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Chapter Four: Development of Federal Human Subjects Regulation
“I had no idea as to what
don Juan wanted, and yet I did understand him to perfection.” Carlos
Castaneda, The Active Side of Infinity, p. 10.
In mapping the ideas, knowledge (and ideas about that), and worldviews
at work in this regulatory system, I will offer observations about the
development of science, the positivist/humanist split (and the distinctions
between them that “really” matter in this analysis, see p. 26, herein) along
with the regulatory system in general that is the focus of this study. By
doing this, it is possible to show which terms, concepts, constructs, etc.
that appeared in the discourse in the “beginning” still appear today, and
how they may be operating. I will consider these cultural-level
reproductions, as Habermas (1984) describes, along with views about the
underlying moral/value and other structures (SINS) that can be seen working
in the system through the text that produces it, as Foucault (1972, 1980) and
Forester (1989) might suggest.
I am not providing a history of science or of the system to be relied
upon as the story for the analysis (rather a story for an
analysis), as I share the belief with Foucault and others{92}*
that a single, accurate, definitive history is impossible. Portraying one’s
own time as unique and a period of great importance, an important
transition, etc., is an unfortunate tendency of many Western thinkers,
Foucault remarked (1983).
What I intend to do alternatively is tell a creation story (what
Foucault might describe as a genealogy, see Knights, 1992, p. 517; or what
O’Connor, 1979, termed “interpretive investigation,” p. 238; also see p. 51
herein) based on texts of laws and rules, events, the ways they were
positioned, and by whom. I do not presume to know the way things “really”
were or are, and it is not necessary nor possible to know that. A primary
goal in doing this study is to find and reveal, to describe
structures (SINS) operating in the system and the possible effects of
abandoning these structures, rather than attempting to explain the
roots or values of these (SINS) STRUCTURES, INSTITUTIONALIZATIONS,
NATURALIZATIONS, SIMULATIONS. To suggest ideas and offer an accounting of
the time at which certain terms or ideas are reported to have first
appeared in the discourse, not when they actually did appear will be
useful to this analysis. To consider the views held by various participants
does not claim absolute accuracy, nor is it nihilistic nothingness. It is
for me simply an acknowledgement that life is liquid and local.{93}*
We react to interpretations rather than an absolute, objective “reality.”
Our eyes are not windows, but sensory receptors (see Kolak & Morgan,
2001, or http://www.wpunj.edu/cohss/philosophy/LOVERS/surprise.htm,
accessed May 25, 2002). Besides, social structures are most often slippery
(sometimes, for some, even slimy) and difficult to grasp. These structures
are implicit and interpretable, liquid, and local. Timmermans (1999)
studied CPR in emergency rooms and described survival rates as “part of a
scientific story in which the assumptions, the interpretation, and the
conclusion are predetermined” (as quoted in Wheeler, 1999, Oct 15, p. A21).
Timmermans says if survival rates are low, CPR researchers recommend more
training and technology; if they are high, CPR training is considered a
success. This is not unlike regulation: if no problems are reported, the
system is successful; when problems (often atrocities, in the case of human
subjects regulation) do occur, more rules, oversight, and enforcement are
“needed.”
Creation stories about how “scientificity” became dominant have been
told many times. This one is drawn predominantly from Polkinghorne (1983),
Anderson (1996), Denzin & Lincoln (2000), and Hamilton (1998).
Given Aristotle’s enduring rules of rhetoric (Original SINS?), it wasn’t
until the 1600s—the time of Bacon (1620; introduction of the
inductive-experimental method), Galileo (assertion that nature is ordered),
and Newton (mathematization of observation)—that science began to rival and
overtake philosophy and religion as the dominant paradigm. These ideas
paved the way for positivism, and it was during this time (from the 1600s
to the Enlightenment) that views of human phenomena (including
communication phenomena) were changed significantly.
In the early days of the reign of science (“positivism” has become too
synonymous with “science”),{iii}*
the Cartesian model was employed, i.e., knowledge was held to the standard
of absolute certainty. About pursuant developments, Anderson (1996) states,
“From Hume (skepticism) to Kant (transcendental idealism, see below, and
also footnote # 94, p. 83) to Husserl (transcendental phenomenology) to
Peirce (semiotics), there have been lines of argument that sought to
liberate the human mind from Locke’s empirical prison” (p. 20). Locke’s
blank-slate passivity paradigm was replaced by Kant’s view that the
knowledge is in the knower. This produced a knowledge that was
nonhistorical, i.e., a knowledge that did not change.{94}*
Dilthey (1900/1969) contradicted, asserting Kant’s view did not account for
the knowledge we have of human phenomena, our understanding of life and
other persons. For Dilthey, and perhaps most relevant to issues in the
present study, the study of life is a consideration of particular
individuals living at a particular time in a particular place, i.e.,
the study of life, and life itself, are local phenomena. It took
some time for these views to infiltrate science significantly, if it can be
said that they have.
As early as 1725, Vico had anticipated the growth of the positivistic
approach to human phenomena and resisted the trend by asserting that we can
gain a true knowledge of human phenomena through the study of history (see
Croce, 1964, p. 19). This movement recognized the life experience of
humans, the emotional and vital feeling of life, and the engagement that
humans have with others and the lifeworld. Vico said what was wrong with
positivism was that it neglected meaningful experience (the “real” world).
(I think of these arguments as falling along a continuum, from absolutism
[modernism], to a mid-ish point at relativism [interpretivism], to the
polar extreme, fragmentation [postmodernism].)
Mill (1910/1972) and Comte (1910){95}*,
co-fathers of positivism, provided a philosophical and logical foundation
for empiricism as the ground of knowledge. The preference for positive
knowledge continues. (I would argue interpretivists [and other though not
all other non-positivists] are more empirical than positivists in today’s
research environment, in large part due to the use of operationalizations
by the latter group.)
“Science” (or the most prominent representation of it, as Habermas or
Derrida might describe it{96}*)
was (and remains) deterministic, reductionistic, and in search of covering
laws of cause-and-effect relationships. Researchers were—and are—held to a
“value-free” standard. The purpose of positivistic science is to describe,
predict, and control. Scientists—again the term “positivists” is
unfortunately too synonymous—utilize experiments, sometimes administer surveys,
and are to report with a (passionately dispassionate?) disinterested,
disconnected (and de-valued) voice.{97}*
Positivists believe this is possible; only those statements free from
metaphysical overtones and personal bias can assure certainty. All
sciences, in this paradigm, are to limit their assertions to these kinds of
positive statements, including the sciences of human phenomena. Social life
is considered to be rational and rule governed and the rules for rational
conduct were to be derived from “scientific” (meaning, then and now in a
very pervasive sense, positivistic) inquiry.{98}*
Positive science became knowledge, as described in Habermas’s
(1984){99}* model, replacing rhetoric, religion, and other
enterprises claiming to know “The Truth.” That this remains the case is
demonstrated rather clearly in many documents. (See GAO, 1991a, p. 113-117,
regarding criteria for evaluating case studies, and GAO, 1991b, regarding
evaluation of structured interviewing.){100}*
Further, Solomon (1985) states “The Tuskegee study reveals the hollowness
of claims that scientific language is always neutral, objective, and
value-free … While all of us appreciate the importance of reason in human
affairs, we also recognize the value of human emotion in tempering our
behavior” (p. 244-45). She continues, “If allegiance to objectivity and
detachment blinds us to other values, it produces neither humane behavior
nor sound science” (p. 245). Allowing those who know less and care less
about our work (i.e., regulators or “jackasses,” see footnote # 238,
p. 230) tell us how to go about doing our work produces work lacking in
values and value, and bearing our names.
