For the Record: Should All Disciplines Be Subject to the Common Rule? Human Subjects of Social Science Research

Jonathan T. Church

Chair, Department of Sociology and Anthropology
Arcadia University (Pennsylvania)

I want to begin with a short story that is part anecdote and part allegory. I am the chair of a small department of sociology and anthropology at Arcadia University. All graduating seniors at my institution must complete some form of senior project that results in a written thesis. Students in my department undertake a formal research project of their own choosing. We find that the emphasis on learning an academic discipline by actually practicing it is pedagogically quite valuable. While these research projects may not be the most original or significant, they are fundamental in helping students understand a particular mode of inquiry.

A few years ago, before I was chair, one of our students who was interested in gender studies proposed an ethnographic study of a "gentleman’s club" in Philadelphia. One of her friends had recently become a dancer there to earn money to put herself through college, and this student was surprised that her friend felt neither exploited nor oppressed by the ogling objectification of the clientele. Rather, she had a certain sense of empowerment, a sort of turning the tables on heterosexism. So the student wanted to learn about the life world of female dancers, and she had an ethnographic entrée into this community, as her friend could vouchsafe to other dancers that she was "cool." But her project adviser, a member of my department, thought that she might have trouble putting this project through our campus institutional review board (IRB). So the adviser met informally with the student and a prominent member of the IRB to talk about the project.

The project raised all sorts of red flags for the IRB member: How would the student protect the anonymity of dancers who might become embarrassed if a wider community found out about their alleged "profession"? What liability would the student face if she found out that illegal activities (perhaps sexual, perhaps drug related) occurred at the club? What specific interview questions did she plan to ask, and how would the interview format protect the identity of the dancers interviewed? What would happen if one night her interview notes were stolen?

Never mind the fact that each dancer performed before dozens of different men each night; or that until questioned by the IRB member, the student had little cause for suspicion of illegal activity; or that informal casual conversation would suffice to cover issues of data collection and informed consent, as it does for many ethnographic studies. Both the student and her adviser read the handwriting on the wall: the project might win IRB approval, but probably not in time to allow the student to complete a senior project and graduate. The student abandoned the project for something much less controversial.

A few weeks later, I was giving a presentation at a liberal arts college in my area, and during the small talk at lunch, I asked my anthropological colleagues at the table what types of projects their students were pursuing. One of them mentioned that she had a student doing a wonderful little study of dancers in Philadelphia strip clubs. "Did you have any problems getting this through your IRB?" I asked. "Why would we? Why would that even go before the IRB?" was the response. "The Common Rule doesn’t apply to classroom activities or research that isn’t federally funded. And there is really no risk to any of the research subjects." Quite true, of course. The difference was that my university has taken the common step of having our IRB review all human subject research taking place on campus, using the Common Rule as an evaluative template.

Returning to my campus, I confronted the IRB member who had so thoroughly dissuaded the student and told him what types of research were permitted on other campuses. The response: "Jon, would you let a first-year medical student perform surgery?"

Now my story does not end here. The following year one of the very brightest students in our program, who had for years been a member of the AIDS activist organization Act-Up and a volunteer at the AIDS Law Project, decided that she would not attempt an ethnographic inquiry on AIDS activists in Philadelphia. This shocked all of her instructors. But as a junior in the program, she had seen what had happened. As a senior, she did not want to waste her time tilting at the IRB. Better to do a statistically significant, but dull, survey of the relationship between healthy eating habits and extracurricular activities of college students, rather than a controversial ethnographic study of AIDS activists that might never be approved.

I was outraged. How dare an IRB have such a chilling effect on research? How could a biomedical paradigm be used like some threshing machine with ethnographic research the resulting chaff? Hell hath no fury like a newly tenured academician. I insisted on being appointed as a member of the IRB.

When the IRB meeting doors closed on a committee consisting mostly of members from the natural and life sciences, the suspicious vision I had formulated of a semisecret fraternity of biomedical authoritarians out to persecute ethnographic research was shattered. These were the same individuals I had worked with for years: principled, ethical, deeply concerned about protecting human subjects, equally concerned that sound research go forward and that unsound research be redesigned so it could go forward.

