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 Chapter 8 :  Notes  |  Appendix A  |  Appendix B

 

 

Chapter Eight: Conclusion

“We are much less Greeks than we believe. We are neither in the amphitheatre, nor on the stage, but in the panoptic machine … is it surprising [then] that prisons resemble factories, schools, barracks, hospitals, which all resemble prisons?” Michel Foucault, Discipline and Punish: The Birth of the Prison, p. 217, 228

Regulation is, inherently yet relatively, restrictive, cumbersome, and myopic. Pursuant of “ideal” forms; focused on standardization. One-best-way absolutism. Bars.

“Every historical period has probably had its particular equivalences of traditionalists, modernists, critical theorists, and postmodernists, those who lament the passing of a purer time, those instrumentally building a future, those concerned with disadvantaged segments and the direction of the future, and those seeing fragmentation and decay mixed with radical potential” (Alvesson & Deetz, 1996, p. 193).

The IRB regulatory system has reached and passed any possible point of diminishing returns, and moved to the creation of detrimental effects. How important is it that we stop participating in our own subjugation, marginalization, and domination, in, at least, the IRB system? It appears that (in this little IRB slice of the world) if we wish to continue to observe the natural world and report what we see in it (i.e., to continue with qualitative methods, it is of critical importance to dismantle major portions of this system, including local “more rigorous” interpretations of federal rules (see p. 181 and 198). We must re-focus on “real” concerns that involve “real” and rapidly expanding risks such as conflicts of interest.

IRB Purpose, and Mine

What are IRBs “really” doing for the benefit of human subjects of qualitative and survey (non)treatments? My experience (not that much of it can be mentioned here in any specific way; in lieu, see quote from AAUP, 2001, p. 241 herein.) suggests that local IRBs convolute the process for researchers, infringe on their rights to conduct free inquiry, and contaminate the natural world. Further, IRBs are not offering “protections” to human subjects of these treatments, mostly because none are needed.{253}* Informed consent, for example, has no bearing when the (qualitative) researcher and participant are necessarily “being ordinary people” as Sacks (1970, as compiled by Jefferson, and included in Atkinson & Heritage, 1984) might put it.

The pursuit of process (regulation) has surpassed the pursuit of purpose (protection). My purpose here is to deconstruct the (many) regulatory apparatuses via the illumination of the self-regulatory behaviors present. I believe this is the most expeditious route to deconstruction and eventual deregulation. Regulators won’t deconstruct themselves; they need our encouragement and assistance. And, we must first see what it is they do to us (the SINS) before we will muster much effort to stop it.

Qualitative Research Issues

Long-term as well as immediate effects of both federal and local regulatory decisions are important to consider. To think about, write about, and act about. Science is, as is religion, politics (see Forester, 1989, p. 3-4). Like religion before it, positivistic science became and both have mostly remained, to use Marx’s words, the opiates of the intellectual and marketing masses for the past few hundred years.{254}* “Common” sense may be coming back into vogue (Alvesson & Sköldberg, 2000), and if it is, situations (including regulations) that “seems odd” to people may begin (or continue) to matter more. Positive connotations of terms such as  “grassroots” and “town hall meetings” are evidence of this possible regaining of respect for the local, the “common knowledge” or “common sense.”{255}* It would appear the programs designed to enhance self-respect (especially trusting and acting on one’s own knowledge and judgment) might be working to enhance the social capital of skepticism and dissention. To demarginalize, de-objectify critics. To embrace and enjoy (rather than only sometimes tolerate) diversity.

Many investigators, particularly students and faculty with whom I’ve spoken from 1999 to 2002, have said there is something more interesting they would explore if they “could get it past the IRB” or they are breaking the rules occasionally, or circumventing the process in order to do something of greater interest and importance to them, and, at least perhaps, to all of us (suggesting for a moment that some findings are useful!). The “need” for these regulatory processes that control many types of minimal risk studies is rarely if ever supported. But, it isn’t questioned in meaningful ways, either. If the need exists, we don’t know it. Participants need no protection from unobtrusive researchers. Researchers need protections to their entitlements: they are entitled to their values, their perspectives, and (most all) their pursuits. But, according to the rules, researchers are required to alter the normal experience (the lifeworld, as described by Husserl, Dilthey, Schutz, and others) of the people being studied (by telling them they are being studied, and in other ways) even though those people are not at risk in any significant way or number. Extremely few participants in social scientific studies are in need of protection at all, as protection already exists when considering the remedies available in criminal and civil courts. And for those who are at risk, it is, I argue, the decisions of researchers that are critical, and not the rules or lack of them.

In explaining to participants that a study is being conducted, the explanation alters the researcher and the researched, i.e., the “real world.” Once they are affected, researchers are, simply, no longer studying the “real” world, but an altered research environment—an artificial world comparable to those of the social psychological experiment and the social survey. And it is altered for no good purpose: not the fear of harming humans, but the fear of harming the rules, the process.

I’m skeptical about changing, affecting, manipulating the natural environment and referring to the data gathered in that environment as “empirical” data. This situation is the result of what I have called “required but unnecessary” regulatory requirements (see p. 36, 48, 185, and 202 herein; also GAO, 2001; AAUP, 2001). Along with every layer of federal regulation also come the attendant local interpretations, often described as (virtuously) “more rigorous.”{256}*

The treatments qualitative researchers ask for permission to inflict include observing people in their natural world, asking people questions in conversation, or recalling relevant aspects of one’s own life in what might be called retro-observation, {257}* reflexive methods (Alvesson & Sköldberg, 2000) and other activities. This is maybe the central reason for the unmanageability, the “unregulat-ability” of qualitative research, the lack of a priori knowledge of what will be data, who might supply it, when the data may become useful or how long it may remain so (see concerns about IRB rules requiring the destruction of anthropological and other data in AAUP, 2001), or even what the point of the studies might ultimately be.

These treatments are at least as innocuous as survey research. However, quantitative and survey protocols are perhaps more familiar to IRB members, and meet with less apprehension, resistance, or scrutiny.{258}* Perhaps IRB members (most of whom demonstrate more familiarity with quantitative methods than qualitative ones){259}* are more comfortable with the quantitative researchers standardized, formulaic, and precise specification of the procedures in step-by-step and moment-to-moment detail all rendered in an explicit, articulated (if unmakeable) promise. For example, a researcher’s local experiences, accurately remembered, reported, and rendered relevant, are not only adequate for use as data (see Hayano, 1979; Foucault, 1980; Crawford, 1996; Denzin & Lincoln, 2000), but often highly desirable. And these particular activities, along with many other qualitative research endeavors, “need” no regulation. (Of course, having a higher ratio of qualitative researchers on IRBs would most likely help everyone involved.)

