Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 33, No. 2, February, 2018

Back Issues

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

Human Research Report - Volume 33, No. 2


IRBs and Investigational In Vitro Diagnostic Device Studies (Pt. 2) … p. 3
IRBs and More Possibilities for Expedited Protocol Reviews … p. 5
IRBs Get Permission to Waive Consent … p. 6

IRBs and Recommendations on Using “HIPPA Exemption” (Pt. 1) … p. 7
Researcher Is Debarred for Failing to Keep Adequate Research Records … p. 8
FDA: Researcher Enrolls Ineligible Subject … p. 9
OHRP: IRB Stops Enrollment of Subjects … p. 10
In Court: Plaintiffs Seek Class Action Status in Lawsuit Against Researchers … p. 11
Compliance Conferences & Courses … p. 12

IRBs and Investigational In Vitro Diagnostic Device Studies (Pt. 2) … p. 3

We now begin to present details of a new draft FDA guidance that we briefly presented in our “In Agencies & Organizations” section last month (as Part 1). The title of the guidance is “Investigational IVDs Used in Clinical Investigations of Therapeutic Products – Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards” (emphasis added to title).

Before we begin our coverage, note that this guidance (in contrast to many others) is open for comments for a full 90 days. Comments are especially due by March 19 to help ensure that comments can be considered in shaping the future final version. As usual, FDA also announced that comments can actually be submitted at any time.

For more information on the guidance, and how to submit timely comments, contact FDA’s David Litwack of the Center for Devices and Radiological Health at 301-796-6697; or Stephen Ripley of the Center for Biologics Evaluation and Research at 240-402-7911. The original announcement about the new guidance appeared in the FEDERAL REGISTER of December 18, 2017, at 82 Fed. Reg. 60022.

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IRBs and More Possibilities for Expedited Protocol Reviews … p. 5

As we described in last month’s lead article, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) has submitted a new set of recommendations to the Department of Health and Human Services (HHS).

In this HRR article, we finish presenting the first set of recommendations on how IRBs can use expedited review on certain types of research. After previously presenting the initial six categories of research that SACHRP recommends would be eligible for such IRB review, we resume here with:

“7. Collection of information for research purposes through activities performed by persons in daily life in individuals and groups whose health will not be adversely affected by the activities” (“SACHRP Recommendations on Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure under the Revised Final Rule,” underline emphasis added to title).

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IRBs Get Permission to Waive Consent … p. 6

In mid-summer of last year, the FDA issued a new guidance describing reasons why it would not necessarily sanction IRBs that waived or altered informed consent for certain types of clinical trials. The agency said that it had received numerous inquiries from IRBs and researchers in recent years asking for explanations and examples of “minimal risk” research for which informed consent of study subjects could be waived.

That guidance, slated as “for immediate implementation,” was titled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects – Guidance for Sponsors, Investigators, and Institutional Review Boards,” (July, 2017, emphasis added to title; on the Web at https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM566948.pdf).

Although relatively brief for an FDA guidance at about four pages, we considered it important enough to present as our lead article in the September 2017 HRR (see pp. 1-3).

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