Revised Common Rule requirements for informed consent

The federal regulations for the protection of human subjects (Common Rule) were revised effective January 20, 2019 to reduce administrative burdens for low-risk research while enhancing protections for research participants. These enhanced protections involved changes to the consent process.

The informed consent requirements introduced via the Revised Common Rule are listed below. These requirements apply to the following types of studies reviewed by the UNR IRB:

  • Greater than minimal risk research
  • Research conducted or supported by a federal agency
  • Research involving prisoners or incomplete disclosure or deception

Revised Common Rule requirements for informed consent (45 CFR 46.116)

General Requirements

Reasonable Person Standard

The subject or their legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and opportunity to discuss that information

Key Information

Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might now want to participate in the research. This part must be organized in a way that facilitates comprehension.

Basic Element of Consent

Include one of the following statements if the research involves collection of identifiable private information or identifiable biospecimens:

  • The identifiable private information or identifiable biospecimens may be used for future research or distributed to other researchers without further consent after identifiers have been removed
  • Information or biospecimens will NOT be used for future research even if identifiers are removed

Additional Elements of Consent (required if applicable)

  • 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;
  • A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
  • 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).