The Researcher's
Bill of Rights
By Harry Perlstadt
The
time has come to restore a reasonable balance between the interests of
researchers and the powers of Institutional Review Boards (IRBs). The
purpose of federal policy for the protection of human subjects is to protect
potential subjects from harm by allowing them to make informed decisions
about the risks of participating in a research project. This policy is
implemented through a set of independent IRBs composed of faculty and
community members with the unfettered power to interpret and enforce the
federal regulations at 45 CFR 46.
With
encouragement and directives from the Office of Human Research Protections
(OHRP), IRBs have expanded their authority over university community members
and thereby may abridge First Amendment rights of peaceful assembly, speech
and the press (which undoubtedly include oral presentation and publication
of scientific knowledge and applications). No effort has been made by
OHRP or IRBs to clarify where the constitutional rights of researchers
end and where university powers begin. While IRBs exercise their power
in the name of research subjects’ interests, there is no protection
against the risk that IRBs will develop constraints on inquiry and publication
that are responsive to the university’s political constituencies
and monetary interests.
The
Belmont Report noted that research usually involves the scientific method,
that is, a set of procedures designed to reach that objective. The general
rule was that research—defined as activity designed to test a hypothesis,
permit conclusions to be drawn, and contribute to generalizable knowledge—should
undergo review for the protection of human subjects. But the procedures
in social research inquiries are commonly no different from ways of associating
with people, inquiring about their lives, and writing about society that
do not require prior review and possible censorship. This is true for
a wide variety of social research, from phone surveys and focus groups
in corporate market research and political campaigns to ethnographic and
other qualitative forms of research, which frequently merge with journalism.
The First Amendment does not speak of “journalism” and makes
no exception for “research” in the liberties it guarantees.
The human research protections system has evolved without regard for constitutionally-protected
forms of assembly, speech and publication, creating a chilling effect
on academic freedom and legitimate scientific inquiry.
The
very indifference of OHRP and IRB administrators to the political values
they threaten indicates the gravity of the situation. Given the diversity
and multiplicity of universities in the U.S., it is inevitable that, without
strong protections, some IRBs will use “the interest of research
subjects” as a guise for restricting research that is not injurious
to subjects but that is offensive to social and political constituencies
deemed crucial to the university’s institutional well-being. Such
institutional conflicts of interests should not apply when determining
claims that a given form of inquiry should be modified or restricted because
of the danger it poses to subjects.
Unfortunately
the human research protections review process yields decisions that are
inconsistent within and across IRBs. An example of inconsistencies within
IRB is that one researcher was allowed to advertise a $25 payment for
participation on a campus flier but another researcher was explicitly
told not to put any payment amount on the flier. An example of across
IRB inconsistencies is that the Centers for Disease Control have received
a waiver enabling them to use “passive consent” whereby students
and youth will receive the CDC Youth Behavior Risk Survey unless parents
or guardians say no but most IRBs will not grant such a waiver for similar
or even identical surveys and
the Office for Human Research Protections insists that “passive consent”
is not permissible. In most cases any appeal of such decisions is internal
to the IRB, with no oversight or review by other faculty committees or
university officials.
Some
IRB’s require researchers to obtain documented informed consent for
asking the very same questions that journalists, market researchers or
public opinion pollsters can ask by properly identifying themselves and
informing the respondent that answers may become part of a public record
or report. Similar problems arise for researchers observing public behavior
that is often videotaped or photographed by the media.
In addition,
IRB’s may set higher standards than required by state law. For example,
if a state law permits verbal consent to receive treatment and has provisions
for the release of aggregate data with proper confidentiality provisions,
it not only seems unfair, but an override of state law for IRBs to require
a researcher to contact every patient and only use the data from those
who sign release forms.
Finally,
it is not the intent of federal policy to dictate acceptable methodologies
or prevent lousy research. It is to prevent harmful research. This important
distinction is often overlooked in an attempt to shield subjects from
what is defined as poor or unnecessary research.
A Researcher’s
Bill of Rights is essential.[1]
In addition to whatever conflicts of interest may exist for researchers
vis-a-vis research subjects, the conflicts of interest that exist for
IRBs by virtue of their institutional location must be taken into account.
The proper framework for thinking about these issues is not the simple
triad of researcher, research subject, and IRB but one that includes the
university’s various institutional interests and the American constitutional
tradition of rights and due process. The disciplinary and professional
associations of scholars and researchers must begin to counterbalance
the institutional interests of universities.
This
suggests that both Universities and disciplinary and professional associations
should develop a policy statement addressing the rights of researchers
with respect to human research protections. Such a Researcher’s Bill
of Rights would include the following provisions:
1) Researchers
and evaluators shall have the right to be told of the waivers to documented
informed consent contained in 45 CFR 46 and have the waivers considered
on the basis of precedent and existing waivers for federal agencies
conducting similar research using similar methods on similar subjects.
2) Researchers and evaluators have the right to use data collected by
state agencies under human subjects provisions governing those agencies
and IRBs cannot set a higher standard than state law or rules nor insist
that researchers get additional documented informed consent from each
client if the agency has already obtained it.
3) Researchers and evaluators shall have the right to claim their research
is exempt from IRB review under existing federal regulatory criteria
except insofar as the source of funding specifically requires IRB approval
of the exemption.
4) Researchers and evaluators shall have the same rights to associate
with and observe people, ask questions, and publish the information
they acquire as does any person whose rights of assembly, inquiry, and
publication are protected by the First Amendment of the U.S. Constitution
unless the receipt of funding for research specifically requires prior
review and approval of research procedures.
5) Researchers and evaluators have the right to fair and uniform procedures
and to due process, including having decisions based on precedent and
consistent from case to case and from university to university, receiving
written reasons for decisions, and the ability to appeal decisions to
a neutral third party.
Harry
Perlstadt , PhD, MPH,
Director, Program in Bioethics, Humanities and Society,
and Professor, Department of Sociology
Notes:
1 The Researcher’s Bill of Rights was created with
the help of Jack Katz, Department of Sociology, University of California—
Los Angeles. (return)
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