The FDA has issued draft guidance outlining the process for FDA/Office for Human Research Protections (OHRP) reviews of pediatric trials that are ineligible for IRB review and approval.

Certain pediatric research under the oversight of the FDA and/or HHS cannot, for regulatory reasons outlined in the draft guidance, be approved by an IRB(s). This research must instead be reviewed and approved by the FDA and/or OHRP before moving forward, the agency explains.

In this situation, the research at hand can only continue if:

• The IRB determines the research provides a reasonable opportunity to further the understanding, prevention or alleviation of a serious issue impacting the health or welfare of children; and
• The FDA Commissioner, the HHS Secretary or both, as applicable, consult with a panel of relevant experts and determine the research does in fact satisfy regulatory requirements or find that it meets the following criteria:
• The research offers a reasonable opportunity to further the understanding, prevention or alleviation of a serious issue impacting the health or welfare of children;
• The research will be conducted in line with sound ethical principles; and
• Provisions are established to adequately obtain assent from the children and permission from their parents or guardians.

With this in mind, the guidance delves into the referral, review and outcome processes for such research, such as how an IRB should refer its trial to the FDA and/or OHRP and how to prepare for the review meeting after a referral is accepted.

It also contains sections on procedural differences between the FDA and OHRP, research that requires joint review and multisite trials overseen by multiple IRBs.

Comments on the draft are due by May 30.

Read the full draft guidance here: https://bit.ly/3lVyFTG.