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US FDA Clarifies Human Subject Requirements for Clinical Investigations

Regulatory Updates | Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • New US FDA guidance clarifies compliance requirements for clinical trial sponsors, investigators and IRBs whose studies fall under both agency and Department of Health and Human Services (HHS) requirements.
  • The guidance focuses on differences in human subject protection requirements between HHS and FDA clinical investigation regulations.
  • FDA is currently updating its clinical regulations to better align with HHS requirements regarding human subject safety and informed consent issues.

New guidance from the US Food and Drug Administration explains how its clinical investigation requirements pertaining to human subject protection policies correspond to US federal policy on human subject protections enforced by the Department of Health and Human Services (HHS).

The guidance is intended to explain how sponsors whose medical device and pharmaceutical clinical investigations must meet both FDA clinical investigation regulations for human subject safety and informed consent as well as HHS’s “Common Rule” for human subject protections should address compliance issues.

In general, the guidance recommends that in instances where FDA regulations differ from Common Rule requirements, “the greater protection to human subjects should be followed.”

Harmonizing HHS Common Rule and FDA requirements

The US 21st Century Cures Act, passed in December 2016, requires HHS to harmonize its own human subject requirements with those of FDA, which HHS oversees. Harmonization is meant to reduce compliance burdens and confusion for sponsors, investigators and Institutional Review Boards (IRB).

To this end, HHS has issued final rules revising its Common Rule, but these changes have resulted in additional differences between HHS and FDA human subject-related regulations. Until FDA completes and finalizes revisions to its own clinical investigation regulations, the new guidance is meant to serve as a reference for affected stakeholders.

Informed consent rule changes

The HHS Common Rule revisions, referred to as 2018 Requirements, include updates to informed consent rules regarding content and organization of forms as well as basic and additional elements of consent, according to the guidance. FDA states that these new requirements do not deviate from the agency’s own informed consent processes, obviating the need for affected sponsors to develop two separate informed consent forms to comply with HHS and FDA rules.

Expedited review policies

Under current FDA rules, IRBs may conduct expedited reviews of certain types of clinical research so long as only “minimal risk” is posed. The agency has identified types of research that qualify for expedited IRB review in a list published in 1998.

The HHS 2018 Requirements also allow IRBs to utilize expedited reviews in minimal-risk situations, but FDA stipulates that IRBs must still refer to the agency’s 1998 list to determine whether a clinical investigation subject to both HHS and FDA oversight qualifies for expedited review.

IRB continuing review requirements

A third difference between new HHS 2018 Requirements and FDA clinical regulations involves rules that IRBs perform continuing reviews of clinical investigations at intervals defined by level of risk.

Although the 2018 Requirements do away with IRB continuing review rules, FDA still enforces such requirements. Thus, IRBs involved in clinical investigations that fall under both HHS and FDA purviews must still meet continuing review requirements until FDA revises its pertinent regulations.

Additional US FDA clinical and medical device resources from Emergo by UL:

 

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