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Chapter Five: Foucauldian Analyses of Texts Constituting the IRB System
“The ‘welfare of the
individual’ is just as imaginary as the ‘welfare of the species …’”
Friedrich Nietzsche, The Will to Power, p. 299.
This chapter includes analyses of several documents created within and
for the maintenance of the IRB system. They include the Advisory Committee
on Human Radiation Experiments, a 14-member body (one representative of the
general public and thirteen experts in bioethics, radiation oncology and
biology, nuclear medicine, epidemiology and biostatistics, public health,
history of science and medicine, and law”) appointed in 1994 by President
Clinton “to investigate reports of possibly unethical experiments funded by
the government decades ago” (ACHRE, 1995, Executive Summary, p. 1). The
ACHRE released its report in 1995. This was one of the most well funded and
accommodated commissions (i.e., presidential instructions were to
give this commission whatever documents it wanted in pursuit of its goals)
ever to study human subjects of research (far and away the largest until
the National Bioethics Advisory Commission [NBAC] in 2001).
In contrast to this broad, historically scoped, upper-executive level
entity’s report, other analyses are conducted on important but less
comprehensive documents produced by federal administrators (who are not
necessarily “representative of the general public” nor “experts.”) One of
these administrative texts is a “state of the system” report produced by
the GAO (General Accounting Office) in 1996, which was used heavily by Sen.
John Glenn in proposing the Human Research Subjects Protection Act of 1997,
an analysis of which is also offered in this chapter (see next paragraph).
The other administrative text selected for analysis is a “guide” to the
Common Rule (for use by researchers and IRB members, or their international
equivalents). This guide was produced by the U.S. Agency for International
Development (USAID) in 1999, and is described as a “companion” to the Common
Rule.
Finally in this chapter, a proposed U.S. Senate bill is analyzed. The
Human Research Subjects Protection Act of 1997 (S.193) was proposed by one
of the most famous research subjects of all time (and U.S. Senator) John
Glenn. The analysis includes not only the text of the Act itself, but the
context surrounding and contributing to the text, i.e.,
consideration about documents supplied by the administration used in
constructing the Act, and the extent to which researchers or participants
themselves were asked to contribute information or ideas about how to best
design a “new program.” (See also footnote # 121, p. 101 for a local
example of this phenomenon.)
These documents were selected in order to focus this section of the
analysis on federal-level operations and development, and for their
diversity (specifically, executive, administrative, and legislative
documents are represented, retrospective looks at the system [GAO and ACHRE
documents] along with contemporary “guides” to it [the USAID text], and how
these documents become “nested”).
Advisory Committee on Human Radiation Experiments (ACHRE) Report:
Analysis
In considering Foucault’s questions (see Appendix A, p.
344; see also Manning, 1989) it becomes apparent that the ACHRE (1995),
while not having the power to make laws directly, does (substantially)
define important terms, including “suffering,” “shortcomings,” “needs”
(four references contained in parts of only two sentences; see introduction
to part 3 of the ACHRE report), “protections,” “basic rights,” “the
interests of subjects,” “the distinction between research and therapy,”
“limits of the benefits of research,” and what is “obscure” and “ambiguous”
(see ACHRE, 1995, Executive Summary, Key Findings, or http://tis.eh.doe.gov/ohre/roadmap/achre/summary.html#findings,
accessed May 25, 2002).
Another observation is that the ACHRE and other bodies refer to
“subjects,” “participants,” and “patients” interchangeably, which is
problematic (see DHHS OIG, 1998d, p. 21; researcher user-list from the
University of Pittsburgh Medical Center, May 23, 2000). This cultural
reproduction (i.e., the term “participant” used in this way) has
become an important point of confusion. That the term “participant”
includes interviewees, survey respondents, the observed (who undergo no
treatment), and clinical patients adds to the notion that
there is no difference among these types of participation, and, following
that, a single set of rules is adequate.{152}*
One term to describe all participants is not adequate, as it makes no distinction
among diverse forms of treatment. And the same may be said about the rules.
In other words, to fail to distinguish among interviewing participants,
observing people, drawing blood, giving people experimental medications,
installing medical devices in peoples’ bodies creates a lack of sensitivity
to “treatment”—the very phenomenon that should be the focus of
protecting human subjects, and therefore, must be the primary focus of
regulators. A similar case can be made with respect to (mis)use of the term
“doctor” rather than “researcher” or the more precise “research doctor.”
Use of other terms is problematic for the qualitative researcher.
Cassell (1982) points out that “Linguistic confusion appears when ‘subject’
is [used to] characterize … someone studied by a wide range of research
methods” (p. 145). Cassell suggests that by using the “familiar
sociological concept of role to analyze the term subject” (p.
144), we can think of roles as coming in pairs, roles indicate
relationships. Following this, “other reciprocal role relationships in
social research are those between interviewer and respondent, ethnographer
and informant, observer and observed. All involve particular relationships
which differ significantly from one another” (p. 145). And, the group of
methods described by Cassell (1982) and discussed above, differ even more
significantly from medical (i.e., drug and device) trials.
The lack of focus on the treatment particularly at the institutional
level (discussed in the following chapters) is one of the primary ways
social scientists are procedurally included, without much thought, into an
ill-fitting system. According to the American Association University
Professors (AAUP, 2001, p. 3), “social-science research was included almost
from the outset in the system of regulatory oversight, although there was
also recognition from the beginning that, in the words of the surgeon
general of the U.S. in 1966, “there is a large range of social and
behavioral research in which no personal risk to the subject is involved”
(Gray, 1982, p. 331). If no personal risk is involved, what
procedures (to protect from risk) can logically be imposed?
