Jim Thomas
Department of Sociology
Northern Illinois University
DeKalb, IL (60115)
jthomas@sun.soci.niu.edu
30 March, 2002
_______________
DRAFT: Prepared for the Midwest Sociological Society annual meetings,
Milwaukee, April 7, 2002.
I am indebted to Lori Bross, Herbert Rubin, Irene Rubin, and various
colleagues at NIU and elsewhere for providing insights and information
that shape the suggestions. The position here does not necessarily
reflect their own views, but their positions were instrumental in
shaping my own.
ABSTRACT
Like it or not, a new age of "ethical responsibility" has emerged
(Thomas, 2001). Institutional watchdogs and moral entrepreneurs
continually remind us, and often require, that we demonstrate prior
to, during, and after, that our research conforms to established
ethical codes. Especially for social science and cultural research,
this has precipitated an adversarial and often hostile relationship
between scholars and watchdogs, especially institutional review boards
(IRBs).
In this paper, I try to balance a critique of IRB practices with
sympathetic suggestions for changing them as an antidote to the
growing pathology of opposition dividing IRBs from the research
community. In identifying selected memes, or cultural replicators,
that fuel this distance, I argue that human subjects protections risk
being reified by apparent moral entrepreneurs who advocate drafting
explicit and immutable prescriptions and proscriptions for human
subjects research. I argue that we need not invent new rules for
protecting human subjects or reduce protections to an immutable set of
prescriptions and proscriptions. I conclude by suggesting ways by
which IRBs can attend to meme-management as a way of reducing distance
from, and animosity to, qualitative social scientists.
RE-EXAMINING HUMAN SUBJECTS PROTECTIONS IN ETHNOGRAPHIC RESEARCH:
UNPACKING THE MEMES OF OVER-ZEALOUS OVERSIGHT
When thinking of research involving human subjects, we rarely pay
attention to their protection until something goes horribly wrong.
Then, we are challenged for an accounting. In response to highly
publicized and sometimes dramatic lapses in scholarship in the past
decade, increased oversight by peers and institutions, and recent
Federal policies and regulations, have made research ethics a priority
at all research-oriented institutions. Like it or not, a new age of
"ethical responsibility" has emerged (Thomas, 2001). Institutional
watchdogs and moral entrepreneurs continually remind us, and often
require, that we demonstrate prior to, during, and after, that our
research conforms to established ethical codes. Especially for social
science and cultural research, this has precipitated an adversarial
and often hostile relationship between scholars and watchdogs,
especially institutional review boards (IRBs).
In this paper, I try to balance a critique of IRB practices with
sympathetic suggestions for changing them as an antidote to the
growing pathology of opposition dividing IRBs from the research
community. In identifying selected memes, or cultural replicators,
that fuel this distance, I argue that human subjects protections risk
being reified by apparent moral entrepreneurs who advocate drafting
explicit and immutable prescriptions and proscriptions for Net
research. I argue that we need not invent new rules for protection
human subjects or reduce protections to an immutable set of
prescriptions and proscriptions. I conclude by suggesting ways by
which IRBs can attend to meme-management as a way of reducing distance
from, and animosity by, qualitative social scientists.
Who Cares?
Why should social scientists take an aggressive stand in
supporting recent Federal guidelines for educating researchers on
human subjects protections? One reason is that it's nicer to be nice
than not nice. Another is that, as methodologists, teachers, journal
editors, reviewers, commentators, and policy makers, we continue to
confront occasional human subjects dilemmas in our respective fields.
Consider a few dramatic examples from qualitative research.
When Humphries (1970) published Tea Room Trade over two decades
ago, he drew unprecedented criticism from social scientists for
perceived ethical flaws in his study of gay culture and lifestyles.
He lingered in truckstop restrooms and watched for gay sexual
activity, on occasion even serving as "lookout" for the participants,
and then surreptitiously recorded their automobile license numbers to
identify them for subsequent follow-up interviews. Joe Kotarba's
(1979) study of intimacy in a public jail visiting room drew shrilly
misguided and somewhat paralogical criticism for questionable ethics
(Deegan, 1980). The dramatic Carnegie Mellon cyber-culture study of
online pornography (Rimm, 1995), later featured as a cover story in
Time magazine (Elmer-Dewit, 1995), came under fire for gross human
subjects violations when it was revealed that ten different levels of
gatekeepers--professionals who should have spotted the lapses--ignored
them (Thomas, 1996a). Mario Brajuha was jailed for refusing to give
his fieldnotes to police when subpoenaed following a suspicious fire
in the restaurant where he collected his data, because he had promised
his subjects anonymity (Brajuha and Hallowell, 1986). His experience
challenged other social scientists to examine their commitment to
protect their subjects. It is in this challenging spirit that I
explore some of the issues underlying attempts to engage in and
monitor the ethics of human-subjects research.