The functioning of the IRB system, especially with respect to
qualitative methods often utilized in sociology, anthropology, education,
and communication research, and to a lesser extent in political science and
psychology departments, is an example of the institutionalization of a
positive definition of science. The notion that all researchers should be
treated the same way as a matter of “fairness,” regardless of the treatment
they plan to implement, is inherently unfair (see Forester, 1989, p. 3, re:
planners, for example). We, as scientists, do not work in a neutral stage,
in some ideal setting involving all affected interests; we work instead in
political and social institutions. We are, at once, political, social, and
scientific actors, and these “selves” are inextricably linked.
Interpretivists for example sometimes seek (or are “forced” to seek)
legitimization by having their study protocols subjected to the same
scrutiny as positivists. This practice of treating all procedures as alike
may be a contributing factor to over-regulation (AAUP, 2001; Brainard,
2000, Mar 17 and 2001, Mar 9; O’Connor, 1979) in the IRB system currently
and historically, and especially in areas of social science research.
Figure 2
Analytic, reductionist, quantitative, particularistic, positivistic,
nomothetic, etic, or micro- or individual-level analysis, and other terms
are used to describe the science – and often positioned as the only
science—that pursues universal laws to guide the study of human
behaviors.{101}* Simply, quantitative methods are used in the search
for generalizations along the X-axis, as described in Figure 2
(above; see also footnotes # 98, 99, and 100, p. 85), while qualitative
studies, if they seek to generalize at all, are more prone to do so along
the Y-axis. When quantitative researchers (positivists) strive to “predict
and control” individual behavior, they are often serving the interests of
organizations (corporations, product manufacturers, and political candidates
and causes, as examples), while qualitative researchers attempt to
generalize about organizations or how people operate within them, often
with the idea of benefiting individuals (although that is not necessarily
what prompts them). An example of qualitative, X-axis thinking is a
researcher’s interest, perhaps, in assisting individuals in the
“negotiation” of the lifeworld within certain organizations, such as
intercultural studies or studies of political movements.{iv}*
None of this suggests, however, that quantitative/positivists and
qualitative/interpretivists cannot or do not work together to produce
results that benefit both individuals and organizations. Nor is there any
suggestion that positivism is inherently more moral or ethical than
interpretivism, or visa versa. However, from a critical perspective, the
desire to control and predict the behavior of individuals is of great
interest for critique (see also Alvesson & Deetz, 1996, re:
anti-positivism).
Postmodern traits, according to Alvesson and Deetz (1996, p. 205-210),
include the centrality of discourse (textuality), fragmented identities
(industrial, technical, and academic specializations, as examples),
essentialistic understanding of people, a critique of philosophy of
presence and representation (as found in Mead, 1934; Wittgenstein,
1953/1975; Heidegger, 1927/1962; and Habermas, 1975), the loss of
foundations and power of grand narratives (Habermas, 1975; Lyotard, 1984;
Derrida, 1981), abandonment of the notion that knowledge is innocent or
neutral (Gadamer, 1960/1989; Heidegger. 1927/1962); hyperreality, simulacra
replacement of the “real world” (Baudrillard, 1983), research aimed at
resistance and indeterminacy (Marx, Horkheimer, Adorno, Deetz, S. Hall, and
others), and a general preference for irony and play over rationality,
predictability and order. Detachment, displacement, and a high level of
disengagement dominate deconstructive postmodernism. Groundlessness is the
only constant. (Power, 1990, describes postmodernism as the death of
reason; Hall, 1986, suggests it is Marxism with hope but without
guarantees,” p. 58.) Values, history, and ethics are considered arbitrary (i.e.,
based on the liquid and local, the lifeworld). Deconstructive
postmodernists hold that most all aspects of human existence are culturally
created and developed in particular, localized circumstances.
Generalizations are, therefore, not reasonable, possible, or desirable
(except to dominators, perhaps, and then only for short-term benefits).
This is not inconsistent with Dilthey’s particular person, place, and time
thesis. The fairly prevalent notions held by regulators, i.e., that
no distinctions between qualitative and quantitative methods (i.e.,
between social and clinical research) need to be made in regulation{102}*
is an example of SINS that need to be re-opened for questioning.
The Sensibility of Different Regulatory Stances
Rorty (1979) comes down equally hard on scientists and humanists when
either side claims a “lock” on truth. He says that there are some
irreconcilable differences between the two groups. He argues that both
groups are self-sealing language communities that don’t—and really can’t—talk
to each other. The questions in one approach don’t have answers in the
other. At the risk of sounding like Punch{103}*
or Miss America, we need to acknowledge and respect each other. In the view
of rhetorician Nichols (1963) “the humanities without science are blind,
but science without the humanities may be vicious.” Similarly, Alvesson and
Deetz (1996) point out that critical theory without postmodernism can be
blind to its own elitism and power, and without critical theory,
postmodernism becomes esoteric (p. 211). It would appear cooperation rather
than competition produces better results, scientific or otherwise.
Technocracy as an outgrowth of positivism. A slogan used to
publicize the 1933 Chicago World’s Fair succinctly presents this
technocratic tenet (demonstrating again the 1984 Habermas model) and
provides testament to its tenacity: “Science Explores: Technology Executes:
Mankind Conforms” Denzin & Lincoln, 1998a, p. 122). Goffman (1971), and
others{104}* long before and since, reject scientific claims of
positivistic sociologists altogether:
The work begins with the
sentence, “We hypothesize that … ,” goes on from there to a full discussion
of the biases and limits of the proposed design, reasons why these aren’t
nullifying, and culminates in an appreciable number of satisfyingly
significant correlations tending to confirm some of the hypotheses as
though the uncovering of pattern in social life were that simple. A sort of
sympathetic magic seems to be involved, the assumption being that if you go
through the motions attributable to science then science will result. But
it hasn’t. (p. xvi)
Habermasian ideas about cultural reproduction{105}*
can be used to illuminate the underlying theme of positivism in both
science and regulation. Texts will be offered (and analyzed in Chapters
Five and Six) as evidence of beliefs such as the existence of absolute and/or
universal truths, value-free science, the ability of humans to accurately
predict and control each other and nature, to order the world, etc. (see
Dreyfus, 1992).
Culturally Reproduced Positivism Operating in the IRB System
Historically, there has been a
heavy emphasis on quantification in science. Mathematics is often termed
the ‘queen of sciences,’ and those sciences such as physics{106}*
and chemistry that lend themselves especially well to quantification are
generally known as ‘hard.’ Less quantifiable arenas, such as biology
(although that is rapidly changing) and particularly the social sciences
are referred to as ‘soft,’ less with pejorative intent than to signal their
putative imprecision and lack of dependability. Scientific maturity is
commonly believed to emerge as the degree of quantification found within a
given field increases. (Guba & Lincoln, 1998, p. 196){107}*
Cultural reproduction: Statistics are of more value than personal
experience
Declaring that “hard data” are more reliable or revealing than personal
experience doesn’t make the declaration true. These notions (biases) are
cultural reproductions; the ideas are commonly believed.{108}*
There is widespread agreement that quantification equals credibility (see
next section); alternately, the idea that local experience is more credible
than a national statistic is not as commonly believed. This is a product of
the (SINS) STRUCTURES, INSTITUTIONALIZATIONS, NATURALIZATIONS, SIMULATIONS
operating in the IRB system, and the academic enterprise at large. This
bias affects IRB rules and downstream interpretations (as will be
shown, especially in the next chapter) including application forms and the
acceptance, revision or rejection of them, for example.
Cultural reproduction: Quantifying = credibility
Regarding the quantification bias, “That this is the case is hardly
surprising,” assert Guba and Lincoln (1998, p. 196). Positivists
focus on efforts to verify positivistic science or falsify post-positivism
(frequently debunking non-positive methods as non-scientific,
ungeneralizable, unreliable, and biased, just for starters.) Formulaic
precision is central when the aim of science is prediction and control of
natural phenomena. Given that the tools are readily available, what is
needed to perpetuate positivistic science is widespread belief in it.