Some of the problems with trying to regulate qualitative research are apparent in the application form (see application form analysis in Chapter Six, p. 174-185, herein). For example, the methods in the qualitative approach are developed (as are the questions) as the process continues. This “reality” considerably confounds any attempt to describe the study in advance{260}* When a researcher is looking at, rather than looking for, it is impossible to be precise in the same way as in a clinical trial or other hypothesis-driven approach in an application process. Regulation makes this type of study “undoable” (or the regulation is undoable, as is the point here) whether it is the intent of regulators (to be impossible) or not. The processes related to regulation corrupt “real world” data whether that is acknowledged by regulators and researchers or not.

Given the rules that have been in place for more than 25 years, I argue that many  “natural” settings have been (historically and continue to be) “altered” rather than “natural,” and the degree to which this may be true is largely dependent upon the affiliation (or lack) of the researcher and the associated IRB regulations or lack of them, and (perhaps most important) the interpretations of the regulations by local IRBs, i.e., what the IRBs required that particular researcher at that particular time to do that may have altered the natural (“real”) environment. Even though the treatment may not have changed significantly, if at all, the environment did (because of the rules), and therefore the results did. Maybe significantly. Maybe not. These rules have and continue to work against what are perhaps the least risky forms of research (see also Geertz, 1988). It doesn’t seem possible that qualitative researchers can both do adequate work and follow the rules (Geertz, 1988, p. 133, who speaks of the right to write ethnography being at risk).

Many qualitative methods involve no activity that is of any greater risk than that found in ordinary everyday life. In many qualitative endeavors, nothing resembling “treatment” is involved. This, I argue, is the prima facie case for abdicating the system. Where can there be risk if there is no treatment?{261}* And where there is no risk, there should be no IRB involvement by definition. Regulations may be (legitimately) viewed as required but unnecessary by many qualitative researchers (and government researchers, see GAO 2001, p. 6).

Concession, Circumvention, Contamination

Researcher concession.  That qualitative research is not easy to regulate is not the biggest problem. That no one has established the need for regulation in the first place, and that very few have openly challenged a system that doesn’t work are bigger problems, in my view.

As the AAUP (2001) suggests, social scientists were co-opted into the regulatory system “from the beginning,” but how did it happen? Why? And why is it that some social scientists aren’t?  I believe social scientists opted in themselves, in part, to enhance the “scientificity” of their work, i.e., to appear more legitimate in scientific terms by succumbing to the same scrutiny as the positivists. (Somewhat as several Indian tribes have become “nations” to, perhaps, “appear” more valid, more sovereign. Also, see Flyvbjerg, 2001 re: the scientificity issue.)

Some individuals (I would argue students are an especially relevant group in this situation) are susceptible to manipulation, which can lead to domination by a group or (an automated) structure. Given power by individuals, driven by (SINS) STRUCTURES, INSTITUTIONALIZATIONS, NATURALIZATIONS, SIMULATIONS including the anthem that conflict is negative, and fueled by tendencies toward compliance and obedience, researchers in the IRB system allow at least two forms of domination, i.e., localized “parental” control of the IRB itself, as well as big-picture peer pressure, i.e., researchers are dominated by the behavior of other researchers.  So, in this case of IRB regulation, what works to constrain and subordinate researchers may be their own concession, based on the desire, following Schutz’ thinking, to maintain a “focus on non-everyday problems” and to take advantage of the “stock of knowledge” as presented by regulators (what might be called “unacknowledged knowledge”). Relieving vital risk and responsibility, one can take solace and defense, if necessary, in “I was just following rules” mentality.

In workplace structures, conflicts are minimized and eliminated with managerial tactics; (SINS) STRUCTURES, INSTITUTIONALIZATIONS, NATURALIZATIONS, SIMULATIONS of the “don’t rock the boat,” “be a team player,” “follow the leader” (even if over the cliff) variety help create there’s-no-problem-here illusions. Certain SINS are reinforced (notions that conflict and rebellion are good are rarely among them, even if it is said that they are welcomed) with doctrines including job enrichment programs, TQM, organization as family, and dress-for-success formulas,{262}* and even research methods classes/seminars, when the leaders advocate/require participation in an unreasonable system, and describe it as “inevitable” and, simultaneously, unreasonable. These models often contribute to illusions (i.e., simulations) of well being, development, progress, happiness, satisfaction, “rightness,” etc. More bars.

“Most members of culted organizations may have choices, but organizational coercion keeps them from being exercised” (Arnott, 2000, p. 93). Culted employees (or conditioned researchers, I suggest) “have turned over their right to make decisions” (p. 93; see also Schutz & Luckmann, 1973, who says, “ … the prevailing social stock of knowledge frees every individual from finding ‘independent’ solutions to broad provinces of typical everyday problems …” p. 298; see also Adorno, 1989a; Horkheimer & Adorno, 1944/1972; and Habermas, 1971).

Qualitative researchers, in particular, have conceded too much for too long. They have conceded so much in fact that they can no longer do their work under the rules. Perhaps inventing circumventions is somehow better, easier, involves less conflict, causes less trouble, etc. than casting off an impotent system. I would agree that in the short term, it is. But not overall. Eventually the “real” world must be “really” encountered, i.e., experienced.

However, in the IRB system, researcher assimilation, in a sense meant by both Baudrillard and Rand, is nearly complete in that compliance is held as equal to protection and as virtuous, or at least inevitable. Compliance, though itself often difficult, remains the path of least resistance, and the need for regulation is too rarely, nearly never questioned. There is no whying. Assimilation into the regulatory system seems inevitable, adding to the likelihood it will be. Baudrillard (1983) makes a similar case about U.S. colonization, “At the beginning [of the process], a moment of stupor and amazement before the very possibility of escaping the universal law of the Gospel. There were two possible responses: either to admit that this law was not universal, or to exterminate the Indians so as to remove the evidence. In general, it was enough to convert them, or simply to discover them, to ensure their slow extermination” (p. 20). So it goes with thinkers, as with Rand’s “[people] of the mind” (Rand, 1957/1992, particularly John Galt’s speech, p. 923).

Researcher circumvention.  Circumvention, public, private, and corporate{263}*, occurs frequently in the face of “required but unnecessary” regulation. Being required to gain informed consent when employing no treatment (observations and/or involvement of non-identified [and therefore non-] participants) is an example of the problem and informal “local” solution, i.e., circumvention.