Both federal regulations and local interpretations of them provide for
expedited and exempted reviews when risks are “minimal” (see 45 CFR §46.101
and University of Oklahoma, IRB policy and procedure, Section 4, as
examples). The OHRP states, “Institutions may elect to review all research
under the auspices of the institution even if the research qualifies for
exemption under 45 CFR §46.101(b)” (OHRP, 1995). Most institutions, it
appears, do this (see below).
The meaning of “exempt” differs from federal to local institutional
uses, and from IRB to IRB. Further, in the regulatory vernacular, “exempt”
is far from the common meaning one might attribute to the word.{153}*
First, self-exemption is not typically allowed in university settings,
though the process for studies that are exempt-able vary considerably. The
University of Oklahoma’s exemption policy is explicit (see OU Policy,
Section 4), though the University of Utah and the University of Texas at
Austin both have policies in place to “review” exempt studies. The
University of Texas at Austin’s policy appears to be the most like a “real”
exemption, at least in terms of time taken for the review. The UT policy
states that every effort will be made to process the exempt studies within
2-3 days. The applications/research protocols that must be submitted for
exempt studies{154}*
must (generally) be read by at least one member of the IRB, and often two
or more “reviewers” are involved in “exempting” a study.
With respect to expedited reviews, the OHRP policy states “An expedited
review procedure consists of a review of research involving human subjects
by the IRB chairperson or by one or more experienced reviewers designated
by the chairperson from among members of the IRB in accordance with the
requirements set forth in 45 CFR 46.110” (http://ohrp.osophs.dhhs.gov/humansubjects/guidance/expedited98.htm,
especially the first footnote, accessed May 25, 2002).
Informed Consent Background.{155}*
In general, it is agreed that the term “informed consent” was first used in
a landmark legal opinion in a medical malpractice case issued in the 1950s
(see ACHRE, 1995, Introduction). However, “consent” was established as a
requirement when the Atomic Energy Commission (AEC) was created in 1947
(ACHRE, 1995, Introduction). The concept was expressed in a letter from the
chief of the AEC’s Medical Division and two AEC lawyers, who summarized
(ACHRE, 1995, Chapter 1, The First Wilson Letter{156}*)
“… it was most important that it be susceptible to proof that any
individual patient, prior to treatment, was in an understanding state of
mind and that the nature of the treatment and possible risk involved be
explained very clearly and that the patient express [his] willingness to
receive the treatment.” (Also note the use of the term “patient.”)
Initially, the lawyers suggested a written release from the patient, however,
it was agreed that at least two doctors’ written certification would be
sufficient (from the First Wilson Letter, as cited in the ACHRE Report,
1995, Chapter 1). So, even early on, (SINS) STRUCTURES,
INSTITUTIONALIZATIONS, NATURALIZATIONS, SIMULATIONS such as the bias toward
believing a doctor’s word ensures that the patient understands the
procedure and is protected, more precisely (two) doctors’ signatures stood
for, i.e., equaled adequate protection.{157}*
Further, the AEC legal staff defined the terms, established the
procedures, evaluated, and revised them. Just how the legal staff was
authorized to take these steps is not entirely clear. The texts were
produced “at least in part, [in a] straightforward effort to define the
rules according to which the AEC would provide contractors with research
funding” (ACHRE, 1995, Chapter 1, The First Wilson Letter). The chair of
AEC’s Interim Medical Advisory Committee in January 1947 requested that the
AEC legal department determine the “financial and legal responsibility” of
the AEC when “clinical investigations” using federal funds are conducted
(ACHRE, 1995, Chapter1).
During the years, the process, (if not the purpose), of informed consent
has changed. Written consent of actual participants was suggested in the
First Wilson Letter in 1947 but later dropped at the request of the chair
of the Interim Medical Advisory Committee (ACHRE, 1995, Chapter 1). With
the implementation of the Common Rule in 1991, Wilson’s suggestion was
(re-) adopted more than 40 years later.
Historical Development Contributing to Complexity of the Federal
System. As mentioned previously, the federal system is difficult
to decipher for federal regulators themselves, and even more so for other participants
in the system. For example, informed consent requirements, as outlined in
the Common Rule (45 C.F.R. § 46, 1991), contain many of the same
requirements for researchers as those first proposed in the 1940s, but
today the requirements are more specific, more articulated (ACHRE, 1995;
see also p. 166, herein). Rules are refined, even re-refined at the federal
level. Next, rules are interpreted by the institutions (the focus of the
following chapters). The IRB system has gained more detail in the 44-year
interim between the 1947 AEC letters and the establishment of the Common
Rule (see ACHRE, 1995, Chapter 14, History of the Common Rule since 1974,
p. 1). For example, more specificity has been added to regulations
regarding the use of fetuses, pregnant women, psychosurgical procedures,
children, prisoners, the mentally infirmed (see the National Research Act,
1974, and recommendations of the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research between 1974 and
1978). The Belmont Report (1979, and also produced by the National
Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research) added more precise criteria for distinguishing
research from medical treatment (see O’Connor, 1979). The sheer increase in
the length of documents during this historical development is evidence of
at least the convolution of regulation today, if not actual increases in
regulatory specificity, scope, and burden.{158}*
Rule refinements (transformations) continue (and continue to beg the
question of the need for many of them, and for any of them in many
situations). The NBAC (1997, 2001) noted the dual standard of protection in
the U.S.: one for subjects in federally regulated research and another for
those in unregulated research, i.e., not funded federally.{159}*
The NBAC (1997) called for a single standard of basic protections, and the
provision that every person in the U.S. who participates in research should
have the twin protections of informed consent and independent review of
risks and benefits involved. If this suggestion is taken (and it was also
discussed by Ellis in his testimony before the House, see U.S. House, 1998,
Jun 11), these and subsequent policymakers (framers, shapers) will change
the status of (quasi) voluntary compliance by universities for studies not
involving federal funds to mandatory status, thereby broadening the (legal,
federal) definition of “participant” substantially (yet changing nothing
about the “real” participation). This NBAC (1997) suggestion has not become
law, though laws were proposed in both the U.S. House and the Senate. (In
the Senate, the Human Research Subject Protection Act of 1997, S. 193; and
in the House, the Human Research Protection and Promotion Act of 2000, H.R.
