Aula 14 - Social Studies of Science-2011-Petty

Social Studies of Science
Extending the rails: How 124

The Author(s) 2011
research reshapes clinics Reprints and permission: sagepub.

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DOI: 10.1177/0306312710396402
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JuLeigh Petty
Center for Medicine, Health, and Society,Vanderbilt University, Nashville, TN, USA
Carol A. Heimer
Department of Sociology, Northwestern University, Evanston, IL, USA
American Bar Foundation, Chicago, IL, USA
Abstract
The purpose of clinical research is to create the scientific foundation for medical practice. In this
way of thinking, the effect on medical practice occurs after the research has been completed.
Social studies of science have debunked the standard model of scientific research, observing that
changes in practice associated with research occur not just because of the results of research
but also because of the practice of research. Drawing on fieldwork in HIV clinics in the US,
South Africa, Thailand, and Uganda, we argue that clinical trials shape medical practice by altering
the organizations in which both medical treatment and clinical trials take place. Three general
processes are central to this transformation: the modification of material environments, the
reorganization of bureaucratic relations, and the prioritization of research values.These processes
unfold somewhat differently in the clinics of poorer countries than in those of wealthier ones.
Keywords
clinical research, diffusion, HIV, medical practice, standardization
Conducting clinical research is an organizational accomplishment with organizational

effects; in the course of producing research results, clinics work out new routines, acquire
equipment, adopt new technologies, retrain staff, and hire new staff. This article exam-
ines how clinical research transforms HIV/AIDS clinics. It demonstrates that organizing
the conduct of research particularly through the introduction of new jobs, technologies,
and standard operating procedures deeply shapes clinical work, exerting an influence
that is probably as important as the influence of subsequent research results. Drawing on
Corresponding author:
Carol Heimer, Department of Sociology, Northwestern University, 1810 Chicago Ave,
Evanston, IL 60208-1330, USA.
Email: c-heimer@northwestern.edu
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2 Social Studies of Science
fieldwork in clinics in several countries, it illustrates how these organizational processes

vary depending on the clinics existing resources, routines, and relationships.
The traditional model of clinical research includes a division of labor between
researchers and clinicians and a more or less sequential progression from identifying
research questions to conducting clinical trials, to publishing research findings, and to
modifying medical practice to take account of those research findings (for example,
Straus, 2005). Once researchers are able to offer clear answers to scientific questions,
healthcare providers are expected to modify medication regimens and therapies in light
of the new information. However, clinicians do not always adapt their practice to bring
it into line with the latest scientific knowledge. The diffusion of innovation is fundamen-
tally social, with opinion leaders playing an important role in encouraging others to
adopt new practices (Coleman et al., 1966; Katz and Lazarsfeld, 1955; Rogers, 2003;
Strang and Soule, 1998; Wejnert, 2002).
Although diffusion studies uncovered important variations in how rapidly innovations
were adopted, the fundamental model explaining the link between scientific research and
clinical practice remained intact. Changes in practice were assumed to be technical and
to follow scientific innovation. Social studies of science debunked this standard model of
scientific research and observed that changes in practice associated with research occur
not just because of the results of research but also because of the practice of research,
and the changes themselves are generally more sweeping than the diffusion literature
suggested.
Early work by Layton (1974) and Rosenberg (1976), and subsequent work on tech-
nology, problematized the idea that technology is simply applied science and drew atten-
tion to the users of technology as innovators and to technology as a driver of social
change. Producing and using research findings depends on and motivates the building of
social and technical networks (Bowker, 1994; Latour, 1983) and social worlds (Clarke,
1990). As Latour (1983: 155) wrote, Scientific facts are like trains, they do not work off
their rails. You can extend the rails and connect them but you cannot drive a locomotive
through a field. Similarly, in his work on decision-making tools in medicine, Berg
(1997) observed that medical workers change their environment so that the tool becomes
less onerous. Lwys (1996) work on cancer research illustrated that clinical research
may be as much about the production of organizational efficiency as it is of technical
efficiency. We argue that modifications in clinic practices smooth the way for adoption
of clinical research because part of the change that would be necessary before scientific
results could be incorporated into a clinics ongoing activities has already been made.
The medical literature supports this observation that the results of clinical trials are
more likely to be adopted in clinics that conduct research. The response to Pediatric AIDS
Clinical Trials Group (PACTG 076), a study demonstrating that antiretrovirals reduced
mother-to-child transmission of HIV, illustrates this point. In the 2 years following the
announcement of the results of PACTG 076, New York hospitals that conducted clinical
trials on mother-to-child transmission were almost twice as likely as other hospitals to
prescribe antiretrovirals to pregnant women (Turner et al., 1999: 982; see Majumdar et al.,
2008, for a similar finding about cardiac care). In addition to drug regimens, research
protocols address such matters as what equipment is used, how work is divided among
professional staff, how records are kept, and what information is collected from patients.

