David Babaian, JD

by David Babaian

Nothing About Me Without Me—A Review of the CAREB-ACCER Conference in Toronto

I recently had the opportunity to attend the 2016 CAREB-ACCER conference in Toronto, where Susan Zimmerman, Executive Director of the Secretariat on Responsible Conduct of Research, and Ivor Pritchard, Senior Advisor to the Director of OHRP, discussed upcoming changes in the ethical review of research on both sides of the border.

Canadian Guidance for Consultation

Ms. Zimmerman highlighted two upcoming initiatives to be published for consultation: a revised TCPS 2 Chapter 11 and the addition of population and public health research examples throughout TCPS 2.

Reflecting a more expansive title (“Interventional Trials”) the scope of Chapter 11 will grow to envelop studies that include prospective assignment to one or more interventions, of which one or more involves more than minimal risk. In this framework, social science studies would fall under its purview.

It is anticipated that sections addressing therapeutic misconception, research-attributable risk, and the requirement to disseminate findings will be relocated in favor of more relevant material, such as guidance for recruitment, community-based participatory research, pilot studies, and sponsor-researcher contracts.

The Secretariat and the Panel on Research Ethics (PRE) plan to provide guidance pertaining to incidental findings, defined as unanticipated discoveries made in the course of research that are outside the scope of the research.

At present, the TCPS 2 explicitly establishes an obligation on the part of researchers to disclose to a participant any material incidental findings discovered in the course of research (Article 3.4). The need for revision arose from concern about the REB’s role in identifying material incidental findings and a lack of consensus around investigator responsibilities. In so doing, a new, separate guidance format—possibly a good practices document—is under consideration to more comprehensively address the myriad possibilities that might confront investigators.

The Secretariat and PRE, with a mandate to determine whether an exemption from REB review is required for research involving the secondary use of human cells, are also exploring revisions to the guidance on research involving cell lines. Currently, the TCPS 2 is inapplicable only if the specimens are anonymous (Article 2.4). Of critical importance in the revision will be what value any proposed guidance adds to human subject protection. This will bear watching as at least one audience member expressed concern over harmonization with evolving U.S. standards.

Commenters on the NPRM Seek Clarity

Coming from south of the border, Ivor Pritchard (of OHRP) summarized the more than 2,100 comments to the NPRM.

A prominent refrain in the comments reportedly focused on the absence of identified tools, templates, and lists important to implementation of the rule (e.g., the exemption tool, the broad consent tool, the privacy standards, etc.). In fact, one excerpted comment challenged the adequacy of the process in light of these omissions.

Perhaps unsurprisingly, the majority of comments addressed the proposed rule as it pertains to biospecimens, while improvements to informed consent received the fewest comments of note. In fact, a significant majority supported a core consent form presenting essential information at the outset. Detractors expressed cynicism over whether the informed consent proposals would have any beneficial effect.

Unexpectedly, considering that the NPRM’s objective is to facilitate valuable research, a significant majority (76 percent of comments addressing the subject) generally opposed biospecimen expansion, and that opposition reached across all stakeholders, including patients, researchers, and the public. Patients understandably feared restricting access to biospecimens and slowing research, while the public reportedly expressed dissatisfaction with broad consent. (67 percent of related comments generally oppose it; 19 percent generally favor it). Broad consent is viewed as an erosion of the very foundation of what it is to be informed.

Interestingly, the limited biospecimen exclusion was the only related proposal reported to garner greater support (63 percent) than opposition (30 percent).

Overall, however, comments related to the proposed exclusions and exemptions challenged their complexity and overreliance on investigator decision-making, particularly in the absence of the identified exemption decision tool.

Comments pertaining to the single IRB mandate were mixed, with institutions understandably reluctant to cede local review as others extolled anticipated efficiency gains. A significant majority favored curtailing continuing review, optimistic about similar efficiency gains. Support and opposition for extending the Common Rule to all research conducted at institutions that receive federal funding for research—more in line with the model in Canada—were evenly split.

From the Great Experiment to Participant Empowerment

No experiment can be more interesting than that we are now trying, and which we trust will end in establishing the fact, that man may be governed by reason and truth…I hold it, therefore, certain, that to open the doors of truth, and to fortify the habit of testing everything by reason, are the most effectual manacles we can rivet on the hands of our successors to prevent their manacling the people with their own consent.
– Thomas Jefferson

At the heart this year’s CAREB-ACCER conference ran the thread of empowerment, whether by maintaining a participant and community focus on research or by more widely invigorating citizen involvement in federal government for the shared good of public health and scientific knowledge obtained through principled and equitable modes of inquiry and, ultimately, implementation.

 

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