3569.) However, the NBAC final report was issued in 2001, and while it is
somewhat more specific, it is not inconsistent with the earlier draft. The
NBAC (2001) concluded (as summarized by Brainard, 2001, Jan 12, p. A 24):
Congress should create a new, independent office to oversee human-subjects
research (exhibiting the more-is-better bias), and the office would develop
and reinforce new, government-wide rules for such research. NBAC (2001)
would require at least half the members of IRBs not be affiliated with the
institution and at least half should not be scientists. Further, the NBAC
(2001) stated Congress should pass legislation requiring that all human
subjects of research be covered under federal regulations—even research
sponsored by corporations without federal funds. Further, IRBs should
directly monitor the informed-consent process when doing so would
significantly enhance protection of human subjects, and that researchers
and IRB members who approve research should be certified by independent
organizations.{160}*
Another problem with understanding federal regulations, and speaking to the
convoluted nature of them, may be the fairly large number of
interpretations at the federal level (various agency “guides” to
understanding the Common Rule, for example). An analysis of one of these
“guides” (published by USAID) is included in this chapter.
Federal Politics and Power: Sounding Good; Saying Nothing.
The IRB regulatory system is clearly affected by political
maneuverings.{161}*
Perhaps commissions and Congress are similar to quantitative
researchers—they have to find significance (numerically, in the case of
quantitative researchers; politically in the case of commissions and
Congress). More than a decade and a half after the Belmont Report (1979),
the ACHRE (1995) issued their final report. From Chapter 15 of the ACHRE
report:
There is no evidence in this
review that research in which human subjects are exposed to radiation is
any more ethically problematic than other kinds of research involving human
subjects; in fact, our results suggest that human subject protection may be
more effective in radiation research than elsewhere, perhaps because some
radiation research is reviewed by a radiation safety committee as well as
an IRB. (Chapter 15, Discussion section, p. 1)
In considering this statement, several assumptions on the part of the
ACHRE are apparent. The first part of this sentence (up to the semicolon)
implies that all research is the same because radiation research does not
differ from “other kinds of research,” with respect to ethical concerns.
The ACHRE declares this is the case based on “no evidence” to the contrary.
The lack of specificity in the use of the term “other kinds” of research
implies the ACHRE knows about “other kinds” of research and can make
comparative judgments about the ethical concerns in each. Readers
(including most significantly policy makers) don’t know how many “other
kinds of research,” or whether the ACHRE’s implication is all other
kinds or any other kind.
In the second part of the sentence, the ACHRE states that their “results
suggest” protections may be “more effective in radiation research than
elsewhere.” The ambiguity of the term “elsewhere” broadens substantially
the scope of the statement. Even more significant, perhaps, is the evidence
offered for the justification of the view that radiation research
protection is “more effective” because “some radiation research is reviewed
by a radiation safety committee as well as an IRB.” The authors of this
part of the sentence, of course, beg the question (i.e., make
SINSful assumptions) that more review (i.e., review by both IRB and
committees) automatically increases effectiveness. Further, given the
greater context of the report in which this statement is contained
(specifically the context of fairly strong criticism of the effectiveness
of IRBs, see next paragraph) it seems inconsistent to (then) use an IRB
review as evidence that “more efficient” protections are delivered.
For example, on the same very same page of the ACHRE report
(Chapter 15, Discussion section, p. 1), the report states:
…our review suggests that
there are significant deficiencies in some aspects of the current system
for the protection of human subjects. We have evidence that the documents
provided to IRBs often do not contain enough information about topics that
are central to the ethics of research involving human subjects such as
voluntariness of participation, fairness in the selection of subjects, and
scientific merit. (ACHRE, 1995, Chapter 15, Discussion section, p. 1)
In this passage, it appears the Commission is labeling and defining
problems and expressing concerns, implying the importance of their
concerns, declaring deficiencies and defining the degree of them, and
defining what constitutes “scientific merit.” First, with respect to
implications about setting criteria, the degree of deficiencies is
“significant” (line 1) in “some aspects” (line 2) of the system, according
to the report. The term “enough” (line 4) used to describe the
information provided to IRBs implies the Commission knows not only what quantity
of information is needed by IRBs, but also the types of information
that is required, i.e., assuming knowledge of the “topics that are
central to the ethics of” (line 4) human subjects research. Further, the
ACHRE indicates exactly what these “central” topics are in lines 5 and 6:
“voluntariness of participation, fairness in the selection of subjects, and
scientific merit.” The importance of these assumptions is that they imply
that the Commission (or other policy makers using the Commission’s report)
can set the criteria, as mentioned, but also it implies/assumes that IRBs
are capable of making these determinations, not only as provided by
law but also in reality. Finally, this argument relies on evidence in
seeming contradiction to statements about the reliability of that evidence
used two paragraphs earlier, i.e., the assumption that reviews of
IRB information can lead to conclusions that some research is “[no] more
ethically problematic than other kinds of research” yet in the second sample
paragraph, IRB documents “often do not contain enough information about
topics that are central to the ethics of research.”