Informed consent provisions require a form that specifies, among other things, that the subject may withdraw from the research project at any time. How does this work in research involving participant observation, for example? And issues of sampling, i.e., people who “wish” to participate may vary substantially from those who are simply observed. As Weppner (1977) observes, this threatens the continued existence of much “street-style” ethnography (p. 41). When Powdermaker (1966, and recalled in Punch, 1998) was confronted with a lynch mob, was she supposed to ask the participants to stop the proceedings while she delivered informed consent forms? Or, worse in my view, was she simply to avoid writing about her experience? Gaining consent is inappropriate because activity is taking place that cannot be interrupted. Researchers (especially qualitative ones, the primary focus of this analysis) may (of necessity, in order to do the kinds of work they do and preserve the study environment) circumvent the process, but, much more rarely, the purpose.  Even if one doesn’t trust researchers themselves to do what is “right,” there are already laws against abusing others (research participants or not). And, there is very little risk, if any, inherently in observational/survey/interview methods; even if researchers using these methods wanted to, there is little they could to do actually harm people.

Contamination of the natural world.  In much fieldwork there seems to be no way around the predicament that informed consent—divulging one’s identity and research purpose—will “kill many a project stone dead” (Punch, 1998, p. 171). And if it doesn’t kill the project, as it can be argued it did in my case and countless others,{264}* it can drastically skew the data and results. And it causes in my estimation, a loss of “spirit” for this kind of research. As I have argued, the study is no longer of the natural world, but of an altered research environment. Data becomes contaminated, often with socially desirable behaviors and explanations, accounts and attributions of participants. The natural world becomes a much more contrived one. IRB requirements so contaminate data that to gather it would be pointless. It could be likened to adding a 50 percent margin of error to a quantitative venture, or finding significance at .0000001.

Even when/if the natural world can be preserved as a place of study, sometimes (as in my case) researchers are simply regulated out of business, i.e., the process becomes impossible to accomplish and/or permission is simply never granted; the application is ignored. “One need not always be brutally honest, direct, and explicit about one’s research purpose, but one should not normally engage in disguise. One should not steal documents. One should not directly lie to people. And, although one may disguise identity to a certain extent, one should not break promises made to people” (Punch, 1998, p.172). I ask, how does this differ from “ordinary life” values? There is no need, indeed no way to regulate these values. People, including researchers, who have these values use them, and those who don’t have or use them aren’t affected by rules in the way the rules were designed to affect them.{265}*

Gans (1982) expresses:

The social scientist attempts to describe the world as it is, and he must therefore observe people in their normal, everyday ways. Should he hide his purpose, either by not telling them of his participant-observation role, or by asking interview questions which get at more than they seem to on the surface, he does so because he has no other alternative. If he bares all his research purposes, he may be denied access to the very society he wants to study. If he forswears participant-observation and gathers his data solely by interviewing, he can get only reports of behavior, but not behavior itself. If he is completely open about his participant-observation or interview questions, his respondents are likely to hide information from him—not necessarily by intention—by giving him access not to behavior but to appearances; not to what people do, but how they would like their doings to appear publicly. (p. 405){266}*

It is “not ethically necessary, nor methodologically sound to make known specific hypotheses, background assumptions, or particular areas of interest” (Van Maanen, 1978, p. 334).{267}* Further, quantitative researchers aren’t required to reveal their hypotheses to participants. As a senior American academic at an ASA seminar on field methods put it bluntly, “You do lie through your teeth” (quoted by Punch, 1998, p. 173). The process of regulating qualitative non-treatment, minimal/no risk research must be revealed as the façade (simulation) it is. Why haven’t we abandoned it before now? SINS.

Too much regulation contributes to another “real” world phenomenon. Unnecessary yet required rules (somewhat like “fascinating but unpublishable” manuscripts; see Wax, 1971, p. ix) and processes create a sort of underground arena of research activity, (what I call) “the invention of circumvention” techniques. Researchers engaged in fieldwork often confess to professional misdemeanors, namely the ones mentioned by Wax (1971, p. 168-170) and Gans (1982, p. 405). Punch (1998) asks “what sanctions should we impose for these breaches of professional standards? Should we drum these miscreants out of the profession? That seems a rather severe punishment for coming clean on their predicaments in the field” (p. 171){268}*. As I asked earlier, what are researchers to do? A similar situation is explored by Manning, 1978, who discusses situationally justified actions (i.e., what I call liquid and local) in the field of policing, this situation being similar to what researchers (and all of us, I would argue) face in the lifeworld. Regulations will never be able to account for every situation, and oversight can never be complete. It must be recognized that people must (and therefore do) decide what to do. Again, guidelines and shared experiences, i.e.,learning how to do things is different (and preferable and possible) from acting as if we can control them.

Abusive institutional interpretations.  As Forester (1983) states:

When organizations or polities are structured so that their members have no protected recourse to checking the truth, legitimacy, sincerity, or clarity claims made on them by established structures of authority and production, we may find conditions of dogmatism rather than of social learning, tyranny rather than authority, manipulation rather than cooperation, and distraction rather than sensitivity. (p. 239-40)

The abyss between federal rules and local institutional interpretations is often huge. For example, the federal system exempts from the process much research that institutional interpretations make impossible under the process (the contamination of the natural world, for example.{269}* Lengthy application processes even when studies are exempt under institutional rules on prima facie conditions are an example. Such prima facie conditions might include requests to interview public officials or to involve participants in observational situations in which the identities of the “observed” (somehow labeled “participants” by authors of the OUIRB handbook, Section 4.4) are not known, and obviously therefore, cannot be recorded. Institutional interpretations do not always accommodate federal rules.{270}* Lawful or not, many IRB rules are created and/or followed by 10s of organizations, 100s of regulators, 1000s of institutions (IRBs), 10s of 1000s of researchers, and 100s of 1000s of two-legged research participants for, often, many years (also see p. 72 herein). Regardless of legality or level or duration of conformity, it seems foolish to ask people to sign a form that says they are being interviewed, or that they are completing a survey. These things are obvious. It seems foolish that we as researchers have to prepare a document that has to be scrutinized by a board, the members of which have perhaps never participated in, much less conducted, qualitative research. These requirements seem foolish because they are foolish.  Many rules are inadequate, ill-fitting, and/or irrelevant when translated from medical science to social science. Some argue that informed consent procedures are unnecessary even in some clinical trials, and inconsistent in others (see Truog, Robinson, Randolph, & Morris, 1999; see also GAO, 2001, p. 3, regarding inconsistencies produced at the federal level).

In my own experience, I have seen the rules constituting the process restrict the view of the process. This is a very serious matter, and contrary to informed interpretations of relevant law.{271}* Legally, administrative rules are based on several tenets. Among them, at least two are locally relevant. First, administrative rules should not contradict higher-level law such as state and federal constitutions and statutes.{272}* It is in no one’s best interest for local IRBs to restrict researchers’ First Amendment privileges.

