Changes in Informed Consent Requirements – 2018 Common Rule

New requirements related to the Informed Consent Document will apply to New Projects and studies that transition to the 2018 Common Rule. Some parts of the consent requirements will only be required if your research is federally funded

New Requirements for Informed Consent (45 CFR 46.116):

  • New General Requirements
    • Reasonable Person Standard Requirements
      • 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 – New Section of Consent
    • 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.
    • This section will only be required in consents for research that is federally funded or supported.
    • Researchers may choose to include this section in any consent that is not federally funded or supported.
  • Informed Consent as a Whole
    • Must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s or legally authorized representative’s understanding of the reasons why one might or might not want to participate.
  • One new 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
              OR
      • Information or biospecimens will NOT be used for future research even if identifiers are removed
    • These statements have been added to the Procedures section of the consent templates and will be required as appropriate regardless of funding.
  • Three new Additional Elements of Consent that are 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).
    • These statements have been added to the Procedures section of the consent templates and will be required as appropriate regardless of funding.