SINS, specifically simulations (Baudrillard, 1983), are demonstrated in
the ACHRE’s use of the term “documents,” (line 3) rather than any reference
to “real” research activity—the ACHRE used the term “documents” as if they
were speaking of the actual research environment. The most that a
researcher can tell the IRB in a proposal or a final report will be
“simulated” in that the account of what happened would be an “average” or
aggregate (and therefore nonexistent) “event” that would be explained by
the researcher. Were the documents executed? How many of the participants
“really” understood them? According to whom? Was the process adequate? Who
says? The documents required tell us very little about what “really”
happened in any specific, local case. This textual process may or may not
serve a purpose or meet the goal (the process will create activity,
but that’s not the same thing as goal attainment, as the
deconstructionist/critical theorist/activist must point out) and the
measure of the usefulness of the process will be based on whether the
information provided in the document is “true” or not, another empty
pursuit, of course.
Could regulators do anything else? YES. They could do nothing (if one
considers that nothing IS something).
Documents serving as stand-ins for regulatory/research activity are
somewhat similar to comments reportedly made by OU President David Boren,
particularly his use of the phrase “model of compliance” rather than “model
of protection” (see p. 206; also Schneider, 2000, Nov 6, for similar quote
from University of Pennsylvania officials in a similar predicament). It is
notable that scientists are not allowed to/do not allow themselves to speak
in such situations generally, adding to the detachment of this discourse
from the realities of research, i.e., the people most directly
involved in what happened (or those involved in similar pursuits) are not
participating in the explaining of what happened (see also Weinberg, 2002,
Jun, re: the lack of scientist’s voices in the cloning debate).
On the next page of the report, the ACHRE (1995, Chapter 15, Discussion
section, p. 2) states that in their own study as well as an independent
review of that study it was found:
… some consent forms currently
in use are flawed in morally significant respects, not merely because they
are difficult to read but because they are uninformative or even
misleading. These are consent forms that have been approved by an IRB, and
still they are problematic … (p. 2)
As with the use of the term “documents” previously discussed, the use of
the term “forms” in line 1 in the preceding paragraph is indicative of the
notion that process meets purpose. And, the ACHRE reverts to the negative
assessment of IRB review, in fact surpasses the earlier criticisms, stating
that IRB review may be “flawed” (line 1){162}*
in “morally significant” (line 1-2) ways. The ACHRE’s suggestion that the
forms are “uninformative” and may be “misleading” (line 3) and
“problematic” (line 4), in combination with the Commission’s earlier
assumptions discussed above, implies the ACHRE has the ability and the
right, the authority to determine what is “uninformative,” “misleading,”
and “problematic” in the informed consent process, in all kinds of
research and, therefore, all kinds of participants, and that
(evidently) IRBs, at least some of them, cannot. Even though the local IRB
is right there, closer to the liquid and local, i.e., “real”
research activity, the ACHRE views itself as more knowledgeable, more able
to know how to inform, how to avoid misleading participants, and how to
define and avoid morally significant problems. These assumptions are not
reasonable, sensible, or possible.
In 1996, about a year after the release of the ACHRE report, the General
Accounting Office (GAO) issued a report to the “Ranking Minority Member,
Committee on Governmental Affairs, U.S. Senate” who was, at the time,
Senator John Glenn. Glenn later sponsored a bill, S.193, 1997; the bill and
its relationship with the GAO document analyzed next are described later in
this chapter.
GAO: Analysis
The first feature of the GAO report (1996) for consideration is
contained in the cover letter. In the first paragraph of that letter, the
GAO acknowledges, employs, perpetuates, and legitimizes the results of the
ACHRE (1995) report by stating: “These and other issues [the 40-year
Tuskegee syphilis study, the injection of elderly patients with live cancer
cells, and the U.S. government’s radiation experiments] related to
protecting human research subjects were recently addressed by the
President’s Advisory Committee on Human Radiation Experiments” (p. 1). The
GAO (1996) concludes (and implies that others including the ACHRE have also
concluded) that these atrocities have “demonstrated breakdowns in the
protection of human subjects in scientific experiments sponsored by the
federal government and others” (p. 1).
The power of certain discursive forms: “In Brief” and “Results”
synopses.
The GAO (1996) in the report to Sen. Glenn, states:
Today’s oversight of tens of
thousands of HHS-funded research and FDA-regulated drug studies appears to
have reduced the likelihood that serious abuses of human subjects,
comparable to past tragic events, will occur. The conspicuous activity of
local institutional review boards and human subject protection efforts by
federal agencies have heightened the research community’s awareness of
ethical conduct standards, increased compliance with federal regulations,
and served as deterrents to abuse of subjects’ rights and welfare. However,
little data exist that directly measure the effectiveness of human subject
protection regulations. (p. 2)
This passage is the first paragraph under the heading “Results in Brief”
(GAO, 1996, p. 2). The abundance of qualifiers in the passage dilutes the
impact of “results.” For example, the GAO states that oversight today
“appears” to have “reduced” the “likelihood” (line 2) that “serious” abuses
(line 2) will occur. “Serious abuses” are at least partly defined as being
“comparable to past tragic events” (line 3). In spite of the qualifiers and
the tentative nature of the first sentence of the passage, the next
sentence seems to ignore the limitations posed by the first, making a
sweeping three-part conclusion. First, the GAO states that “conspicuous
activity” (line 4) of IRBs and federal agencies “have heightened the
research community’s awareness” (not “appear to have” but have, and
further, not simply changed awareness, but heightened it, and not just
certain individuals but, it is implied, the entire “community”) of
“ethical conduct standards” (line 6). On the surface, this second sentence
appears to be a more assertive statement, however, if one considers the
statement speaks to “heightened” “awareness” (fairly elusive concepts, both
awareness and height of it across individuals) rather than improved
protections. The second broad conclusion (positioned as
“results”) is that this “conspicuous activity” on the part of IRBs and
federal regulators has “increased compliance with federal regulations”
(lines 6-7) and the third sweeping conclusion is that these activities have
“served as deterrents to abuse of subjects rights and welfare” (line 7-8).