A second tenet of administrative law is that people subjected to the law are to be treated “the same way,” however, similar to the notions of “a greater good” or “universals in human behavior,” this is an idea with very low correspondence to conditions in the “real” world. Even in the face of this system flaw, many regulators persist in attempts to write “comprehensive” rules (that pretend) to cover any situation (clinical or social) that might arise, ensuring (in their imagination, perhaps) that the abstract system is the “same” for any participant. Rules added to existent ones (ones that were not the “same for all” and that did not prevent crimes or atrocities) won’t help. Next, nothing can be done “comprehensively” and attempts to standardize the lifeworld in such a way is often of no great consequence in meeting the purpose for “comprehensive” policies, rules, etc. (Attempts to be “comprehensive” similar to looking for universals in human behavior.) Additionally, as demonstrated in at least two situations, those with very similar proposals and requests are not treated “the same way” by the OUIRB (student exemptions and other situations described herein, including the lack of disposition of my own applications). This speaks, in my opinion, more to the nature of life than the (in)competence of the OUIRB (or others). In this regard most administrative law is set for failure. The extent to which we ignore this failure is the extent to which these systems work. We first build the bars, and then put ourselves on the restricted side of them. And then, we just sit there in Schutzian relief. An Adornological sanctuary.

The American Anthropological Association (2001, Feb 15), in addressing proposals made by the National Bioethics Advisory Commission in their draft report (see NBAC, 2001) states that “proposed rule changes ... could jeopardize the future of anthropological research” (p. 1). A lawyer who represents academic-research institutions and who sits on the National Human Research Protections Advisory Committee, said, referring to a Maryland Court of Appeals decision regarding the use of children in studies, that all research involves some amount of risk, and that the court’s decision effectively raised safety requirements for research involving children to unprecedented heights. “It’s a no-risk standard,” he said. “That’s certainly farther than they need to go” (quoted in Curry, 2001, Sep 7, p. A32){273}*. Currently the Bush administration is requiring “agencies to ensure than any scientific results they release be “capable of being substantially reproduced” (Brainard, 2001, Sep 28, Daily News; also see description of Bush’s plan, p. 2-3, herein). This of course is not a goal of many social science pursuits, and, many researchers who conduct social science research do not believe it is possible, desirable, or (as in my case) desirable to believe it is possible (critical theorists and other anti-positivists for example).

In many ways, the regulations don’t fit, i.e., they don’t fulfill their intended purpose, and the process often produces negative affects associated with under- and over-regulation in a given context, and is very prominently featured in the regulation of social science research, and elsewhere.

IRBs, and regulatory entities generally, operate in a closed fashion (most IRB meetings are closed, for example, and local IRBs don’t usually solicit input when considering rule changes, we don’t vote for IRB members, etc.). These boards issue statements rather than provide explanations, and they do so according to their own time frame. Local IRBs are in no regulated way accountable to the people they serve, participants nor researchers.

For example, the OUIRB makes no commitments about how long the approval process takes (as the University of Texas at Austin does, see p. 134, herein), the board often answers correspondence aggregately, i.e., “facelessly,” without a specific voice, does not demonstrate an attitude of service to (many) students, and provides no adequate form of appeal (see OU Policies and Procedures, Section 10, Part 5; see also p. 225, herein).

So, here and now, what are qualitative researchers to do? They are marginalized and dominated, much like faculty members are by administrators, doctors by insurance companies, and lots of other “real world” horrors. I argue that qualitative researchers are a muted group, particularly students. Muted group theory (Kramarae, 1981) utilizes interpretivist/interactionist notion, based on Mead’s (1934) theory of objects, that the power belongs to those who label (and not inconsistent with Foucault’s ideas).{274}*

Label Power

Quantitative exemption-by-label.  Speaking to inconsistency in IRB regulation, given that much qualitative work takes places before quantitative instruments are used, i.e., during the development of instruments, much of the “real” research conducted by quantitative researchers is not acknowledged as research, and therefore “gets past the IRB.” This is in spite of the fact that much of what quantitative researchers are doing (when developing instruments, for example), treats people as “subjects” in that they are subjected to more than being watched. This way of treating the developments of instruments constitutes what might be called an “exemption-by-label.” In the “real” world, human subjects are involved, but they are not labeled as subjects because the (often very similar) activities are not labeled as research. Positivists often do not acknowledge that asking people questions about instrument clarity, pre-testing survey instruments, etc., is human subjects data. I’m not advocating these activities should be regulated, but to exempt by label rather than by treatment is a troublesome inconsistency in the system, and, of course, evidence to support a reduction of regulatory interference in these types of work at least as much as it provides evidence to support an increase in scrutiny.

Because of the lack of clarity in rules, many times researchers in the newer social sciences have not opted into the system (i.e., they don’t realize they are “researchers”) and have not been forced to participate thus far. I have learned in conversations with people that certain departments doing very similar “treatments” are much less aware of IRB regulation. Cultural geography, civil engineering, and film studies in particular have come into my awareness in conversations during the past few years.{275}* These departments have not labeled the IRB as necessary or relevant; nor, it appears, has the IRB, in this case, labeled cultural geography, civil engineering, or film studies as non-compliant.

Student exemption-by-label.  With respect to student exemptions, and just as institutions have opted in to IRB scrutiny for all subjects, whether the study they are involved in involves federal funds or not, where is the logic in suspending the process based on whether or not the researcher is earning course credit, i.e., is a student? Aren’t all human subjects of research equal in terms of deserving protection? Don’t researchers have the right to pursue questions of interest without unreasonable interference? We must acknowledge the dialectic between participant rights and researcher rights exists, and there are limits to what rules of any kind can do with respect to that tension.

Assurance-by-label.  In terms of providing assurances, we cannot predict to what uses research will be put. Who can define “undeserved harm,” “greater than minimal risk,” even “somewhat greater than minimal risk” and other equally vague terms often used in guidelines{276}*. For example, when graduate students refer to a dissertation, do they mention it will be housed in a library, indexed in a variety of places, and open to all? The more sensitive the activity being studied, the more likely it is that participants will fear consequences, and the “single most likely source of harm in social science inquiry (i.e., non-medical) is that the disclosure of private knowledge can be damaging” (Reiss, 1979, p. 73). Professional codes (rules) and what is considered sound advice (norms) may not be at all clear in the field, given that the “real” world is highly liquid and local.  “Real life” and, therefore, the research environment must accommodate various degrees of impression management, manipulation, concealment, deception, etc. It is the job of many qualitative researchers to determine ways these activities operate (along with other SINS). And hardly can a researcher “explain” to a participant first what the study is about, and then gather meaningful (unaffected) data about these same phenomena. To even explain that “research” is being conducted adds to the level of impression management, enhanced use of socially desirable (i.e., altered) behaviors and other “affectations” described. There is no process and no assurance that can make “real life” conform, no more than we can control the weather or other aspects of the natural (i.e., “real”) world. We can offer our own personal assurances to do the best we can. That should not be confused with absolute assurance, and certainly not with a written form, regardless of the title of that form, who demands it, or who signs it. It may be the best we can do, or it may not be, but it is not assurance, regardless.

