Chapter One: Introduction
“But here let me say that
no one should suppose it could ever be possible to devise a set of rules or
laws to provide us with the answer to every ethical dilemma … such a
formulaic approach could never hope to capture the richness and diversity
of human experience. It would also give grounds for arguing that we are
responsible only to the letter of those laws, rather than for our actions.”
The Dalai Lama, Ethics for The New Millennium, p. 27.
Regulation of human subjects research is tricky and important business,
occurring in social, political, academic, and economic environments. It
affects individuals not only as regulators, researchers, and participants
in research, but as members of society, politicians and the political,
academics and intellectuals outside the academy, and people with a variety
of economic interests.
Institutional Review Boards (IRBs), charged with approving, revising,
and/or rejecting research proposals, regulate researchers most directly
(although researcher self-regulation may be more prominent, as discussed
later in this chapter, p. 33-34; also see Alvesson & Deetz, 1996,
especially p. 205). IRBs—not too indirectly—affect which research projects
will or won’t be undertaken as researchers become conditioned, entrenched
within (often invisible) unquestioned boundaries set by the regulatory
system in the larger social context.
The present work may best be described as a critical organizational
communication study, or a critical study of regulatory “management” (as
described by Alvesson & Deetz, 1996 and 2000; Alvesson & Willmott,
1992; Alvesson & Sköldberg, 2000; see also Redding & Tompkins,
1988). Texts produced within and around the IRB system are utilized as
data, and methods include Foucauldian analyses (Foucault, 1972; also see
Manning, 1989, in his examination of the Nuclear Installations
Inspectorate, especially p. 217-233) and resistance readings of the texts,
as well as other critical methods. The Institutional Review Board
regulatory system, especially as it applies to certain qualitative and
survey methods (methodological distinctions are described in more detail
below), is in need of scrutiny (see DHHS OIG 1998b, 2000b; GAO, 2001). The
purpose of the study, ultimately, is to make an effort to change this
system. This will require, as I argue herein, changing the view of
individuals toward the system. This study is designed to enhance
understanding of the ways texts work to produce negative effects and an
overly restrictive regulatory situation in social science. As described by
Redding and Tompkins (1988), the critical perspective within the field of
communication involves issues of emancipation and empowerment, material
interests and who possesses them, conflict and struggle over meaning, domination,
instruments of oppression, power relationships, distorted communication,
infinite realities, ideology, and hegemony (see also Alvesson &
Willmott, 1992, and Alvesson & Deetz, 2000).
“To a greater or lesser extent, politics suffuses all social scientific
research (Guba & Lincoln, 1989, p. 125; see also Forester, 1989, p.
3-4). The bureaucratic suffusion of politics into research and some
of its consequences is illustrated by the problems created by the Bush
administration’s efforts to regulate the quality of scientific information
released by federal agencies. This is an effort to hold federal agencies
more accountable for the money they receive (i.e., the guidelines
are not necessarily purported to have anything to do with science directly,
though it is likely the rules will affect scientists, and therefore,
science) according to sources reported in Brainard (2002, Mar 29b). An
example is Bush administration standards “to govern the quality and
objectivity of scientific information released by federal agencies”
(Brainard, 2001, Sep 28, Daily News) released in 2001 (Office of Management
and Budget, [OMB], 2001, Oct 1). A number of difficulties (such as defining
“quality,” “utility,” “objectivity,” “integrity,” “influential” findings,
and even “affected party”) and typical problems associated with attempts to
standardize exist with the rules. (If scientists at the National Weather
Service deliver a “low quality” forecast, are they to re-issue a “quality”
forecast after the fact? And, as will be discussed at several points
herein, the likelihood of finding definitions that hold across the broad
spectrum of research types is slim. For example, what constitutes “quality”
varies among clinical, social, and critical research methods, as does the
role of “objectivity” and perhaps most significantly, the types of
treatments, risks, or lack of them.) Of particular concern is the
requirement that research findings released by federal agencies be “capable
of being substantially reproduced,” suggesting the agencies could somehow
“ensure the results could be verified independently” according to Brainard
(2001, Sep 28, Daily News). The Office of Management and Budget (OMB)
states that peer review may not be sufficient (OMB, 2001, Oct 1), at least
indirectly suggesting that bureaucrats/regulators might somehow be better
suited to assess the quality of research. Finally, OMB statements indicate
a recognition that problems are inherent in “developing detailed,
prescriptive, ‘one-size-fits-all’ government-wide guidelines” yet the
agency proceeds to offer guidelines anyway, stating the guidelines were
designed “to be generic enough to fit all media, be they printed,
electronic, or in other form” implying the form of the dissemination
of information rather than the gathering and analysis of information (or as
mentioned, the treatment to be used) is the reason one size doesn’t fit
all. It also appears inherently problematic (probably impossible) to make
meaningful guidelines “generic enough to fit all.” These statements are, I argue,
offered to meet political ends more than practical ones.
Most research is conducted in universities (Walker, 1996, Nov 8), and
these activities are subsequently used as baselines by government to devise
regulations. Government rules, in effect, supercede individual researcher’s
desires, under the premise that researchers must be at least indirectly
supervised, can’t be left to their own devices, i.e., they can’t be
trusted, and this view is reinforced by the OMB statement devaluing
peer-review quoted in the previous paragraph. If Bush’s recommendations are
implemented, it will not necessarily be scientists who judge science, but
regulators (who may or may not be researchers, i.e., no provisions
are made for ensuring experienced researchers are selected as regulators,
nor are there rules/guidelines requiring/suggesting that various
methodologies be represented in the regulatory apparatus) will judge the
“quality and objectivity” of studies and results. As I will show,
regulators already do have more to do with what kind of “science” is
conducted and in what ways than any other group.
It is not the purpose, but the process of human subjects
regulation (particularly as it is applied to many social scientific
methods) that is absurd. Re-opening these processes to scrutiny (via
critical analysis) more readily leads to identifying and remedying problems
(see Alvesson & Willmott, 1992; Alvesson & Deetz, 2000; Horkheimer,
1937/1976; Adorno, 1989a; Horkheimer & Adorno, 1944/1972). Some of the
most controversial leading edge projects (gene therapy, stem cell research,
and genetic engineering in agriculture are current examples) {1}*
are difficult for regulators to categorize, consider, or control. Yet, the
common regulatory response to new areas of research (or atrocities) is to
make more rules (see Office of Protection from Research Risks [OPRR, 1999],
especially the section entitled “An opportunity for federal leadership,” p.