There are number of reasons, some ethical, others in our
self-interest, why scholars should take aggressive measures to protect
human subjects. Any alone provides sufficient grounds, but in the
aggregate, they are a compelling reason to support professional,
Federal, and institutional oversight initiatives.
First, ethical behavior, including human subjects protection, is
inherent in, and essential to, scholarship. Second, awareness and
practices of protecting human subjects enhance the credibility of
research and contribute to a climate of trust and integrity in
establishing rapport with subjects. A single egregious violation by
one researcher poisons the credibility of others as well. Third,
members of the academic community, even those not directly involved in
research, identify and reaffirm the principles of responsible
scholarship in manuscript review, teaching, advising, and collegial
discussions. Awareness of potential problems raises red flags that
enable peers to pro-actively screen for potential problems. Fourth,
promoting ethical standards complies with Federal and institutional
requirements and helps ensure a positive professional image internally
and externally.
Fifth, promoting human subjects protections increases familiarity
with potential issues in one's one field as well as in other fields,
illustrating the complexity of seemingly simple potential problems.
Such cross-fertilization helps to bind researchers across disciplines,
such as oral history, sociology, business, anthropology, education,
and nursuing. Sixth, promoting human subjects protections creates an
awareness of the rationale that guides identifying and resolving
problems. As Marquart and Thomas (1988) and Bakker (2001) have
argued, formal ethical rules or the ethical codes of professional
organizations are not always helpful, and sometimes sharing
principles, instead of rigid precepts, helps resolve some problems.
Seventh, ethical awareness increases recognition of the investigator's
own location in the process of scholarship and our obligations to the
public served by our scholarship. Sometimes, the researcher owes
conflicting allegiances to subjects (Marquart and Thomas, 1988), which
requires us to identify where our ethical loyalties lie and who we are
bound to protect. Eighth, an awareness of ethical issues contributes
to shared awareness of the diversity and complexity of issues facing
practitioners involved in human subjects research, and promotes an
environment of collegial recognition and discussion.
Protection of Human Subjects: Enter the IRB
Human subjects are protected in many ways, such as researchers'
and professional codes of ethics and conventional research norms. The
most formal and rigorous method is by IRBs. IRBs are mandated for all
institutions receiving Federal funds (Title 45 CRF, Part 46) and are
intended to protect the rights and well-being of human subjects,
especially in biomedical and behavior research. Institutional review
boards emerged out of Federal research guidelines begun in 1947 and in
1974 formalized in 45 CFR 46. They provide the broad guidelines
established by the Federal government to protect the welfare of human
research subjects. In 2000, President Clinton directed all Federal
agencies to review their IRB procedures, including an assessment of
the degree of compliance by research institutions receiving Federal
research funding. By statute, IRBs are comprised of institutional
personnel, but function as a proxy for the Federal government in
attaining institutional compliance with Federal regulations.
The hybrid mix of interests and missions of IRBs contributes to
their often confusing policies and practices. Their location between
the Federal government and their institutions is best understood as a
type of franchise, in some ways similar to a McDonald's hamburger
chain. Like individual McDonald's franchises, which ostensibly serve
their communities while accountable to corporate headquarters for
profits, service, and other operations, IRBs are located within and
staffed by the academic community in their institutions. Although
universities appoint IRB members, provide resources, and create
guidelines for attaining IRB consent, like a franchise, they are
exempt from normal "community" accountability. Section 46.104 of 45
CFR 46 specifies that an institution engaging in research "shall"
provide satisfactory written assurance that it will comply with the
Federal requirements of 45 CFR 46. The regulation's assurance is
evaluated by the Office of Human Research Protections (OHRP), an
office within the Department of Health and Human Services, that can
"approve, disapprove, or enter into negotiations to develop an
approvable one." In situations at the University of Illinois/Chicago,
Duke University, Rush Hospital (Chicago), and Johns Hopkins University
that made the news in recent years for non-compliance, the OHRP halted
their research, presumably by suspending their institutional
Assurances. In other words, they revoked their "franchise" not for
failing to protect human subjects, but for failing to follow Federal
rules.
