The Revised Common Rule and Informed Consent: Broad Consent
While the industry waits for additional guidance on the Revised Common Rule, there are some aspects that are worth taking note now. This is a series of blog posts that address various important changes for research professionals to keep in mind as they implement the Revised Common Rule.
BLOG POST #2 — Broad Consent
One of the significant changes in the Revised Common Rule is the introduction of Broad Consent., a new type of consent intended to serve as a substitute for traditional informed consent in certain circumstances. “Broad Consent” is a very specific term in the revised regulations used to describe a regulatory pathway, and is different from the concept of obtaining consent for future use of information or specimens under the prior regulations.
The new regulations also provide two new exempt categories for the storage, maintenance and research use involving identifiable private information or identifiable biospecimens when broad consent has been obtained.
Broad consent may prove to be problematic, particularly for large medical centers or health care systems, due to the documentation requirements. The regulations stipulate that an IRB cannot waive consent for storage, maintenance, or secondary research use of the identifiable information or identifiable biospecimens if an individual was previously asked to provide broad consent and refused. Such tracking requirements may make broad consent very difficult to implement, and may limit its usefulness.
A Broad Consent Form must contain certain elements in order to be valid. The following elements are unique to broad consent, and must be included:
- A general description of the types of research that may be conducted with the information or biospecimens that a reasonable person would need to make a determination
- A description of the identifiable information or biospecimens that might be used in research, whether sharing might occur, and the types of institutions or investigators that might conduct such research
- A description of the period of time allowed that the information or biospecimen would be stored and maintained or used for research purposes (may be indefinite)
- Statement that the subject or LAR will not be provided details about specific research studies that might be conducted using the information or biospecimens including the purposes of the research and that they might have chosen not to consent to some of those specific research studies
- Results may not be disclosed to subjects
- Contact information for questions about rights and storage and use of the information and specimens, and whom to contact if the event of a research-related harm
These elements are required in every broad consent document, and cannot be waived.
For More On The Revised Common Rule and Informed Consent, see our previous article on Concise Summary