13). These rules often have unintended effects (and do not meet the
intended purpose). We stay mired where we never should have walked, bogged
in what Baudrillard (1983) calls a cultural simulation—substituting signs
(rules, words) for reality, making no distinction between the process and
reality, normalizing meaninglessness (see Baudrillard, 1983, p. 4). {2}*
Attempting to predict disasters and control the research world with one set
of rules for all treatments—spanning at least from observations of the
natural environment (too often contaminated when regulatory requirements
are followed, as I will argue) near one end of a continuum to installation
of devices and drugs into (often desperately sick and vulnerable) peoples’
bodies (near the other extreme)—is fallible, dubious (and ludicrous)
behavior.
Other considerations make the IRB system an interesting site for study,
and a timely one. Developments in the world, particularly in the economic
domain, affect research. Medical research is becoming more and more a
commercial enterprise (Schmidt, 2002, Mar 29; DHHS OIG 2000a; Blumenstyk
& Wheeler, 1998, Mar 20); lines between academia and commercialia
are blurrier than they have been previously{3}*
and many administrators (and legislators and governors{4}*)
applaud this.{5}* It is also reasonably apparent that conflict of
interest issues become more prominent when money is involved (and when
researchers are invested in their findings{6}*).
Academics serve business.{7}*
According to Kenneth Getz, Director of Center Watch in a telephone
conversation cited May 26, 1998, and reported by the Department of Health
and Human Services, Office of Inspector General (DHHS OIG, 1998d), “The
clinical research market is roughly a $4 billion market. It is estimated
that about 75 percent of clinical research is industry-sponsored” (p.
A-1){8}*. And, of course, independent social scientists
conduct large amounts of market research, product development research, and
other studies directly sponsored by industry. “The amount of interest in
encouraging the commercialization of university-developed technology has
just exploded,” said Dan Berglund, the president of the State Science and
Technology Institute (as quoted in Schmidt, 2002, Mar 29, p. A26), and
Berglund indicated he thinks there is no question that the view of the role
of universities in most states is changing. And in summarizing a corporate
movement against genetic engineering of crops, Patagonia points out one of
the rather obvious conflict-of-interest issues in this situation. “The
underwriting of science by corporations (through university grants)
certainly influences the studies agricultural scientists pursue, or don’t”
(Patagonia, 2002, Spring; see also Tacio, 2002).
From personal relations within, between, and among researchers across
several communication genres and related areas of study, to complex
university research environments, and further, to the powers and policies
of the federal government research entities, these contexts and their
attendant constraints substantially influence research design,
implementation, and, consequently, outcomes (see Gubrium & Silverman,
1989).
Issues surrounding the roles of Institutional Review Boards (IRBs) are
of critical importance in academia, and central to the functioning of the
research environment. To test and adopt methods, procedures, boundaries for
claims, and to make discoveries have existed as the primary goals of
science since The Enlightenment. And since that time, with more and more
frequency, these tests involve the use of human subjects. Further, from the
apodictic to the assertoric, a persistent temptation exists to apply
procedures, methods, claims, and more recently, regulation developed for
the medical sciences to social sciences.
The IRB regulatory system is nonsensical as it relates (or fails to
relate) to many social science methods; the rules are often not right or
wrong, but ill fitting and irrelevant. For example, federal and local
regulators describe their rules as “minimal standards,” the “basement” or
“foundation” for the regulation of research (as is expressed in many of the
Office of Human Research Protections (OHRP) documents cited herein, and
these descriptions are based, in part, on the notion that the federal
government should operate in a way that creates the least restrictive
environment for those regulated, especially in matters related to public
health and safety, areas of rule-making generally reserved to the
states.) For some proposed treatments, (and particularly
non-treatment observation) federal regulation alone is hardly a foundation.
It is inapplicable or unduly restricting, though substantially less so than
layers of “more rigorous” standards (often perceived as virtuous) imposed
proudly {9}* by local IRBs.
In this attempt (even presumption) that one-rule-fits-all-methods, it is
perhaps clear that both the rules and the methods are well established. It
does not follow however that the rules and the methods work well together.
The regulatory system and many qualitative methods are and have always been
incompatible. Qualitative researchers have acquiesced, conceded, and have become
involved in this regulatory process against their will and sensibility (see
O’Connor, 1979; Klockars, 1979; Wilkins, 1979; Whyte, 1987; Punch, 1998;
Flyvbjerg, 2001).
Human Subjects Regulation Issues for Consideration
Several questions should be re-opened with respect to the IRB system,
including this positivistic bias described by Knights.{10}*
And Agar (1980) suggests that the intent{11}*
behind the “bureaucratic feeding frenzy” is a good one, “but the
procedures{12}* are becoming an annoyance that may or may not have
anything to do with insuring that the intent is realized” (p. 183). Not
only is there a lack of whying{13}*
on the part of researchers, but also researchers (and regulators) are
asking “wrong” questions about the IRB process. For example, qualitative
researchers find themselves asking “How do I make a successful
application?” or “When might I know whether my protocol is approved?”
rather than “Why should I ask for approval?” And IRB and other regulators
are asking questions of researchers that many perceive to be beyond the
scope of the regulators’ interests (see Brainard, 2000, Mar 17; 2001, Mar
9; and Campbell, 1998, Apr 3).
It seems the regulatory system may have abundant form but inadequate, if
even existent, substance. Atrocities and infractions happen that rules, i.e.,
administrative law in the case of IRBs, are in place to prevent.
Conversely, many people who have no knowledge of the rules often “follow”
them. There are rules that are ignored and therefore do not work; there are
rules that cannot be understood and therefore do not work; there are rules
that are unknown and therefore do not work; and there are rules that are
unlawful themselves that may or may not, and maybe should not work; there
are rules that allow unsafe or exploitative behaviors and certainly should
not work{14}*; there are interpretations of rules and therefore
they do not work consistently, and so on. The inherent fallacy that rules
are doing what they call for on the surface has perhaps even deeper roots
in criminal law.
Regarding form, if a research study proposal is standardized, “normal,”
has been done before, or “contributes to the body of knowledge,” it is
perceived to be safe, i.e., less risky in a legal sense. It appears
these pseudo-qualities take considerable priority over saying anything
important, significant, risky, difficult, or interesting. This is not to
imply that a research project can’t both conform to IRB regulations (or
other rules such as those presented in stylebooks) and render interesting
results, but that occurrence is as likely to be by coincidence as by
design.
Regulators have demonstrated their concern, and appear frustrated and
confused (see DHHS OIG, 1998b-e, 2000b; GAO, 2001){15}*.
Federal regulators and members of local IRBs find themselves in a somewhat
common bureaucratic situation of administering rules that no longer fit the
affairs they are to control as evidenced by the steady stream of calls for
and actual issuances of “updates” in virtually every regulatory system one
could imagine and also evidenced by the steady pressure on the regulatory
organization from inside and out (see Brainard, 1999, Nov 18; 1999, Dec 13;
2000, Feb 4; and 2000, Sep 13; AAUP, 2001; Ellis testimony, U.S. House,
1998, Jun 11, and others cited later) to acknowledge deficiencies in the
rules, particularly as the deficiencies pertain (or not) to new areas of
research, as mentioned above (i.e., stem cell and gene therapy
research, as examples).
