always be obtained in the form of a signed consent document (options for implied broad consent and verbal broad consent do not exist)
How to Write Broad Consent Forms
- Consent forms/texts/scripts must be clearly written in plain language (typically at an 8th-grade reading level) so participants can fully understand the implications of participating.
- Scientific, medical, and technical terms should be avoided if possible or, if they must be included, clearly defined in simple language.
- If research is to be conducted in a language other than English, copies of the forms/texts/scripts should be provided in that language and English.
Components of Broad Consent Forms
Currently we do not have a template for a broad consent form, but all forms are federally mandated to include the following information:
- A description of any reasonably foreseeable risks or discomforts to the subject;
- A description of any benefits to the subject or to others that may reasonably be expected from the research;
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and
- If appropriate: a statement that the subject'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;
- If appropriate: For research involving biospecimens, 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).
- A general description of the types of research that may be conducted in the future. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted;
- A description of the identifiable private information or identifiable biospecimens that might be used in future research, whether sharing might occur, and the types of institutions or researchers that might conduct this future research
- A description of the period of time that the identifiable private information or identifiable biospecimens may be stored, maintained, and used (the period of time could be indefinite)
- A statement about whether subjects will or will not be informed of the details of any subsequent research
- A statement that research results either will or will not be disclosed to subjects.
- An explanation of whom to contact for answers to questions about the subject's rights and about storage and use of the subject's identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm.
Keeping and Sharing Records of Broad Consent
If a researcher obtains broad consent under Exempt Category #7, they must document it and share it with their institutional IRB. Their records must indicate which research subjects gave broad consent and which ones declined, and these records must be submitted to their IRB so that the IRB can reference these records when other researchers apply, in the future, to use these data or biospecimens. Along with the records, the researchers should resubmit a copy of the broad consent form (the form that had been approved by the IRB at an earlier date).
The Rights on Non-Consenting Research Subjects to be Excluded from Future Research
If a researcher applied to use secondary data or biospecimens under Exempt category #8, they cannot include the information or biospecimens of individuals who declined to give broad consent. If records show that an individual was asked and refused to provide broad consent, the IRB cannot waive informed consent to the use of the subject’s identifiable private information or identifiable biospecimens in a secondary study.