Sechrest (1992) argues such a widespread notion persists—that only
quantitative data are valid or of high quality.{109}*
This is evidence of the structure within a structure—of what has become
valid or true in science. As
mathematization of the ideas of a science becomes possible, that science
becomes more valid. Because mathematics can offer proofs, and derive an
(positioned to be the) "answer," if a finding can be
quantified, it represents “proof” whereas if we see or experience
something, it proves nothing “scientifically” speaking, and regardless, it
may be that neither the quantified or the experiential result passes the
Grandmother Test.{110}*
A local example of this cultural reproduction is the clear preference for
the words of others over the “reality” of personal experience in the
graduate learning environment (the latter often referred to disparagingly
as “merely anecdotal,” implying immaturity and irrelevance).
How is one paradigm replaced by another? As geocentric cosmologies were
replaced by heliocentric worldviews, as The Truth and History are replaced
by provisional truths and personal histories (not assuming any of these
conversions is complete or, for many, even possible), what is happening?
Life is transition, moving, dynamic. Liquid. Local. One contemporary
transition is not from positivism to postmodernism, rather
toward the inclusion of postmodernism, a recognition of the need for
deconstruction, and acknowledgement of ways life is liquid and local, and
most relevant perhaps, not regulate-able. A minute-by-minute active
negotiation, encumbered with the incredible (and often non-credible) weight
of tradition.
“Realistic social scientists do not mention tradition,” Shils remarks
(1981, p. 7). Tradition, as described by Shils (1981) is much like
Habermas’s (1984) cultural reproductions. For example, one might catch a
glimpse of the bars when considering the words “communication
traditionalist.” Reading “traditional” literature (for non- and
anti-positivists) can be likened to watching the wheels (Lennon, 1980) or
pacing the cage (Buffett, 1996).{111}*
The scholars I have brought to demonstrate “traditional” works in
communication (see footnote # 111, p. 94, below) are those inextricably
linked to positivistic science. Shils (1981) suggests the concept of
tradition lost formative value in The Enlightenment. Knowledge accepted via
authority was replaced by science (putting new “authorities” in place.).
Science, and through it, knowledge, became the “experience of the senses
and its rational criticism” (p. 4). Knowledge is (remains) tied to money,
as well (see Lyotard, 1984, who stated “games of scientific language become
the games of the rich … whoever is wealthiest has the best chance of being
right … An equation between wealth, efficiency, and truth is thus
established,” p. 45). Deetz (1995) states, “Information [defined as
codified knowledge] is only loosely connected with decisions, hence,
political power struggles and processes of social control substitute for
rationality” (p. 136), and quotes Lageza (1992) who says, “Information and
decisions are linked by knowledge claims … knowledge claims have an
interactive and rhetorical dimension” (p. 7).
Becker (1993, as cited in Denzin & Lincoln, 1998a, p. 8) says
qualitative and quantitative research methods differ in significant ways,
because of differing ways of addressing the same set of issues (for
example, the uses of positivism, acceptance of postmodernism, and the
examination of constraints of everyday life). Each tradition is governed by
different structures: genres, their own classics, and their own preferred
forms of representation, interpretation, and textual evaluation (see
Becker, 1986b, p.134-35). The variance across qualitative methods is also
relevant. Regulation is difficult enough within either the
qualitative or the quantitative tradition, leading to no surprise that across
traditions involving such diverse methods, it is very unlikely that one set
of rules will ever fit all methods{112}*
(or, more precisely, treatments).
Emerging Alternative Methodologies
Postpositivists suggest there is no correct method to follow (see
Richardson, 1994; Denzin & Lincoln, 1998a, 2000). As noted, Goffman
(1971, p. xvi) argued that no authentic science is simply an
activity of following methodological recipes that yield acceptable (and
statistically significant) results. Along similar lines, Hall (1989) argues
that critical theory rejects the “body counts” of survey research, “which
consistently translate issues that have to do with signification, meaning,
language, and symbols into crude behavioral indicators” (Hall, p. 42), an
outgrowth of operationalism (see Bridgeman, 1927, as cited in Anderson,
1996, p. 19).
One effect of adopting these views (i.e., broad acceptance of
diverse methods) is the possible expansion of notions about what
constitutes science and what science of any kind can do. With these
postmodern, postpositive views emerging, the likelihood of science becoming
a creative search designed to better understand the ways of things is
enhanced, and scientists will be allowed to use a broader variety of
sometimes improvisational approaches, responsive to, rather than the SINS
in science-defining dogma, the particular questions and subject matters
addressed (and will be called “scientist” even when not employing
positivism).
The downside of these views is that the distinction between social
science and other scholarly activities loses its edge. A postmodernist
might answer, “Who cares?” I would agree. No distinction can exist.
In other words, it is not the process (method) but the purpose
(understanding) that matters.
Considering the differences in various research approaches is useful
because it points us to the differences in treatments traditionally
associated with various approaches. It is important to recognize that these
basic philosophical orientations or worldviews are not mutually exclusive,
exhaustive, nor totally contradictory. A dichotomy (between qualitative and
quantitative research) has emerged for several reasons—some historical, and
some practical (see Liska & Cronkhite, 1994). A recognition that a
variety of philosophies are at work, to a greater or lesser extent, in many
studies is important because the variety has a bearing on what sorts of
standards IRB regulators may reasonably/properly enforce with respect to
differing forms of research. These qualitative/quantitative, social
science/medical science distinctions are relevant to the purpose herein,
because “treatment” (and only treatment, as I have argued) is what
should concern regulators.{113}*
“Themes of the Enlightenment are deeply embedded in modernist management
theory” (Alvesson & Deetz, 1996, p. 194). Three such Enlightenment
leftovers, (i.e., cultural reproductions, SINS) at work in this
system (and all three beg the assumptions that life can and should be
standardized) include blanket assurance provisions{114}*
(the “same page” the federal government requires all institutions receiving
federal research dollars to be on{115}*),
the Common Rule (45 C.F.R. § 46, 1991), and informed consent
(perpetuating/reifying the “positive” notion that if we can standardize the
actual paper form, we can somehow standardize the “real” world; see Lincoln
& Guba, 1989; Sobal, 1984).
Leftovers related to blanket assurance, the Common Rule (45 C.F.R. § 46,
1991), and informed consent include expertism/respect for authority, i.e.,
who is given the power to name, establish criteria, and define terms.{116}*
In this case, “process” and “punishment” are examples{117}*
along with “adverse effects” and “timely reporting”{118}*
as reported by Brainard (2000, Apr 14 and 1999, Nov 12); hierarchical
rigidity (for example, in which arenas discourse gains legitimacy); and
absolutism/one-right-way-ness (demonstrated in the ways parts of the
regulatory process have become entrenched as objects of discourse,
especially in education/the academy and to great potential detriment, i.e.,
if unorthodox approaches aren’t accommodated/accepted/promoted at
universities, then where? Few profiteers allow very much unorthodoxy).
Finally, ways the notion that standardization is desirable or possible can
be shown to be SINSfully operating within the system.
Power in the System
Power of federal system, effects on institutional system, and
subsequent effects on researchers. Knights and Morgan (1991), using
Foucault’s discursive practices model, point to a number of power effects
of corporate strategy discourse, including the sustaining and enhancement
of the prerogatives of management, the generation of a sense of personal
security for executives and managers, and the facilitation and
legitimization of the exercise of power. These power effects are operating
in the IRB system, for example, the withholding by regulators of federal
funds for research (regulatory coercion, the exercising of legitimate
power), the voluntary adoption of the federal rules by institutions (sustaining
and enhancing the prerogatives of regulators without coercion), the
approval/disapproval of researchers’ protocols (generating a sense of
security and importance for regulators themselves, via control of
researchers), and even the self-regulatory behavior of researchers
themselves (facilitating and legitimizing the power of regulators).
Adorno’s (1989b) comments about internal (or self) coercion to maintain the
status quo are fitting here: “The whole business keeps creaking and
groaning on, at unspeakable human cost, only on account of the profit
motive and the interiorization by individuals of the breach torn in society
as a whole” (Adorno, 1989b, p. 272).