IRBs review all proposals to first determine whether a scholarly
activity involves research, and second, whether it involves human
subjects. If the answer to both is affirmative, the IRB then
determines the extent to which protections of subjects must be
detailed by the researcher to comply with Federal and institutional
guidelines. Especially since President Clinton's directive,
universities across the country have rigorously and aggressively
expanded their procedures and scope of oversight. IRBs generally break
applications for research approval into three categories. The first,
exempt status, refers to proposals that are judged to possess minimal,
if any, risk to human subjects, as defined by Federal guidelines. If
exempt, proposals need not be reviewed further by the IRB. Contrary
to some misconceptions, "exempt status" does not mean that such
research need not be submitted to the IRB, but rather that it must be
submitted to the IRB, which then makes the exempt determination. The
second category of applications are those that, while they may pose
minimal risk, nonetheless should be given closer scrutiny. Third are
proposals in which the research methodology may pose sufficient risk
to human subjects such that a full IRB review is required. The third
category generates the most controversy, because IRBs may ask
well-meaning questions out of ignorance, fear, cautious expediency, or
ideological opposition in assuring that the research complies with
existing policies.
The most egregious and dramatic recent violations of human
subjects research have come from the medical sciences, typified by the
University of Minnesota paying the U.S. $32 million in the late 1990s
to settle a lawsuit alleging over two decades of illegal drug
profiteering and mishandling of grant funds (cite); allegations of
violations of informed consent policies in the Virginia Twin Study in
1998 that shut down all Federally-funded biomedical research at
Virginal Commonwealth University; and the suspension of medical
research in 1999 at the University of Illinois/Chicago for alleged
improprieties of human subjects protection.
Yet, the definition of human subjects is broad. Consistent with
guidelines of other professional organizations (Thomas, 1996b), the
definition from Title 45 CFR Part 46, "Protection Of Human Subjects"
defines a human subject as:
...a living individual about whom an investigator (whether
professional or student) conducting research obtains
(1) data through intervention or interaction with the
individual,
(2) identifiable private information."
While Federal guidelines generally connote an intention of
protecting human subjects primarily in biomedical and behavioral
research, the definition has been intepreted to also include observees
and conversational partners in less intrusive research as well. As
the examples of controversial research summarized above indicate, the
necessity of protecting human subjects in all research is
indisputable. The controversy lies not so much in the laudable goals
intended to protect people, but rather in the means to implement them
and how the means risk encroaching upon academic freedom and
unrestricted inquiry.
Memes and Idiopathy
The images generated by researchers' stories describing
frustrating experiences with IRBs create memes, or the cultural
replicators by which we create and maintain cultural meanings:
Just as genes propagate themselves in the gene pool by
leaping from body to body via sperms or eggs, so memes
propagate themselves in the meme pool by leaping from brain
to brain via a process which, in the broad sense, can be
called imitation (Dawkins, 1976: 206).
Examples of memes include tunes, ideas, clothes, or fashion. In
the case of IRBs, the circulation and acceptance creates and reaffirms
pejorative labels that demonize IRBs as the narratives that shape them
are announced, accepted, circulated, and perhaps even embellished
through iterative tellings. The original narratives need not actually
be accurate. They need only be announced, iteratively circulated,
accepted as accurate. This creates image-management problems for the
IRB.
It's hardly a secret that IRBs have a bad image. They are seen by
many scholars as a genetic mutation of the doctrinal purification
rituals of the Spanish Inquisition conducted by Joe McCarthys in
leisure suits and primitive barbarians subverting the ages-long
doctrines of free inquiry. While the criticisms may be unfair, they
are perpetuated at least in part by the continued distance that the
IRBs create between themselves and the research constituencies they
ostensibly serve. This adversarial relationship can be attributed in
part to a form of idiopathy, a disease of the IRBs own making. Among
the many memes the IRB has generated, four stand out: Idiosyncrasy,
idiocity, idolatry, and ideopraxis. The following examples are drawn
from colleagues' reports across the country.
Idiosyncrasy.
Idiosyncrasy refers to the particularistic behaviors or views of
individuals or groups that depart from conventional standards or
norms. For IRBs, this refers to the discretionary interpretations of
the Federal or institutional guidelines that ostensibly guide the
procedures and outcomes of IRB decision making. This includes
misguided or questionable interpretations of policy and replacing
existing guidelines with personal preferences. For example, an IRB
member might depart from existing policies that would waive the need
for signed consent form of persons who provide data for research and
instead require that signed consent forms are required whenever data
is collected from individuals, regardless how unfeasible such forms
might be. As an illustration, one IRB board vehemently opposed the
covert study of drug dealers by a participant observer because it
seemed unethical to be involved in even indirect observation of
illegal activities on such a "hot-button" topic. Here, the issue was
not one of protecting human subjects, or even the reputation of the
university, but rather the imposition of IRB members' personal ethical
views in ways that restrict inquiry. The result is that IRBs shift
from being a protector of human subjects to gatekeeper of acceptable
research ethics.
