Jim Thomas / Northern Illinois University

When thinking of research involving human subjects, we rarely pay attention to 
ethical issues 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 most research-oriented institutions.

Like it or not, a new age of "ethical responsibility" has emerged (Thomas, 
2001a).  Institutional watchdogs and moral entrepreneurs continually remind 
us, and often require, that we demonstrate prior to, during, and after our 
research that our research conforms to established ethical codes. 
This has led to an adversarial and often hostile relationship between
scholars and watchdogs, especially institutional review boards (IRBs)
and more recently, federally mandated committees developing educational
programs on the Responsible Conduct of Research (RCR).
In this paper, I argue that ethical precepts, while a cornerstone of research, 
risk being refied by moral entrepreneurs who advocate drafting explicit and 
immutable prescriptions and proscriptions for Net research.  I argue that we 
need not invent new ethical rules or to reduce ethical behavior to an 
immutable set of prescriptions and proscriptions.  We need only increase our
awareness of and commitment to established ethical principles. At stake in 
this discussion is not only why we should continually examine the possible 
ethical quandries that arise in Net research. I conclude by discussing the 
implications for Institutional Review Boards (IRBs) and federally mandated 
training for the Responsible Conduct of Research (RCR).

                            WHO CARES?
Why should social scientists take an aggressive stand in supporting recent 
federal guidelines for educating researchers on responsible research?  One 
reason is that it's nicer to be nice than not nice.  Another is that, as 
methodologists, teachers, journal editors, reviewers, and commentators, we 
continue to confront ethical dilemmas in our own field.  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.  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).  When allegations of 
plagiarism arose in two nationally-prominent sociology journals in the 1990s, 
executive boards of the relevant societies were confronted with allegations 
of their potential complicity in malfeasance.  The dramatic Carnegie Mellon
cyber-culture study of online pornography (Rimm, 1995), later featured as 
a cover story in Time magazine (Elmer-Dewitt, 1995), came under fire for 
gross ethical and methodological violations when it was revealed that ten 
different levels of gatekeepers--professionals who should have spotted the
lapses--ignored them (Thomas, 1996a).  Mario Brajuha refused to give his 
fieldnotes to police when subpoened following a suspicious fire in the 
restaurant where he collected his data (Brajuha and Hallowell, 1986). His 
experience challenged other social scientists to examine their commitment 
to protect their subjects. It is in this challening spirit that I explore 
some of the issues underlying attempts to engage in and monitor the ethics of
human-subjects based research.
There are number of reasons, some ethical, some in our self-interest, why
scholars should pursue the highest ethical standards.  Any alone provides 
sufficient cause, but in the aggregate, they are a compelling reason to 
support professional, Federal, and institutional initiatives on oversight 
of standards.

**First, ethical behavior is inherent in, and essential to, scholarship.

**Second, awareness and practice of ethical principles enhance the credibility 
of research and contribute to a climate of trust and integrity in scholarship,
teaching, and artistry.  Third, members of the academic community, even 
those not directly involved in reseach, identify and reaffirm the principles 
of responsible scholarship in manuscript review, teaching, advising, and 
collegial discussions.

**Fourth, promoting ethical standards complies with Federal and insitutional
requirements and helps ensure a positive profesional image internally and 

**Fifth, Ethical promotion increases familiarity with potential issues in 
one's one field as well as in other fields, illustrating the complexity of 
seemingly simple potential problems.  

**Sixth, promoting ethics creates an awareness of the rationale that guides 
identifying and resolving problems.  

**Seventh, ethical awareness increases awareness of the investigator's
own location in the process of scholarship and our obligations to the
public served by our scholarship.

**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.
This ethical reasons are translated into human subjects research in
the social sciences in many ways, including through personal integrity,
professional codes and standards, and the collegial peer review process.
At the institutional level, two mechanisms exist. The first are
Institutional Review Boards (IRBs) mandated by the federal goverment for
all institutions receiving federal funds, and the second is 
are federally-urged Responsible Conduct of Research (RCR) programs.

Because of increased oversight of and intervention in the ethics of 
scholarship by Federal agencies in the past two years, some feel that IRBs 
and RCR programs go too far in attempting to protect human subjects, creating 
instead bodies of overzealous moral entrepreneurs who restrict academic 
freedom and stifle research.  Defenders of IRBs and RCR programs argue that 
they are bound by federal guidelines and only ask "tough questions" and 
support research by ensuring compliance with federal regulations.