So why is there this chilling effect on ethnographic research? What is clear to me is that where there is only a single university IRB to review all research either falling under the Common Rule or extending past the remit of the Common Rule to include all research involving human subjects, then IRB membership is usually dominated by scholars whose expertise is in clinical and biomedical research. As a result, flexible interpretations of the Common Rule that take into account different types of inquiry are foreclosed. There is no conspiracy here. Most of the research coming before IRBs is from clinical and biomedical fields of study, and thus it makes sense for universities to establish IRBs to evaluate this kind of research. Because the Common Rule itself is rooted in a biomedical paradigm that tightly matches the everyday research activities and scientific common sense of the majority of IRB members, ethnographic research often strikes an IRB as inherently problematic.

Let me give an example. Much biomedical research takes place within a laboratory setting. This means that before any procedure can be carried out on a human subject, informed consent must be obtained from the subject in the form of written documentation. Consent is always given prior to the actual research taking place. The researcher is ethically obliged to inform the subject of potential risk. Consent is the precondition for research, but not part of the research.

By contrast, ethnographic research usually takes place in settings where the human subjects live, and it is the researcher who enters the setting. Informed consent is an ongoing interaction between the researcher and the members of the community who are being studied. Further, consent is subject to the cultural rules and understandings of that community. Consent is not obtained before one does the research, but is part of the constant activities of doing ethnographic research. One must establish bonds of trust and negotiate consent. An important aspect of this negotiation is informing the subjects under study that the researcher is an ethnographer examining those subjects’ cultural practices. Sometimes, the subjects may alert the researcher that the investigation may impose more than a minimal risk to their well-being. And usually all of these interactions take place in casual conversation over a period of weeks or months—not prior to beginning a structured interview. Often, the demand for signed consent appears as rude, potentially threatening, and a breach of the trust previously established.

Within the biomedical paradigm, consent is viewed as an event (it is given or it is not), while the ethnographic paradigm sees consent as a process (it waxes and wanes through the interactions of researchers and study participants). As Mary Margaret Overby noted in the April 2001 issue of Anthropology News, the National Science Foundation’s Division of Behavioral and Cognitive Sciences and the American Anthropological Association have both suggested that "the methodology of participant observation in ethnography poses no or minimal risk to human participants. Thus participant observation studies should qualify for administrative IRB review."

But for members of IRBs who have a biomedical background, red flags are raised when the ethnographic researcher does not immediately seek consent, or asks for a waiver of consent in writing. To these IRB members, it appears that both the letter and the spirit of the Common Rule are being violated, and that the ethnographer is at best cavalier about the protection of human subjects. How can one trust that this research really poses minimal risk? Here begins the fetish of the outlandish imagining of possible risk and the relentless bureaucratic pursuit of increasingly detailed research protocols, some of which may even go so far as to require that the ethnographer destroy research materials and records, making longitudinal and comparative research impossible.

A sort of disciplinary cross talk occurs: the ethnographer thinks that he or she has been scrupulously honest in presenting a research project with minimal risk, while the IRB member senses a flawed and incomplete research design that may put individuals at risk. The IRB member concludes that more information is needed at a full review. The daily administration of the Common Rule on so many university campuses is where the chilling effect for ethnographic research is created. While this chilling effect may well reflect the particular circumstances of a specific university’s IRB, the net negative result for ethnographic research has become national in scope. Remedies for this situation must take place at both the national level—where the Department of Health and Human Services’ National Human Research Protections Advisory Committee and Office for Human Research Protections can make a critical difference—as well as through the efforts of social scientists, historians, and journalists at the local level.

What specifically is to be done? Here are a few suggestions. First, universities should establish IRBs that specialize in social, behavioral, and historical research. If a university cannot create an IRB for this purpose, then the IRB should appoint more than a single social scientist to serve on the committee. (I use the term "social scientist" in the broadest sense to include academicians who don’t perceive themselves as "scientists.") Second, ethnography and methods of participant observation should be included in the listing of kinds of research that are subject to expedited reviews under the Common Rule.

Third, professional associations like the American Anthropological Association should create guidelines for IRB members that describe best practices (as seen by anthropologists and other social scientists) for implementing the Common Rule. The National Science Foundation is already formulating a series of Web-accessible, frequently asked questions about the application of the Common Rule to different kinds of research. This significant step is in the right direction, for it will allow ethnographers who appear before IRBs to cite an authoritative government position for how to apply the Common Rule to their research. Fourth, ethnographic research should be reviewed by an IRB member familiar with the best practices in the discipline.