“Real” unregulate-able life keeps appearing. Reactionary responses to
media “heat” lead to rule quagmires, for example the Bush administration’s
guidelines mentioned early in this chapter. Defining terms related just to
these regulations has taken more than a year, and may never be “finished.”
Another example is the case of oral history: older people who are most
often the participants in historical research constitute a protected class
under IRB rules. Difficulties in getting these studies approved have
increased according to the Association of Oral Historians (see American
Association of University Professors, AAUP, 2001). (Far from being harmed,
many of these elderly participants are eager to share their stories;
interaction and attention of this kind has been shown to have positive
benefits (see intergenerational literature, particularly Baumhover &
Beall, 1996, and this situation, I would suggest, is an example of the
Hawthorne effect, i.e., attention and being asked about oneself is
positive, often enhancing the self esteem of people.) Even the idea that
these researchers are required to make application to an IRB is unknown to
many of these historians and unreasonable to many more (see Brainard, 2001,
Mar 9).
Bureaucracies are often ill equipped to handle the issues of the day (or
the volume of the week). Rules are outpaced by “real” life, with which we
must eventually contend. “Real” life is dynamic, and, by definition,
ambiguous. It is a liquid target, and a local phenomenon. While a variety
of thresholds exist for various participants’ suggestions about the
dysfunctional aspects of the IRB (or any) system, eventually nearly all
participants will describe some aspect of the system as deficient, absurd,
frustrating, unreasonable, etc., whether they are regulators, regulatees,
or regulatands. For example, regulators, often politically appointed and
motivated, point out the “problems” (deficiencies) with the former
administration’s regulatory efforts, or regulators themselves indicating
they don’t understand how to apply a rule, or even how to explain it to
regulatees. In turn, regulatees often criticize the system as unreasonable
and vague (deficient). These criticisms are justifiable: The system is
deficient, unreasonable, and absurd if regulators can’t explain rules to
researchers, and neither group can explain adequately the rules to
participants in research. Actual observation of the informed consent
process as it occurs between researchers and participants is rare. One of
the only occasions for close scrutiny of this process occurs when an investigation
of an infraction occurs. In many cases the participants indicated they did
not even understand the basic difference between research and treatment
(see Advisory Committee on Human Radiation Experiments [ACHRE], 1995; DHHS
OIG, 1998b, 2000b). This of course is perhaps the most important “minimum
standard” and is frequently not met in part because of the
complexity and interpretation and execution of the rules.
In other cases, researchers are sometimes confused, according to IRBs
interviewed by Department of Health and Human Services (DHHS) investigators
(DHHS OIG, 1998b), about what types of research need to be submitted to the
IRB. New objects of study and new methods to address questions emerge
continually (and thankfully) and, while emerging ideas often contribute to
better understandings, they also contribute to regulatory confusion
(emerging ideas are, by definition, non-standard). However, researchers
don’t call into question (often enough, loud enough, or with a broad enough
scope) the limitations of the regulatory process itself (i.e., what
regulations can do, or prevent), and the limitations imposed on
researchers (what regulations prevent us from doing). Such is the
nature of intellectual captivity, of bars{16}*—we
fail to acknowledge regulation as a matter of choice; we seem to view it
(when we see it at all) as something inevitable and unchangeable. We
“confine” ourselves, build our own bars, and stay within them.
A second area of confusion exists in the ways that IRBs are
inconsistent, as is the nature of any localized (and temporally located,
therefore, every) system (see DHHS OIG, 1998b, p. 3 for description of the
basic structure of this system, and the General Accounting Office [GAO, 2001,
p. 3] for description of OHRP role; for a discussion of the inconsistencies
at the federal level generally, see GAO, 2001, p. 3 and 11{17}*;
for more specific inconsistencies between the Food and Drug Administration
[FDA] and the National Institutes of Health [NIH], see Burd, 1994, Jul 13;
at the researcher level, Sobal, 1984). I maintain that all “real” systems
are local, and in the case of IRBs, there was a (perhaps rare) convergence
of the desire for the regulation system to be local and the local nature of
the “real” world. This situation, coupled with the transient nature of
scholars’ lives, (i.e., not often does a scholar study and
subsequently work at that same institution for an entire career), creates
the potential for more confusion on the part of the scholar/researcher.
Further confusion is produced because IRBs are inconsistent on at least
two vortices. First, they establish local rules, so there is variance
across IRBs (OHRP, 2002, Apr 2; ACHRE, 1995; DHHS OIG, 1998b, 1998c, 1998d,
and 2000b; also variance across federal agencies, see Burd, 1994, Jul 13;
GAO, 2001, p. 3; see also Appendix B,
Legal citations section, p. 350). Second, and more problematic, IRB
decisions are internally inconsistent, making it impossible for a
researcher to adjust, i.e., to know how to make a successful
application. Nearly identical applications may be treated differently by
the same IRB.{18}* And, it appears not all departments within
universities adopt the process of IRB approval (see findings of DHHS OIG
and GAO reports, among others). One graduate student told me that when
he{19}* asked about the IRB in the English and cultural
geography departments, only one professor seemed to know what he was
talking about. When I asked students from other departments (long before I
recognized any of these conversations as potential data) they seemed nearly
obsessed with the IRB and its requirements and impact on their research, or
attempts at research. Regardless of the “accuracy” of the comments
from any of these and other students, if accuracy is discernable or distinguishable
at all in this instance, the fact that students make such comments
indicates confusion about the process. Students and faculty members have,
in numerous conversations of which I have been a part, expressed an
understanding and acceptance of the purpose for regulation, and often
suggest that the process and the purpose appear unrelated to each other.
It is perhaps no surprise, then, given the confusion of regulators and
researchers, that the researched—the very people who should be informed
before giving consent — are confused. Perhaps “confused consent” is a more
apt label (and is considered in more detail below, see p. 114, and p. 222;
see also ACHRE, 1995, Discussion of part 3, http://tis.eh.doe.gov/ohre/roadmap/achre/dispart3.html,
accessed May 25, 2002).
Official regulators (federal or institutional) are not the only forces
working to create rules. Qualitative researchers themselves continue
working to establish a set of ethical standards to guide their research,
according to Deyle, Hess, and LeCompte (1992). I would argue that a set of
ethical standards is already guiding (individual, local) qualitative
researchers, and that what Deyle, et al., are actually talking about is a written,
(and thereby more legitimate in the view of some) formalized statement of purpose
or a set of procedures (the kind of interference Klockars, 1979,
warned against, see p. 35 herein). Regardless of who is writing rules, or
whether they are called guidelines or rules, many qualitative and survey
researchers are being squeezed into an ill-fitting regulatory space.