Human subjects are protected in many ways, such as reseachers' 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 (45 CRF 45) 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 guidlines
begun in 1947 and in 1974 formalized in 45 CFR 46, the broad guidelines
established by the federal government to protect the welfare of human
research subjects, primarily in biomedical and behavioral research.
In 2000, President Clinton directed all Federal agencies to review
IRB procedures, including an assessment of the degree of compliance
by research institutions receiving Federal research funding.

The IRB reviews 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 described by the
researcher to comply with Federal and institutional guidelines.
Especially since President Clinton's directive, universitiesacross 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 and 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 
are those that, while they pose minimal risk, should be given closer scrutiny.
Third are those proposals in which the research methodology may pose 
sufficient risk to human subjects to require a full IRB review to examine 
the safeguards designed to protect human subjects from possible injury or 
harm. The third category generates the most category, because IRBs may ask 
well-meaning questions out of ignorance, fear, cautious expediency, or 
ideological opposition in assuring that the research complies with existing 
In the examples of social science research described above, the heart of 
responsible research procedures, and certainly the concern of IRB oversight, 
is the protection of human subjects.  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; allegations of 
violations of informed consent policies in the Virginia Twin Study in 1998 
that shut down all federally-funded biomedical research at Virginia 
Commonwealth University; the mid-1990s allegations of research fraud 
against AIDS scholar Robert Gallo; the suspension of medical research in
1999 at the University of Illinois/Chicago for alleged improprieties of 
human subjects protection; and the brouhaha at Northwestern University over 
whether a postdoctoral reseacher has the right to publish research without 
permission of their professors (Curry, 2001).
Yet, the definition of human subjects is broad.  Consistent with
guidelines of other professional organizations (Thomas, 1996b),
the NIH definition from Title 45 CFR Part 46, "Protection Of Human
Subjects," consistent with the explicit or implied definitions of
social science professional organizations, defines a human subject
   ...a living individual about whom an investigator (whether
   professional or student) conducting research obtains
      (1) data through intervention or interaction with the
      (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 and harmful research as well.  As the examples of 
ethically 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 how means to implement them risks encroaching upon 
academic freedom and unrestricted inquiry.


Recent Responsible Conduct of Research committees represent the second
major federally-mandated means to assure the integrity of all research.
With the intent to expand awareness of the responsibilities underlying
the conduct of all research beyond simply human subjects issues, the U.S. 
Public Health service recently enacted a policy that public and private 
sector research institutions implement training on research ethics 
(NIH, 2000).  How the education occurs and who should receive the education 
will be left to individual institutions. However, the intent of the RCR 
policy is clear:  All researchers, even those whose work is not federally 
funded, should receive at least some RCR education (NIH, 2001).  Failure to
comply with RCR guidelines could jeopardize an institution's federal funding.
Although federal implementation of this "Responsible Conduct of Research" 
(RCR) initiative has been delayed for a year because of a jurisdictional 
dispute with Congress (Tauzin and Greenwood, 2001), many universities have 
begun exploring ways to assure compliance with RCR guidelines in anticipation 
of the policies taking effect in October, 2001. 

The Office of Research Integrity (ORI) identifies nine core areas for 
educational training (ORI, 2000):
      a) data acquisition, management, sharing, and ownership
      b) Mentor/trainee relationships
      c) Publication practices and responsible authorship
      d) Peer review
      e) Collaborative science
      f) Human Subjects
      g) Research involving animals
      h) Research misconduct
      i) Conflict of interest/commitment
Influenced in part by the Boyer (1990) principles, NIU has proposed expanding 
the audience for participation to all scholars with a Resonsible Conduct of 
Scholarship program.  It also has added two additional program areas:
Fiscal and administrative responsibility and environmental health and

Unlike IRB oversight, RCR programs are not limited to concern with human 
subjects.  They are intended to create an understanding of the broader 
processes of scholarhip and the ethical dilemmas that can arise.  RCR 
programs, unlike IRBs, do not provide rules or guidelines to which 
scholarship must conform. Rather, they attempt to create, through various 
types and levels of education, an shared culture of the problems
and possible guidelines for solutions to ethical dilemmas confronted by
academics. Yet, because the grow out of federal oversight of research,
they also have generated considerable controversy across the country.
Combined with increased scrutiny by Institutional Review Boards (IRBs), 
critics of the new federal "responsibility initiative" have increasingly 
expressed concerns that compliance with the new policies may jeopardize 
academic freedom, First Amendment rights, and the free flow of
 empirically-based ideas.

