Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 33, No. 7, July, 2018

Back Issues

Here’s an inside look at what you will receive in the digital newsletter, including actual excerpts.

IRBs Exemption From Review

IRBs and Exemption From Their Review … p. 5
IRBs and Guidance on Pregnant Women as Research Subjects … p. 7
IRB Minutes Covered in Joint Federal Guidances … p. 8

FDA: IRB Transfer of Power to Another IRB Questioned By Agency … p. 9
OHRP: University Admits To No Informed Consent or Prior IRB Review of Study … p. 10
In Court: IRB’s Approved Study Is AtCore of Lawsuit Against University … p. 11
Compliance Conferences & Courses … p. 12
Licensing Rights for This Subscriber … p. 12

IRBs and Exemption From Their Review – Pt. 4 … p. 5

We conclude here our presentation of recommendations submitted to HHS by the Secretary’s Advisory Committee on Human Research Protections (SACHRP) regarding “benign behavioral interventions.” These recommendations would definitely affect IRBs and are currently under HHS review.

As we have seen previously, the recommendations come in the form of a Question-and-Answer (Q&A) format. This month we present useful research examples from the Q&As that go beyond the more bare framework of the actual regulations on the protection of human subjects. These examples make the regulations more understandable in that IRBs can use real-life experimental conditions to determine whether such “benign behavioral” studies can be exempt from IRB review.

We resume here from where we left off last month with the study examples given in response to Q #10 (i.e., “Is at least one of the following conditions regarding privacy protections met? – If not, then the study is not exempt from IRB review”).

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IRBs and Guidance on Pregnant Women as Study Subjects – Pt. 3 … p. 7

As we first described in last month’s HRR, the FDA is encouraging the inclusion of more pregnant females as human subjects in clinical trials. However, said encouragement is tempered by consideration of the risks of such research participation, and by the need to weigh risk-benefit ratios for the special risk factors of including pregnant females in clinical studies. These special considerations are critical in IRB reviews of relevant research.

Last month we presented the 10 special study related factors that FDA describes its recent guidance titled “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.” This month, we present more of FDA’s recommendations as contained in the guidance’s Section III – “Ethical Considerations.”

“IRBs are required to possess the professional competence necessary to review the specific research activities that they oversee (21 CFR 56. 107(a)). IRBs must include persons who are knowledgeable in areas about the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice (21 CFR 56.107(a))” (guidance, April, pp.5 of 11, underline emphasis added; on the Web at https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM603873.pdf
).

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IRB Minutes Covered in Joint Agency Guidances – Pt. 7 … p. 8

The recent federal IRB guidances address how and when to record minutes of IRB meetings, including IRB minutes for particular types of protocol reviews. Both FDA and OHRP have worked together to harmonize these guidances.

In the May HRR we presented guidance details on IRB minutes when research with children is involved, using the FDA version as our focus. This month, we conclude coverage of the FDA’s guidance on IRB minutes when children are the research subjects. In addition, we present federal guidance recommendations for IRBs when other types of research are involved as well (e.g., emergency research).

IRB Minutes and Research With Children

“Both OHRP and FDA have issued guidance to assist IRBs with handling clinical investigations that include children as subjects and that have been referred under 45 CFR 46.407 or 21 CFR 50.54.8

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