Idiocy.
Sometimes, the concerns and requirements of IRB boards -- however
well-meaning they may be -- seem foolish and exceed what, to
researchers, appear reasonable. This may often be attributed to a lack
of IRB understanding of the nature of research, especially in
fieldwork.
As an example, a nationally respected and experienced scholar
submitted a proposed study of women in jails to her IRB. The
population being studied, largely Hispanic, was to be interviewed in
English, the fieldnotes taken in English, and the analysis done in
English. Yet, the IRB inexplicably insisted that the fieldnotes be
transcribed into Spanish, even though the transcripts would not be
automatically shared with the interviewees. The problems of faulty
translations and the unnecessary additional time and costs of
transcriptions aside, there was no reasonable justification for such a
requirement. Although the issue was resolved satisfactorily, it
exemplifies the type of intrusion and increased stress for researchers
that escalate the animosity between scholars and IRBs.
In another case, a scholar wanted to engage in a study with a
methodology that included auto-ethnography, which refers to drawing
from the researcher's own life, using herself as the "human subject"
from whom data are drawn. According to the researcher's account, the
IRB suggested that she actually needed IRB approval to study herself.
The Board's argument was that, while it might appear silly, Federal
regulations were silent on, and made no exemption for, self-analysis.
Therefore, it would be best to obtain IRB approval to assure
compliance. Reportedly, wiser heads prevailed, and the issue was
dropped. Yet, such stories drive scholars' fears that IRB actions are
unreasonable, even capricious, thus reinforcing the meme of idiocy.
Idolatry.
Idolatry, an excessive devotion to mythic symbols, characterizes
IRBs in the eyes of some scholars. This can take many forms, including
seeming excesses in attempting to identify even the most extreme
scenario that could put a subject at risk. This can range from
slavish adherence to the letter of Federal and other guidelines to
extreme protection of subjects in improbable research scenarios.
As an example, a researcher at one institution was faced with the
dilemma of addressing the issue of informing prisoners from whom he
might collect data through conversations or by simply observing them
that he must explain to the prisoners that sharing information would
not affect the parole board's decision to release them. Federal
regulations, as written, appeared to require this. However,
implementation by the researcher seemed inapplicable, because this
state no longer uses parole to release prisoners, other than for an
insignificant number sentenced prior to 1978. While some minimal forms
of administrative discretion might affect some prisoners, parole isn't
a significant mechanism. In reality, this example is a unfair, because
the IRB did not itself formally raise the issue. As a courtesy, the
researcher was informed of the rule prior to submitting his proposal
to allow the researcher to address the Federal policy. This example
illustrates the shared dilemma for both the IRB and scholars: The
Federal emphasis on human subjects protections requires full
compliance, and in case of a Federal audit, both researchers and IRBs
must demonstrate that they scrupulously complied with the rules.
Ideopraxis
IRBs function as ideopraxists, or people assigned to carry out an
idea. Prior to 2000, IRBs generally limited their scope to the spirit
of human protections. Since then, they have been mandated to impose
Federal principles and policies on the research community. Two
examples illustrate how this has occurred and the impact it has had on
scholars.
First, IRBs have dramatically expanded the rigorousness of their
examination of human subjects research. This has created the
perception that oversight is characterized by memes of idiosyncrasy,
idiocy, and idolatry. In the examples above, the questions were
motivated by well-meaning people who take their oversight
responsibilities seriously. But, Federal guidelines have escalated the
scrutiny of research procedures, and the expansion of the definition
of human subjects provides one example.
Some institutions believe that data derived from any living
person requires IRB approval. While often just an unfortunate choice
of loose wording, this nonetheless motivates the wrath of scholars
doing auto-ethnography or who observe people in situations where there
is no reasonable expectation of privacy. Observing people in a public
setting in which there is no interaction or intervention, and in which
no identifiable private information is collected or reported, simply
does not fall within the Federal definition of "human subjects."
Recall the definition from 45 CFR 46:
(f) _Human Subject_ means a living individual about whom an
investigator (whether professional or student) conducting
research obtains
(1) data through intervention or interaction with the
individual, or
(2) identifiable private information....INTERACTION
includes communication or interpersonal contact
between investigator and subject.