However, like IRBs, RCR committees, too, are seen as moral entrepreneurs intent
on imposing madatory guidelines on scholars, and the excesses of the former
erroneously imputed to the latter. This creates a problem for both by
increasing fears that academic freedom is being subverted by external
oversight, and by making it more difficult for both IRBs and RCR programs
to attain their goals.  Much of the solution lies in helping IRBs clean up 
their image.  

                       IDIOPOTHY AND IDEOPATHY?

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
of the continued distance that the IRBs themselves 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 problems the IRB has created, three 
stand out: Idiosyncracy, idiocity, and idolatry. The following examples are
drawn from collegues' reports across the country.


Idiosyncracy 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 the replacing existing guidelines with
personal preferences. For example, an IRB member might depart from
existing guidlines that 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. In a second example,
one IRB board vehemently opposed the covert study of drug dealers by
a participant observer because it seemed unethical to be involved in
even an indirect observer of illegal activities on such a "hot-button"
topic, even by scholars. Here, the issue was not one of protecting
human subjects, or even the reputation of the university, but to the
IRB members' personal ethical views.  The result is that IRBs shift from 
being a protector of human subjects to gatekeeper of research ethics.


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 Engish, and the analysis done in English.  Yet, the IRB inexplicably 
insisted that the fieldnotes be transcribed into Spanish, even thought 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-ethnograpy, which refers to drawing from the researcher's
own life, using herself as the "human subject" from whom data is 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 therefore made no exemption for, self-analysis. Therefore,
it would be best to obtain IRB approval to assure compliance. Reportely,
wiser heads prevailed, and the issue was dropped.  Yet, such stories drive 
scholars' fears that IRB actions are unreasonable, even capricious.

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.

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 bythe researcher seemed inapplicable, 
because this state no longer uses parole to release prisoners, other than an
insignificant number sentenced prior to 1978. While some minimal forms
of administrative discretion might be affect some prisoners, parole
isn't a significant mechanism. In reality, this example is a unfair,
because in reality the IRB did not itself formally raise the issue.
As a courtesy, the researcher was informed of the rule prior to submitting 
his proposal. The intention was to alert the researcher to 
federal policies that he might want to address in his proposal.
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 followed the rules.


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, 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 to the perception that oversight is 
charactized by idiosyncracy, idiocy, and idolatry. In the examples above, 
the questions were motivated by well-meaning people who take their oversight
responsibilities seriously. Yet, federal guidelines have escalated
the scrutiny of research procedures.  The expansion of the definition of 
human subjects provides one example.

Some institutions believe that the study of any person requires IRB approval. 
This motivates the wrath of scholars doing auto-ethnography or who
observer 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:"

     (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, while well-meaning, have 
become moral entrepreneurs and are 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, including my own,
drive concerns over enforcment 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.

Retro-approval is the requirement that data collected from human
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 developed research for conferences or publications, requires IRB
approval to pursue publication or presentations. 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 ogranzation to which a manuscript or abstract has been 
submitted, thesis/dissertation, etc.) that the data were collected without 
IRB approval."

Because there is no time limit, and because the policy would appear to
include informing professional societies at which a paper was presented 
of lack of IRB approval, some scholars judge this a Draconian punitive
sanction, one that if both unreasonable and unfeasible.

Another policy seems to challenge academic freedom. One university
IRB policy specifices:

     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, specifying content of research publications is not.

From this, 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-approval.

A third conundrum raises the question, "what constitutes research?"
Drawing from 45 CFR 46, the federal guidelines covering human subjects,
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 
ambitous set of papers.  Does "systematic investigation" refer to data 
collection, or to the analysis?  Does, as one astute observer noted, 
systematic imply that the researcher created the method, or that the method 
derived from the structure of an a priori set of circumstances that drove 
the method such that the reseacher placed himself in an existing setting that 
was not research-centered?  Do IRBs determine all this?

                      CLEANING UP THE IMAGE OF THE IRB

At my institution, the IRB has generally been helpful. Even when
requiring additional information, which sometimes seemed maddeningly,
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
my many as "The Great Satan," a Grand Inquistor. How can IRBs shape
it's image?  They are often seen 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 expierences of colleagues across the country.