Questions as labels.  Basic political issues, i.e., issues that many would advocate should be argued “happily ever after,” are in this way transformed into (labeled as) technical problem-solving issues, according to Alvesson and Deetz (1996). For example in the IRB system, attempts to regulate how people should take care of other people via standardized handbooks, forms, codes of conduct, etc., are not productive. Qualitative researchers and many others should be asking “Why am I doing this?” (i.e., the application procedure, for example) rather than the technical (non) problem solving activity of asking, “How do I do this?” The differences in the questions posed serve to frame (à la Goffman) a bad system as inevitable.

Rules Aren’t Values

In the context of the protection of human subjects, procedural rules do not replace nor work in lieu of values. As procedural rules are substantially less salient than values, rules are most often unnecessary (often not even known). If people have values, these procedural rules don’t matter. Circumvention of rules may become the norm when the rules are not tied to a purpose, have no value, cannot be understood, etc. If people don’t have values, these procedural rules don’t matter, either.{277}* The system—since its development, through all the debates, changes, chances to change not taken, and under the (current and past) rules—remains only as good as the conscience of researchers. (And sometimes rules become tools used to perpetuate harmful situations. See Solomon, 1985, regarding Tuskegee syphilis study; see Morley & Shockley-Zalabak, 1991, for discussion about mature organizations and constraint on innovation.)

Researchers are, as are people in general, usually (even overwhelmingly) humane and ethical. It seems pointless to ask them to write about their ethical stance in dozens of nearly identical IRB applications. Ethics are relatively stable over time, therefore this application activity is a form of redundantly inappropriate penance (and based on SINS). The system has produced risk in certain research areas. Especially risky to researchers. To research. To free inquiry.

Alternatives{278}*

IRB members’ and researchers’ preconceived and perpetuated (SINS-ful) notions of research and regulation must be altered.  “Social structure should grow from the bottom rather than be enforced from the top” Deetz (1995, p. 170) concludes. The irrelevant, overly restricting, often justifiably circumvented, ill-fitting, debilitating system as it relates to qualitative methods in particular must be decentered and disprivileged, from within or outside or both. Regulators (bureaucrats and other cultists), who operate in deeply entrenched systems, may be “unmeltable ethnics” (Denzin & Lincoln, 2000, p. 68), i.e., maybe they cannot change. Where that is the case, the system’s dismantling must begin from the outside.{279}*

The contemporary common-sense credo “It’s easier to beg forgiveness than ask for permission” implies two pervasive ideas: first, prima facie, permission is (at least perceived as) difficult to obtain; people experience some degree of apprehension and/or anxiety about it. Second, forgiveness is (again, perceived as) easier to obtain, perhaps because the acts for which one might seek absolution (if not salvation) were great, pretty good, worked out all right, were reasonable, at least defendable, somehow understandable. Justifiable. As I have argued, researchers (and others dominated unnecessarily and unreasonably), circumvent (justifiably) processes, as distinguished from purposes.

Rather than attempting to fix the process (by abandoning rather large portions of it in some cases), researchers have tended to avoid making changes in the rules, as reported in GAO (2001), and DHHS OIG reports (in particular 2000b).{280}* In considering the IRB system (and other regulatory entities) we may regularly see (then quickly look the other way) violations of the process (rules), for example reports may be late and paperwork backdated, bids may be split, etc. Much more rarely do we see violations of the purpose (people). Even more rarely do we look away from harmful situations. This is supported by the talk surrounding sanctions, i.e., federal sanctions were (in no way to minimize the exceptions) overwhelmingly for non-compliance with rules rather than “harming” people (Brainard, 2000, Mar 17; see footnote # 136, p. 117, about U. of Virginia, Duke, and Chicago). Notably, the sanctions were nearly the same in terms of breadth, depth, and duration, whether non-compliance with processes was alleged, or a death reported. In other words, federal regulators don’t seem to consider the severity of the (sometimes actual) “crime” when assessing punishment, much like the institutional regulators don’t appear to consider treatment types when assessing protocols (though I have heard it said that while the OUIRB makes little distinction between asking questions and injecting drugs, they do make a Big Deal about the details of questions, occasionally raising opposition to questions about occupation, marital status, and general income level on questionnaires). This opens the door to the argument that the focus of local IRBs is the maintenance of the flow of funding or the avoidance of litigation long before any issues of human protections. This is, I argue, in large part to the acknowledgement on the part of regulators including Koski, Ellis, Grob, and others quoted extensively herein who have said even though sanctions are issued, rarely is the problem abuse of a patient (and never in what I’ve learned has an interview or survey participant claimed damages, certainly substantially more rare than the already rare abuse of patients in medical trials); it is almost always a paperwork (i.e., a process) deficiency.  If, on the other hand, abuses were frequent and severe, I do believe IRB members would be focused on those participant concerns related to the problems (not to imply they would devise relevant rules, but they would most likely be talking about the problems as they relate to the abuse as they see it). And once again, if the government or an IRB defines something as “NO RISK BEYOND THAT FOUND IN ORDINARY LIFE” then what is it they see themselves “protecting” against?

Alternative One: Blanket Assurance for Researchers

Because there is (virtually) no direct regulatory oversight of the research process, a blanket assurance system for researchers would more accurately reflect what is “really” going on in the research environment (i.e., perpetuating a less abstract simulation, perhaps).{281}* Researchers, on their honor, carry out their protocols as approved, or they don’t. Only the researcher and the participant, in a liquid and local negotiation, directly oversee (or undersee or see at all) the process. Researchers, including (if not in particular) students, should be able to readily explain how they handle issues involving privacy and confidentiality, and one “blanket” explanation of the researcher’s policy, adequately ambiguous, is adequate. Even researchers, because of the liquid and local nature of the world, cannot predict every situation that might occur, and subsequently ask and gain approval for each situation, each new idea that emerges along the course of the study. Researchers (those who interact with participants) must be able to explain their intentions to specific participants at specific times using their own values as guidance. Participants are not without their own abilities, specifically the ability to use their own values in agreeing to participate or not, or to continue participation, etc. In other words, the notion of “needing to be protected” is patronizing in many cases. Finally, it must be acknowledged that that law itself is a liquid and local phenomenon.