It is difficult to understand the next sentence in this context, especially
the acknowledgement that “little data exist” that “directly measure” the
“effectiveness” of regulations. If we consider what “effective” regulations
might be, primarily they would be followed, i.e., complied with. For
regulations to be ignored doesn’t imply they are “effective.” So if there
is no data (evidence) that the rules are effective, how does the GAO
conclude (within the same paragraph, especially) that the “heightened
awareness” of the “research community” leads somehow to “ increased
compliance” and as “deterrents to abuse?” I conclude that such
“Reviews of Findings” and similar discursive forms are powerful (and
substantially oversimplified) texts, whether accurate or epistemologically
sound or not. They help create and perpetuate illusions. Synopses (and
sound bytes) simulate reality, mostly via over-simplification.
In viewing these passages collectively, not only are these commissions
and federal agencies allowed to say that something is (consent forms
flawed, awareness heightened, and compliance increased, for example), but
what the (alleged) flaws are, what the effects of (allegedly)
heightened awareness and (allegedly) increased compliance are. This
requires any contra argument include at least two levels: first,
countering the existence of the phenomenon at all, and only then addressing
the folly of any proposed conclusions, results, or solutions. I argue,
based on these examples, that it is at this first level, i.e., the
assumption without question of the existence of the phenomena as described
by the “experts” presented by the government, where many (SINS) STRUCTURES,
INSTITUTIONALIZATIONS, NATURALIZATIONS, SIMULATIONS operate, i.e.,
the SINS dwell in the assumptions by researchers (and regulators and
others) that regulators know what needs to be included in consent forms
across the range of study types and risks, and/or that measures required of
researchers produce the intended effects on research participants or are
even accomplished in the way the regulators intended, and/or assumptions
that statements such as “we’re all working together to produce (in some
logical way) a system that benefits the participants of research” are true
(for everyone involved). Further, the commissioners and regulators seem to
be myopically focused on the process, making little if any
distinction between the process and the purpose of regulation, and
operate with the apparent bias that more rules, regardless of the
ineffectiveness of past rules, offer solutions to problems. Finally, as
pointed out, the rules offered as solutions have little to do with the
original “problem” which itself is often not established. As the preceding
three passages indicate, (SINS) STRUCTURES, INSTITUTIONALIZATIONS,
NATURALIZATIONS, SIMULATIONS are shown to be operating in many of the
assumptions made by both the ACHRE (1995) and the GAO (1996), as well as
the regulatory bodies about which they are reporting.
Human Research Subject Protection Act of 1997: Analysis
The year after the GAO (1996) report, Sen. John Glenn introduced the
Human Research Subject Protection Act (S. 193, 1997).{163}*
As proposed, Glenn’s bill would have escalated regulatory power. In
his comments introducing the bill (S. 193, 1997; see Congressional Record,
p. S645, 1997, Jan 22) Glenn states, “What it comes down to is there are no
criminal fines or penalties for violating the spirit or the letter of that
Nuremberg Code that should be the basis of all of our informed consent in
this country… In fact, our own Constitution says ‘The right of the people
to be secure in their persons … shall not be violated’” (Congressional
Record, S645, 1997, Jan 22). He adds, “there is no explicit statutory
prohibition against improper research … there is no law on the books
requiring that informed consent be obtained” (Congressional Record, p.
S645, 1997, Jan 22). These statements suggest that criminal penalties would
make laws better (both the spirit and the letters; of course making laws
against violating the “spirits” of laws has proved to be problematic
historically; see also GAO, 2001, p. 7). Glenn also cites in his comments
the ACHRE (1995, final report), the NBAC (1995, interim progress and status
reports), and the GAO (1996).
Glenn (Congressional Record, 1997, Jan 22, p. S645) states that four
“major gaps” exist in the current regulatory system. Several (SINS)
STRUCTURES, INSTITUTIONALIZATIONS, NATURALIZATIONS, SIMULATIONS can be
illuminated within this political, as distinguished from scientific,
discourse.
First, Glenn says, not all agencies have adopted the Common Rule; he
names specifically the U.S. Department of Labor and the Nuclear Regulatory
Commission (NRC). This suggests a SINS-ful bias toward regulation,
specifically toward belief in the effectiveness of at least the Common Rule
(an institutionalization; “I” in SINS), if not rules in general and/or the
belief that rules operate for the “common good” (belief in rules in
general/for the common good are examples of the first “S” in SINS,
structures, and a Habermasian cultural reproduction). Further, Glenn’s’
remark suggests that a “common” rule for all agencies is not only possible,
but desirable (a structure, i.e., the belief that standardization is
good, possible, needed, required, etc., and also the Common Rule itself is
an institutionalization-al outcome of the structure; and, finally, these
activities and the talk seem normal to most of us, i.e., whether we agree
with Glenn, or even believe him, we find it normal that people would talk
about rules in this way of “rules solve problems” or “rules protect
people.”
