Elements of Broad Consent

Required elements of broad consent:

1. A description of any reasonable forseeable risks or discomforts;
2. A description of any benefits to the participant or others that may reasonable be expected from the research;
3. A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained;
4. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled;
5. If appropriate, a statement that the participant’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit;
6. 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);
7. A general description of the types of research with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect broad consent would permit the types of research conducted;
8. 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, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens;
9. A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which 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 could be indefinite);
10. Unless the participant or their LAR 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 participant’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;
11. Unless it is known that clinically relevant research results, including individual results, will be disclosed to the participant in all circumstances, a statement that such results may not be disclosed to the participant; and
12. An explanation of whom to contact for answers to pertinent questions about the storage and use of  information and specimens, and to voice comments or concerns about participants' rights, and whom to contact in the event of a research-related harm.