Nor is private information collected:
"Private information" includes information about behavior
that occurs in a context in which an individual can
reasonably expect that no observation or recording is taking
place, and information which has been provided for specific
purposes by an individual and which the individual can
reasonably expect will not be made public (for example, a
medical record).
Such apparent over-reaching contributes to the concerns of a
growing number of national scholars that IRBs, however well-meaning,
have become moral entrepreneurs who unnecessarily subvert academic
freedom and the expansion of empirical and conceptual development,
especially in the cultural studies, such as occur in ethnography.
A second significant issue that troubles scholars is how IRBs
enforce compliance. Current policies at many institutions drive
concerns of enforcement and compliance. The two most troubling are
those of retroactive approval and the need for annual renewal of IRB
approval for projects previously approved if data collection continues
or if data collected under previous approval continues to be used in
ongoing analysis or publication.
The retroactive approval is the requirement that data collected
from human subjects cannot continue to be used unless the IRB approves
the methods of data collection and its uses. For example, some IRBs
would argue that a scholar who visited a massage parlor over a period
of several months and later used the visits to develop research for
conference papers or publications, requires IRB approval. The IRB at
one institution notifies scholars that if they have used human
subjects without IRB approval, the IRB will recommend to university
authorities that the scholar notify funding agencies or "the
appropriate publication outlet (journal or organization to which a
manuscript or abstract has been submitted, thesis/dissertation, etc.)
that the data were collected without IRB approval."
Because there is no statute of limitations, and because the
policy would appear to include post-hoc notification to professional
societies sponsoring a conference at which a paper was presented that
the paper lacked IRB approval, some scholars judge this a Draconian
punitive sanction both unreasonable and unfeasible.
Another policy seems to challenge academic freedom. One
university IRB policy specifies:
If the data were collected for a thesis of dissertation, the
methods section must contain a statement that the data were
collected without IRB approval.
Dictating what an author, even a graduate student, must write in
the text of research confirms, for some, that IRBs are out of control.
While it might be acceptable to include the non-approval caveat in a
prefatory page, dictating the text of research publications is not.
Because of such prescriptions, some scholars fear to approach the
IRB. But, the more common result is confusion over what the IRB
requires and what outcomes follow from non-compliance.
A third conundrum raises the question, "What constitutes
research?" Drawing from 45 CFR 46, research refers to a systematic
investigation, including research development, testing and evaluation,
designed to develop or contribute to generalizable knowledge. But,
when does research become "research," and when does a living human
become a "subject?"
Consider the example of a scholar who attends a 12-step substance
abuse program for 12 months as a client, and keeps a detailed diary on
conversations, observations, and other experiences. After a year, the
scholar begins to recognize themes, patterns, concepts, and
theoretical connections emerging from the diaries and decides to
publish the insights, drawing from the diaries as data. Do the people
referred to in the diaries now become human subjects? When the
researcher's experiences began, he was simply recording observations
of interest that seemed relevant to his life. Later, they stimulated
his thinking, and he began to "systematically" organize these past
experiences into a conceptual framework. Then, subsequent observations
were organized around this framework with the possibility, but not the
certainty, that they could be the basis of an ambitious set of papers.
Does "systematic investigation" refer to data collection, or to the
analysis, or to dissemination "intended to develop or contribute to
generalizable knowledge?" Does, as one astute observer noted,
"systematic" imply that the researcher created the method, or that
instead the method derived from the structure of an a priori set of
circumstances that drove the method such that the researcher placed
himself in an existing setting that was not research-centered? Is
this the IRBs decision?
Meme Maintenance
At my institution, the IRB has generally been helpful. Even when
requiring additional information, which sometimes seemed maddening,
they were invariably supportive and served more as researchers'
advocates rather than adversaries. Yet, even at my institution, with
an eminently reasonable and helpful IRB, the Board is still perceived
by many as a Star Chamber whose career-affecting decisions are final,
unappealable, and capricious. Here, I offer a few policy-oriented
suggestions drawn from my own experience, but that seem relevant to
the experiences of colleagues across the country. Each is
cost-effective, designed to facilitate researcher compliance while
protecting the integrity of inquiry, and easily implementable. Some
of the suggestions overlap, but are separated for analytic
convenience.