How Power is Derived
“Forester (1989) distinguishes between unavoidable and socially
unnecessary disturbances, between socially ad hoc problems [liquid
and local “reality” issues] and more socially systematic, structure-related
sources of distortions [SINS]” (as quoted in Alvesson & Deetz, 1996, p.
204). Organizations may be understood as structures of systematically
(nonaccidental, non-questioned, and possibly avoidable) distorted
communication. Without regard to the extent to which distortions can be
avoided in practice, knowledge and insight of these distorted
communications are certainly of value. From a communication perspective,
organizational power might be described based on the extent to which power
is (perceived to be) gained/maintained through dogma (closed communication)
or dialogue (open communication), for example.
Alvesson and Deetz (1996) suggest corporate visions and cultures are
strategic local narratives that aid management’s objectives (see X-axis
description, Figure 2,
p. 87). They also create and maintain the local hierarchies and
“relationships of power” as Foucault (1972, 1980) describes (see also
Clegg, 1989, re: “circuits” of power). These localized visions, sometimes
manifested in grassroots movements, town hall meetings, quality circles,
company picnics—and corporate and other cults—could be viewed (risking the
oxymoron) as “grand local” narratives, i.e., local stories including
who is in charge, what to wear, when to talk, where to shop, why rituals
are done and how they are done, and so on. And on.{119}*
And in the case of the IRB system, the instructions have become more and
more detailed. More and more cumbersome, restricting, ambiguous, voluminous
(as I show below, for example, see p. 166, re: consent forms; p. 282, re:
assurance documents, and footnote # 139, p. 119, re: historical documents
related to the system).
Power in the IRB System. Applying Forester’s (1993, 1989)
structural phenomenology idea yields the following formulation: In the IRB
system, at both federal and institutional levels, the discursive activities
constitute a dogmatic entity that defines terms and procedures without
offering justification.{120}*
The system sometimes has the appearance of an open system, taking on the
role of educator rather than enforcer (holding seminars, maintaining
user-lists, and more recently providing $28.5 million in grants to help
research institutions improve their efforts to protect people who volunteer
for medical research, see Brainard, 2002, Mar 29a; see also NIH, 2002, Mar
5, or http://grants2.nih.gov/grants/guide/rfa-files/RFA-OD-02-003.html,
accessed May 25, 2002). At other times, the system is blatantly (and
curiously) closed, for example, the OUIRB’s due process and appeal
provisions, or administrative rule changes done without input from more
than a few people{121}*.
An applicant at OU may, under the rules, only request a hearing before the
very board that disapproved the application. The OUIRB’s written rules
provide no other avenues of appeal.{122}*
Problems with a lack of specific written appeal procedures include the lack
of standardization in the process (generally a highly valued goal of
regulators), lack of clear access to the appeals process (leaving those who
might wish to appeal wondering how and to whom), lack of written guidelines
leave the process “optional” (increasing the potential for regulators and
administrators to say in certain cases “there’s not really anything that
can be done” or “this situation appears normal, sorry you’re frustrated”)
and, finally, the lack of written rules for appeal procedures leaves the
process wide open to improvisation (an unusual accommodation to be given to
those enforcing/making “rules” or “laws”). Collectively, this lack of
written guidelines, then, contributes to the likelihood that more “uneven”
application and administration of the rules will occur. It contributes to
the condition that make appealing an action an option of the IRB
rather than the researcher who is denied permission to conduct
research. The lack of a written, specific appeal process is in apparent
contradiction to obligatory due process and appeal provisions of law
generally, and this particular absence of rules seems to benefit,
overwhelmingly, those making (rather than those who may be attempting to
understand or follow) the rules.
Historical Development of IRB System: Early, Middle, Later, and
Contemporary Stages
Early stages. “The history of human subject protections follows a
fitful journey between trust and tragedy, from the Hippocratic oath to the
Holocaust, from the Nuremberg Code to Tuskegee, from the Common Rule (45
C.F.R. § 46, 1991) to the irresponsible administration of pyridostigmine
bromide to U.S. troops in the Gulf War," said Rep. Christopher Shays,
Chair of Congressional hearings about IRBs (Institutional Review Boards:
A system in jeopardy, 1998; see also Campbell, 1998, Apr 3; Charo,
1999, Mar 26).
More than 50 years ago, judges of the Nuremberg court announced their
verdict in the trial of 23 Nazi doctors for crimes against humanity (see
ACHRE, 1995, particularly Chapter 2). The trial followed the discovery of
gruesome medical "experiments" performed on prisoners of war.
Since at least the time of the trials, and adoption of the Nuremberg Code
in 1947, society has maintained skepticism about the nature of research and
the inherent conflicts of interest present in all research.
Distrust seems justified. Even after the adoption of the Nuremberg Code,
and the subsequent Declaration of Helsinki by the World Medical Association
in 1964, abuses persist as noted (specifically Tuskegee, New
York/Willowbrook, anthrax vaccination of military personnel,{123}*
etc.; see also Lemonick & Goldstein, 2002, Apr 22).
Also in 1947, the Atomic Energy Commission (AEC) was created in the
U.S. The AEC was a major source of research funding, a major user of
human subjects (for radiation experiments), and has been described as a
major violator of human rights (see ACHRE, 1995, Chapter 1; see also
CNN.com, 2001, Jan 15 for related contemporary issue re: uranium missile
fears). So, the problems (atrocities) appeared in the U.S. consciousness
and began to affect policy. However, because these government agencies
operated in the name of national security, most of what the U.S. government
researchers did to people wasn’t made public until decades later.
A 1966 article by Harvard medical researcher Henry Beecher brought
prominent attention to human research abuses within U.S. medical schools
and hospitals (not insignificantly, this was one of the first times
problems outside government research were publicly exposed), citing
22 cases involving highly questionable ethics. Atrocities (and lesser
infractions), along with the eventual acknowledgement of them, contributed
to passage of the National Research Act (1974) that set forth the formal
requirements for establishing IRBs. Food and Drug Administration (FDA)
regulations followed in 1981. By 1991, 16 federal agencies had adopted the
Federal Policy for the Protection of Human Subjects, known as the “Common
Rule” making regulations applicable to all human subjects research these
agencies conduct or sponsor.{v}*
Beecher (1966) stated, “Ethical errors are increasing not only in
numbers but in variety” (p. 1354) and offered as an example the “recently
added problems arising in transplantation of organs” (p. 1354). Today, stem
cell research and gene therapy, and intensifying conflict of interest
issues are newer versions of the problems Beecher noticed.
Between 1944 and 1974 in the U.S., (enhanced by works such as Beecher’s)
tensions between the treatment of patients and clinical research (between
humanitarian values and the pursuit of knowledge, i.e., between
therapy and research) emerged throughout the medical science community.
This activity was a product, at least partly, of the times—the wartime
atrocities revealed during the post-war years, and later the activism of
the 1960s, sometimes militant, and often centered on human rights issues
(including the rights to say and to know, self-determinism, individual
rights and autonomy, etc., see particularly information about the Berkeley
Free Speech Movement, 1964, http://home.att.net/~enfield/fsmhist1.html,
accessed May 25, 2002). These developments contributed to the
institutionalization of informed consent. (See p. 135 regarding the first
known use of the term.) Federal sanctions occurring between 1999 and 2001,
specifically those at Duke University, the University of Oklahoma, and
Johns Hopkins University (see Andrews, 2000, Mar 10), indicate that ethical
struggles to find the proper balance between the rights of patients and the
rights of researchers, between safety and discovery, and between over- and
under-regulation continue in American society. Basic questions remain about
what constitutes “advancing medical science” or the loftier “improving the
quality of life” (which are nearly coterminous and often subsumed by
“attempts to advance one’s career” or “protecting the flow of funding;” see
also Shilts, 1987). Just where does “protecting the rights and interests of
patients” fit in with keeping one’s job, avoiding litigation, playing the
game, and covering one’s ass? Arthur Beaudet, chairman of the
department of molecular and human genetics at Baylor College of Medicine
says, “Let’s face it – we’re all interested in our careers,” and adds,
“Investigators could be perceived as having a conflict of interest with
their own desire to be successful” (as quoted in Brainard, 1999, Dec 17, p.
