RE-EXAMINING THE ETHICS OF SOCIAL SCIENCE RESEARCH: FACING THE CHALLENGE OF OVER-ZEALOUS OVERSIGHT 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 externally. **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. PROTECTION OF HUMAN SUBJECTS: THE IRB 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 policies. 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 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 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. RESPONSIBLE CONDUCT OF RESEARCH 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 safety. 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. 1. IDIOSYNCRACY 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. 2. 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 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. 3. 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. 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. 4. 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, 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 questioning. 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 issue. 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. BIBLIOGRAPHY American Sociological Association (ASA). 1997. ASA Code of Ethics. http://www.asanet.org/ecoderev.htm 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. Curry, Dan. 2001. "Chemistry Journal Shelves Article After the Author's Former Mentor Raises Objections." Chronicle of Higher Education. June 4. Pp?? 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 Tauzin, W.J. and James Greenwood. 2001. Letter from Congressional Subcommittee on Oversight and Investigations to Office of Research Integrity. February 5. http://ori.dhhs.gov/html/programs/congressionalconcernsinquiry.asp Thomas, Jim. 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.
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