Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 33, No. 4, April, 2018

Back Issues

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

Vol. 33, No. 4, April, 2018


IRBs and Investigational Device Studies … p. 3
IRBs and Direct v. Indirect Costs … p. 4
IRB Guidances on Meeting Minutes … p. 5

IRBs and Exemption From Their Review … p. 6
IRBs and Use of “HIPPA” Exemption … p. 7
In Congress: IRBs Must Be More Involved … p. 8

FDA: IRB Failed to Comply With Regs … p. 9
OHRP: IRB Must Submit Voluminous Documentation to Federal Agency … p. 10
In Court: Defendants Try to Quash Case … p. 11
In Agencies & Organizations … p. 12
Licensing Rights for This Subscriber … p. 12

IRBs and Investigational In Vitro Diagnostic (IVD) Studies – Pt. 4 … p. 3

We continue here with presenting a recent FDA guidance titled “Investigational IVDs [In Vitro Diagnostic Devices] Used in Clinical Investigations of Therapeutic Products – Draft Guidance for industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards” (emphasis is added to title).

In this month’s article we conclude our presentation of FDA’s recommendations to IRBs and other on how to handle Investigational IVDs with “Non-Significant Risk” (NSR) devices. We saw last month that even in situations where an IDE (Investigational Device Exemption) may not be necessary (e.g., when risk to subjects are low), it is still necessary to obtain IRB approval.

This month, we begin with an important documentation note regarding relevant studies that includes something of a time-saver for researchers in covered situations. It may not be a major time-saver, but anything can help, especially in complex or multisite studies.

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IRBs and Direct Versus Indirect Costs – Pt. 3 … p. 4

We continue here with a topic we addressed last month on IRBs and the use of indirect versus direct costs to support certain IRB activities that are funded by the National Institutes of Health (NIH).

Our focus is on single IRBs (“sIRBs”) that review multisite studies. Whereas this choice has traditionally been left up to multisite projects to address, that is no longer true. Effective January 25, multisite studies funded by NIH must use only an sIRB to review relevant protocols.

We continue here with where we left off last month on this IRB financial support topic; namely with the NIH’s “Frequently Asked Question” (FAQ) #9.

“9. When single IRB activities are charged as direct costs, under which budget category on the SF424 (R&R) detailed budget form should these direct costs be listed?

Applicants may include the various costs associated with single IRB review under any detailed budget category that is appropriate for the cost being requested (e.g., salary & fringe for individuals listed under Personnel, or fees listed under Other Costs), in accordance with the recipient’s method of charging single IRB costs” (“NIH Policy on the Use of a Single IRB for Multi-Site Research Costs,” no date; on the Web at https://www.osp.od.nih.gov/clinicalresearch/nih-policy-on-the-use-of-a-single-irbfor-multi-site-research-on-costs/?pdf=10881).

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IRB Minutes Covered in Joint Agency Guidances – Pt. 5 … p. 5

Of the two recent joint guidances on IRB minutes issued by FDA and OHRP, we are presenting portions of the FDA version. We continue here with where we left off last month, as follows:

“2. Suspension or Termination of IRB Approval

Both OHRP and FDA regulations authorize an IRB to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects (45 CFR 46.113; 21 CFR 56.113).

Any IRB action to suspend or terminate IRB approval that occurs at a convened meeting must be documented in the minutes (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)). Any suspension or termination of approval must include a statement of the reasons for the IRB’s action (45 CFR 46.113; 21 CFR 56.113)” (“Minutes of Institutional Review Board (IRB) Meetings – Guidance for Institutions and IRBs,” September, 2017, p. 6 of 13, underline emphasis added; on the Web at https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM470154.pdf).

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