1. Communication. IRBs must communicate with faculty. Many of
the problems described here result from the IRB failure, especially
for qualitative researchers, to promote an understanding of its roles,
goals and what is expected of researchers in their proposals. More
simply, IRBs create many of their own problems by not countering
misconceptions, by appearing unresponsive to legitimate criticisms,
and by continuing to reinforce the image that they are an independent
tribunal with power over scholarly careers. Communication, at a
minimum, must include a clear definition of the expectations and
guidelines of IRB criteria and how they can be met. Researchers should
not be expected to be mind readers and play a continual game of
"catch-up" as each new response to questions generates an iterative
game of further question-and-answer.
2. IRB Oversight. Currently, IRBs lack an institutional appeals
process other than repeated submissions of the methodology to the same
committee. The problems of idiosyncrasy, idiocy, idolatry and
ideopraxis could be mitigated by a mediating body to whom researchers
could appeal when challenging decisions and policies. An
institutional IRB oversight board, representative of scholars familiar
with human subjects research from diverse disciplines, could serve as
a buffer between both groups in resolving many of the problems that
arise, or at least providing a mechanism for negotiating.
3. IRB Advisory Resource. Institutions should establish an IRB
advisor to assist faculty in preparing their proposals prior to
approval. This not only symbolizes an IRB/scholar unity, but also
functions to reduce the possibility of iterative questioning that can
result from the perceived need to second-guess IRB expectations.
4. Open Discussion. IRBs should engage in public dialogue with
faculty through public forums, roundtables, debates, discussions, and
periodic open-ended input sessions in which faculty can express their
concerns. The feelings of powerlessness expressed by those frustrated
with IRB practices result in part from the often justified perception
that IRB members are aloof, anonymous, and impervious to faculty
concerns. Critics perceive that they have no means to redress or
challenge existing policies.
5. Interpreting Guidelines. IRBs are faced with the dilemma of
working through and interpreting existing guidelines, and defining how
they apply to scholars at their institutions. Yet, many of the
interpretations, as suggested in the examples above, seem ad hoc, even
Kafkaesque. IRB discretion to interpret rules should be curtailed,
there should be oversight on the interpretations to reduce
idiosyncratic or ideological intrusions, and IRBs should provide a
forum for input on how rules are interpreted.
6. Minimalism. To protect their institutions from embarrassing
lapses in human subjects protections, or to assure bureaucratic
paper-trail documentation in case of a Federal audit, some IRBs may
interpret Federal guidelines in ways that dramatically expand
oversight, such as redefining human subjects research as studies of
"any living human." Instead, IRBs should be encouraged to take a
minimalist, conservative approach, confining themselves to the letter
of the law and not expanding in ways that are neither justified nor
acceptable. Institutions should not leave interpretation of policies
to an a single person, or even to a single committee. Rather, a
committee of scholars representative of human subjects research should
participate fully in helping to establish institutional guidelines
complying with Federal regulations, but that do not go beyond them in
unintended ways that result in a chilling effect on research.
7. Universalism. Currently, institutions set their own policies,
which of course preserves institutional autonomy. But, in the case of
IRB oversight, this leads to wildly varying interpretations of
policies such that two scholars at two different institutions
conducting a joint research project run the time-consuming and
stress-inducing risk that the project will be approved at one
institution and not at another. IRBs should communicate not only with
their own constituency, but with their peers elsewhere, engaging in
dialog and allowing opportunities for their constituencies to
participate as well. While some IRB members may attend appropriate
conferences or monitor highly visible cases of non-compliance, these
tend to address the major issues of protection rather than the
smaller, often esoteric, and highly specific protections issues more
common in social science than in biomedical or behavioral science
research.
8. "Grandfathering." The fears of some faculty that they will be
penalized for past research for not bringing it before an IRB when the
rules were nonexistent, ambiguous, loosely interpreted, or ignored,
could be reduced by publicizing current rules. There should also be
explicit an unequivocal specification of the types of studies that are
exempt from IRB oversight to assuage the fears of researchers who
anticipate consequences of possible "witch-hunts" and assure that
there will be no retroactive search-and-destroy missions.
9. IRB Training. It is no secret that IRB personnel do not share
equal expertise or familiarization with the issues. While IRB
personnel ostensibly receive orientation with rules, given the power
they have over researchers--over both research procedures and
psychological well-being--they should be required to have rigorous
training in all aspects of human subjects research, Federal laws,
their responsibility to scholars as well as human subjects, and above
all, common sense.
10. Assessment of Need. Both institutions and IRBs should
periodically assess the need for human subjects protections. The adage
"if it ain't broke, don't fix it" applies to review of research as
well. How many of the risks identified by the IRB actually constitute
realistic potential outcomes? At what point can researchers decide for
themselves that a project need not be submitted for IRB approval
because the costs of review far outweigh any reasonable risk to
subjects? How much review is actually needed? The broader issue here
is that perhaps the pendulum of protection has swung too far, and a
balance is needed both at Federal and institutional levels.
