Sunday, September 16, 2012

Could Guidance and Feedback Replace Rote Compliance?

Murray Dyck and Gary Allen, both of Griffith University in Australia, argue that "the review process should be an advisory and collegial one—not one that focuses on compliance, enforcement and gatekeeping."

[Murray Dyck and Gary Allen. “Is Mandatory Research Ethics Reviewing Ethical?” Journal of Medical Ethics (August 3, 2012), DOI: 10.1136/medethics-2011-100274.]

Dyck and Allen find that "mandatory IRB review procedures would not themselves reach the ethical standard expected of researchers."

  • "Respect for Persons: Mandatory review is a clear failure to show respect for persons (researchers) because it presupposes that researchers cannot be trusted to design and implement research that respects the rights of participants unless researchers are made accountable to an IRB to do so (even though IRB procedures also presuppose the ethical integrity of the applications for ethical approval) . . .
  • "Merit and Integrity: Mandatory multiple reviews of multisite research indicate that IRBs do not trust the merit and integrity of other IRBs and their failure to accept the judgment of other IRBs shows disrespect for other IRBs’ members." . . .
  • "Justice: IRBs often place what, at face value, is an unfair burden on researchers." . . .
  • "Beneficence: . . . Although there is minimal empirical evidence that the oversight provided by IRBs is effective in protecting research participants from human rights abuse, there is clear evidence that IRB reviews impose tangible costs on society that greatly exceed even the costs in time and money that are expended in complying with IRB procedures."

Yet Dyck and Allen are not opposed to ethics review; they are opposed only to mandatory ethics review, and they suggest replacing it with a system of guidance and persuasion.

Instead of promoting rote compliance with inflexible and universal rules, the role of an IRB should be to facilitate and resource the reflective practice of researchers. A simple, but significant, shift would be to move ethical review from approving a proposed project to providing guidance and feedback on submitted projects. An IRB may play a useful role in identifying ethical issues and suggesting how to deal with them, but otherwise, responsibility for research ethics needs to return to the researchers who use the feedback they receive in a reflective and project-appropriate way. Rather than policing compliance with standards that can have limited usefulness for some methods, participant populations and contexts, such an advisory review would aim to assist researchers in reflecting on the specific ethical challenges of their research.

Crucially, they argue, "There should be resources available to assist researchers during the planning, conduct, analysis and reporting of results. Institutions should establish networks of research ethics advisors—colleagues who can be approached for advice and support."

This is exactly what is missing from the current system: a network of people and published material to which researchers can turn for insight on their specific challenges. Mandatory review goes hand in hand with mortifyingly stupid ethics training. An IRB focused on advice and support might be more likely to lure researchers with guidance relevant to their particular projects.

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