Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 35, No. 9, September, 2020

Back Issues

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

Subject Confidentiality

IRBs, FDA, and Subject Confidentiality … p. 3
IRBs and Use of “HIPAA Exemption” … p. 4
IRBs and “Key Information” in Consent … p. 5

IRBs and Research During COVID-19 … p. 6
IRBs and COVID: Statistical Factors … p. 7
IRBs and Human Subject Eligibility
in Clinical Cancer Experiments … p. 8
Compliance Comment Deadlines & Notices … p. 9
FDA Warning To: Texas Physician … p. 10
In Court: Wade v. Oregon Health Sciences Univ. … p. 11
IRB Compliance Conferences & Courses … p. 12
Licensing Rights for This Subscriber … p. 12

IRBs, FDA, and Certificates Of Confidentiality
(CoCs) – #8… p. 3

With this article, we conclude our coverage of the FDA’s advice to IRBs, researchers, and others on how and when to apply for a special protection for human research subjects; i.e., via Certificates of Confidentiality (CoCs).

Below we present a sample of the exact language that FDA recommends be used when applying to the FDA for a CoC. The full text of that language is contained in the guidance that we have been highlighting; namely, “Certificates of Confidentiality: Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff.”

We recommend use of the following language in the request letter to facilitate FDA’s review:

The requestor is engaged in biomedical, clinical, or other research, in which identifiable, sensitive information is collected or used (


IRBs and Use of HIPAA Review Exemption – #14 … p. 4

With this article, we conclude our coverage of an important set of recommendations from the Secretary’s Advisory Committee on Human Research Protections (SACHRP) for IRBs and researchers that is titled “Attachment B – Recommendations on the Interpretation and Application of §__104(d) (4) the ‘HIPAA Exemption.’”

As is typical of many SACHRP documents, this set of recommendations was an attachment to a cover letter that was submitted to HHS. The recommendations are currently under review by HHS.

Due to more recent and pressing IRB issues, we have been interspersing our articles on this IRB review exemption with other topics … until now.

The “HIPAA Exemption” allows IRBs to waive their reviews, and the need for informed consent, for certain secondary research projects involving identifiable private information or identifiable biospecimens (e.g., see HRRs for May, 2019 through September, 2019, and for December, 2019 through April, 2020). We resume below with SACHRP’s final note about this IRB exemption, related state laws, and FDA requirements.


IRBs and “Key Information” In Informed
Consent – #5 … p. 5

We continue in this article with our coverage of a very useful set of IRB recommendations released by the Secretary’s Advisory Committee on Human Research Protections (SACHRP). As usual, the recommendations appear in an attachment to a letter submitted to the Secretary of the Department of Health and Human Services (HHS).

The recommendations address a number of major informed consent issues. They comprise the SACHRP’s response to a series of six consent questions posed to it by the federal Office for Human Research Protections (OHRP).

In turn, the OHRP questions are based on questions frequently posed to OHRP by IRBs throughout the country.

We resume with more of the SACHRP’s response to “Question 5” from OHRP that addressed several benefit and risk topics in human subjects research, as follows below.

See HRRs for September 2019, October 2019, February 2020, and March 2020 for previous installments in this series of informed consent articles.