In the several incidents Glenn uses to support his contention (see
below, in this paragraph) that there “really [is] a problem out there” and
not just a “paper loophole,”{164}*
Glenn’s evidence addresses only in tangential ways the “lack of Common Rule
adoption” (the “problem” as Glenn expresses it, i.e., failure to
adopt the Common Rule will result in a catastrophe). In making his case
that there are problems that his law would fix,{165}*
Glenn relies on the ACHRE report (1995), and several incidents: the use of
homeless alcoholics by a pharmaceutical company, psychiatric experiments on
children and mentally ill in New York, FDA approval of the use of human
growth hormone, implantation of fertilized embryos in patients without the
consent of the donor, and unapproved use of drugs. Only in the case of the
implantation of embryos is one of the main provisions of the Common Rule
(informed consent) addressed. And, none of the situations Glenn describes
involve the two agencies (Department of Labor and the Nuclear Regulatory
Commission) he mentioned as not having adopted the Common Rule, central to
supporting his “problem” thesis. (See also Foucault’s questions and
examples of analysis, Appendix A,
Examples 1 & 2, p. 346-347.)
The second gap in the system as Glenn views it is that not all research
institutions voluntarily adopt the system, and “if any improper research is
discovered at these institutions, there are very few steps available to the
federal government to do much about it” (p. S645; see also Ellis testimony
before U.S. House, 1998, Jun 11).{166}*
Glenn points out most institutions receiving federal funds for any purpose
do apply the Common Rule. This (SINSful) statement implies the federal
government is effective at doing something about improper research, and
begging the questions once again of the need for the Common (or any) Rule,
and how a system that lacks direct oversight differs in any meaningful way
from a system based on voluntary compliance. Finally, his provisions for
penalties, etc. (see p. 153, below) do not address this statement, i.e.,
the solution doesn’t match the problem as presented (if not established).
Third, “a huge area of all the private medical research out there
... is not under the Common Rule unless they just choose themselves to just
voluntarily do it” (p. S645), Glenn says. With this statement, Glenn
reinforces the (SINSful) notion that human agency (active voluntary
compliance in this case) is somehow less legitimate or effective or
valuable than laws on the books with no or little oversight of them. Again,
if no oversight is conducted, compliance is (in any “real” way)
voluntary. Glenn further implies with his statement that voluntary
compliance is not adequate,{167}*
and further it implies that there can be something like “compulsory
compliance.” (I would add that the local liquid nature of the world would
imply that the term “voluntary compliance” is redundant, and “compulsory
compliance” is impossible.) Glenn’s statement also indicates a (SINSful)
belief that the Common Rule constitutes protection, that application
of the Common Rule—by law—is needed. (Notice the use of “by law,” rather
than by action, see quote from the Dalai Lama, p. 1, herein.)
Glenn’s bill (S. 193) proposed new rules that would require all research
facilities to register with DHHS, and the registration would include
stating “the principles governing the research facility” with respect to
human subject research, naming the official responsible for the human
subjects of research at the facility, providing a membership roster of IRBs
at the facility, and “attestation that the research facility is complying
with the protection requirements of the Common Rule” (Congressional Record,
1997, Jan 22, p. S645). The legislation included a three-year
re-registration requirement and a grandfather provision for those entities
already operating under project assurances with DHHS; Glenn pointed out
that “the vast majority” of U.S. research facilities “have such
assurances.” Use of the term “assurances” rather than “assurance documents”
indicates the institutionalization of paperwork as protection and
the naturalization that a signature on a document assures
compliance. This usage is also an example of a simulation (Baudrillard,
1983) in that the difference between the assurance and assurance document
has become indiscernible.
In addition, the proposed law included “criminal penalties for failure
to comply with the act … [making it] a felony offense to experiment on
someone without their informed consent” Glenn states (Congressional Record,
1997, Jan 22, p. S645; for related activity with respect to DHHS proposals
to implement fines{168}*,
see Brainard, 2000, Jun 2; for more recent federal views, see GAO, 2001,
Research Protection and Promotion Act of 2000, and, at this writing, the
current legislative incarnation, Human Research Subject Protections Act of
2002, dubbed the “biggest overhaul” of human research protections since the
enactment of the Common Rule legislation in 1974, and in which greater
statutory authority and more severe penalties—than in Glenn’s 1997 bill—are
proposed; see Washington Fax, 2002, Mar 28).
The proposed legislation does not address the problems or needs as
described, and only one of Glenn’s four “gaps” was consistent with the
evidence he brought to support for the need for a law: the fourth “gap,”
specifically that some agencies have not adopted the DHHS rules regarding
protected classes (such as the mentally infirmed, prisoners, children,
etc.). It would appear, given the problems Glenn cited, that a broadening
of the procedural provisions might enhance awareness of these additional
protection mechanisms. That of course does not automatically translate to
more actual protection. Further a huge majority of the research in the U.S.
is channeled through DHHS, which has adopted the Common Rule.{169}*
Though the fourth “problem” as presented by Glenn does seem more supported
than the other three, the affect of the law he recommends would be minimal
because not much research proportionately is done by other agencies and
many of those have already “voluntarily” adopted them. Even though this may
be a “real” problem, its existence in this system is in no way clear. In
deconstructing-language, then, it is a whole bunch of talk about a
teeny-tiny slice of the “real” world, and a big political production having
little to do with protection of research participants (see also Appendix A,
Example 2, p. 346-347).