A37; see also Blumenstyk, 1999, Apr 9; 2000, Nov 6 and 2001, Apr 26;
Mangan, 2000, May 19 and 2000, Oct 30; and Schmidt, 2002, Mar 29, regarding
various state legislative actions to commercialize research at state-run
universities).
This is a rendition of the classic debate between the common good versus
individual rights and freedom, and the neo-classic rendition in this
regulatory system, specifically debates between what constitutes research
(benefits for the masses) and what constitutes therapy (treatment for the
individual). It is also indicative of a belief someone (or some “body”) can
know what the common good is (see O’Connor, 1979, especially p. 226; Nietzsche,
1968; and Rand, 1957/1992), or that such a condition exists. It follows
that common good and individual freedom are (SINS) STRUCTURES,
INSTITUTIONALIZATIONS, NATURALIZATIONS, SIMULATIONS, i.e.,
institutionalized, simulated, naturalized structures, just not “real” (in
an absolute sense), nor real(ly) just. Common good and individual freedom
are social constructions similar to “average.” None of these exist in the
lifeworld. They are examples of the abstract being treated as concrete{124}*.
With respect to common good and individual freedom, we act as if they are
good (always) and possible (ever); we treat them as “real,” somewhat like
promotions in the workplace, i.e., promotions are perceived by employees
as “always” beneficial; employees do not question (until later, perhaps)
whether they themselves actually benefit or whether the promotion may
benefit management most (and of course, this is often perceived as good
management). It appears “really” there is (a condition that is) good for
you, good for me, good for us, good for them, but there is no “common
good.” Yet we allude to it, respond to the “need” for it, and live in ways
that are designed to accommodate it. Even when we can see in our immediate
surroundings a workable solution to a current problem, we may restrict
ourselves from doing what seems right in the situation, rationalizing “I
can’t do that for you, because everybody might then expect it.” In other
words, it wouldn’t be in the interest of the (abstract) “common good” to do
what makes sense for the (concrete) particular good (i.e., one’s
life at the moment).
These questions and debates become more complex, often unanswerable,
though answers may flow freely. Newer, narrower, and more specialized
problems associated with developments in science, such as gene therapy
trials, stem cell research, and their attendant ethical considerations have
emerged.{125}* American regulative bodies are not prepared for
their arrival. As in the past, atrocities may serve as catalysts in the
system, a system that is built primarily to offer a reactionary response.
Middle stages. In 1974, the Department of Health, Education, and
Welfare (HEW) published regulations, pursuant to the National Research Act
(1974), governing the protection of human subjects. The Act created the
National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research, the members of which authored the Belmont Report
(published in 1979; for information about the Act and the text of the
Belmont Report, see http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm,
accessed May 25, 2002), a guiding document in American research policy (see
also O’Connor, 1979). Additionally, the Common Rule—the guiding tenet for
contemporary researchers—has its roots here, although the Rule wasn’t
codified until 1991 (45 C.F.R. § 46, 1991). It took at least 17 years to
write this one procedural contribution, the purpose of which was
overwhelmingly being met without the Rule.{126}*
As another example, it took more than three years for the government
regulators to define “scientific misconduct,” according to Brainard (1999,
Nov 19), much less to determine what the degrees of or
penalties for it may be (see also NIH, 2001, Jun 26, p. 4-6, regarding
attempts to define behavioral and social sciences; and problems with the
Bush administration proposals, p. 2-3 herein).
Later stages. The Common Rule (45 C.F.R. § 46, 1991, explained in
detail below) is a guiding institutionalization, (actually an
“institutionalization” within layers of other SINS) a construction that is
an attempt to legislate not only integrity but also humanity. It can be
argued that it is not feasible, not “enforceable” to act (because of an
Act) as if we can control the hundreds of thousands of interactions between
researchers and participants. It can be argued that the Common Rule (45
C.F.R. § 46, 1991) is an instance of social-level delusion, detached from
reality, a Baudrillardian (1983) seduction into simulation.{127}*
We act as if the Act is protection.
Private research that is not supported by the government, or researchers
who are not seeking FDA approval of a drug or medical device are not
required to apply the Common Rule to research. Therefore, the government
has little recourse (and even less direct knowledge because of lack of
engagement in the process, commonly termed “oversight,” but what might be
more precisely described as “technological” or textualogical
oversight{128}*) if “improper” research practices occur. Federal and
institutional regulators define what is improper yet do not traditionally
“see” improprieties unless called to their attention by death, injury,
complaint, lawsuit, or whistleblower, i.e., until a problem/atrocity
occurs and is reported.
The Common Rule, officially titled “Federal Policy for the Protection of
Human Subjects,” (45 C.F.R. § 46, 1991) is the result, as we can see, of
regulations being slowly developed by various federal agencies throughout
the 1980s, until the Rule was adopted in 1991. The Common Rule requires
institutions receiving federal support and federal agencies sponsoring
research to establish internal committees—IRBs—to review research proposals
for their potential risk to human subjects.{129}*
The Rule also requires that “legally effective”{130}*
informed consent of the subject or legally authorized representative be
obtained, and that researchers should maintain written documentation of the
consent, i.e., the signed consent forms (45 C.F.R. § 46.111).
Further, DHHS regulations specify 14 elements of informed consent, eight of
which are required, according to a written statement from Ellis, director
of OPRR from 1993 to 2000, (and responsible for bringing more sanctions
than any previous director), to the U.S. House 1998, Jun 11:
The consent document must
provide to the participant: 1) a statement that the study involves
research, an explanation of the purposes of the research and the expected
duration of the subject’s participation, a description of the procedures to
be followed, and identification of any procedures which are experimental;
2) a description of any reasonably foreseeable risks or discomforts to the
subject; 3) a description of any benefits to the subject or to others which
may reasonably be expected from the research; 4) a disclosure of
appropriate alternative procedures or courses of treatment, if any, that
might be advantageous to the subject; 5) a statement describing the extent,
if any, to which confidentiality of records identifying the subject will be
maintained; 6) for research involving more than minimal risk, an
explanation as to whether any compensation and an explanation as to whether
any medical treatments are available if injury occurs and, if so, what they
consist of, or where further information may be obtained; 7) an explanation
of whom to contact for answers to pertinent questions about the research
and research subjects’ rights, and whom to contact in the event of a
research-related injury to the subject; 8) a statement that participation
is voluntary, refusal to participate will involve no penalty or loss of
benefits to which the subject is otherwise entitled, and the subject may
discontinue participation at any time without penalty or loss of benefits
to which the subject is otherwise entitled. (U.S. House, 1998, Jun 11, p.
45-46)
Ellis’ report states: “A researcher who seeks to recruit an individual
for research without conveying these elements of information in language
understandable to the potential subjects is not obtaining informed
consent” (U.S. House, 1998, Jun 11, p. 6; emphasis in original). There are
no separate informed consent provisions or guidelines for those researchers
employing observational and other unobtrusive methods, i.e., there
is no accommodation for the substantial variance in treatments. In the
interest of treating all researchers the same way, i.e., being
“fair,” and based on both social desirability and legal interests, one set
of rules to be equally applied to everyone is being culturally reproduced
(naturalized, institutionalized) by the participants in the IRB system,
contributing substantially to irrational, irrelevant, and ill-fitting regulation
for much research activity (see Nelson quote, in Brainard, 2000, Apr 14;
DHHS OIG 1998b, 1998d, 1998e; ACHRE, 1995; AAUP, 2001). Adorno (1989b)
states, “Irrational institutions are useful to the stubborn irrationality
of a society which is rational in its means but not in its ends” (p. 273).