Prominent in the federal rules is the requirement that the informed consent of participants be obtained and a record of that consent maintained. I support this part of the process. Informed consent may or may not be a written form. Allowing researchers to develop the consent process to suit the needs of the particular participants balanced with the needs of the researcher is the only sensible, “doable” process based on the nature of life. A blanket “oath” is the best (and only) way to go about this.

Alternative Two: Making Important Distinctions

Researchers must counter the labeling power of regulators, making clear the distinctions between patients and non-patients (participants), doctors and researchers, therapy and research, and (see below, Alternative three) exempt vs. exemption process. Further, these terms must be used as specifically as possible, and new labels developed as needed. Researchers themselves have much power to label, and it should be used. If a coalition of professional organizations{282}* (such as the AAUP, anthropology groups, oral historians, and others joining each other) encourages their membership to label their studies “NO RISK” and “EXEMPT UNDER FEDERAL RULES” regardless of whether an application form has a space for it or not, is an example. All of these alternatives are especially important for social scientists, and most of all for qualitative researchers employing unobtrusive methods.

Alternative Three: Avoid Attempts to Regulate Liquid and Local Phenomena

We must avoid the pretense that regulators can successfully define for the world (and for participants in particular) what constitutes protected and non-protected classes, sensitive and non-sensitive topics, and obtrusive and unobtrusive research and other phenomena too slippery to standardize. Whether an organism is a fetus, a child, or a prisoner is generally discernable (pregnant women are somewhat less so). Researchers, overwhelmingly, would not have difficulty distinguishing these classes. However, what an individual may consider sensitive or obtrusive is not regulate-able.

What exemptions are is not necessarily the problem, but the interpretation of what can be done in the process of exempting (“the process of exempting” is an apparent oxymoron, but it is literal in this situation) is problematic, i.e., it doesn’t work as an exemption. One may consider just the time to make the application to “real”-ize it is not an exemption, for example. Exemption, if not left to the fine devices of the researchers themselves (this system is in lieu of admission that this is “really” the case, of course), should be post-card simple: Will participants be identifiable? Any kids? Anybody who’s incarcerated? Any feti involved? Neither researchers nor regulators should be troubled by anything more and federal law allows for such a system.

In fact, to do more than “really” exempt, when that is the label used, produces at least one problem. Both students and their professors new to the area of regulation may misinterpret the label used with the widespread meaning of the word “exempt.” That is, student researchers and their advisors may take the word literally, and this would be acceptable if they were reading/operating under the federal regulations, but taking the word “exempt” at face value in local interpretations is not acceptable. (Students can be thrown into a “research misconduct” inbox and have their projects, including dissertations, held up until the “problem” is settled, for example.) If a student or faculty advisor or researcher finds the local policy unclear, a logical place to seek clarification would be to read the federal rules on which the local interpretations are based. The federal exemptions might lead a student or other researcher to conclude they are exempt and fail to make an application to the local IRB. In this case, potentially, a very costly mistake. What “seems right” (in this case following federal law) is “locally” wrong. Federal exemption is not local exemption is not exemption in the common definition of the word; the word then becomes a very slippery, if not meaningless, term. And, how are the readers of these texts to know words don’t mean what they “usually” mean?

Alternative Four: Insist Treatment be the Focus of IRB Consideration

Somewhere along the way, science lost to politics. Faculty lost to administrators.{283}* Researchers lost to regulators. Doctors lost to the insurance industry. And so on and on we see the victories of capitalism. Scientists, doctors, faculty members, and researchers are required to do things that don’t “seem right.”  Things that don’t “make sense.” (For example, preparing syllabi before meeting a class, prescribing or failing to prescribe certain medications or treatments, etc.). These losses are alarming, but not as alarming as the fact that scientists, doctors, faculty, and researchers are mostly conceding. There seems to be no “fight” on the part of researchers. Maybe we just don’t have time. Productivity is winning over possibility (see Lyotard, 1984, re: performativity). Research is losing to regulation, via concession, circumvention, and contamination.

Micro-management of minutiae: A reason to live.  Debates in IRBs too often focus on minutiae. "Oftentimes, IRBs get very mired in consent forms," Jeffrey P. Kahn, director of the Center for Bioethics at the University of Minnesota-Twin Cities. "That should not be their main focus. They need to keep their eyes on the prize, which is the protection of subjects of research.” Federal rules require consent forms to contain many details, “so that's an easy place to spend time," Kahn said. "To try to assess risks and benefits is a more difficult and ongoing challenge'' (as quoted in Brainard, 2000, Mar 17, p. A-31; see also list serve postings from University of Pittsburgh Medical Center{284}* and University of Utah’s online handbook which includes a five-page consent template, and a 25-page assurance document (MPA), the University of Texas at Austin’s consent template has grown from less than two pages to more than 10 pages in two years and the Texas MPA from 19 to now 23 pages long; OUIRB doesn’t have one available online (as of May 2002), but the University of Oklahoma Health Science Center does (see entry in bibliography for website); it is 10 pages long (see University of Utah listings in bibliography, and also University of Texas, University of Oklahoma, etc.).

The number of research proposals that review boards assess each year has at least tripled in the past 20 years (in part due to the “inclusionary” definitions of who “must” participate), while the number of boards has remained about the same, says Charles R. MacKay, an NIH scientist studying the effectiveness of review boards for the agency (quoted in Walker, 1996, Nov 8). The GAO (General Accounting Office) reported in March that in some cases, panel members spent only one to two minutes on each proposal{285}* (Walker, 1996, Nov 8). Brainard (2000, Mar 17) concluded the IRB members operated more like manuscript editors than researchers. This situation also illustrates Foucault’s ideas about texts as constitutive of organization.

Campbell (1998, Apr 3) quotes Milton Goldberg, president of the Council on Governmental Relations, representing 140 universities that account for 90 per cent of the federal research grants to academe was quoted, “IRB time is precious; regulatory refinement of the type suggested here [loosening rules for expedited reviews of some kinds of research] allows the IRB to focus more attention on research in which the risks to human subjects are greatest.” I would agree that there are surely more important matters for consideration than the wording of a form for a study that should be exempt under federal rules.