1. Communication. IRBs must communicate with faculty.
Many of the problems described above result from the fact, especially
in qualitative research, IRBs fail to promote an understandind of its
goals and what is expected of researchers in their proposals.
More simply, IRBs create many of their own problems by not countering
misconceptions, be appearing unresponsive to legitimate criticisms,
and by continuing to reinforce the image that they are an independent
tribunal with power over scholarly careers. This, at a minimum, must
include clear definition of the expectations and guidelines of 
of IRB criteria and how they can be met. Researchers should not be
expected to be mindreaders and play a continual game of "catch-up"
as each new response to questions generates a reiterative game of
further questions in a Sysyphusean game of seemingly eternal

2. IRB Oversight. The problems of "idiosyncracy, idiocy, and 
idolatry" could be mitigated by a mediating body to whom reseachers 
could appeal when challening decisions and policies. An IRB oversight 
board, representative of scholars familiar with human subjects research, 
could serve as a buffer between both groups in resolving many of the
problems that arise, or at least on providing a mechanism for negotiating

3. IRB Advisory Resource. Insitutions 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 IB expectations.

4. Open Discussion.  IRBs should engage in public dialogue with faculty
through public forums, roundtables, debates, discussions, and period
open-ended input sessions in which faculty can express their concerns.
The feelings of powerlessness expressed by those frustrated with IRB
practices results, in part, from the often justified perception that
IRB members are aloof, anonymous, and impervious to faculty concerns.

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
interpretations, 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
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 opportunites
for their constituencies to participate as well.

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
nonexistence, ambiguous, loosely interpreted, or ignored, could be
reduced by making public 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
fear consequences from perceived "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. RCR Training. Programs in the responsible conduct of research,
which are geared toward all those engaging in research,
generally include provisions to share issues of human subjects protection
with researchers. However, RCR programs could include specific and
detailed guidelines on how to navigate through IRB concerns.
It is also critical that IRB members be chosen who are representative
of the human subjects research community, and to reduce the turnover
on committees to facilitate consistency and annual shifts in focal concerns.

11. Remedial Reminders. The IRB and its oversight committee should 
issue period 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
constitutents serve no purpose and only alienate those whom it serves.
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." Who do the IRBs serve, researchers, subjects,
or fearful bureacrats trying to protect their domain?  More simply, are 
they researcher advocates or adversaries?  This issue, far more complex 
than it seems, lies the heart of many of the public relations problems the 
IRB incurs for itself.

14. The Qualitative Bias. Not without justification, qualitative
researchers, especially ethnographers, perceive IRBs as reflect
a bias for quantiative research. Because Federal regulations were
designed primarily for biomedical and behavioral sciences,
the criteria for assessing research tend to be constucted in ways that
are inapplicable for those for whom the unit of analysis is the culture,
not the individual. Also, Federal guidelines were not designed for
research in public spaces, yet IRB procedures tend to expand them 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 do not neatly fit the categorical
descriptions expected by the IRB.

15.  The Chillng Effect. Judging from colleagues, IRBs have had
a demonstrable chilling effect on some scholars who have
shifted their research agendas to other areas 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 impact is has
on research, especially on grant applications.

16. IRBs should be aware of the professional standards guiding 
researchers. For example, some IRB members vehemently cling to the belief
that covert research is never justified, and that consent 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 may, on occasion,
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 research subject to its oversight and research that is 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 does the line lie? IRBs ought take great care to
restrict its domain.

18. Avoid Patronizing. Many scholars feel that the IRB assumes faculty
lack ethics, experience in dealing with human subjects, and an 
understanding of risks. In the perception of some, the IRB acts as if
human subjects researchers have been in need of its wisdom to guide
them from sin. Yet, many scholars have had far more experience in
dealing with the ethical and other complexities of dealing with human
subjects than the combined IRB. When IRBs dismiss researchers' experiences,
their training, and their 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 there are
many mechanisms currently in place to provide guidance and oversight.

19. Finally, 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.

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 suggestion, the fact remains
that IRBs face a dilemma: They can, finally, begin to aggressive
cooperative 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)

How 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 strong fears of researchers has been translated
into fear of and animosity toward the 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 do 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 practicies 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.
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 communiction, public dialog, and
aggressive re-examination of the complex relationship between 
oversight bodies, regulatory bodies, and those they affect.

American Sociological Association (ASA). 1997. ASA Code of
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:

Brajuha, Mario and Lyle Hallowell.  1986.  "Legal Intrusion and
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Curry, Dan. 2001.  "Chemistry Journal Shelves Article After the
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____. 2001. "Frequently Asked Questions for the Requirements for
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