Lastly, certain kinds of research—for example, oral history interviews or work by professors of journalism—should be excluded altogether from IRB review. If that cannot be done, IRBs should issue annual blanket exemptions to academic departments for projects with minimal risk. The departments should determine risk status at an initial review, and submit findings of risk to the IRB for a yearly evaluation.

Linda Shopes

Historian
Pennsylvania Historical and Museum Commission

In this presentation, I will discuss the concerns that historians have about the application of the government’s human subjects regulations to our work, especially oral history interviewing. I will describe oral history as it is understood by historians, outline the problems historians have encountered with the regulations as they have been interpreted by their local IRBs, and suggest that the biomedical model of research driving the regulatory structure does not fit our work. In addition, I will pursue the idea that the definition of research in the federal regulations does not apply to oral history and identify the available protections for oral history interviewees outside the government’s regulatory system.

For historians, the term oral history refers to preplanned, open-ended, in-depth, generally tape-recorded, and frequently transcribed interviews with individuals whose firsthand experiences are deemed to be of historical significance. Although the transmission of knowledge about the past through the spoken word is certainly the oldest way in which humans have learned about history, historians distinguish between casual conversations about the past and oral history. The latter is a disciplined inquiry. It is framed by prevailing historiographical questions, governed by certain methodological protocols, and preserved on tape or disk for the record. Most fundamentally, oral history is a way of getting at information and perspectives not otherwise available in existing documents.

Historians conduct interviews to develop archival source material for future scholarly work or to carry out their own scholarly research. An example of the former are the hundreds of interviews conducted by the Oral History Research Office at Columbia University during the last fifty years; an example of the latter are the interviews with former southern textile mill workers conducted by historian Jacqueline Hall and her colleagues at the University of North Carolina during the 1970s that formed the basis of their award-winning book, Like a Family: The Making of a Southern Cotton Mill World, first published in 1987.

There is considerable overlap between these two approaches to oral history. Scholars conducting interviews for their own research are encouraged to place their tapes in a public repository, so that others can draw upon that work. And some scholars do not conduct interviews themselves, but draw deeply from archival collections, like those at Columbia. Many historians also use oral history in their teaching and in the production of films, radio programs, museum exhibitions, and other sorts of nonprint, public forms of historical presentations.

I think it is important to state that for historians, oral history is not understood as research on human subjects, but rather as research with other human beings. An oral history interview is an interactive process, in which the questions of the historian-interviewer elicit the responses of the narrator, which in turn influence the historian’s subsequent questions. The quality of an interview depends as much on the methodology employed and the relationship between interviewer and narrator as it does on the significance of the events being recalled and the sharpness of the narrator’s memory. As historian Michael Frisch wrote in A Shared Authority: Essays on the Craft and Meaning of Oral and Public History, oral history is distinguished by a "shared authority" between narrator and interviewer, as they work together to develop a particular account of the past.

IRBs claim the right to review oral history because, according to the Common Rule, data obtained though "interaction" as well as "intervention" with living individuals is subject to regulatory oversight. Oral history interviewing involves interaction. Yet the Common Rule exempts from oversight research that uses interview procedures unless the information obtained is "recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects" and "any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability, or be damaging to the subjects’ financial standing, employability, or reputation." While most oral history interviewees can be identified if in no other way than by their recorded voice, in most circumstances the information obtained does not "place them at risk of criminal or civil liability or damage their financial standing, employability, or reputation." Thus, most oral history should be exempt from regulatory oversight.

IRBs, however, tend to be risk-averse bodies and, if complaints received by the American Historical Association (AHA) and the Oral History Association (OHA) are an accurate gauge of what is happening, increasingly do not exempt oral history research projects. In fact, historians have reported that they have been told to submit detailed questionnaires for IRB review prior to conducting any interviews, to maintain narrators’ anonymity, and to destroy their tapes or retain them in their own possession after an interview.2 Each of these requests violates a fundamental principle of historical research.

An oral history interview is an open-ended inquiry, structured around a set of topics but with ample room to follow the logic of the exchange. While anonymity is always an option in oral history, anonymous sources lack credibility in history. Knowing the precise identity of a narrator is important to assess that person’s relationship to the topic under discussion and hence the perspective from which he or she speaks. And historians are professionally committed to open access to sources as a way of evaluating and building upon scholarship.