Federal regulatory bodies: Who makes rules and define terms.
Bodies explicitly charged with establishing policy regarding some aspect or
context of human subjects research include, in addition to the NIH and the
FDA, the U.S. House and Senate, the judicial system, the National
Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research, the Commission on Research Integrity, Applied Research
Ethics National Association (ARENA), the executive branch: President
Clinton in his 1997 apology for the Tuskegee tragedy, the National
Bioethics Advisory Commission (NBAC), the Advisory Committee on Human
Radiation Experiments (ACHRE), the Office of Protection from Research Risks
(OPRR, now renamed the Office of Human Research Protection, OHRP), and
others. These entities are “voices” in the discursive formation (Foucault),
actors in the Burkian scene or Goffman’s stage, perpetuators of
Baudrillardian seduction and simulation. What is notable about this is that
professional organizations, universities, researchers, or participants are
marginalized, involved generally on an ad hoc basis, i.e.,
they aren’t integrated into the standing decision-making process, but only
invited (allowed) to speak (usually briefly) in the press, at Congressional
hearings, in commission meetings, etc., and often in situations that
resemble indictments (see U.S. House, 1998, June 11, particularly Ellis
testimony, as an example).{131}*
This is not to say that professional organizations of doctors and teachers
and university administrators do not establish policy (see AAUP, 2001, and
publications of professional organizations, particularly the Consortium of
Social Science Associations, the American Anthropological Association, the
American Sociological Association and others; see Appendix B, p.
349 for website addresses). These entities do establish policy, locally, as
do researchers and the researched, via the use of unwritten and often
informal conventions, as often, perhaps, as (their interpretations of)
written or explicit rules (see Punch, 1998; Geertz, 1988; Hall, 1989). And
individual researchers establish policy, as well, demonstrated in their
personal behaviors, even if no one (a regulator, for example) is watching
and even if the participants don’t “see” it themselves. In other words,
participants may feel they need the protection of regulation, when “really”
they already know whether they should or wish to answer a certain question,
or whether they feel comfortable filling out a survey questionnaire. People
establish policy continually in their lives. Within the liquid-and-local
reality frame, a participant chooses whether to show up for the scheduled
interview or not, whether to answer any particular question or not, decides
whether to answer honestly or not, etc. This may have something to do with
social rules, but not IRB rules, I assert, because most of the rules are
not even known to participants (see also Foucault’s, 1980, comments
about universal and specific intellectuals, p. 126).
To be “explicitly charged with establishing policy,” as are the entities
mentioned above, means these bodies (and individuals, see Shalala, 2000,
Dec 21){132}* are allowed to label (see Campbell, 1999, Oct 22, and
Brainard, 1999, Nov 18, as examples), impose procedures, sanctions, and
fines (where federal dollars are involved this is explicit, but is
voluntary or at least implicit otherwise, see Campbell, 1999, May 21;
Brainard, 2000, Feb 4; OHRP, 2001, July 19; Andrews, 2000, Mar 10; and
Brainard, 2000, June 2). These bodies may shut down research activities
(before or after the onset of the activity), and/or withdraw, withhold, or
deny funding (in virtually every announcement of grants available from the
government, the standardized language covers the rules that must be
followed, including the process, reporting, record keeping, etc. The
penalty for breaking the rules in every case is the withdrawal of the
funding; see also OHRP, 2001, Jul 19, letter to Johns Hopkins University).
Technically this involves rescinding the MPA (Multiple Assurance Document)
generally for only a few days (see Campbell, 1999, May 28, for example).
Exceptions were the University of Illinois at Chicago and the University of
Colorado Health Sciences Center in Denver (see Brainard, 1999, Oct 8 and
Brainard, 1999, Oct 29). In seven sanctions issued prior to November 1996,
only one suspension was enacted; the institutions, except the University of
Virginia, were cited for violating rules, but allowed to continue
conducting research involving human subjects under close government
supervision (see Walker, 1996, Nov 8).
Governmental impact on the research environment extends beyond laws and
rules, to include the reports of (mostly presidential and always political)
commissions. The ACHRE report (1995, Roadmap section), commenting mostly on
human subjects in medical research, states:
… contemporary human subject research does not suffer from the same
shortcomings witnessed in the 1940s and 1950s, but poses different issues
that need to be addressed…We found that subjects needed protections to
ensure their basic rights to consent to or to refuse participation in
research. While this need to protect the right of consent continues, in the
current period we found that subjects also need protections to ensure their
interests are served in understanding the distinctions between research and
therapy and the limits of the benefits research may offer. (p. 3)
The writers of the report conclude that written information provided to
participants is often obscure, and ambiguities about crucial differences
between research and medical care (therapy) are likely contributing to
confusion between the two on the part of research participants (see also p.
17 herein, re: “confused consent” issues). In general, the ACHRE (1995)
report states that consent forms over-promised what research could offer
sick patients and downplayed the potentially negative research effects on
patients’ quality of life. Earlier, at a meeting organized by Public
Responsibility in Medicine and Research, a Boston-based group that educates
professionals and the general public about ethical, legal, and policy
issues related to research, Jay Katz, professor of law, medicine, and
psychiatry at Yale University, said physicians needed to be more careful
not to exploit the trust that patients place in them and to draw a sharp
line between what they propose as a treatment and what they propose as
research (as quoted in Wheeler, 1991, Dec 4, p. A14; see also the
organization’s website: http://www.primr.org/,
accessed May 25, 2002).
As is probably apparent, the federal system is difficult to discern.
Texts are innumerable. Researchers face a daunting task in attempting to
decipher the regulations, but also in determining who to listen to, i.e.,
whose discourse applies to their own. Even federal regulators themselves
acknowledge the convoluted nature of the system. According to Ellis in his
testimony before the U.S. House 1998, Jun 11:
The federal authorities over
IRBs are partitioned in a most complex way … the universe of involvement of
human subjects research is broad, and the outer limits are actually unknown
... two statutes that are especially pertinent: first the Food, Drug and
Cosmetic Act, and the Food and Drug Administration discharges its
responsibility under that statute to protect human subjects when an
investigational drug, device, or biologic is involved. Second, the
Department of Health and Human Services, under the Public Health Service
Act, discharges its responsibility when DHHS funds or support are involved.
That’s where my Office for Protection from Research Risks sits. And the
jurisdiction of these two statutes overlap … share congruent regulations on
informed consent and Institutional Review Boards. The Food and Drug
Administration conducts numerous IRB inspections. Our office conducts very
few site visits… [DHHS] is formally yoked with 16 other departments and
agencies. We are in lock-step. We share a common rule … any change in
regulation for the protection of human subjects … at the federal
level must be agreed upon by 17 departments and agencies. (U.S. House of
Representatives, 1998, Jun 11, p. 51-52; see also GAO, 2001, p. 3)
In the community of regulators, NIH is one of eight health agencies that
is part of the U.S. Department of Health and Human Services (DHHS). Within
NIH, the Office of Extramural Research oversees the bulk of research funded
by the NIH. Within the Office of Extramural Research was, until May 2000,
the location of the Office of Protection from Research Risks (OPRR). The
OPRR was the entity that, until the change in May 2000, had the most direct
federal government contact with local IRBs.{133}*
(For information about the past and current structure of DHHS, go to
www.dhhs.gov and for NIH, www.nih.gov; see also GAO, 2001 for a “state of
the system” report).
Contemporary stage. An estimated 3,000 to 5,000 IRBs
operate in the U.S.{134}*
Federal regulations require that the boards have at least five members with
varying backgrounds (45 C.F.R. § 46.107). At least one member must have
primarily scientific interests, one must have primarily nonscientific
interests, and one must be otherwise unaffiliated with the institution in
which the IRB resides. A frequent feature of institutional compliance is to
fill these latter two roles with a single individual.
