Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 35, No. 12, December, 2020

Back Issues

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

Parental Permission for Research

IRBs and Parental Permission for Research … p. 3
IRBs and Charging Subjects to Participate … p. 4
IRBs and Developing Drugs During COVID … p. 5

IRBs and Research With Prisoners … p. 6
IRBs and Reviewing “Live Case Presentations” … p. 7
IRBs and Research on Renal Impairment … p. 8
FDA Warning To: Houston, TX IRB … p. 9
In Court: Wade v. Oregon Health Sciences Univ. … p. 10
Compliance Comment Deadlines & Notices … p. 11
IRB Compliance Conferences & Courses … p. 12
Licensing Rights for This Subscriber … p. 12

IRBs and Parental Permission In Research
With Children (#2) … p. 3

We continue this month with coverage of recommendations for IRBs and researchers on special aspects of research with children. We introduced this topic last month in the HRR, and it is based on proposals from the Secretary’s Advisory Committee on Human Research Protections (SACHRP).

We resume with the SACHRP’s response to questions posed to it by the federal Office for Human Research Protections (OHRP). These questions, in turn, have been raised by IRBs throughout the country. The focus of these recommendations are the complications associated with “parental permission” for allowing research involving their children when the parents may not be “reasonably available.”


IRBs and Charging Subjects to Participate
in Research (#3) … p. 4

We resume here with a controversial topic for IRBs; namely, the ethical and regulatory aspects of research in which the human subjects are charged for their participation. We last covered this topic in the May HRR as we described the particular challenges posed for IRBs in such studies. Importantly, as recognized by the Secretary’s Committee on Human Research Protections (SACHRP), the number of these types of studies appears to be expanding in the U.S.

We resume by concluding the relevant SACHRP section of a series of SACHRP proposals for regulatory changes for this area. This section is titled “Sponsors’ Motivation for Proposing Pay-to-Participate Trials.” We’ve already presented some reasons why researchers conduct such trials.


IRBs and Developing Drugs and Biologics
During COVID-19 (#6) … p. 5

We continue here with more details for IRBs and researchers on a particular aspect of research on COVID-19 involving human subjects. The aspect in question is titled “Statistical Considerations.”

Statistics are not often covered in discussions of regulations and policies for IRBs, but they can certainly affect assessment of the importance of study results. In turn, this can affect weighing risk-benefit ratios of studies and the assessment of whether or not the involvement of human subjects in a study is worth the risks to the subjects.

We present here portions of the relevant FDA guidance on such human subjects research regarding a study’s proposed analysis of the efficacy of an experimental product.