Changes in the “real” research world, the lack of change in “real”
regulation, and “real” escalation in litigiousness have created
difficulties for everyone involved in this system. Regulators are unable to
keep up with the needs of the research community, (DHHS OIG, 1998b, 1998c,
1998d, 2000b; ACHRE, 1995) and researchers find themselves lost in a paper
maze-to-nowhere. Participants in research are at least as misguided and
confused as they have ever been, and probably more so as research becomes
more specialized, complex, and costly (or profitable). Somewhat
ironically, the participants—the very people for whom informed consent and
other provisions exist — are those least affected by them. While regulators
and researchers focus intently on informed consent documents, research
participants, as described in the various reports cited, sign them, but
often they don’t understand or even read them thoroughly. {20}*
One must ask what difference it “really” makes. If informed consent
documents read more like the fine print of contracts (this being a prime
example of legal issues, specifically fear of litigation, driving the
system), it stands to reason that participants would treat the two
documents in much the same way, i.e., mostly ignoring the fine
print. On the other hand, in qualitative and survey research, informed
consent documents state the obvious (you are being interviewed, you are
completing a survey, and so on), so participants remain confused. In this
latter case, participants may be puzzled about why they are being asked to
sign a form that states the obvious. This might make even the most
unsuspecting of participants at least a little suspicious. (The form
creates in my way of thinking an unsettling “real life redundancy.”)
Informed consent forms for these research activities are mostly
meaningless; the purpose is important, but the process is
impotent.
The proliferation of research studies, stresses created by growth in
both volume and diversity, along with the rise in the number of private and
academic IRBs, the intensifying of commercial interests (DHHS OIG 2000a;
Blumenstyk & Wheeler, 1998, Mar 20; Andrews, 2000, Mar 10, and 1999,
Jan 29; Amos, 2000, Apr 26), and structural changes at the federal level
combine to make this a very good time for taking a snapshot (implying
“natural setting” and “unposed”) of the IRB regulatory system. In the face
of continuing political, moral, and scientific debates about anthrax
vaccine administration to troops during Desert Storm (see CNN.com, 2001,
May 2; 2000, Oct 11), the debates surrounding gene therapy and stem cell
legislation (see references listed, footnote # 1, p. 5; see also Time’s
cover story, “At your own risk,” Lemonick & Goldstein, 2002, Apr 22
[released two days before the defense of this dissertation], which includes
many of the cases presented here), and other issues suggest a study such as
this one is appropriate and timely. (And Alvesson & Willmott, 1992,
Horkheimer, Adorno, and others would argue that anytime is a good time to
scrutinize “managerial” or regulatory ideologies.{21}*)
With the infiltration of technology into every aspect of our lives, the
consideration of managerial motives is particularly important today. “These
technologies for information distribution provide sensory as well as
behavioral domination” (Deetz, 1995, p. 165). And Lyotard (1984) says, “In
the computer age, the question of knowledge is now more than ever a
question of government” (p. 9).
In 1995, the Advisory Committee on Human Radiation Experiments (ACHRE)
called for more direct oversight of the informed consent process. In June
1998, the DHHS OIG (1998d) made the explicit suggestion that more direct
oversight of the informed consent process is needed; this was reiterated
three years later in a General Accounting Office (GAO) report (2001). DHHS
OIG (1998e), issued in October 1998, indicated the federal oversight
process should be reengineered. This talk has added momentum to my efforts.
Rules proliferate in a litigious social system. Rules are, in litigious
societies, often made in attempts to avoid (or create an environment for
the proliferation of) lawsuits{22}*.
The casualties of this system as mentioned are scientists, doctors,
faculty, researchers, and other members of the intelligentsia. Eventually,
rules restrict behavior until nearly nothing can be done (including taking
a critical look at the University of Oklahoma’s IRB, as will be explained).
It appears, for example, that a review of IRB minutes might be a rich
source of data.{23}*
Federal regulators, in enumerating the problems they found at Johns Hopkins
University in July 2001 (and seemingly supporting my contention about the
“richness” of them), wrote “minutes of IRB meetings do not yet exist for 18
of the last 21 meetings dating back to October 2000,” that “the minutes of
meetings for all IRBs often failed to document the basis for requiring
changes in research,” and that “IRB actions were not documented separately
for each individual protocol” (from the letter declaring sanctions, issued
by the Office of Human Research Protections [OHRP, 2001, Jul 19, p. 6],
available http://ohrp.osophs.dhhs.gov/detrm_letrs/jul01a.pdf,
accessed May 25, 2002). These comments speak not only to the activities,
focus, and priorities of regulators, but also to the ways IRBs are
conducting various aspects of their business (see also http://www.uab.edu/lister/hopkins.htm
for information about this case, accessed May 25, 2002, and to read Hopkins
officials’ statement in which they say they believe the OHRP action to be
“an unwarranted, unnecessary, paralyzing, and precipitous,” see http://www.hopkinsmedicine.org/ohrpsuspends.html,
accessed May 25, 2002, [Johns Hopkins, 2001, Jul 19, p. 1]).
Call for Overhaul
The IRB system is in flux, and this, I perceive, is typical of social
structures in general. At the risk of replacing existing dogma with new and
just as impotent dogma, it appears this regulatory system must be updated
or eliminated to allow certain qualitative researchers to work in the
natural world. It seems very clear that, for all the time and effort
devoted to making, maintaining, and enforcing universal rules, these
attempts (and the rules) have made little difference. Universals are
problematic for many reasons (see Whyte, 1987; Goffman, 1971; Gardner, 2001,
Mar 9, and others re: similar efforts in positivism). Lyotard (1984)
states, “ … we are all stuck in the positivism of this or that discipline
of learning, the learned scholars have turned into scientists, the
diminished tasks of research have become compartmentalized and no one can
master them all” (p. 41).{24}*
Within the public and (fueled by the) mass media, distrust in the
system—the entire research enterprise—persists, and seems justified.
Examination and analysis about how atrocities have occurred and how they
are viewed (ACHRE, 1995; President’s Commission for the Study of Ethical
Problems in Medicine and Biomedical and Behavioral Research, 1981),
consideration of the potential for lasting effects (ACHRE, 1995; DHHS OIG
1998b, 1998e), and acknowledgement about the very limited role
administrative rules actually play in affecting the behavior of any of the
participants (Greenberg, 2001, Jan. 19; AAUP, 2001; Brainard, 2001, Mar. 9;
Campbell, 1998, Apr. 3, Brainard, 1999, Nov 12, Manning, 1978, and others)
may yield useful information about the (SINS) STRUCTURES,
INSTITUTIONALIZATIONS, NATURALIZATIONS, SIMULATIONS{25}*
in operation.
