SUMMARY:

A new version of the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) “Common Rule”, governing federally funded human research, took effect January 21, 2019. This new guidance is the first update to the regulations since they were published in 1991. The FDA has issued guidance (October, 2018) to help provide direction, stating that it

…intends to undertake notice and comment rulemaking to harmonize, to the extent applicable, FDA’s regulations with the revised Common Rule. Because FDA has not revised its regulations, FDA is issuing this guidance to reduce confusion and burden associated with complying with two different sets of human subject protection regulations.

Consent Forms

Establishes new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process.

• A summary will now be required at the beginning of the consent document, with a concise explanation of the following elements
  • Consent sought for research and participation is voluntary
  • Purpose
  • Reasonable foreseeable risks
  • Benefits to participant or others that may be expected
  • Appropriate alternatives
• The expectation is that the summary will not be more than a few pages in length
• The final rule allows flexibility, such that consent summary may not be required if the actual consent document is relatively brief

Private Information and Biospecimens

Allows the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens. Broad consent will be an optional alternative that an investigator may choose instead of, for example, conducting the research on nonidentified information and nonidentified biospecimens, having an institutional review board (IRB) waive the requirement for informed consent, or obtaining consent for a specific study.

• A researcher may prospectively request a broad consent for unspecified future research from a subject to store, maintain and perform secondary research on identifiable private information and biospecimens
• The pre-2018 rule that investigators can conduct research on biospecimens and data that had been stripped of all identifiers or coded without obtaining consent remains unchanged

New Exempt Categories

Establishes new exempt categories of research based on their risk profile. Under some of the new categories, exempt research would be required to undergo limited IRB review to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens.

• The purpose of these categories is to reduce regulatory burden and help IRBs concentrate on studies that are truly higher risk to participants
• With the establishment of new categories, some exempt categories may require limited IRB review to ensure that there are appropriate privacy safeguards for identifiable private information
• There is a new exempt category involving benign behavioral interventions with adult subjects
  • Benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing
  • Participants must prospectively agree to the intervention and information collection
  • The research may not involve deception (unless subjects are prospectively informed that they will be misled)
  • While interventions and specimen collection is not allowed, collection of sensitive and identifiable data will be allowed
  • This section now includes most surveys, interviews and educational tests in adult research

Single IRB for Multi-Centered Studies

Creates a requirement for U.S.-based institutions engaged in cooperative research to use a single IRB for that portion of the research that takes place within the United States, with certain exceptions. This requirement becomes effective 3 years after publication of the final rule.

• Any federal agency involved in research can determine whether a single IRB is appropriate
• The goal of this change is to allow the IRB to better protect all the participants in a particular study, avoiding multiple IRBs getting involved with the same study

NOTE: The IFR does not delay the compliance date for the cooperative research provision of the revised Common Rule, which remains January 20, 2020

Elimination of Continuing Review for Exempt Research

Removes the requirement to conduct continuing review of ongoing research for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow up in conjunction with standard clinical care.

• This change acknowledges the lower risk profile of studies that fall under expedited review, allowing IRBs to focus on higher risk research

KEY POINTS:

• The Common Rule is established at the federal level
  • State and local IRBs may require additional protections
• The main goal of the regulations is to protect research participants
• The above is a summary of key highlights
  • For further detail see ‘Learn More – Primary Sources’

Learn More – Primary Sources:

Final Revisions to the Common Rule

Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations

Federal Register: Federal Policy for the Protection of Human Subjects

The Common rule, Updated (NEJM)

What do revised U.S. rules mean for human research? (Science)

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