Alternative Five: Passive Rebellion (Researcher Self-exemption)

Engaging in passive rebellion (in this case, ignoring the local IRB system in favor of following federal rules), and encouraging others to do so is the kind of dissent that is dis-allowed by managerial domination (Alvesson & Deetz, 1996; Willmott, 1993, and the works of Marx, Horkheimer, Adorno, and others). These are the debates that are silenced by “following rules is best even when rules are bad” (SINSful) mentality (though I argue it isn’t “really” thinking).{286}*

(Regulators) allowing researchers to exempt themselves (if researchers choose not to take their entitlement to exemption under federal rules) would represent a shift on the part of local IRBs from a Theory X to a Theory Y (McGregor, 1960) stance. Researchers are capable of reading and interpreting rules; they are capable of exempting themselves from the process. If or when they have questions about exemption, they can always choose to go to the IRB for clarification (making IRB “really” useful). Many federal government agencies (including the FDA and NIH) seem to agree, saying that IRB time is precious and should focus more attention on research involving the greatest risks to humans (see Campbell, 1998, Apr 3, ACHRE, 1995). Researchers conducting no-harm studies should for the benefit of the researchers and regulators, (and “no-harm” being what it is, the regulated, too) should be exempted from the application process. The American Political Science Association (APSA, 2001, Feb 14) states “expedited reviews [are found] to be expeditious in name only” and that “to insist that [research posing no threat to participants] should be subject to even administrative review unnecessarily burdens both investigators and the review process” (p. 2).

A blanket assurance document from the researcher could certainly include a commitment that informed consent will be obtained and records of it maintained (this is also reasonable for the researcher’s own self interest), that the researcher would comply with all federal and state laws as they pertain to the treatment of others. If the researcher is in doubt as to whether a class of people is protected, or whether an issue is considered sensitive (although, as I have argued this can only be decided locally, by the person actually answering the questions, or refusing to) the researcher can make a formal request for a ruling (interpretation) to the local IRB (and rendering another benefit: IRB members can have a focus on more substantive protection issues, thereby better serving researchers and the researched). Questions such as treatment and class of participants does not require a lengthy application for the researchers, nor any review on the part of the IRB. Further, a (truly expedited) process would also reduce the tension between what the local IRB typically considers “expedited” and “exempt” to mean, and what researchers consider the meanings to be. Further, the long stream of applications could be greatly reduced if the researchers were “really” exempted, the provisions for which are already in place at the federal level (OHRP Human Subjects Policy specifically states institutions may review studies which are exempted under federal provisions, but that the review process is not required. See http://ohrp.osophs.dhhs.gov/humansubjects/guidance/hsdc95-02.htm, accessed May 25, 2002. Also see Campbell, 1997, Oct 24, for an example).

Additionally and significantly, the “need” for this regulation has not been established. The process is debilitating in the rather obvious ways just mentioned, i.e., burdening both regulators and researchers, as mentioned, by contributing to self-censorship of ideas and draining the energy from researchers. Not just the physical energy the process requires, but the system drains enthusiasm from researchers. Most seem to agree the process is not needed, yet we allow it to persist.

It is important to point out that everyone was exempt until about 25 years ago (with the passing of the National Research Act in 1974). And, the rules that were put into place in the 1970s were limited in scope. These rules were only expanded to include nearly everyone in 1991, barely more than a decade ago. And it is also important to note that before the rules were put into place, the biggest atrocities by far were perpetuated by researchers working for the federal government (see ACHRE, 1995). This “inclusionary” trend (now invasionary) on the part of regulators does not work and is not needed.

Miscellaneous and Mostly Missed Opportunities to Address “Real” Needs

The following ideas may be useful attempts to change the system. First, a registry of projects that are exempted might be useful to universities, for statistical purposes and decision and labeling practices. Next, local IRBs might dismantle portions of their oversight mechanisms that are unneeded in order to invest in re-directing efforts to situations involving risk to participants such as conflicts of interest, as mentioned. And, IRBs might become more concerned with other “problems” such as hammering out policies to protect researchers who (boldly) report findings that anger drug companies or other researchers, etc. (see Blumenstyk, 1999, Apr 9). There are pressing issues (perhaps), but these are not the issues consuming the energy of the system.

Finally

I advocate these alternatives, and want to make one more point about the centrality of treatment in regulation. As stated, if there is no treatment, there “needs to be” no regulation. The language here is important, i.e., there is a difference between “regulation is not needed” and “there needs to be no regulation.” Government, including institutional IRBs, is obligated to create the least restrictive environments rather than the most invasive and impotent policies.

Social Darwinists feel government should intervene only when necessary to remove barriers that limit laissez-faire practices. Progressives on the other hand, hold that government should accommodate—ideologically, legally, and financially—the pursuit of social progress (Hamilton, 1998). These ideas are apparent in current IRB regulatory debates, and progressives are ahead in defining what the IRB system of regulation “should” be doing. The (SINS) STRUCTURES, INSTITUTIONALIZATIONS, NATURALIZATIONS, SIMULATIONS of positivistic, progressive dogma are operating, demonstrated by researchers’ self-censoring, conforming, compromising convolution of their programs of research and their rights to free academic inquiry. These compromises may be much more severe and costly than the researchers wish to or even can acknowledge. Many, apparently, don’t see the bars.

The pretense of value-free inquiry for the human disciplines is over, and researchers now struggle to develop situational and transsituational ethics that apply to any given research act, or across similar acts. This doesn’t “standardize” the system, though; ethics can only be applied in more limited ways than (perhaps) we wish, i.e., we might be able to “bridge” across a farm pond, but not the Pacific. We must make our expectations more realistic. Neither regulators nor regulations are suited for or to this task. Researchers themselves, in conjunction with their participants, are the most qualified—morally, intellectually, politically, and practically—to decide exactly what to do in a particular situation.

Who could be opposed to reducing oppression? (Or apple pie, moms, or libraries?) Who would oppose lessening the workload on both IRB members and researchers? Being able to devote more time (researchers, professors, and regulators) to the consideration of protection issues surrounding research that carries greater risks to humans?

Maybe qualitative researchers themselves (as mentioned earlier) have concerns about how “scientific” their work “appears” to be. I argue that abandoning an impotent IRB system does not lessen the scientific nature of qualitative research. If anything, it works to energize the field, currently demoralized by watching free inquiry going the way of (dripping into the same sewer as) academic freedom and rights to intellectual property{287}*.

It appears promises born during The Enlightenment and continued during the reign of positivism just haven’t been kept. There is plenty that “positivism” can’t do. Absolutism and standardization are flawed concepts. SINS-ful perpetuation of these regulations and practices obscure important alternatives and silence important debates (for example, use of the term “radical” when terms such as “practical” or “reasonable” are at least as appropriate).

Developments in medical science during the past 30 years are nothing short of amazing, yet many diseases remain. Life goes on; death goes on. There is plenty regulators can’t do; and even more they shouldn’t attempt. And, plenty that researchers shouldn’t allow them to attempt.