An additional point may be made about Glenn’s evidence. The “results” of
Glenn’s research, and “legitimizing discourse” are based on the use
of (somewhat incestuous textual) data, (GAO, 1996, reliant in
substantial part on ACHRE, 1995, and both then used to build the case for
the Act of 1997).{170}*
This series of political discourse includes President Clinton’s apology for
the Tuskegee incident later in 1997, the series of DHHS OIG reports issued
between 1998 and 2000 from the executive branch, along with the various
congressional hearings conducted in close temporal proximity (and, it could
be argued, in response) to each other (see Appendix A,
Example 3, p. 347). These activities constitute essentially a debate
between the executive and legislative branches of the federal government,
designed around a topic that allows politicians to show concern about
“innocent victims” of research, to assume moral high ground, appear busy
doing something good, important, and effective, etc. Few voices of
scientist, researchers, or the researched or even local IRB members are
heard. These political activities might also be used to illustrate the
spinning (literally in contemporary usage) of the seduction (i.e.,
“political positioning”) into the simulation of “public
service.”{171}*
While it is not reasonable to offer “causal links” (in an absolutist
sense) between these events{172}*,
it is also unnecessary to do so. That these events flow from each other, i.e.,
are temporally located near each other, is an important consideration (see
also Appendix A,
Example 4, p. 347-348). The release of the ACHRE final report in 1995, the
establishment of the NBAC and production of interim reports by the
Commission, the introduction of S. 193 in 1997 and H.R. 3569 in 2000,
release of the DHHS OIG reports between 1998 and 2000, fueled by the
Tuskegee apology in 1997, Gelsinger’s death in 1999, and Roche’s in 2001
have culminated at least so far in a few very minor changes in the
process.{173}*
Other political observations. Another argument that this
activity on the part of Congress and the administration was (mostly)
politically motivated is that Congress and President Clinton (who weren’t
exactly playing well together at the time; Clinton was impeached in December
1998) had to show deep (at least equal) concern and outrage for the victims
of research (specifically, the long-overdue public acknowledgment of the
Tuskegee tragedy). President Clinton’s highly publicized (and politically
effective, maybe even sincere) apology in 1997 to the victims and survivors
of Tuskegee was not lost on the U.S. Congress, each house of which
introduced a bill in the 1997 session (see also Appendix A,
Example 5, p. 348). Science is politics, and “has always been in conflict
with narratives” (Lyotard, 1984, p. xxiii; see also Greenberg, 2001,
Jan 19). The spin and positioning of the campaigners (some regulators, some
researchers, university presidents, professional organizations, senators,
and presidents) are apparent. The competition to claim ownership of the
solution, not to mention the political value of demonstrating interest in
protecting people, concern, compassion, outrage, etc. (and in the process
vilifying all researchers) is evident, and not unique to this system.
Larger cultural reproductions (SINS) of compassion (that everyone should be
compassionate and in defining what constitutes compassion in any given
situation), intelligence (that we can measure it or that we can
meaningfully use the term given there are so many different intelligences),
doing a good job (who sets the standards for “good” etc., and the bias for
work over play), operating in the public interest (a simulation, as
described above), etc., provide substantial political mileage for
legislators, federal regulators, and presidents. This political activity
affects the “real” world of research in only minor ways in terms of the
purpose but creates sometimes mind-boggling procedural effects. While the
political activity may result in changes in approval ratings, it much less
frequently results in substantive rule changes: neither S. 193 nor H.R.
3569 passed, for instance, and no changes were made to Title 45 during this
time.{174}* H.R. 4697 was introduced May 9, 2002 (Human Research
Subject Protections Act of 2002), and called by Sen. Edward Kennedy, the
“biggest overhaul” of the system since 1974 (see Southwick, 2002, May 3;
and Washington Fax, 2002, Mar 28).
One “real” effect of these political activities was the proliferation of
sanctions (not to be confused with a proliferation of protection
nor even a proliferation of compliance, though either or both might
occur) issued from May 1998 to June 2000 when Ellis was OPRR director. His
subsequent removal and the dismantling of the office, in the name of
“concern” and “reform” seemed contrary to those ends. The activities were
more about politics than protection (see Deetz, 1995, p. 130, re: politics
of perception, politics of experience, politics of personal identities,
etc.).
If Glenn’s bill had passed, all research on human subjects would have
been governed by federal protections. Data would have been collected that,
for the first time, would document the extent and conditions of research on
human beings in the U.S. Anyone using human subjects without their consent
would have been subject to criminal penalties although as I have argued,
protections are provided in already existent civil and criminal laws (which
may be among the reasons the bill died without a hearing). These bills, as
with many similar ones, worked well politically but were legally, and
mostly practically, impotent. This discourse does speak to the desire on
the part of some (Glenn and U.S. Representatives Towns and Shays, GAO,
2001, and others) to broaden and deepen regulatory power, and to make
criminal penalties more explicit, (illustrating several SINS including
notions that laws work, that people accept the notion that laws work, that
more control is possible (through law), or is required, needed, desirable,
etc.)
USAID: Analysis
The U.S. Agency for International Development (USAID) points out in its
1999 publication entitled “How to Interpret the Federal Policy for the
Protection of Human Subjects or ‘Common Rule,’” (February 2, 1999; see http://www.usaid.gov/pop_health/resource/phncomrule2.htm,
accessed May 25, 2002) that the publication is intended to be used as a
“companion” to the Common Rule. USAID authors state, “institutions must
also adhere to other laws and regulations applicable to their human
subjects research including state law, foreign laws, and human subjects
procedures of the FDA” (p. 1). “Trust in the honest, conscientious judgment
of the human beings who serve on IRBs is pivotal to the entire system of
protection of research subjects” (p. 1). Further, the USAID (1999) document
states though certain types of research are exempt under the Common Rule,
“they should not be considered exempt from common ethical standards” (p.
