Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 35, No. 2, February, 2020

Back Issues

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

Expanding Subject Eligibility

IRBs and Expanding Subject Eligibility … p. 3
IRBs and Research On Prisoners … p. 4
IRBs and “Key Information” in Consent … p. 5

IRBs and “Live Case Presentations” … p. 6
IRBs and New Consent Alterations/Waivers … p. 7
IRBs and Certificates of Confidentiality … p. 8
IRBs and HIPAA Review Exemptions … p. 8
In Congress: Research Regulations & Ethics … p. 9
FDA Warning To: California Researcher … 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 and Expansion of Study Subject
Eligibility Criteria – #6 … p. 3

We continue here with more coverage of a recent guidance released by the FDA that is titled “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs.” This guidance contains detailed recommendations on how researchers and IRBs can increase the diversity of human subject pools.

For IRBs, human subject recruitment, enrollment, and retention are key components when reviewing protocols. This recent FDA guidance provides many tips on how IRBs can review researcher strategies for such experimentation factors.

We continue here where we left off last in our ongoing coverage of this guidance with our December 2019 HRR (see page 5). The recommendations are phrased by FDA as direct suggestions to researchers, IRB members, and others, as follows.


IRBs and Research On Prisoners – #2 … p. 4

We continue here with a development being closely followed by IRBs, researchers, and research administrators throughout the country; namely, a possible major violation of the regulations on the protection of human research subjects.

As we described last month, the nationally-based consumer advocacy group Public Citizen has called for investigation of a company known as BioCorRx and an investigation of the State of Louisiana over allegedly unethical research on prisoners (see January HRR, p. 4). Public Citizen’s analysis of the alleged violations are detailed and we continue presenting highlights below.

Before proceeding below with the conclusion of the Public Citizen’s press release in late November of 2019, note that Public Citizen also submitted a lengthy letter to FDA calling for a federal investigation of the company and the prison system that allegedly approved the research without IRB review.


IRBs and “Key Information” In Informed
Consent – #3 … p. 5

We continue here with current recommendations on informed consent for IRBs, researchers, and others as issued by the influential Secretary’s Advisory Committee on Human Research Protections (SACHRP). We resume where we left off with our last article on this topic (see the October 2019 HRR, p. 3), in which SACHRP presents – and then addresses – specific questions on consent as posed to it by the federal Office for Human Research Protections (OHRP) on behalf of the research compliance community.

“Question 2:
Please consider whether the elements of consent listed in the preamble [to the new Common Rule] generally should be considered to encompass key information. Should all of the listed elements of informed consent be considered ‘key information,’ or, depending on the design and context of the study, would some of this information not necessarily be ‘key’?” (‘Attachment C – New ‘Key Information’ Informed Consent Requirements,’ October 17, 2018, pp. 4-5 of 12; on the Web at