When existent administrative rules don’t work, why is it that we make
more of them?{26}* Why is it our knee-jerk response to do so? How did we
get like this?{27}*
Was it in the same/a similar way we contributed to (by not resisting or
whying) the entrenchment of a pro-positivism bias, i.e., trusting
statistics more than our lived experience?{28}*
(See Goffman, 1971.) Deviation is inherent (and desirable) in (life and)
rules, so attempts to standardize life via rules is delusional (and
undesirable, too). It seems that standardization is inherently “expected”
of rules, and attempts to standardize experience (i.e., the
lifeworld) in terms of the ideals of “uniform application of law,” “blind
justice,” “(separate but) equal education,” and other myths, proliferate in
numerous levels of society{29}*.
Even with provisions of the Nuremberg Code (1949), the Declaration of
Helsinki (1964, and amended in 1975, 1983,1989, 1996, and 2000), the
Belmont Report (1979), regulations, and the history of research atrocities,
abuses persist. Thalidomide distribution, the administration of cancer
cells to chronically ill and senile patients, the Tuskegee syphilis study,
uranium miners studied without their knowledge or consent,{30}*
and even more recent events{31}*
have occurred though considerable regulation was in place, designed to
prevent them. What rationale supports the need for more rules? Rules don’t
work. (Manning, 1978, states: “… rules can only function as resources for
organizing and rationalizing a given contingency,” p. 77.) From this one
might imply, and I do, that rules serve to create and maintain standards by
which actions are justified (or not), and are related to issues such as
social desirability, political correctness, and legal liabilities. Rules
may guide behavior when people are aware of and accept the idea of their
usefulness, but rules do not “ensure” anything.
Regardless of what rules may actually do, rules don’t prevent atrocities
(Brainard, 2000, Apr 14). Even the “ultimate” rules, i.e.,
constitutional and near-ultimate federal statutes don’t work. Extended
arguments to support these assertions have been made. Alcohol
prohibition didn’t work (see Amendment 21 of the U.S. Constitution, Repeal
of Prohibition). Marijuana prohibition isn’t working (U.S. Department of
Health and Human Services, Substance Abuse and Mental Health Services,
Administration Office of Applied Studies, Preliminary Estimates from the
1995 National Household Survey on Drug Abuse; Becker, 1953, 1963; National
Organization for the Reform of Marijuana Laws [NORML], 1999; Novak, 1980).
Laws prohibiting certain sexual and social conduct don’t work, hence
creating “criminals.” (See Associated Press and other news stories related
to the Boston and numerous other archdioceses, and Utah polygamists, as
examples.) And, rules to prevent atrocities in research don’t work. Solomon
(1985), who conducted an analysis of journal articles produced by the
Tuskegee researchers, for example, argues that “journal reports of the
Tuskegee syphilis study … employ rhetorical conventions which can obscure
and de-emphasize any ethical, non-scientific perspective” and discussed
“the role that rhetoric played in the study’s continuation” (p. 233). Much
of the rhetoric employed in journal articles is similar to that employed in
regulations, by design. (The rhetoric then becomes part of the “fine print”
we block and move without reading, sign without understanding, etc.; we
often listen to what the people who prepared or are presenting a document
say, we choose to believe what people say or follow along with what others
are doing, signing documents without reading the “fine print.” Examples are
ignoring the fine print on the back of credit applications, loan contracts,
or admission tickets.){32}*
This would indicate that rules (and the automatic following without
questioning, i.e., the bias toward and default to make and comply
with administrative rules) worked to the detriment of the Tuskegee
“participants.”
Proposals for new rules proliferate when there is a failure, and often
the proposed rules are remote to the original problem (See Agar, 1980, p.
183; for specific criticisms of the IRB system regarding the lack-of-fit of
administrative rules, see ACHRE, 1995; DHHS OIG, 2001b; OHRP, 2001, Jul 19.
See also the Littleton argument, below, footnote # 40, p. 29.) We’re
swinging in the dark at an unknown target when the first thing we think
about is “what went wrong with the rules” and/or “we must need more rules”
and second, since we don’t know what we’re doing, we make irrelevant and
ill fitting regulations. We then keep them around for eons and,
unfortunately, “build” on them, spin webs of them.{33}*
This of course is a cycle that can be broken only with near-endless
dissention and intense, perpetual whying in every kind of meeting for eons
to “unbuild” (deconstruct) the web of regulation, and as I hope to make
clear, that starts with changing our minds about administrative rules and
their value.{34}* Adding to the woes, new rules often have unintended
effects. For example, in the Littleton tragedy, the talk about instituting
new rules about the selling of guns is removed from the issue of what
17-year-olds can bring to school. In the IRB system, rules related to
informed consent, and mostly designed to protect patients by making clear
distinctions between therapy and research, are irrelevant to the needs (or
the lack of them) that might exist for interview participants or survey
respondents who undergo no treatment.{35}*
It may be helpful at this point to explain that it is this lack of
treatment (and lack of any substantial risk) that is the most common reason
for highlighting differences between qualitative and quantitative methods.
Later, other distinctions are mentioned such as the difference in
qualitative and quantitative methods with respect to a priori
hypotheses and the lack of them. I also explore the distinction between the
role of researchers’ values and objectivity in quantitative and qualitative
methods in general. In making these distinctions, I do not imply
that qualitative and quantitative research methods are somehow “opposite.”
I argue simply that in a general way, qualitative and quantitative research
methods are different in some important ways that (I suggest should) affect
the ways they are regulated (or not regulated). See also Becker’s (1993)
views discussed on p. 94 herein, for more about qualitative/quantitative
distinctions.
Flowing from the position that rules don’t work (in the way they are
intended or perceived to work, if at all) is argument surrounding the
placement of values in human conduct. Many hold, as I do, that people
“prevent” atrocities by virtue of their own virtues (i.e.,
values).{36}*
“Prevention” has little if anything to do with written codes, rules, and
regulations.{37}* Lyotard (1984) states, and others support his
notion, “Most people have lost the nostalgia for the lost narrative. It in
no way follows that they are reduced to barbarity. What saves them from it
is their knowledge that legitimation can only spring from their own
linguistic practice and communicational interaction” (p. 41). Morley and
Shockley-Zalabak (1991) suggest “proponents of the ‘strong culture’
perspective view the construction of social realities, which contribute to
shared values, as the very core of culture and central to high
organizational performance” (p. 422; see also Deal & Kennedy, 1982) and
“the more an individual values what the organization values, the more
likely the individual is satisfied with communication activities and has
positive expectations about the organization” (p. 427). Morley and
Shockley-Zalabak (1991) state, with respect to the evolution of
organizations (relying on the work of Schein, 1985), “organizational
maturity brings cultural constraint on innovation with an emphasis on
preservation of the past” (p. 425). I will demonstrate this entrenchment of
habits, i.e., the ways we do things, is present in the IRB system.
