Developing Broad Consent form

BROAD CONSENT

Broad consent is the seeking of prospective consent from subjects to unspecified future research for the storage, maintenance, and secondary research use of private information or identifiable biospecimens. It serves as an alternative, not a waiver, to the standard informed consent requirements for a specific research study. Broad consent can be used under exempt categories 7 and 8.

Broad consent was designed to balance public concerns about the use of biospecimens for research without consent and the importance of advancing science using the wealth of collected data. Broad consent will provide subjects with a choice to say no to storage, maintenance, and secondary research.

Investigators must keep track of which subjects provided broad consent and which subjects refused. Tracking broad consent may require a complex system to tag and track biospecimens and subject consents.

Below is an outline of the broad consent. It can also be downloaded here

Broad Consent

  1. Study Title:
  2. General description of the types of research that may be conducted using the secondary data:
  3. Description of the information or biospecimens that might be used in future research; whether sharing might occur; and the types of institutions or investigators that might conduct research:
  4. Description of the length of time that the information or biospecimens may be stored, maintained, and used:
  5. A statement about whether subjects will or will not be informed of the details of any subsequent research.
  6. A statement that research results either will or will not be disclosed to subjects.
  7. Contact information of the investigator
  8. Elements from the list below to be included as deemed appropriate
    • Risks/Discomfort to human subjects
    • Benefits to human subjects
    • Confidentiality of the data
    • Voluntary participation statement
    • Commercial profit (when appropriate)
    • Whole genome sequencing (when appropriate)