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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

After several delays, the revised US Federal Policy for the Protection of Human Subjects (also known as the Common Rule) went into effect on January 21. The Common Rule is generally applicable to research conducted or supported by one of the federal departments or agencies that has integrated the rule into its own regulations (e.g., US Department of Health and Human Services (including the National Institutes of Health), US Department of Agriculture, US Department of Defense). Some clinical trial sites may also apply the Common Rule across all clinical research projects, regardless of funding source, through a US Office for Human Research Protections Federal Wide Assurance.

Despite the mandate under the 21st Century Cures Act to harmonize FDA regulations with the Common Rule to the extent practicable and allowable under existing legislative provisions, FDA has yet to propose aligning regulations. Rather, FDA issued guidance titled Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations. As of right now, while FDA is aware of new inconsistencies between its human subject regulations and the revised Common Rule, the agency has advised that when a given study is subject to both sets of regulations, the rule that offers greater human subject protection should be applied. The guidance sets forth FDA’s position on the following areas of potential discrepancies between the Common Rule and FDA regulations:

  • Informed Consent: While the revised Common Rule has changed the content and format requirements for the informed consent document, FDA states that the changes are not inconsistent with FDA’s current informed consent policies and guidances, and thus two separate informed consent forms are not necessary to comply with the Common Rule and FDA regulations. Notably, FDA already proposed a rule and issued guidance generally consistent with the Common Rule regulations that permit institutional review boards (IRBs) to waive or modify informed consent documents for certain clinical investigations presenting minimal risk (see our prior post, Waive Goodbye to Some FDA Informed Consent Requirements, and prior LawFlash, FDA Clarifies Consent Requirements for Certain Minimal Risk Clinical Investigations).
  • Expedited Review: The revised Common Rule modifies the conditions for expedited IRB review (i.e., IRB review carried out by the IRB chairperson or designee only). Under the revised Common Rule, if the investigation involves research categories deemed eligible for expedited review in the HHS/FDA 1998 list, an IRB may use expedited procedures unless the reviewer determines that the study involves more than minimal risk (i.e., there is a presumption that the research is minimal risk). Under FDA’s rules, however, expedited review may only be used if the reviewer finds that the research involves no more than minimal risk (i.e., there must be an IRB minimal risk determination). As a result of this difference, IRB reviewers must continue to apply this higher standard (and associated documentation requirements) when determining the applicability of expedited review for FDA-regulated studies.
  • Continuing Review: Under the revised Common Rule, continuing review (i.e., review of research at intervals appropriate to a study’s degree of risk, and at least annually) is no longer required in certain circumstances, such as when research is eligible for expedited review. FDA, however, will continue to require IRB continuing review.

FDA stated in the guidance that the agency will issue rules in the future to harmonize, to the extent applicable, its regulations with the new Common Rule. The timing around issuance of the new rules remains unclear, particularly in light of the partial government shutdown.

Until FDA harmonizes its rules, clinical investigations for FDA-regulated products that are also subject to the Common Rule will continue to be subject to differing and sometimes inconsistent obligations for the protection of human subjects. Sponsors, investigators, and IRBs should ensure that they understand what regulations apply to their clinical investigations and, if both apply, follow the regulations that offer greater human subject protection.