The behaviors of participants demonstrate the tendency to avoid thinking,
to follow without question. Also ideas such as “the letter of the law”
implies a single and “correct” interpretation exists, i.e., an
example of inherently futile absolutism. These behaviors greatly affect the
research environment, as I will also show.
I am arguing that ossification, while maybe not part of the problem
directly, (because the problem is a lack of whying), is the by-product of
the problem of not thinking, defaulting to rules, etc., and this ossified
mass is big, heavy, and hard to move out of the way. An even more stubborn
mass than calcareous deposits. Solid. Heavy. Stuck. Inertial. To add
further complication, this mass is invisible/we are blind.{38}*
Strong “real life” evidence suggests most people don’t want to commit
inhumane acts, {39}*
don’t even wish to see them, and those who are inhumane are not stopped by
administrative rules. Why not? Because those who commit inhumane acts have
no regard for people, why would anyone expect respect for rules
from such a person? To think otherwise is, I suggest, social-level
delusion. Individuals’ morals and values rather than rules are the (SINS)
STRUCTURES, INSTITUTIONALIZATIONS, NATURALIZATIONS, SIMULATIONS protecting
the human subjects of research (and most other humans).{40}*
Individuals’ morals and values are the SINS because what we accept as
natural (normal{41}*)
and reasonable creates the simulation that we live in. My point is that our
acceptance, our creation of “normal” or “natural” is often by default
rather than conscious consideration of choice.{42}*
Contemporary developments in the federal regulatory structure create an
interest for study. The Office of Protection from Research Risks (OPRR) was
moved from the National Institutes of Health (NIH) where it had been since
1972, to the Secretary of Health and Human Services’ office (a move “up”
the bureaucratic ladder), “in order to enhance the office's power,”
according to a statement made by the Department of Health and Human
Services (DHHS) Secretary (see Healy, 1999, Jul 30). The office is
now known as the Office of Human Research Protection (OHRP), changed
effective June 18, 2000 (see Federal Register, 2000, Jun 13; see also GAO,
2001, p. 3), and mostly notable as it relates to who has the right to name
and re-name, and the timing of the event, as noted in the Chronicle of
Higher Education (see Brainard, 2001, Jan 5; Federal Register, 2000,
Jun 13), i.e., the changes came less than a year after the September
1999 death of research patient 18-year-old Jesse Gelsinger in a gene
therapy trial at the University of Pennsylvania{43}*
(Brainard, 1999, Dec 17; see also Gelsinger, P., 2000) and recommendations
of the OPRR in June 3, 1999 (see Wheeler, 1999, Oct 8; OPRR 1999), and
amidst the revealing reports of the DHHS OIG (particularly 1998b, 1998d,
1998e, 2000b) and the GAO (1996; see also 2001, for argument that
“problems” still exist), the new OHRP director’s own statements about the
need for reform (Brainard, 2000, Sep 13), and introduction of a bill in the
Senate (see Human Research Subjects Protection Act, S. 193, 1997).
Whether the entity is called the Office of Protection from Research
Risks or the Office of Human Research Protections is not particularly
significant. The power to name (and re-name) the office is of interest,
however. Also of interest is the change in the enforcement effort (based on
the increased number of sanctions issued during 1999 to mid-2000),
immediately followed by a dismantling and restructuring of a big part of
the enforcement system. And, as mentioned, government reports have
suggested more direct oversight of the informed consent process is
“needed,” and that the federal oversight process should be “reengineered”
(see DHHS, OIG, 1998b, p. iii and xi; GAO, 2001). As of
mid-2001, the OHRP initiated an elaborate IRB registration (see http://ohrp.osophs.dhhs.gov/humansubjects/finreltn/faq.htm,
accessed May 25, 2002). This registration system itself it could be argued
is an outgrowth of the congressional realization that one did not exist;
Ellis couldn’t tell the representatives how many IRBs function in the U.S.
(see U.S. House, 1998, Jun 11).{44}*
For some reason this seemed important to them, i.e., that the
legislators seemed to think that knowing the (exact, or close to it) number
of IRBs was indicative of “doing a good job” as an administrator, or
something akin to that assessment. The number of IRBs overall doesn’t seem
particularly important or relevant to designing the way an individual IRB
is to operate to adequately protect human subjects of research.
Purpose of Study
It appears the IRB system (including federal regulation, institutional
renditions, and self-regulatory behavior) that has existed for at least 25
years in the U.S. is in a somewhat common situation of administering,
imposing rules and regulations that no longer fit important aspects of the
“real” world they are meant to constrain (and, as time goes by, often have
less to do with the intended purpose, i.e., protecting human
subjects). The IRB regulatory system may be described as a simulation
(Baudrillard, 1983),{45}*
a discursive formation (Foucault, 1972) that will be made more visible in
the interest of critique (and perhaps deconstructing and abandoning). This
system is in need of scrutiny, for the benefit of regulators, researchers,
and the researched. Management, and regulatory entities, should be openly
and regularly questioned and challenged, for the benefit of management and
the managed. “Management [is] a social phenomenon meriting serious critical
examination” as “established management discourse and practice tends to
incorporate and ‘swallow up’ larger and larger domains of social and
personal life, such as culture, conflict, and even pleasure” (Alvesson
& Willmott, 1992, p. 3; see also Burrell, 1992).
The system of regulation for human subjects research in both social and
medical science has reached a point of diminishing returns, even
detrimental effects. This is the essential problem of concern for the
present study. The “grand narrative” and other institutionalized structures
surrounding (particularly social) science regulation must be re-opened,
questioned, and revised or eliminated. First they have to be exposed.{46}*
Fundamental debates continue about the very soul of research, including
the tensions among the goals of social science and research ethics, bureaucratic
protection and secrecy, political control and individual rights and
obligations (Whyte, 1987; Garfinkel, 1967; Bantz, 1981; Greenberg, 2001,
Jan 19; Pence, 2001, Jan 12; ACHRE, 1995).
Much IRB regulation, for example, is designed to protect the privacy of
participants of research. But, what is public and what is private? (See
O’Connor, 1979, p. 249; Kelman, 1982; Caplan, 1982; Denzin & Lincoln,
2000, and others.) When can research be said to be “harming” people? Who
has the right to decide? In what ways are ethical norms institutionalized?
Or are they? How do respect, beneficence, and justice work? Accountability?
Responsibility? To what extent do deception, invasion of privacy, or
other “harms” occur? And to what extent do those rare cases damage field
relationships, contribute to researchers becoming cynical and devious,
and/or enrage participants? How many times is the greatest harm damage to
the reputation of social scientific inquiry-at-large? And, how many
potential benefits are lost (not to mention the rights of researchers in a
more general way) because researchers give up trying to get a study
proposal, or a type of study proposal (e.g., covert yet treatment-less
studies) “past the IRB?”
