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Who Needs to Comply With the Revised Common Rule and What Does It Mean for Informed Consent Forms?

Do I Need to Comply With the Revised Common Rule?

The final revisions to the Common Rule, which governs the use of human subjects in federally funded research, went into effect on January 21, 2019. While most requirements are already in effect, not everyone is sure whether they will need to comply with the changes.

In its simplest interpretation, any institution receiving federal research funding for new studies involving human subjects must follow the new guidance. There are few nuances, however. To determine whether your research project requires compliance, consult the following decision tree and read through the following frequently asked questions (FAQs).

Revised Common Rule Compliance Decision Tree

 

advarra revised common rule decision tree imAGE

                  KEY:       Old Common Rule — Before January 21, 2019

                                Revised Common Rule — After January 21, 2019

Key Changes to the Common Rule*

  • The definition of human subject research has been expanded
  • There are both new and revised exemptions
  • New “limited IRB review” is required for some exemption categories
  • There are new ICF elements
  • Continuing review is not required for minimal risk studies; minimal risk studies will not have an expiration date
  • Grant reviews are no longer required, except for with the Department of Justice (DOJ)
  • Waiver of consent is no longer needed for screening and recruitment purposes
  • Institutional policy may be followed when state law does not define who can be a legally authorized representative (LAR)
  • The option to apply OHRP regulations to non-federally funded research (aka “checking the box”) on the Federalwide Assurance (FWA) is no longer available

    *The complete updated regulations and additional guidance are available from the Office for Human Research Protections (OHRP). 

FAQs on Compliance

The following frequently asked questions provide further detail on applying the various Common Rule regulations. However, the decision is ultimately up to each institutional review board (IRB) to determine how they will apply certain aspects. Be sure to consult with your IRB of record to understand your study’s specific compliance requirements.

  • When does the revised Common Rule apply?
    • The revised Common Rule applies to federally funded research approved on or after January 21, 2019 (exception: DOJ-funded research). It does not apply to FDA-regulated research. However, sponsors of FDA-regulated research may want to include the new key information and consent elements — described in the next section — in their ICFs. Including this information does not transition the study to the revised Common Rule.
  • When does the old Common Rule apply?
    • The old Common Rule applies to federally funded research approved prior to January 21, 2019 and to DOJ funded research regardless of the approval date. It may also be applied to non-federally funded research. Additional sites for studies approved prior to January 21, 2019, may continue to be reviewed under the old Common Rule rather than the revised Common Rule.
  • Which rules apply if a new study is not federally funded or FDA-regulated?
    • IRB policies will vary — some will apply the old Common Rule, some the revised Common Rule, and others may have a different regulatory approach to this type of research altogether.  Consult with your reviewing IRB to understand your specific requirements.
  • When both FDA and the revised Common Rule regulations are governing, which should we follow?
    • The FDA has not revised its regulations to align with the revised Common Rule. So, if you find yourself in a situation where both apply, the FDA regulations should be followed.  However, the FDA will allow the additional consent form information (key information and the four new consent elements) to be included in consent forms for FDA-regulated research, and this information must be included if the study is both FDA-regulated and subject to the revised Common Rule.
  • Can a study approved under the FDA regulations elect to follow the revised Common Rule?
    • FDA-regulated research that is not federally funded may incorporate the consent provisions in the revised Common Rule. Other provisions (such as the new exemptions, changes in continuing review, and the new waiver criteria) cannot be voluntarily applied to FDA-regulated research.
  • Can a study or site that is not subject to the revised Common Rule add the key information section and new elements to their ICF?
    • Yes, studies that are FDA-regulated or approved under the old Common Rule can add the key information and new consent elements to their ICFs. Making these revisions to the ICF will not transition the study to the revised Common Rule.
  • Can a study approved under the old Common Rule transition to the revised Common Rule?
    • Research that is not FDA-regulated may be transitioned to the revised Common Rule. However, IRBs’ policies on transitioning studies will vary, so check with your IRB of record to understand their approach.

What Is Changing With My Study’s Informed Consent?

Many of the revised Common Rule’s changes aim to make informed consent more meaningful, so that research subjects have the necessary information to make informed decisions. In practice, this means many researchers will need to update the way they write their ICFs. Whether or not your research needs to comply with the Common Rule, it’s a good idea to have a general understanding of the updates as it is likely you will encounter ICFs that incorporate them.

Below are a few high points from the revised Common Rule’s ICF requirements regarding the inclusion of a new key information section and new consent elements.

Providing Key Information

The new key information section must be provided in an organized, focused fashion at the beginning of your ICF. The information about your study should be concise yet provide enough detail to help subjects understand why they might or might not want to participate.

The standard practice is to provide the information that a reasonable person would want to have in order to make an informed decision about whether to participate. Consider the following questions when developing the key information for your study’s ICF:

  • What are the main reasons a subject will want to join this study?
  • What are the main reasons a subject will not want to join this study?
  • What is the research question the study is trying to answer? Why is it relevant to the subject?
  • What aspects of research participation in this study are likely to be unfamiliar to a prospective subject, diverge from a subject’s expectations, or require special attention?
  • What information about the subject is being collected as part of this research?
  • What are the types of activities that subjects will do in the research?
  • What impact will participation in this research have on the subject outside of the research? For example, will it reduce options for standard treatments?
  • How will the subject’s experience in this study differ from treatment outside of the study?
  • In what ways is this research novel?

NOTE: If information included in your key information section also satisfies the basic elements or additional elements of informed consent (under 45 CFR 46.116[b] and [c]), this information does not need to be repeated later in the ICF.

Including A New Basic Consent Element

If your research involves the collection of identifiable private information or identifiable biospecimens, your ICF must now include a notice about whether the information and biospecimens collected as part of the current research might be stripped of identifiers and used for future research. To satisfy this requirement, include the information in one of the following statements:

The information and/or biospecimens collected as part of this research may be de-identified for use in future research studies or distributed to another investigator for future research studies without additional informed consent.

OR

The information and/or biospecimens collected as part of this research, even if identifiers are removed, will not be used or distributed for future research studies.

It is important to use caution when implementing the second statement in your ICF, as it can be very challenging to keep subjects’ information or biospecimens from being used for future research. This is not to say the second statement should not be used; you will just need to be extra vigilant to make sure the information/biospecimens are distributed in accordance with the ICF.

Outlining New Additional As-Necessary Consent Elements

Information for the following situations should be included in your ICF only when appropriate:

  • Commercial Profit

A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subjects will or will not share in this profit.

  • Clinically Relevant Results
    A statement whether clinically relevant research results, including individual research results, will be disclosed to subject and, if so, under what conditions.
  • Genome Sequencing
    A statement clarifying, for research involving biospecimens, whether it will involve 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).

The effort to enact the new Common Rule guidance has been a long and drawn out process. Even with the final stages of transition behind us, it will continue to take plenty of communication and patience to fully comply: Many researchers are still working through the final stages of implementation. However, with the help of your IRB, you should be able to understand and navigate these requirements clearly and confidently, doing your part to improve the quality of research and overall experience for study subjects around the world.