11. Remedial Reminders. The IRB should systematically issue
periodic reminders to researchers about the obligations and
expectations of the IRB. Especially important are periodic reminders
to researchers who are required to renew approval.
12. Tact. Heavy-handed or threatening letters by the IRB to its
constituents serve no purpose and only continue to alienate the
research community. If the IRB appears to function more as policer
than protector, it will increase the alienation of faculty and
exacerbate the problems it currently faces in trying to secure
cooperative compliance.
13. Defining the "Master." Do the IRBs serve researchers,
subjects, or fearful bureaucrats trying to protect their domain? More
simply, are they researcher advocates or adversaries? Because of
their status both as de facto and de jure proxy for Federal agencies,
this issue is far more complex than it seems, and lies the heart of
many of the public relations problems that IRBs incur.
14. The Qualitative Bias. Not without justification, qualitative
researchers, especially ethnographers, perceive IRBs as reflect a bias
toward quantitative research. Because Federal regulations were
designed primarily for biomedical and behavioral sciences, the
criteria for assessing research tend to be constructed in ways that
are inapplicable for those for whom the unit of analysis is the
culture, not the individual. Also, Federal guidelines were not
originally designed to monitor or review research in public spaces,
yet IRB procedures tend to expand into this domain as well. IRB forms
are designed for nomological-deductive research, and the
narrative/story-telling style of ethnography and similar qualitative
methods does not neatly fit the categorical descriptions expected by
the IRB.
15. The Chilling Effect. Judging from colleagues, IRBs have had
a demonstrable chilling effect on some scholars who have shifted their
research agendas to other areas in order to avoid the perceived hassle
of undergoing continued "IRB inquisitions." The IRB should not only
recognize the possible chilling effect it has on research, but should
also systematically assess the broader impact it has on research,
especially on grant applications.
16. Recognizing Professional Standards. IRBs should be aware of
the professional standards guiding researchers. Researchers, with
rare exceptions that cannot be prevented by IRB oversight, are held to
high ethical standards by peer review, organizational ethical
committees, and the codes of conduct of professional organizations.
For example, some IRB members vehemently cling to the belief that
covert research is never justified, and that consent forms are always
required in all research involving human subjects. But, the American
Sociological Association, as one example, explicitly acknowledges in
its code of ethics that consent forms, on occasion, may be neither
necessary nor feasible. It also acknowledges that, in some
circumstances, covert research may be necessary and appropriate. IRBs
should take great care not to attempt to replace professional
standards with their own.
17. Establishing Limits. IRBs should establish explicit and
unequivocal parameters on what constitutes human subjects review and
what does not. Much of the current confusion involves "exempt"
research, which refers to research that an IRB, on review, judges to
be exempt from its purview. But, other types of research are exempt
from submission to the IRB altogether. Where lies the line? IRBs ought
take great care to restrict its domain by defining what does not need
review.
18. Avoid Patronizing. Many scholars feel that the IRB assumes
that faculty lack ethics, experience in dealing with human subjects,
and an understanding of risks. In the perception of some researchers,
the IRB acts as if human subjects researchers have been in need of its
wisdom to guide them from malfeasance. Yet, many scholars have had far
more experience in dealing with the ethical and other complexities of
human subjects research than the combined IRB. When IRBs dismiss
researchers' experiences, training, and past history, researchers feel
patronized, become offended, and the distance between the two
escalates. IRBs should recognize that scholars have obligations to
their peers, their subjects, and their professional organizations, and
many mechanisms are currently in place to provide guidance and
oversight.
19. Reign in the Scope. IRB boards should remember that their
domain is the protection of human subjects, not broader ethical
oversight. Few IRB members are trained in metaphysics, and their
attempts to intrude only lead to chaos.
20. Researchers Obligations. The previous suggestions identify
ways that the IRB can improve its image. But, researchers also have an
obligation. By aggressively raising IRB issues both within and outside
of their institutions, and by engaging in education of and dialog with
IRBs and colleagues, the more egregious practices of oversight can be
modified, policies challenged, and the myth-making power of the horror
stories rechanelled in ways that more fully integrate the needs of the
IRBs with those of both human subjects and the academic community,
thus altering the loosely-coupled relationship between researchers,
IRB, and Federal agencies.
