FDA Guidance Clarifies Agency Regulations v. Revised Common Rule

October 15, 2018

The FDA released new guidance last week on how researchers can comply with both agency regulations and pending Common Rule revisions that protect human subjects in clinical trials.

The guidance focuses on requirements for informed consent, expedited review procedures and IRB continuing review. It says new requirements for informed consent documents in the revised Common Rule — the baseline body of regulations across federal departments and agencies for human subjects in clinical research — don’t conflict with any FDA regulations. But the agency says IRBs still have to comply with its regulations for expedited and continuing reviews.

IRBs must conduct continuing reviews of research at least once a year at “intervals appropriate to the degree of risk,” the guidance says. For expedited review procedures, IRBs must adhere to the 1998 list for FDA-regulated clinical investigations, including those subject to both HHS and FDA regulations.

David Borasky, vice president of quality management for the Copernicus Group Independent Review Board, says this is essentially business as usual, noting the guidance doesn’t reveal anything new about the FDA’s plans for harmonization between agency regulations and the Common Rule revisions.

“This is the consistent message from FDA since the Common Rule revisions were published almost two years ago,” he tells CenterWatch.

The bottom line is that FDA regulations for human subject protection and IRBs won’t change when the Common Rule revisions take effect in January, Borasky says. That means clinical investigations regulated by both the FDA and the Common Rule will still have to comply with agency regs if they’re more stringent.

“The FDA still has an expectation that institutions, IRBs, sponsors, etc., continue to follow the FDA regulations as written, even when their requirements go beyond what is required by the revised Common Rule,” Borasky says.

He adds that the real question is how soon the agency will release more “substantive” guidance on its harmonization plans and what it will allow IRBs to implement between the time the Common Rule revisions go live and it harmonizes its regulations (set to be completed in December 2019) as part of the 21st Century Cures Act.

Read the guidance here:


-By James Miessler