4). For example, a particular survey may be exempt, but USAID (1999) points
out that it is “common courtesy and otherwise generally reasonable to ask
permission and provide some simple information to respondents” (p. 4). The
interest in promoting ethical behavior outside the Common Rule is “not
intended as a mandate for more structured procedures,” they continue, but
rather “to advance cultural ethical norms for research and non-research
activities alike, to be exercised with discretion by institutions and
individuals” (p. 4). They point out that consent forms should not be
confused with the informed consent process: “It is important to
recognize the informed consent process is a process of communication and
not just a legal requirement” (p. 3). The guide’s authors suggest the
process should use “simple, understandable language” and should emphasize
“required and most important” information, avoiding large amounts of “additional
information of marginal use” to giving consent (p. 3){175}*.
The authors add that the process should also involve actively listening to
participants’ individual concerns, and that researchers should request
participants restate the major points related to the study.
The suggestion (or what might be termed, risking the oxymoron, suggested
requirement?) that participants be asked to restate the major points
related to the study rather than a suggestion that participants be able
to restate the major points seems inconsistent with the USAID statement
that informed consent forms should not be confused with the process.
Further, it seems the authors are beyond the scope of their charge with the
comment about the advancement of cultural ethical norms for both research and
non-research activities. And the “trust” in “human beings who serve on
IRBs” may be pivotal, but more crucial (because so little oversight of the
process is conducted, possible, needed, or desirable) is trust in
researchers and participants themselves (see O’Connor, 1979).
Other General Observations
Critics (deconstruction of term). GAO (2001) states, “Some
critics have argued that there are too few sanctions to match the range of
violations that occur. Acknowledging this problem, DHHS is considering a
proposal for legislation that would enable FDA to levy civil monetary
penalties for violations of … important research practices” (p. 7). The GAO
did not elaborate on who the “critics” are (we can fairly presume these
critics are not associated very closely with social science pursuits), nor
do they provide any evidence on which they “acknowledge” (or establish, if
and when they feel compelled to do so) the “problem.” And, as mentioned,
this report and others illustrate the bias toward the belief that any of
this makes a difference to the participants of research. “Critics of
the bill argued [there is] no evidence that the absence of regulation had
caused significant harm to substantial numbers of people, and asserted that
the measure was a solution in search of a problem” (Charo, 1999, Jun 25, p.
A64).
The use of the term “critics” quoted in the previous paragraph is
notable. This often-used term is almost a disparaging one, implying
“troublemaker,” “rebel,” “boat rocker,” or the nearly-if-not-ultimately
objectifying “obstacle.” The term certainly carries substantially less
weight than “U.S. Senate,” or House, or Senator or Representative, Cabinet
Secretary, or even Presidential spokesperson, or OPRR Director, especially
when “critics” aren’t named specifically, or balanced in stature with
proponents. In the written language, the proponent group is comprised of
People described with Proper Nouns garnering Capitalization Status. A less
biased presentation would be comparison of comments from two senators—one
pro, the other con—or two researchers, etc. Use of the voiceless
objectification “critics” is an example of the ways cultural-level (SINS)
STRUCTURES, INSTITUTIONALIZATIONS, NATURALIZATIONS, SIMULATIONS become
entrenched, and work to vilify criticism, conflict, and dissention, in
spite of often explicit but seemingly empty comments about their
usefulness.
Institution and researcher impact. The changes that
actually made a difference in the “real” world of research involved moving
the OPRR essentially up two hierarchical steps in the organizational chart.
The organizational structure, prior to the change, was: at the top, the
Secretary of DHHS, then DHHS director, then director of the Office of
Extramural Research, then OPRR. The change placed the OHRP directly under
the Secretary of DHHS (Federal Register, 2000, Jun 13; Brainard, 2000, May
26b). A new director was named, which is significant as mentioned
previously, because more sanctions had been issued by Ellis than all other
previous directors combined and only one sanction has been issued since,
that against Johns Hopkins in July 2001 (see Appendix A,
Example 6, p. 348).
Summary
These political debates, bills, hearings, and proposals from the federal
government are an indication of who has (been given) the right to change
things and the criteria they may establish. And it demonstrates the way contra
activity is controlled. The mostly disgusting proliferation of suggestions
about ways to standardize, centralize, and regulate research practices has
occurred, but “real” changes in “real” research (and the elimination of
“real” atrocities) have not occurred nearly as often.
The system, at the federal level, has grown bigger and slower, more
specific yet more ambiguous, less responsive yet more aggressive. This
growth is just as apparent at the institutional level, with more IRBs of
more types reviewing more research, in terms of volume and diversity, than
ever before (DHHS OIG 2000b).
The federal portion of this system reacts in emergencies, called “major”
problems, “precipitating events,” or “catalysts.”{176}*
Too often, these are euphemisms for “atrocities” and (generally overcoming
remorse) “fear of litigation.” According to Daniel K. Nelson, University of
North Carolina, “Our system for protecting human research subjects has
evolved in response to relatively isolated events” (as quoted in Brainard,
2000, Apr 14, p. A45). Former Secretary of Health and Human Services
Shalala stated, in response to the Gelsinger death “in this town, anecdote
becomes data” (as quoted by Marwick, 2000, May 4, p. 1). These events
affect all researchers particularly because essentially the same processes,
i.e., reactionary regulatory responses, have occurred at the
institutional level, to be considered in the following chapter.
Perhaps nowhere is there a better demonstration of the explosion of
information than in the world of academic inquiry (consider medical
innovations alone!). Regulating that inquiry is important, and this is
because people, the human subjects of research, in this case, are
important. Of equal concern I contend is the avoidance of over-regulation,{177}*
not only at the federal level but at the institutional level of
interpretation as well.{178}*
These interpretations are the focus for the analysis included in the next
chapter.
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