“Management is too potent in its effects upon the lives of employees,
consumers and citizens to be guided by a narrow, instrumental form of
rationality” (Alvesson & Willmott, 1992, p. 1). I suggest this is
especially true in terms of researchers and regulators who often know
little about the type of research they are “regulating” at any given
moment. And this overly narrow and often uninformed “guidance” for social
science researchers in particular (i.e., those who employ methods
without treatments such as observation, survey research, etc.) is combined
with the problem of researchers’ consenting to this frequently absurd
system through their very participation in it.
Hamilton (1998) in arguing that participatory research is emerging,
points out that Habermas has focused on the deconstruction of science (p.
126). Habermas (1971) suggests that Cartesian absolutism be replaced with
mutual understanding, and that social research is “an interactive rather
than a controlling process,” (Hamilton, p. 126). Habermas (1971) states
“objectivism deludes the sciences with the image of a self-subsistent world
of facts structured in a law-like manner; it thus conceals the a priori
constitution of these facts” (p. 69; see also Sunwolf & Seibold, 1998,
p. 287). “Participants aim for mutual understanding over the
coordination of their subsequent actions. Applied research, therefore, is
not about social conformity but about social justice” Hamilton (1998, p.
126) concludes. Finally in this vein, Derrida (1978) states that
deconstruction brings down the “unities” of meaning, theory, and self, and
Cooper and Burrell (1988) state, “It is [such] legitimizing meta-positions
to which postmodernism objects” (p. 98). (See Figure 2,
p. 87; X-axis designed to aid and/or imply conformity [marketing research
is an X-axis phenomenon, for example]; Y-axis designed to study effects of
structures on people [workplace features and their effects on workers, for
example].)
And how would those who would try to institutionalize ethics answer
critical theorists and postmodernists who would likely say that
institutionalization is domination? That respect, beneficence, justice,
accountability, and responsibility are entirely local phenomena{47}*
and cannot be given a general or universal definition in any meaningful,
standardized way. Attempts to control them amount to attempts to control
thinking. (I use the many wags who have uttered, “you just can’t legislate
morality” as further evidence of the futility in this.) These questions
address ethical, moral, legal, professional, theoretical, and practical
problems and positions – and the answers, along with the view none exist –
that continue to reverberate in classrooms, boardrooms, and conferences, in
all parts of the academy and beyond. As mentioned, the focus of this study
is how regulation affects social science, and in particular qualitative
researchers.
The implication for fieldwork
is to be most wary of any and all attempts to fashion rules and
regulations, general guidelines, rules of ethics, or standards of
professional conduct, which would allow well-meaning bureaucrats and
concerned colleagues to mobilize punishments for morally dubious behavior.
Doing so, will, I think, only have the effect of forcing decent
fieldworkers to lie, deceive, wear masks, misrepresent themselves, hide the
methods of their work, and otherwise dirty their hands more than their
vocation now makes morally necessary. (Klockars, 1979, p. 279-80)
“It is time to get on with the multidisciplinary project called
qualitative research. Too much critique will stifle this project” (Denzin
& Lincoln, 1998a, p. 410). And, I would add, too much regulation has
had the same affect. Durkheim (1933, pp. 65-110; 1951, pp. 335-392, as
quoted in Grabe, 1999) argues “the ritualization of crime is a powerful
means to draw publicly the line between good and evil, thereby constructing
morality” (Grabe, 1999, p .156). I will argue that regulation works much
the same way, in that “rules” imply notions about what is right and wrong.
There are many arguments against this notion, i.e., that many rules
aren’t strict enough to prevent wrongs, others are overly restrictive,
disallowing what many might call “right,” “good,” or at least “reasonable”
in any given liquid and local situation, i.e., the lifeworld, and
still other rules are required but unnecessary, irrelevant, and/or
ill-fitting. (See footnote # 93, p. 81, re: “liquid and local.”)
Tensions between bureaucratic protection and political control;
necessity (or lack of it) for covert activity (O’Connor, 1979, p. 250),
secrecy or deception (a clinical example is the use of placebos, which
involves all of these things, however, i.e., blind participation,
not knowing whether a patient takes “real” medicine, not to mention issues
related to the right to receive “real” medicine, etc.); individual
rights and common good; and between therapy and research perpetuate debate
about the use of human subjects.
Simply, the most significant reason for doing this study this way is to
open authority to questioning, a theme I find to be of enduring value. To
reveal (SINS) STRUCTURES, INSTITUTIONALIZATIONS, NATURALIZATIONS,
SIMULATIONS involved in the construction and operation of the IRB system is
a primary goal for this study (see Alvesson& Willmott, 1992; Alvesson
& Deetz, 2000; Horkheimer, 1937/1976, 1972, and 1989; Adorno, 1989a).
And, ultimately (and consistent with the goals of critical
management/regulatory study), I hope to contribute to efforts to reform the
IRB process, specifically to create true and complete exemptions for social
researchers who deliver no treatment to participants—to emancipate these
researchers employing unobtrusive methods from local interpretations of
federal rules, as I will explain in the next several chapters.
“Through obscuring the construction process, institutional arrangements
are no longer seen as choices but as natural and self-evident … [this]
protects them from examination” (Alvesson & Deetz, 1996, p. 199).
Adorno (1989a) describes mass media in a way that is relevant: It is not “a
question of primary concern for the masses, nor of the techniques of
communication as such, but of the spirit which sufflates them, their
master’s voice. The culture industry misuses its concern for the masses in
order to duplicate, reinforce, and strengthen their mentality, which it
presumes is given and unchangeable” (p. 129).
I call for renewed questioning of the IRB system (i.e. whying to
regulators, each other, and ourselves, and about regulations and the
“management” of them), with specific emphasis on the relationship between
qualitative methods and regulation. I call for the widespread de-regulation
of social science research restrictions when no treatment and no protected
classes are involved, the acknowledgement of the “real world” lack of
direct oversight and lack of reasonability of attempting or possibility of
attaining it{48}*. It is already the case that researcher compliance is
“really” only voluntary (without oversight, it can be nothing but). We, as
researchers, cannot be watched every minute, and even if we could who would
do the watching? What do they know? Would they say what they know or would
they say what they are “supposed” to say according to the “script” of the
rules and policies? Would they know what they were doing, i.e.,
would they think they were saying what they mean, when they might “really”
be saying what they think others wish to hear? It is this kind of whying that
should be more prevalent in the face of regulators/regulation.
I believe we have allowed too much control to be taken by “the process,”
too much control about what we have to “obtain consent” to do ourselves.