IRBs have also asked historians how they will recruit narrators and to consider the consequences for persons who refuse to consent to an interview. Neither issue is relevant to historical interviewing. Oral history narrators generally are not recruited from a potential pool of subjects, as is often the case with research subjects in medicine and sociology. They are selected because of their particular, often unique, relationship to the events under study. The only consequence of refusing to participate in an oral history interview that I am aware of is the resulting absence of that person’s version of events from the historical record.

IRBs understandably seek to protect oral history interviewees from harmful consequences that could result from public disclosure of information conveyed in the interview. Yet I could cite any number of examples in which this concern has been applied in misinformed, indeed silly, ways. Let me note just two.

More than one IRB has cautioned historians to refrain from asking about illegal activities. The good intention is clear, but this sort of caution can prevent interviews with civil rights activists, for example, who have routinely broken the law in acts of civil disobedience. And recently, I received correspondence about an incident in which a research administrator informed university IRB members that they had a responsibility to protect individuals and communities from research that could prove embarrassing to them, or could put them in a bad light. As one historian asked, "If I am studying racism, am I to protect people from their own racism?"

The argument is made that examples such as these do not undermine the essential soundness of the ethical principles embodied in the government’s regulations, and that the problem lies with their misinterpretation by local IRBs. That may be true in some instances, and careful, consistent application of existing regulations would certainly improve matters for historians. But how many misinterpretations are necessary to establish that an essential disjuncture exists between these regulations and the way history works? More to the point, insofar as the regulations inhibit critical inquiry on the grounds that the results may be damaging in some way to individuals or communities, they violate core principles of historical inquiry in a democratic society. The historian does not protect people from judgments issued at the bar of history, but holds them accountable before it—with prudence and judiciousness, of course, and always based on scrupulous research and a careful assessment of extant sources. Constraints on critical inquiry violate the principle firmly held by historians that public knowledge of the past serves the public good, however painful, difficult, or even incriminating that knowledge may be to specific individuals or communities. To ignore this principle puts us all at risk.

There is a still deeper consideration: perhaps oral history interviewing is not research as the term is defined in the Common Rule, and therefore should be excluded altogether from regulatory oversight. Certainly, the original intent of the regulations had nothing to do with historical research, for the ethical abuses that formed the context within which the regulations developed all occurred in biomedical and behavioral research. The Common Rule defines research as a "systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." By this definition, the oral history projects of undergraduate students, typically assignments with pedagogical goals, are not research and thus should be excluded from review.

But oral history interviews undertaken by graduate students and other scholars, like all historical research, do proceed more or less systematically. We define and delimit the questions governing our inquiry based upon broader historiographical questions deemed significant and then go to the sources—including oral sources—that can answer these questions throughout the research process. Questions are redefined and unexpected leads pursued in light of new findings. But historians do not engage in a research methodology that includes "testing and evaluation" of hypotheses in the clinical sense of the term.

But does, in fact, historical research "contribute to generalizable knowledge"? The federal regulations do not define "generalizable knowledge," but it is reasonable to assume that the term cannot simply mean knowledge that lends itself to generalizations, for generalizing characterizes every form of scholarly inquiry, indeed all forms of human communication. Rather, the meaning of the term seems to be rooted in the biomedical and behavioral origins of the Common Rule. In this sense, generalizable knowledge seeks underlying principles or laws that have predictive value and can be applied to other circumstances for the purpose of controlling outcomes.

All of this is far removed from historical inquiry. Historians seek to explain the causes of particular events, the politics of particular situations, or the motives of particular groups. Oral historical inquiry is the most specific of all forms of historical investigation, for it usually wants to understand the experiences and perspectives of a single person. While historians reach for meaning that goes beyond the specific subject of their inquiry, they do not reach for generalizable principles of historical or social development.

I also suggest that there is a fundamental difference between the physical or psychological harm that can result from scientific experiments on human beings and the emotional distress that can result from recalling an embarrassing, painful, or even damaging aspect of one’s personal history, a concern expressed by some IRBs. The difference lies not in the level of suffering, for surely recalling an event from one’s past can be enormously painful, but in the cause of the suffering: the scientist’s direct intervention, on the one hand, and the consequence of talking about what has already happened, on the other. In this sense, there is something fundamentally, perhaps epistemologically, different between research that occurs in the present moment of an experiment and research designed to elicit knowledge in the present about that which occurred in the past.