We have become more diverse in the way we study human behavior. To maintain a “real” qualitative/quantitative dichotomy is no longer, if it ever was, reasonable.{288}* The art is matching the right method with the right question rather than determining, with an absolutist, dogmatic, hegemonic mentality what the right method is. Questions should lead the researcher, rather than a philosophical allegiance to a way of answering (or as in the present study, describing and whying).

The case is similar for regulation. Matching the right regulation with the right treatment (the right risk), speaks to the purpose for regulation, rather than declaring The Process, entrenching it, and maintaining it, all the while begging the questions “Who is being harmed?” and “Where is the need?” “What is the point of this?” “HOW CAN THIS BE?”

As mentioned elsewhere, in the world of regulation eventually almost all parties to a particular regulatory system will admit it contains ambiguities and absurdities. That we have become conditioned to accept this as “natural” or “the best we can do” is a manifestation, as described, of (SINS) STRUCTURES, INSTITUTIONALIZATIONS, NATURALIZATIONS, SIMULATIONS. Sometimes, regulators should do (and “really” can do) nothing. I support acknowledging rather than ignoring the limitations of rules and rule makers.

Values guide rather than rules; humanity is more basic than is compliance. The local situation, i.e., the treatment, the topic, the situation, and the “needs” of the study, and a researcher’s own values are parts of the formula. Generalized, and thereby often irrelevant, rules are numerators totaling zero. And, we know the effect of that on denominators. Nothing remains nothing.

The values of research participants should be acknowledged, as well. Research participation in the past may have been more altruistic. Many participants were willing to participate in studies that might benefit others, even when the potential benefit for them personally was negligible or nil. And, that might be true today (see CNN.com, 2002, May 26), except participants aren’t often given that chance. Contemporary (local) clinical research is marketed, packaged, spun. Participants, particularly sick ones (because medicine is where the money is), are taunted with “potential treatment benefits” and “hopeful preliminary results.” And of course, before results can be produced and sold (published), patients (or healthy participants) must be found and convinced. This spin creates further ambiguity in the therapy-research dialectic, and contributes more to “spoiling the field” than any contribution a qualitative researcher could muster. These are concerns that should be the focus of IRB attention.{289}* More and more frequently doctors own stock in companies that are “interested” in the scientific data. In earlier times, we perhaps had over-zealous doctors (or more precisely, research doctors) to fear. Now we have greedy, over-zealous research doctors to fear. Medical journals are in a similar predicament, the debate presented in a variety of media and especially prominent in the past decade.

Interview or survey participation will never be as risky as giving a person a drug or installing a medical device. The line between therapy and research conflict will never be as convoluted for interview and survey participants. How-to questions about the IRB application process remain, often asked by researchers in “minimal,” “no treatment,” and/or “no risk” situations (in methods classes and on user lists, for example). But more important by far, yet too rarely asked, are the questions about why.

Difficult but necessary versus required but unnecessary.  Changing systems is difficult, but desirable, (and for certain kinds of minimal risk research) necessary. Opposition to existing structures occurs, according to Foucault (1980), not through assumption of the role of the universal intellectual but through that of the specific intellectual. (Earning respect on one’s own terms for example, or the demonstration of one person making a difference, of being the one who “gets the cheese;” see footnote # 292, p. 293.) Foucault (1980) describes “specific intellectuals” as ordinary people who understand their circumstances and have the ability to express themselves independently of the “universal theorizing intellectual” (a “life is local and liquid” perspective). “Not in the modality of the ‘universal,’ the ‘exemplary,’ and the ‘just-and-true-for-all,’ rather within specific sectors, at the precise points where their own conditions of life or work situate them” (p. 126). We are too often discouraged from engaging in selective ethics, situational leadership, anecdotal evidence, gut feelings, even merit raises, seeming to prefer dogma to thought. Why? In our simulation, it is easier. We’ve made it “safer” to go along. Why? Even where we see the simulation, it is, sadly but evidently, more acceptable than change for most. Apathy wins.

(SINS) STRUCTURES, INSTITUTIONALIZATIONS, NATURALIZATIONS, SIMULATIONS related to the belief that interpretation is not scientific, and that leaving things to people’s own judgment is bad or risky, and other “matters of subjectivity” are too often demonized, one of several somewhat obvious SINS of positivism and Taylorism. This demonizes humans (at least doubts them, a priori, yet we give trust, a priori and in perpetuity it seems, to rules, systems, and officials). Disturbingly, during manual recounts of ballots in Florida in 2000, strong insinuations were made that machines were more reliable, more accurate, and more neutral{290}* than the humans making and operating them, for example.

Foucault (1980) says this specificity is the level at which criminals challenge prison conditions, welfare workers and clients seek to change the bureaucracy, consumers organize against corporations, and, I would add, the regulated challenge the regulators, faculty challenge administrators, doctors challenge insurance companies, people (individuals) challenge (local) (SINS) STRUCTURES, INSTITUTIONALIZATIONS, NATURALIZATIONS, SIMULATIONS. Whying should become more prominent in every discourse, according to my dogma.

I do not subscribe to the notion that something called “the greater good” exists or that standardization is possible or desirable (Nietzsche, 1968). Regulatory processes, which are purported to operate in (even ensure in the vernacular of some) the “greater good” cannot. Regulations might have a tendency to work somewhat for some people sometimes. To acknowledge this is not nihilistic, rather it is a prerequisite to better regulation.{291}*

It might be at this moment in a dissertation that an “Ideas for future study” section “should be” forthcoming. However, I feel in this, and similar cases of qualitative research, that it is inappropriately risky to do so. It might be later said, given the local interpretation of federal rules, that I gathered data in a premeditated fashion (via living and talking about issues relevant to that life) rather “authentically” recalling “data.”

No matter how many times we may say it, write it, read it, or hear it, most of the time regulatory systems are not “the best we can do.” But they will remain “all that we have” until we acknowledge we don’t want (to tolerate) what we have anymore. And that acknowledgement will only be the beginning of deconstructing the IRB system.{292}* “What can we do?” should not, in this case, be asked rhetorically. It is time to realize the “games of power” are, or have already become, “states of domination” (Foucault, 1988, as quoted in Hindess, 1996, p. 99). There has been too a long period of contortional, conformiating compliatorianism. It is now time for, at the least, some new definitions. Perhaps a new dictionary will be next.

Who will be the Hundredth Monkey (Schell, 1982)? At what point will those for whom systems do not work stop contributing to the “requisite level of mass loyalty” to those systems (Habermas, 1975)? When will we openly, publicly, recognize the legitimation crisis in the regulation described here? When will we begin to act in public ways to change rather than conform to bad policy?

If we keep quiet about what is wrong, we are part of what is wrong.

 

 

 

 

 

 

 

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