Informed Consent Supplement

To Bring Existing, IRB-Approved Documents into Compliance with the Revised Common Rule

The revised Common Rule (45 CFR 46 Subpart A), effective January 19, 2018, introduces additional requirements pertaining to informed consent documents. These new requirements are in two categories:

  • a brief presentation of key information at the beginning of the informed consent document
  • four new required elements of informed consent

IRBMED has developed a supplemental text box to assist researchers in bringing existing, IRB-approved informed consent documents into compliance with these new requirements.

Introductory overview

In accordance with the revised Common Rule (45 CFR 46 Subpart A), informed consent documents 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 not want to participate in the research.” IRBMED has developed a supplemental text box that serves a template to assist you in creating this brief overview. The information in the overview may be addressed in greater detail elsewhere in the document; the purpose of the overview is to begin the informed consent process by introducing potential subjects to key points about participation in your study.

HHS states the following in its summary of the revised Common Rule:

In general, we would expect that to satisfy [this requirement], the beginning of an informed consent would include a concise explanation of the following:

  1. the fact that consent is being sought for research and that participation is voluntary;
  2. the purposes of the research, the expected duration of the prospective subject’s participation, and the procedures to be followed in the research;
  3. the reasonably foreseeable risks or discomforts to the prospective subject;
  4. the benefits to the prospective subject or to others that may reasonably be expected from the research; and
  5. appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the prospective subject.

As a general matter, a brief description of these five factors would encompass the key information most likely to assist a reasonable person (or legally authorized representative) in understanding the reasons why one might or might not want to participate in research. However, we recognize that this determination is necessarily fact-specific and that IRBs and institutions may require that somewhat different (or additional) information be presented at the beginning of an informed consent to satisfy [the requirement].

Additional required elements of consent

The revised Common Rule introduces four new elements of informed consent. The first of these is required for all studies, whereas the other three are required only when appropriate to the particular research at hand.

Per the revised Rule, informed consent documents must contain:

One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:

  1. A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
  2. A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

To comply with the above requirement, include the appropriate statement in the supplemental text box.

The following additional elements of consent are required only when appropriate given the nature of the research at hand:

    • 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).

Address any of these elements of consent, if appropriate to your study, within the supplemental text box.

Click here to return to the Transition to 2018 Regulations page.