An interview is a constructed and therefore a somewhat artificial interaction, but it is not an experimental situation; it is a dialogue, with mutual participation. While narrators may not fully understand the concerns driving our questions, they do know we are asking them questions in a conversational setting. They can thus choose how to respond. They can—and do—refuse to answer specific questions; give misleading, incomplete, inaccurate, or false information; and refuse to participate in the interview. Unlike subjects of experiments or clinical trials, they retain a great deal of personal autonomy as well as control over the research itself.

Lastly, I draw attention to the ethical standards for the conduct and use of interviews developed and promulgated by the AHA and the OHA, which are grounded in an understanding of the politics of knowledge and include a clear statement about the need for the informed consent of narrators.3 Neither the AHA nor the OHA has received complaints of ethical lapses from anyone who has been interviewed by a historian, and no complaints have been filed with the courts.

Moreover, as John A. Neuenschwander makes clear in Oral History and the Law, historians, like everyone else, are bound by the laws of libel not to communicate falsehoods about a living person and by laws governing a person’s right to privacy. They are also bound by the laws of copyright, because an oral history interview is understood to be the intellectual property of the interviewee, until—or unless—he or she assigns that copyright to an archive or to an individual researcher. At the conclusion of an interview, a narrator is asked to sign copyright releases, which also define the terms according to which the interview can be used by others. An interviewee can require anonymity, can restrict access to all or portions of the interview for a given number of years, can forbid users to quote directly from the interview, and can require potential users to obtain their permission before consulting the interview.

In sum, the current regulatory system governing research on human subjects is simply incongruent with oral history interviewing. It has been used inappropriately to inhibit critical inquiry, and it is based on a definition of research far removed from historical practice. Moreover, historians are acutely aware of the ethical dimensions of our work and have well-developed professional standards governing oral history interviewing. I would like to see oral history recognized as lying outside the research domain inscribed by the Common Rule. Barring that, I would like to see a careful delimitation of ways current regulations can be applied to oral history interviewing.

Margaret A. Blanchard

William Rand Kenan Jr. Professor
School of Journalism and Mass Communication
University of North Carolina at Chapel Hill

The longer I am involved in teaching journalism and mass communication, the more discouraged I become with the role of our campus IRB in the review of research projects. As chair of the local IRB in our School of Journalism and Mass Communication, I spend many hours trying to get IRB proposals in shape for review. After our local committee reads the proposals and suggests changes, the student or faculty member must make the changes. Yet I do not believe that we have had one proposal accepted as written in the last year.

Many of the projects reviewed actually go beyond the board’s legal mandate. That is so because the administration has expanded the board’s role as a result of (mis)interpretations of national-level decisions or concern among university officials about federal retaliation for not following more than the letter of the law. My department has interacted with our campus IRB over the years on issues such as an attempt to deny a master’s student her diploma because she did not obtain IRB approval for calling newspaper executives to ask for copies of printed material generally available to the public; a demand that a student prove that a source was not her father; and a requirement that the students or faculty members conducting a mail survey instruct recipients that the survey could be mailed back unanswered, thus increasing the cost of the survey and decreasing the likelihood of obtaining sufficient responses.

We have been lucky in that we have been able to negotiate an agreement that keeps the IRB away from the journalistic products of our students. Such an arrangement is necessary when you teach journalistic skills in one classroom and the principles of freedom of the press just down the hall. We are not as lucky when it comes to teaching research skills to our graduate students in one classroom and the principles of freedom of the press in another classroom. In the latter situation, the IRB supervises research projects and unwittingly subverts the teaching of First Amendment principles. The dissonance caused by this split is substantial, and it is what brought me before the National Human Subjects Research Protections Advisory Board. My colleagues and I in journalism and mass communication have four particular concerns about IRB oversight in our field.

First, we believe that the IRB interferes with our teaching mission. It is important that we teach our students our ethical standards and our research techniques, not those of another field. Although our IRB manual says that the standards applied should be those prevalent in each individual field, in truth we are asked to meet biomedical standards that are often not carefully explicated or explained.