For example, first-hand direct experience belongs to the experience-er,
thus no “consent” can be required.{49}*
Are we to sign our own informed consent forms before we ask ourselves to
“describe” our own(ed) experiences? Whether considered to be in non-protected
classes or not, (the categories themselves are in no way determinate,
definitive, or “real”) adults participate moment-to-moment in their own
lives. As researchers/people, we ask questions, scientifically and
socially, formally and informally. When we are asking as scientists, we act
as scientists. We often use tape recorders and notebooks, making them
obvious to participants/conversants. We ask whether or not the person
(participant) wishes to be anonymous in our reports, if in fact we even know
the identity of the person with whom we may be speaking or about whom we
may have recollections.
Based on this “real world” description, I assert that social researchers
as I have described embrace the purpose of regulation, but abandon
the local processes. It is often the case in what I have seen in
local IRB interpretations, that the federal government is in a better
position to make viable rules than are local boards. First, the federal
government in making administrative rules only has two higher levels of law
to consider, and to avoid contradicting: the U.S. Constitution and federal
statutes. The local IRB must contend with both of those legal levels, as
well as a state constitution (or in the case of multiple site studies,
numerous state constitutions), state statutes, and often a university
handbook (or, again, several in the case of multiple site studies).
Additionally, the local IRB, which in theory given the larger legal “maze”
would need more legal expertise to write rules that would stand up
to court or other procedural challenges, has less legal expertise at
its disposal than do federal agencies, traditionally.
Agar (1980) writes about IRB regulation, “there are hundreds of problems
here” (p. 183) for ethnographers and social scientists. “If minors are
involved, how do you get parental consent, especially if the study is of
some behavior of the minor that s/he does not want the parents to know
about?{50}* Or what if it is an experiment in which you cannot
tell the subjects exactly what is going on because it would bias the
results?{51}* Or what if the sample is drawn from an institution
where it is questionable that the subject has any “choice?” (p. 183-84).
Agar (1980) continues, “An ethnographer would not object to the spirit of
protecting human subjects – it is just that the written form can be
a problem” (p. 184). Several documents cited herein support the idea that
the written informed consent form has little to do with actual process of
consent (see US Agency for International Development [USAID, 1999]; ACHRE,
1995; and others). These administrative rules can be difficult in any kind
of research (qualitative or quantitative, social or medical, treatment and
non-treatment methods) because much research is conducted to develop new
knowledge and is therefore unpredictable (see Brainard, 2002, Mar 29b).
“There are too many cases in science where you can’t measure relevance in
5, 10, 15, or 20 years,” said Irwin Feller, a professor of economics at
Pennsylvania State University at University Park, and quoted by Brainard
(2002, Mar 29b, p. A25).
I suggest, assuming the risk inherent in any dogma, the present system
be replaced with a “blanket assurance.” (See Lofland’s idea of a
“certificate of competency” for field researchers, as mentioned in Punch,
1998, p. 157; and see the University of Oklahoma, IRB policy and procedure
[http://research.ou.edu/policy/IRB_Human_Subjects_Policy.html,
accessed May 25, 2002], specifically the provision for student researchers
under Section 5.) Lofland’s idea represents a “professional guideline”
outcome, whereas blanket assurance is a “self-regulatory” outcome, to be
adopted by researchers in lieu of countless contrived applications and
other mute parts of the process. This is taken up in Chapter Eight.
Among the benefits of deregulation may be the preservation and expansion
in the diversity of research approaches, the enhancements that diversity
brings, the enhanced view of diversity itself, and the raising of the
“actual” social capital of diversity, not just the discourse surrounding
it. To show respect for the unorthodox, the non-traditional, the
non-standard, the strange and the weird is beneficial, I contend. To
demonstrate the (SINS) STRUCTURES, INSTITUTIONALIZATIONS, NATURALIZATIONS,
SIMULATIONS associated with, and the folly of, “being normal” or even
attempts to define what that may be is useful.
Outline of Contents
Forester (1993) suggests the importance of linking control structures to
daily experience in forming what he terms a “structural phenomenology” (p.
140; see also p. 73 herein). Further, Forester holds that the organizing of
attention is a central feature of administrative and organizational
processes of social reproduction. As Forester advocates, I will present an
illustration (what Forester calls a map) of the “formal mandates, informal
routines, and various precedents [that] frame participants’ attention”
(Forester, 1989, p. 159), viewing both the staging and framing of social
(in this case regulatory) interaction. The data for this study is written
communication, i.e., “discursive formations” (Foucault, 1972, pp.
31-49) along with a few of the author’s recollections, presented at (I’m
told minor) risk of breaking (local interpretations of) rules about the use
of one’s own direct personal experience. The risk is in the potential of
having one’s direct first hand experience “swallowed up” in the
interpretations of some local IRB as constituting human subjects data
although no human subjects were subjected to treatment and none are
identified in these recollections.
Employing Foucault’s position that discourse constitutes organizations,
and the value he and others place on ordinary texts, i.e., the
written products of ordinary, local, day-to-day existence of regular people
doing regular things, the data for this study, as described, is
predominately these forms of texts. With respect to organization of the
present study, and consistent with Habermas’s (1984) model explained in the
next few paragraphs, Foucault suggests the rationalities of government are,
among other things, associated with discipline and the “shepherd flock” model
(see Hindess, 1996, p. 20). Foucault presents each of these rationalities
as present at a number of levels, from external supervision to
self-regulation and personality modification (see Hindess, 1996). Chapter
Two contains epistemological/theoretical considerations and Chapter Three,
the data and methods employed here.
Habermas’s (1984, 1987, p. 107) model of reproduction includes three
areas that work well to explain some of the chapter divisions in this
study. First in Habermas’s model is “cultural reproduction of worldviews,”
including ideas, knowledge, beliefs, etc. In Chapter Four, the development
of the IRB system of regulation is discussed, how it came about and parts
of the “original” (and ever-evolving) system that have been rather
consistent in the discourse, and remain apparent. Chapter Five includes
Foucauldian analyses and resistance readings of various documents produced
within the system, including government reports, local application forms,
and documents designed to provide guidance to compliance.
The second part of Habermas’s (1987) model is “social integration,”
during which norms and other patterns of social membership are reproduced.
This corresponds to the focus of analysis for Chapter Six, i.e., the
institutional reproductions of federal regulations. An example of this
level of analysis is scrutiny of the “translation” of the Code of Federal
Regulations and similar texts to university research policy handbooks.
Renditions of events in the press, and comments of university officials and
researchers also provide insight about IRB system operations.
Third in Habermas’s (1987) model is “socialization” which includes the
development and alteration of social identities, motives, and expressions
of self. Chapter Seven includes an analysis of the affects on the
identities, motives and self-expression of researchers.
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