The Revised Common Rule and Informed Consent: Consent Waivers

The Revised Common Rule has a few important changes regarding consent waivers.

Under the revised Common Rule, broad consent is provided as an alternative to the informed consent requirements for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. If an individual was asked and refused to provide broad consent, the IRB is prohibited from waiving informed consent at a later date for the use of the subject’s identifiable private information or identifiable biospecimens in a secondary study. This means that this information must be tracked. This may be complicated, particularly for larger health care institutions and systems, and therefore the broad consent mechanism may not be widely utilized.

Of note is that the use of the individual’s materials in a nonidentifiable manner in secondary research continues to be permissible, even if there was a refusal to broad consent, since this particular use would not otherwise require a waiver of informed consent since the activity does not constitute research with human subjects.

The Revised Common Rule also adds a new waiver criterion. In order to waiver or alter consent, the IRB must find and document the following:

  • The research involves no more than minimal risk to subjects;
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • The research could not practicably be carried out without the requested waiver or alteration;
  • (New as of January 21, 2019) If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format; and
  • Whenever appropriate, the subjects or legally authorized representative will be provided with additional pertinent information after participation

The term “practicably” has not been clarified in the revised rule.

In the case of recruitment and screening of research subjects, the pre-2018 rule required an IRB to determine that informed consent can be waived under the .116(d) criteria before investigators could record identifiable private information for the purpose of identifying and contacting prospective subjects for a research study. Although not considered a “waiver,” under the new rule, an IRB can approve an investigator’s proposal to obtain information directly from a prospective subject, or to obtain already collected identifiable information or identifiable biospecimens by accessing records or stored biospecimens, for purposes of screening, recruiting, or eligibility assessment, without the informed consent of the prospective subjects.

The Revised Common Rule’s section on waivers or alterations of consent can be complicated, so it is important for research professionals, researchers and IRBs to review the changes and the exceptions.

 

For More On The Revised Common Rule and Informed Consent, see our previous article on Broad Consent

The Revised Common Rule and Informed Consent: Broad Consent

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

The Revised Common Rule and Informed Consent: Concise Summary