When we had an IRB training session last fall, IRB leaders told us that they had no intention of interfering with freedom of the press, and that is why they were steering clear of our journalistic product. When we asked them about the application of press freedom to other kinds of academic work, we were told the courts would have to decide that issue. But in many areas, the courts have extended freedom of the press to books and other ways of disseminating knowledge.

The desire to protect a university’s federal funding is understandable. Duke University had its federal funding frozen briefly because it had not instituted proper protections for participants in biomedical research. That action was enough to send shivers down the spines of administrators in Chapel Hill. Even so, invoking such concerns as a reason to monitor how scholars in disparate academic fields train their students is an infringement on academic freedom.

We lobbied to have a member of our faculty sit on the IRB after one of our professors had an (in)famous encounter with the board. This faculty member, in a survey course he taught regularly, wanted to study drug use on campus, but the IRB was worried about embarrassing students or perhaps causing them legal problems as a result of their being asked about their use of drugs. The university’s attorney eventually cleared the project, but the professor has had similar problems getting approval for surveys on binge drinking, date rape, and academic dishonesty. These topics are of critical importance to the university community, yet each could lead to problems for the participants. Because of these potential problems, IRB roadblocks have multiplied. The professor says he now limits his class projects to "bland topics and archived records." That decision, understandable as it is, limits our students’ preparation for work as journalists and the university’s ability to learn about campus problems.

Although we ultimately succeeded in our efforts to have one of our faculty members serve on the campus IRB, we have not reaped great benefits. We submit most of our projects to the IRB with a request that they be exempt from review or receive an expedited review. Only the IRB chair reviews applications accompanied by such requests. Over the past two years, the two people who have held this position have required researchers to submit increasing amounts of detailed information about their projects. Telephone calls to set up interviews must be scripted, and questions must be listed even though such a requirement ignores the spontaneity of the interview situation. Projects are eventually exempted from review or reviewed on an expedited basis, but the burden on the researcher in providing documentation to the IRB is still significant. Only an exclusion from review would ameliorate this problem.

Our second concern is that the IRB interferes with our ability to evaluate our profession and make suggestions for its improvement. Much of our academic work consists of interviewing, surveying, and working with professionals in journalism, advertising, public relations, and related fields. The people we seek to include in our research projects do not_understand IRB requirements that they be told of their right to drop out of a study or not to answer a question. For them, signing a consent form is clearly government intrusion into an arrangement into which they want to enter freely. If the master’s or doctoral student or faculty member cannot approach these professionals on an equal footing, then our ability to study the field is damaged from the beginning. To have to explain IRB procedures to mass communication professionals makes our scholars appear as immature and poorly trained individuals who need external supervision.

If the IRB is in place to make sure that no harm is done to subjects of research, perhaps it is time to look at the damage that can be done to those who conduct the research. Because of the way that IRB review undercuts individual and institutional reputation, it could well cost students opportunities for jobs, faculty members opportunities for tenure and promotion, and academic programs opportunities to raise necessary funding to maintain their positions.

Our third concern is that IRB supervision demoralizes many of our faculty members and students. I have seen students alter research projects to avoid IRB contact. I have seen some give up projects because of the red tape involved. I have heard words such as "thought control" used far too often in a university setting to refer to the acts of this government-sponsored agency. And more and more people are beginning to refer to the "IRB wars." If there is an educational purpose behind the IRB review, it seems lost on many in our discipline.

It is clear to me that intellectual curiosity, the backbone of university training, especially at the higher levels, is actively discouraged by the IRB. Research projects must ask only surface questions and must not deviate from an acceptable path approved by a remote group of people who seem to have no faith in our ability to conduct research on our own and no training in our field.

Many of my colleagues do not want to challenge the IRB, because they are concerned about drawing attention to themselves and to their work. They fear such attention will lead to further supervision by the IRB and more restrictions on their work. "Don’t rock the boat," they say. "Let’s keep a low profile. Maybe the IRB will not cause problems for our particular research project."

But ignoring the IRB is becoming harder to do, because it is becoming harder to understand just what the IRB wants. We have tried to improve our proposals in response to IRB requirements. For example, I send students to see scholars who have had proposals similar to theirs approved to find out just exactly what the scholars did to satisfy the IRB. But even when the model is followed, it is not enough; something more is always required. Besides taking my time and that of the local committee and the scholars, the process involves substantial delays in getting projects approved and started.

