Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 33, No. 8, August, 2018

Back Issues

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

IRB Review Not Needed Before Applying

IRB Review Not Needed Before Applying … p. 3
IRB Minutes Covered in Joint Guidances … p. 4
IRBs and “Broad Informed Consent” … p. 5

IRBs and Research With Human Specimens … p. 6
Complaint Causes Consent Changes … p. 7
In Congress: Senator Investigates OHRP … p. 8
FDA: IRB Minutes Do Not Include Votes … p. 9
OHRP: No Proof for One Charge … p. 10
In Court: Defendants Say Lawsuit Must Fail … p. 11
Compliance Conferences & Courses … p. 12
Licensing Rights for This Subscriber … p. 12

IRB Review Not Needed Before Seeking Funds – Pt. 1 … p. 3

As noted elsewhere in this HRR, and has been pointed out by numerous others, the ongoing and future need for new federal guidances on human subject protections is great indeed. The newly revised, and theoretically now “final,” 2018 version of the “Common Rule” contains dozens of major changes to IRB requirements and subject protection procedures.

On July 20, the federal Office for Human Research Protections (OHRP) issued three new such draft guidances for IRBs and the research compliance community in general. The guidances are titled: (1) “Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements;” (2) “When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements;” and (3) “Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements.”

Prior IRB Review Requirement Dropped

For this article, we focus on the first guidance listed above, dealing with IRB reviews before an application or proposal is submitted for potential federal funding.


IRB Minutes Covered in Joint Agency Guidances … p. 4

We have described in the past how an IRB’s failure to create and maintain accurate and complete minutes has led to serious problems for applicable IRBs. One of the reasons for the problem with inadequate minutes is that IRBs cannot later prove that their reviews were appropriate – even if they were.

As we have been presenting for several months, the current joint FDA and OHRP guidance on IRB meeting minutes issued a few months ago contains numerous specific recommendations for how to document IRB protocol reviews for various types of human subject studies.

For example, we have already described the agencies’ latest advice on IRB minutes when medical device studies are involved. In addition, we have described the agencies’ guidance when emergency research is involved.

The emergency research discussion is especially useful for IRBs, in our opinion, because it includes how and when an exception can be made to the usual requirements for informed consent.

This month, we resume where we left off last month in our coverage of IRB minutes, with attention to special populations of human research subjects.


IRBs and “Broad Consent” For Certain Studies – Pt. 1 … p. 5

With this article we begin coverage of four new sets of recommendations submitted to the HHS by the Secretary’s Advisory Committee on Human Research Protections (SACHRP). The committee has been meeting for several years and has issued numerous major recommendations already affecting IRBs, researchers, and research institutions.

The four sets of new recommendations, addressing the current Final Common Rule are contained in four “Attachments” to an April 11 letter submitted to HHS by SACHRP, as follows: “Attachment A – FAQs Relating to Recommendations on Broad Consent;” “Attachment B – Implementation European Union’s General Data” (subtitled “Implementation of the European Union’s General Data Protection Regulation and its Impact on Human Subjects Research”); “Attachment C – FAQs, Recommend. and Glossary: Informed Consent” (subtitled “FAQs, Recommendations, and Glossary: Informed Consent and Research Use of Biospecimens and Associated Data”); and “Attachment D – Granting Exceptions for Single IRB Review for Multi-Site Research” (subtitled “Points to Consider: Granting Exceptions to Requirements for Single Institutional Review Board Review for Multi-Site Research”).