Most IRBs remain in large teaching hospitals and medical centers (see
Walker, 1996, Nov 8), but the addition of new commercial and hybrid
settings (an example of such a hybrid organization is found at the
University of Oklahoma: the H.A. Chapman Institute of Medical Genetics, a
private research organization, is located on the OU Tulsa Schusterman
campus) has created new research situations (DHHS OIG 2000a). Also,
multi-site trials are much more common today and add to the difficulties of
adapting the old regulatory system to the new world of research. At the
time many of the rules were written, studies were typically conducted by a
single researcher with a small number of subjects, much lower financial
stakes, and far fewer conflict of interest concerns.
Power shift. Ellis was named director of OPRR in January
1993 (see Brainard, 2000, May 30). He brought more suspensions in 20 months
than in the 20 years prior to his appointment. Since October 1998, federal
regulators have “imposed an unprecedented series of suspensions on campus
research efforts involving human participants, after finding that some
institutions were not following mandatory guidelines{135}*
meant to safeguard the safety and dignity of the participants” (Brainard,
2000, Feb 4). Notice that the accusations, indeed the sanctions, did not
involve the purpose of regulation, i.e., protection of
participants from harm,{136}*
rather harm to the process, the regulatory structure, was the
concern (see Brainard, 1999, Sep 10). The process was at risk.
Papers weren’t filed{137}*
in many of the sanction cases, the implication being that if the papers had
been filed (that is, the process had remained intact) that the
filing of paper would protect people (meeting the purpose). The process
of paper filing has become institutionalized, i.e., SINSful{138}*;
the paper forms are equated with protection of research participants,
rather than with the much more tangible (i.e., actual, “real”)
situation of protection of the university/IRB personnel from
somewhat remote, yet potential problems with federal overseers,
researchers, or (even) participants. This process is a manifestation of the
“I” in SINS, specifically universities and regulatory agencies
(institutions) have developed a pattern of paper filing, and have
perpetuated it—an institutionalization organized by the texts that
come before and after any given piece of paper being put into the process
at any given moment (see also footnote # 72, p. 64). The result is that the
institutional-level players (IRB members and administrators) fulfill the
(paper, textualogical) process, without ever seeing an informed
consent process in the lifeworld, without ever meeting a
participant, without any contact (at least a very high probability of no
contact) with the “real” research process at all. This also demonstrates
the Baudrillardian idea of simulation (the second “S” in SINS). We
are seduced by the “goodness” of the (stated purposes for) rules to create
the paper process, and further seduced by the fulfillment of the paper
process, which in turn, further contributes to the simulation of
protection.
SINS and paper processes: Further explanation. The paper
process is accepted, institutionalized, as “the way we do things,” and its
acceptance is based on structures (i.e., ideologies) such as
“the way we do things is good” (i.e., effective, meets the goal),
and “these things are good for us” (the goal is worthy/possible). These are
three stellar leaps of faith; the more faith we have, (I would add that I
believe this is mostly passive defaulting rather than active faith) the
deeper the SINS, i.e., the more invisible the STRUCTURES; the more
firmly entrenched the INSTITUTIONALIZATIONS become, accepted, not
questioned even when they seem unreasonable or ineffective. NATURALIZATIONS
occur as objects become “obvious,” “normal,” or “natural,” this based on
the sheer number of people who participate in the process, perpetuate it,
mostly without question, without whying. NATURALIZATIONS support and perpetuate
INSTITUTIONALIZATIONS; and we are more easily seduced into more complete
SIMULATIONS (i.e., situations involving processes ever more detached
from “real” lifeworld events).
These phenomena would likely be observed in many regulatory entities and
other organizations.{139}*
But situations vary in interesting ways. I’ll give two somewhat contrasting
examples. First, consider the probation process for criminal offenders. The
probation process involves as a central feature a “real” world, a contact
visit in the lifeworld, between the probation officer and the “real”
parolee, a local attached “reality” (and realizing that not all such
appointments are kept, of course.) Alternatively, consider typical unemployment
insurance procedures. An unemployed person goes to the Employment Office
and completes a form that states s/he has solicited work at some number of
places during the past few weeks or month. This form, in the organizational
view, actually constitutes the process of “looking for work.”
The unemployment paperwork is similar to the IRB assurance document
process between the federal government and the institutions (described more
fully below, footnote # 140, p. 121) though the employment example is more
local, i.e., the parties to the process (the unemployed person and
an employment service employee) are directly involved in the making and
accepting of the assurance. As pointed out above, the IRB assurance
document is negotiated among people who often conduct no research at all
and who rarely if never meet each other in person. The parties to the
making of the assurance document are the federal regulators and
institutional administrators, not, in the normal course of things, the
researchers or research participants who actually “fulfill” the assurance,
an assurance they didn’t write, and often have never read. This paper-only
process also adds to the detachment (i.e., hyperreality) of the
“assurance” from the research environment. Regulators and administrators
particularly are seduced by the goodness of the ideas in the document and
the faith in the overall bureaucratic process to believe such a document
can be meaningful, will have an impact, will be followed, is possible to
accomplish, etc.
In the employment paper process example, it is not significant (with
respect to getting the unemployment check issued) whether the unemployed
person actually sought employment or not. It is only significant
that the person fill out the paperwork, correctly and on time, etc. The
unemployed person gets the check for doing the paperwork, not for “really”
looking for work. It is a charade, a “just tell me what I must hear”
presentation, and known to all parties as a charade, but as a “natural” (or
at least “normal”) charade, i.e., it has come to be the “way we do
things.” This is unlike what happens if a parolee doesn’t show up to
fulfill the paperwork process … s/he is declared to have absconded from
parole, and a warrant is issued for his or her arrest, making running from
parole much more than a paper process.
The assurance document. The assurance document is perhaps
an important example of (SINS) STRUCTURES, INSTITUTIONALIZATIONS,
NATURALIZATIONS, SIMULATIONS operating in the federal-institutional
interface.”{140}* Regulators, both federal and institutional, function
as if this document protects participants, i.e., as “real”
assurance. Yet, it would be nearly impossible for the regulators to
know what effect, if any, the assurance document has. It is impossible for
the regulators to know how the assurance document/process works because no
“real world” oversight exists (nor can it practically, “real”-istically
exist) to assure the assurance (see Brainard, 2000, Mar 17). In other
words, without direct oversight or exposure to the process, assurance can only
be voluntary (i.e., self-controlled) rather than
regulator/regulation-controlled, and is detached from reality, (hyper-real,
simulated). The assurance process creates the illusion of assurance by
containing promises that processes are and will remain in place according
to federal rules to ensure the protection of research participants.
When the “real” world crashes through, shatters the simulation with the
occurrence of a research-related death or injury, a whistleblower, or a
paper process failure (the latter, fortunately, being the most common), the
focus of regulators and the regulated, often immediately and nearly always,
turns to an assessment of what went wrong with the process that was
in place to ensure such problems (or tragedies) were prevented. In
this case, the process is an institutionalization (the “I” in SINS),
the notion that the process can prevent problems is a structure (the first
“S” in SINS) that underlies the simulation (the last “S” in SINS) that
protection, based on the formulaic production and dissemination and even
the occasional reading of texts, is somehow ensured. That we do all
of this is natural, (the “N” in SINS) even if it seems unreasonable, illogical,
pointless, etc.
