Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 35, No. 3, March, 2020
Here’s an inside look at what you will receive in the digital newsletter, including actual excerpts.
IRBs and Single IRB Reviews … p. 3
IRBs and HIPAA IRB Review Exemption … p. 4
IRBs and “Key Information” in Consent … p. 5
IRBs and Certificates of Confidentiality … p. 6
IRBs and Requirements for Single Reviews … p. 7
IRBs and Expanding Subject Enrollment … p. 7
Compliance Comment Deadlines & Notices … 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 Reviews of Research Protocols By
a Single IRB – #2 … p. 3
With this follow-up article we present more highlights of a recent announcement advising IRBs and researchers about key aspects of the new federal requirement for “single IRB reviews” of applicable experiments.
As we described in the January HRR (see pp. 1-2), the federal Office for Human Research Protections (OHRP) used the announcement to help clarify some reported IRB confusion over possible exceptions from this particular feature of the “revised Common Rule” on the protection of human research subjects.
OHRP refers to a similar requirement by NIH on single IRB reviews to discuss the respective involved rules. We resume here where we left off in the previous installment, as follows.
“Cooperative Research Conducted or Supported by NIH
The NIH policy on the use of a single IRB for multi-site research has been in effect since January 25, 2018. It requires all U.S. sites participating in NIH-funded multi-site studies (i.e., two or more sites) involving non-exempt human subjects research where the sites are following the same protocol to use a single IRB for the review” (84 Fed. Reg. 64432-64433 at p. 64432, November 22, 2019).
IRBs and Use of HIPAA Review Exemption – #12 … p. 4
We continue here with our coverage of the new “HIPAA Exemption” whereby the usual IRB protocol review and attendant informed consent regulations do not apply to certain covered activities.
In last month’s article (see p. 8) we presented the initial portion of a document section titled “Use of Information Added to Database After Secondary Research Begins” in the document titled “Attachment B – Recommendations on the Interpretation and Application of §__104(d)(4) the ‘HIPAA Exemption’.”
IRBs and “Key Information” In Informed
Consent – #4 … 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 (or the SACHRP).
We resume where we left off with our last article on this topic (see the February HRR, p. 5), wherein SACHRP presents the final portion of its answer to “Question 4” in a series of Q&As.
Question 4 dealt with possible risks for human research subjects, as well as potential benefits. We conclude presenting highlights of that particular recommendation section with:
“Regarding item 3 of the preamble list, ‘the reasonably foreseeable risks or discomforts to the prospective subject,’ SACHRP notes that it would be preferable to refer to the most important risks, due to frequency or magnitude, rather than reasonably foreseeable risks ….” (“Attachment C – New ‘Key Information’ Informed Consent Requirements,” October 17, 2018, p. 6 of 12; on the Web at https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-c-november-13-2018/index.html).