Human Research Report

Protecting Researchers and Research Subjects

Vol. 30, No. 12, December, 2015

In This Issue

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

V30 N12 In This Issue

Informed Consent Changes Proposed … p. 3
Human Subjects and “Harmonization” … p. 4
IRBs Accused of Being Too “Reticent” … p. 5
IRB Guidance on Meetings and Minutes … p. 6

IRBs and New Technologies … p. 7
IRB Changes in New National Report … p. 8
FDA: Criteria, Schimeria, Let’s Enroll
        You in This Study Right Now! … p. 9
OHRP: Institution Must Submit Documents … p. 10
In Court: Researcher Fails to Convince Panel
        That He Didn’t Understand Misconduct … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

Informed Consent Changes Included in New Proposals … p. 3

We continue here with more coverage of the huge NPRM on changing human subject protection regulations. In this article we present highlights of proposals regarding informed consent and related challenges for Institutional Review Boards (IRBs).

Many claim that consent forms have evolved to protect institutions rather than to provide potential research subjects with some of the most important pieces of information that a person would need in order to make an informed decision about whether to enroll in a research study. Instead of presenting the information in a way that is most helpful to prospective subjects — such as explaining why someone might want to choose not to enroll — the forms often function as a sales document or as a means to protect against institutional liability rather than as genuine aids in good decisionmaking.

There is also a growing body of literature that suggests informed consent forms have grown too lengthy and complex, adversely affecting their ability to convey the information needed for prospective participants to make an informed decision about participating in research.

The goal of the proposed changes to the informed consent form and process is to facilitate prospective subjects’ decision about whether or not to participate in a research study, thereby enhancing autonomy (80 Fed. Reg. 53933-54061 at page 53987, September 8, emphasis added).


Human Subject Protections And Agency
“Harmonization” … p. 4

As we continue to present highlights of the recent massive NPRM on human subjects protection, we now move on to an area that has remained controversial for years. That area is the harmonization” (or lack thereof) of regulations between agencies. This area has continued to pose numerous challenges for many Institutional Review Boards (IRBs).

The most notable example of this problem is found in discrepancies between the human subjects regulations of the overall Department of Health and Human Services (DHHS) versus those of the Food and Drug Administration (FDA).

From the outset of development of the Common Rule, the importance of consistency across the Federal Government has been recognized. Each Common Rule department or agency may issue its own guidance regarding the protection of human subjects. Consequently, there may be variations in the guidance issued (see 80 Fed. Reg. 53933-54061 at p. 53980-53981, September 8, emphasis added).


IRBs’ “Reticence” to Be Flexible Is Criticized … p. 5

The Secretary’s Advisory Committee on Human Research Protections (SACHRP) recently submitted recommendations to Sylvia Burwell, the Secretary of Health and Human Services (HHS). Those recommendations consisted of a 3-page summary cover letter and three attachments — (1) “Attachment A: Recommended Guidance on Minimal Risk Research and Informed Consent,” (2) “Attachment B: Recommendations Regarding Application of the Common Rule to Clinical Data Registries Under the Medicare Access and CHIP [Children’s Health Insurance Program] Reauthorization Act of 2015,” and (3) “Attachment C: Return of Individual Results and Special Consideration of Issues Arising from Amendments of HIPAA [Health Insurance Portability and Accountability Act] and CLIA [Clinical Laboratory Improvement Amendments].”

The September 28 SACHRP cover letter is on the Web at,2015lettertothehhssecretary.html.

Problems Due in Part to “Reticence” of IRBs

Focusing on “Attachment A,” we find that SACHRP finds fault, as do many others, with current informed consent forms.