The assurance document completes a portion of a socially constructed
regulatory process. The institution provides a ceremonial document (the
assurance) with words dictated by the regulators. The assurors
(institutions, IRBs) make promises to the assured (federal regulators) that
may or may not be kept (as is the nature of all promises) but that can
provide a basis for various kinds of additional paperwork processes, from
grant applications to sanctions, i.e., an assurance must be on file
to apply for grants. And the assurance document is often the “rope” used to
hang research institutions, i.e., nearly always among the array
of “charges” is violating the assurance document (see as an example
the OHRP’s letter to Johns Hopkins, http://ohrp.osophs.dhhs.gov/detrm_letrs/jul01a.pdf,
accessed May 25, 2002). Further, it cannot be assumed that the assurance
document directly addresses nor changes the research environment because
the local participants in the assurance ceremony do little if any research,
and the researchers and research participants who are directly involved in
research overwhelmingly don’t even know the document, process, or ceremony
exist. To summarize, the “assurance” is an institutionalized process
sustained by people who most often aren’t involved in the research process
they are making and accepting promises about, and this process seems
natural (i.e., has been normal for many years). The assurance
process is not tethered in (attached to) “reality,” rather it occurs apart
from the research environment, is detached from the research process and
those conducting it. It is a process involving people making promises about
things they don’t do in their own lives and can’t control in the lives of
others. It is hyperreal in that very few “real” researchers know what an
assurance document is, what it is for, what it says, who signed it, or who
sent it. It has no direct meaning for the researcher, and less meaning for
the research participants or patients in medical trials who, in
overwhelmingly large numbers, do not even know it exists.
According to DHHS OIG (2000b), published in April 2000, NIH/OPRR had
conducted an on-site investigation{141}*
at only one institution between April 1997 and May 1998. However, between
June 1998 and March 2000, it conducted ten on-site investigations.
Similarly, FDA’s number of routine on-site investigations of IRBs increased
from 213 in FY1997 to 253 in FY1998, and to 336 in FY1999. Further, OPRR’s
reviews, which resulted in the suspension of federally funded research at
eight institutions (beginning with sanctions at Duke in May 1999 to the
most recent to be included in Brainard’s comment, sanctions at the
University of Oklahoma in June 2000){142}*
have been particularly influential in drawing attention of the national
research community to the (in)adequacy(ies) of IRB oversight and human-subject
protections.{143}*
For more than a year after the “restructuring” of the federal system,
described in the next paragraph, no sanctions were imposed until, prompted
by the death of a healthy volunteer, Johns Hopkins University was
sanctioned in July 2001.
After the death of 18-year-old Jesse Gelsinger, a research patient at
the University of Pennsylvania in 1999, and the discovery that six prior
deaths had not been reported as required by federal law (see footnote # 43,
p. 30, herein), the OPRR was criticized by legislators, members of the
public, NIH officials, the FDA (in issuing sanctions), bioethicists and
others for not doing enough to protect research volunteers (see Brainard,
1999, Nov 12 and legislative hearings transcripts, particularly in the
questions raised by Reps. Towns and Shays in Institutional Review
Boards: A system in jeopardy, 1998). In June 2000, Ellis was
“reassigned,” and the OPRR was moved (up the regulatory food chain) to the
Office of the Secretary of DHHS (Brainard, 2000, May 30). This development
can be interpreted in numerous ways, of course. Naming a new person at that
particular time, i.e., just as Ellis was enforcing the rules he was
stripped of his responsibility to do so, and the changing of the structure,
location, and name of the OPRR (to the not-so-different OHRP) may indicate
a desire, on the part of regulators and researchers alike, for change in
the role and/or boundaries of the system.{144}* In other
words, Ellis, while enforcing the provisions of law may have called
attention to a lack of support for the law. It could also be argued that
the overhaul/reorganization activities, including Ellis’ reassignment, were
at least in part political responses (see Brainard, 2000, May 26a, and
1999, Sep 10, as examples). In this case, it was socially desirable for the
federal regulators to appear responsive and caring in the face of mounting
pressures: the release of the concern-ridden ACHRE report (1995), the
Executive Order forming the NBAC (see Clinton, William J., 1995, in
bibliography), President Clinton’s public apology in 1997 for the Tuskegee
incident, the DHHS OIG reports (issued from 1998 to 2000), capped by the
Gelsinger death in 1999, and other sanctions following. It could be argued
that the federal regulators had to do something. (Also see
Nelson, quoted in Brainard, 2000, Apr 14, p. A45.) And whatever the federal
regulators do affects institutions and researchers with little or no regard
to treatment, in large part because of federal regulators’ (expressed)
beliefs that consideration of the distinctions among treatments is not
necessary.{145}*
Avoiding litigation. Hayes, Hayes, and Dykstra (1995)
suggest when IRBs make mistakes, thorough, periodic
evaluations—particularly ones conducted externally—would serve to re-orient
the groups to their missions and objectives. Hayes, et al., state the IRB
process is too important not to include careful evaluation. They further
suggest such procedures protect not only human subjects, but also
institutions and investigators against liability.{146}*
These and other comments (numerous similar ones from government reports,
DHHS OIG 1998b, 1998e, and 2000b; ACHRE, 1995; U.S. House of
Representatives, 1998, Jun 11, for example) support the idea that, in
addition to (or superceding) any motivation toward human subject
protection, legal considerations drive the IRB system.
In comparing medical and social sciences, “in the past, particularly in
medical research and psychological experimentation, there was a
considerable amount of deception and, in some cases, a demonstrable element
of harm” (Sieber, 1992, p. 4) including (in an example given by Sieber)
distributing LSD to visitors at a brothel{147}*
and filming the incident with a hidden camera. “One person committed
suicide while under the influence of the drug” (p. 68). Attempts to control
this deception have also had an impact on social science in general, for
example enhanced regulation and scrutiny of the informed consent form, and
what some consider local IRB interference in areas exempted by the federal
government (45 CFR § 46.101){148}*.
Federally funded (and most other) research{149}*
in the U.S., as mentioned, must conform to the process described here including
auditing by review boards. In addition, professional associations have
adopted and advocated/required the following of (i.e., attempted to
institutionalize) various codes of conduct.{150}*
To this end, there is disagreement about many things. As presented,
regulators vacillate between positions of “stricter enforcement” and the
“relaxing of rules,” i.e., between enforcer and educator personas
(Brainard, 2000, Feb 4, and Mar 17; 2001, Mar 9) and professional
organizations struggle with whether to attempt to establish “guidelines”
and “policies,” even “certification” schemes of their own (see AAUP, 2001;
Punch, 1998).
Even though contradictory opinions exist (a seemingly healthy, desirable
condition), attempts to stifle dissention are apparent. Approving of the
effort to cooperate with federal authorities, Sieber (1992) says, “In
essence, there is a strong argument, reinforced from disparate but powerful
forces,” that “sound ethics and sound methodology go hand in hand” (p. 4).
Translation: Believe as we believe and do as we do and you will be sound
(and heard). And protected from legal liability. And called a “good team
player.” And so on. The Grand Narrative produces The Grand Illusion (see
Baum, 1900/1965).
Many voices, (AAUP, 2001; ACHRE, 1995; Brainard, 2000, Feb 4; Brainard,
2000, Mar 17; Brainard, 2000, May 30; Brainard, 2001, Mar 9; Campbell,
1997, Sep 12; Campbell, 1998, Apr 3; Campbell, 1998, Dec 18; Charo, 1999,
Jun 25; Charo, 1999, Mar 26; DHHS OIG 1998b; DHHS OIG 1998d; DHHS OIG,
1998e; DHHS OIG, 2000b; GAO, 1996; GAO, 2001; Geertz, 1988; Gray, 1982;
Greenberg, 2001, Jan 19; Protecting human subjects: Status of
recommendations, 2000; Institutional review boards: A system in
jeopardy, 1998; Hall, 1989; Hayes, Hayes & Dykstra, 1995; Healy,
1999, Jul 30; NBAC, 1997 and 2001; OHRP, 2001; Okie, 2001, Aug 6; Pence,
2001, Jan 12; President’s Commission for the Study of Ethical Problems in
Medicine and Biomedical and Behavioral Research, 1981; Punch, 1998; Tropp,
1982; and Wheeler, 1991, Dec 4) are suggesting (and have been for more than
20 years now) that the system (especially as it pertains to the regulation
of non-treatment, no risk approaches) doesn’t work. I join the chorus. The
purposes remain important, and the processes, impotent.
Fortunately, the process is text (Foucault, 1972). It can be
rewritten.{151}*
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