Washington Monthly - September/October 2014 - 64

Still, we can do better than we are doing now. The simplest, boldest reform would be to restrict IRB jurisdiction
to a narrow range of research projects. Finland, for example, requires researchers to seek ethics review only when
they intervene "in the physical integrity of subjects," deviate from informed consent, study children under the age of
fifteen, use "exceptionally strong stimuli," or risk subjects'
long-term mental health or security. All of these terms
would require elaboration, but a study like Sue's-based on
interviews with consenting adults-would likely proceed
without any mandatory review.
Closer to home, Canada has shown what reforms are
possible when the rule-making process is made more inclusive. In 1998, Canada imposed a system much like that
in the United States, resulting in howls of protest from researchers and what sociologist Will van den Hoonaard has
called "increasing homogeneity and impoverishment of the
social-scientific methods."
But unlike U.S. regulators, Canadian rule makers listened to these critics and included them in a revision process. New guidelines, issued in 2010, include an entirely new
chapter on qualitative research, acknowledging that since
qualitative researchers do not plan experiments in advance,

The review too often turns
into a farcical imitation
of ethical deliberation,
as boards obsess over
typographical errors or
wildly improbable dangers.
ethics boards cannot demand the same detailed protocols
common in medical studies. The chapter also notes that anonymity isn't for everyone, whether because narrators wish
to be named or because people in power deserve to be held
to account for their actions.
Canada also guarantees its researchers the right to appeal decisions of ethics boards, and endorses academic freedom, including "freedom of inquiry, the right to disseminate the results of that inquiry, freedom to challenge conventional thought, freedom to express one's opinion about
the institution, its administration or the system in which
one works, and freedom from institutional censorship."
That may sound obvious, but it is the envy of U.S. scholars,
who see IRBs as failing to consider such freedom in their
quest to protect from every imaginable harm.
And in the United States, the federal government has
finally at least acknowledged the problem. In 2011, the Department of Health and Human Services, along with the Of64

September/October 2014

fice of Science and Technology Policy, conceded that "overregulating social and behavioral research in general may
serve to distract attention from attempts to identify those
social and behavioral research studies that do pose threats
to the welfare of subjects and thus do merit significant oversight." More generally, they accepted the need to reduce
"burden, delay, and ambiguity" for investigators in all areas
of research. Scholarly associations were quick to agree, as
was a National Research Council study, which hoped to "increase the efficiency and effectiveness of human subjects'
protection, while reducing burden overall."
One key proposal in the 2011 announcement called for
a shift from reliance on prior review of nearly every protocol to a system in which, for low-risk types of research, "researchers would file with their institution or IRB a brief registration form (about one page long) that provides essential
information about the study." These forms could be audited
periodically to make sure researchers were playing fair, but
researchers would not have to wait weeks or months before
starting their work.
A complementary proposal from the National Research
Council would be to "build a stronger evidence base" about
the effects of participating in research. That reform would
help researchers like Sue, whose IRB knows little about the
real-world ethical dilemmas that ethnographers face, and
tends to base its decision on what bioethicist Ezekiel Emanuel has termed "gut reactions ... which is worthless."
Unfortunately, regulators have not acted in the three
years since the federal proposals were published. Part of
the problem may be resistance from Public Responsibility in Medicine and Research (PRIM&R), a nonprofit that
certifies-and thus tends to represent-IRB administrators whose career tracks depend on continued IRB jurisdiction, and that has enjoyed close contact with federal regulators. In its comments at the time, PRIM&R argued against
empowering researchers to determine by themselves what
studies require review. If there's to be a one-page form,
PRIM&R wants its members checking off on it.
Another reason for the holdup is that so many different federal agencies now share IRB regulations (known as
the Common Rule), and each would need to agree on any reform. As a Department of Veterans Affairs research official
warned in early 2013, "Given the current political climate
and the often divergent interests of the seventeen agencies
that adhere to the rule, meaningful systemic modernization
of the Common Rule is not likely to occur any time soon." By
summer 2014, rumors spread that the next step, a proposed
revised regulation, might appear within months-but also
that it could make things worse, not better.
Zachary M. Schrag is a professor of history at George Mason University and author of Ethical Imperialism: Institutional Review Boards
and the Social Sciences, 1965-2009. His Institutional Review Blog,
http://www.institutionalreviewblog.com/, features details on many
of the incidents described in this essay.


http://www.institutionalreviewblog.com/

Washington Monthly - September/October 2014

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