At the heart of this list of suggestions lies the credibility of
IRBs, the support they receive from faculty, the protection of
research integrity, and and protection of academic freedom. Whether
people agree or disagree with these suggestions, the fact remains that
IRBs face a dilemma: They can, finally, begin to more fully cooperate
with faculty to the same extent that they expect faculty cooperation,
or they jeopardize their credibility in the institutional community
while, ironically, attempting to establish it with the Federal
agencies to whom they are accountable.
Conclusion: Idiopathy (Redux)
__________ _________ _____
Who needs ethics? We all do. One area where we can demonstrate
our ethical practices lies in the protection of human subjects. So,
the question isn't "Do we need human subjects protections" and IRBs,
but rather how the policies are implemented. The current fears of
researchers have been translated into animosity toward IRBs, resulting
in acrimony, hostility, threatened non-compliance, and considerable
angry discussion both at national and institutional levels. Many of
the concerns are legitimate and risk subverting academic inquiry.
Others, however, reflect the IRBs' own attempts to decipher complex,
ambiguous, and sometimes excessive guidelines.
I have attempted here to identify some of the sources of concern
and how these generate the current antipathy for IRB practices and
policies. Many of the problems separating IRBs are the result of
Federally imposed restrictions over which IRBs have little control.
Others, however, are the result of the isolation of IRBs and the
misunderstandings that all stake-holders have about the constraints
and needs of each other. I have argued here that much of the distance
between IRBs and the research community can be resolved by
cost-effective meme maintenance. The solution is to recognize that
the antidote to idiopathy, the current state of affairs in which IRBs
arguably generate many of their own problems, is a healthy injection
of more communication, public dialog, and aggressive re-examination of
the complex relationship between oversight bodies, regulatory bodies,
and those they affect.
BIBLIOGRAPHY
American Sociological Association (ASA). 1997. ASA Code of Ethics.
http://www.asanet.org/ecoderev.htm
Bakker, J.I. 2001. "Ethics Protocols, Symbolic Interaction and Social
Construction: Hermeneutic Rules of Exegesis and Casuistic
Outcomes." Unpublished Manuscript, University of Guelph.
Boyer Commission. 1990. Reinventing Undergraduate Education: A
Blueprint for America's Research Universities. The Boyer Commission
on Education Undergraduates in the Research University. New York
State University: Stonybrook.
Brajuha, Mario and Lyle Hallowell. 1986. "Legal Intrusion and the
Politics of Fieldwork: The Impact of the Brajua Case." Urban Life,
14:454-478.
Dawkins, Richard. 1976. The Selfish Gene. New York: Oxford
University Press.
Deegan, May Jo. 1980. "On Responsibility in Ethnography: Comment on
Kotarba." Qualitative Sociology. 3(Winter): 323-329.
Elmer-Dewit, Philip. 1995. "On a Screen Near You: Cyberporn." Time
Magazine, pp. 38-43. July 3.
Federal Register. 1991. Part II: Federal Policy for the Protection of
Human Subjects; Notices and Rules. Washington: U.S. Government
Printing Office.
Humphreys, Laud. 1970. Tearoom Trade; Impersonal Sex in Public
Places. Chicago: Aldine.
Kotarba, Joseph A. 1979. "The Accomplishment of Intimacy in the Jail
Visiting Room." Qualitative Sociology, 2(September): 80-103.
Marquart, James B. and Jim Thomas. 1988. "Dirty Knowledge and Clean
Conscience: The Dilemmas of Ethnographic Research." Pp. 81-96 in
D. Maines and C. Couch (Eds.), Information, Communication and
Social Structure. Springfield, Ill.: Charles C. Thomas.
National Institute of Health (NIH). 2000. "Required education in the
Protection of Human Research Participants."
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html
____. 2001. "Frequently Asked Questions for the Requirements for
Education on the Protection of Human Subjects.
http://grants.nih.gov/grants/policy/hs_educ_faq.htm
Office of Research Integrity (ORI). 2000. "PHS Policy on Instruction
in t he Responsible Conduct of Research (RCR)." U.S. Department of
Health and Human Services.
http://ori.dhhs.gov/html/programs/finalpolicy.asp
Thomas, Jim. 2001. "Do Sociologists Need 'Ethical Education'?" The
Midwest Sociologist. 44(September): 5.
_____. 1996a. "When Cyber-Research Goes Awry: The Ethics of the Rimm
'Cyberporn' Study." The Information Society. 12(2): 189-197.
_____. 1996b. "Introduction: A Debate about the Ethics of Fair
Practices for Collecting Data in Cyberspace." The Information
Society, 12(2): 107-117.