Often, the review process seems to be more about gamesmanship than anything else. It is far from a learning experience and certainly does not develop respect for the IRB and its rules. Our IRB officials have even acknowledged in training sessions that they apply standards of biomedical research to the social sciences, but that does not stop them from doing so. Attempts to revise the IRB rules have yet to move much beyond the biomedical model.

As for me, I am joining a fellow media historian in leaving the contemporary period behind. It is far safer in the nineteenth century. We both have substantial reputations as media historians of the twentieth century, but, as she told me, you do not have to worry about the IRB when you work in the nineteenth century. I am also debating whether to continue to supervise dissertations in twentieth-century history because of IRB involvement and interference with research plans.

A better formula for demoralizing graduate students and faculty members could not be imagined. A better formula for stultifying research is beyond contemplation. That formula is today in place, thanks to the IRB.

Our fourth issue is that we believe that IRB supervision of our research violates the First Amendment and its strictures against prior restraint. We believe that the First Amendment guarantees that the press in all of its manifestations is free from governmental interference. The IRB is a governmental intrusion on freedom of the press. Review by an IRB is a prior restraint on press and academic freedom, because it requires individuals to seek the government’s approval before initiating a project. The agency of government involved is the Department of Health and Human Services through its Office of Human Subjects Protections.

The IRB regulations imposed on journalism and mass communication scholars are clearly inappropriate. The rules were written for biomedical research. The National Endowment for the Humanities was correct when it chose not to accept the restrictions imposed by these rules. Yet national officials administering IRBs ignore this distinction, and local boards follow suit. The research done by most students and professors on campus does not cause physical harm to its subjects. And physical harm should be the sole basis for IRB review.

Our school is in the forefront of what we hope will be a developing First Amendment protest of the use of the IRB in regulating our research. We have, in fact, already contacted a lawyer employed by the North Carolina Press Association to determine how best to proceed on legal grounds.

One difficulty in our efforts is that the IRB generally approves projects after much delay and many changes. That creates problems for establishing a cause that could be settled by a court. An alternative is to argue that IRB rules and how they are applied to journalism and mass communication research create a chilling effect on intellectual freedom and academic research.

If I had my way, the IRB would remove itself from any matters not involving federally funded research or potential physical harm. That would be more in line with the government’s original mandate, to which few of us object. I would like to see the surveys and focus groups used in our programs removed from IRB supervision, because it is our responsibility to teach our students how to use these techniques properly and effectively. We are the ones to supervise such training—not an anonymous, autonomous body across campus representing an equally anonymous and autonomous body of federal bureaucrats. We should be presumed capable of teaching proper techniques rather than being presumed incompetent.

Most of my students and colleagues, however, would settle for excluding journalistically based research techniques and continuing to submit surveys and focus groups as well as experiments to IRB review. I can see merit in using this step as an introduction to change, but we must move toward widening the freedom of students and faculty to do the sort of research for which they were trained unless a danger of physical harm exists. Only then should we be forced to deal with an IRB.

Endnotes

1. In 1991 the U.S. Department of Health and Human Services issued a set of revised regulations for protecting the rights and welfare of human subjects of research. The regulations—known as the Common Rule and subscribed to by sixteen other federal departments and agencies, among them the National Science Foundation, the Department of Agriculture, the Department of Education, and the Department of Defense—constitute the core regulatory structure for research that involves human subjects and is funded by the federal government. Among the federal agencies that do not subscribe to the Common Rule is the National Endowment for the Humanities. The Common Rule, formally titled "Protection of Human Subjects," is part 46 of Title 45 of the Code of Federal Regulations. Back to Text.

2. Unless otherwise noted, this discussion and following descriptions of historians’ difficulties with their local IRBs are based on 136 responses to an online survey conducted by the American Historical Association in spring 2000; see also messages related to IRBs on H-Oralhist, archived at <http://www2.h-net.msu.edu/˜oralhist>.Back to Text.

3. See Principles and Standards of the Oral History Association, 2nd ed., available at <www.dickinson.edu/oha/EvaluationGuidelines.html> and "Statement on Interviewing for Historical Documentation," in the American Historical Association’s Statement on Standards of Professional Conduct, 2001 ed., available at <www.theaha.org/pubs/standard.htm>.Back to Text.

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