Petty and Heimer 3
According to Timmermans and Berg (1997: 297), the resuscitation protocols and
oncology research protocols they studied were the means through which facts can be
produced and, at the same time, a crucial part of the networks through which the facts can
be performed (italics in original). In clinics that conduct research, then, research results
enter a world that has been re-made in ways that ease their implementation.
Data and methods

Drawing on fieldwork, interviews, and documents from five HIV clinics in the US, South
Africa, Thailand, and Uganda, we examine the organizational processes through which
the clinic is reshaped by research. Here, we present one part of a larger study of the
legalization of medicine, a process in which more formal rules about care, research, and
payment have supplanted relatively informal regulation by professional peers. Such rule-
based regulation has diffused well beyond US borders, sometimes freely adopted by
medical workers eager for the legitimacy conferred by American medical science, at
other times imposed on foreign scientific colleagues by American funding agencies and
research organizations. This paper focuses on organizational change as a side effect of
the rules governing research.
The study included HIV clinics engaged in both treatment and research in countries at
varying levels of development (see Table 1). The Ugandan and South African fieldwork
was conducted in the early stages of large roll-out programs, funded by international
donors and national governments, to provide antiretrovirals through HIV clinics. The
Thai governments program, organized around GPOvir (the locally produced generic),
was more established at the time of our fieldwork.1 The South African clinic did less
research than the other clinics discussed here. However, it had a strong affiliation with an
American university and was expanding its research activities, focusing especially on the
development of drug resistance. The scaling up of research at the South African clinic
provided an opportunity for us to observe organizational learning. Conversely, the
Ugandan clinic was in the process of adding more care independent of its research pro-
grams. Thus, the Ugandan clinic allowed us to observe organizational unlearning, as
staff members figured out how to scale back research-related services that required
resources unavailable in a sustainable clinic treatment program. Although the clinical
and research programs in the American and Thai clinics were more settled, these clinics
continued to initiate new studies; preparing for new studies often required the clinic to
redeploy and retrain staff, procure equipment, and institute new record-keeping routines,
as well as make arrangements for new treatment interventions. The Thai researchers
were also eager to design research responsive to local issues and sensitive to Thai condi-
tions as well as to participate in internationally funded multi-site studies.
In the five clinics, we observed variation in the overlap between research and care
ranging from nearly complete overlap to almost none. Because all of the clinics were
outpatient facilities, care is shared with or taken over by others when patients require
hospitalization. In the Ugandan and Thai clinics, essentially all outpatient care was ini-
tially provided through research. Therefore, clinical needs often had to be fitted around
research protocols. With the recent addition of grant-funded treatment programs in the
Ugandan clinic, treatment no longer needs to fit the strictures of the research program,

Table 1. Comparing the five sites: clinic characteristics
4
US1 (private) US2 (public) Thailand South Africa Uganda
Research program Major research facility Sub-site of another Began as research facility Began as treatment Began as research facility
research program with treatment program program with research with treatment program
added later added later added later
Location of Outpatient HIV clinic Stand-alone HIV clinic Stand-alone HIV clinic Outpatient HIV clinic Stand-alone HIV clinic
research and in hospital building not on main hospital not on hospital grounds in hospital building not on hospital grounds
treatment grounds
activities
Medical school Physicians hold medical Physicians hold faculty Top tiers of physicians No formal tie between Top tiers of physicians
affiliation school appointments; appointments in one hold medical school clinic and local hold medical school
research nurses are of two medical schools appointments (in Thailand medical school, but appointments (in Uganda
employees of university or other countries) collaborations with or the US)
university faculty;
formal ties with US
medical school
Hospital affiliation Research formally part Clinic is sub-unit of Clinic is a clinical center Clinic is sub-unit of
Clinic not subunit of
of medical school and hospital of the medical school hospital hospital, but clinic
treatment formally part hospital; also has ties research often carried out
of university hospital to other local health in hospital and hospital
organizations staff are also employed
by research facility
Major sources of Research funds from US Research funds from Research funds from US Research funds from US Research funds from US

funds NIH and pharmaceutical US NIH; funds for NIH,Thai government, and NIH (via US university); NIH; funds for treatment
companies; funds for treatment from US pharmaceutical companies; funds for treatment from US PEPFAR and
treatment from insurance government (Ryan funds for treatment from US PEPFAR, South Ugandan government
White, Medicare, from Thai government African government
and Medicaid) (NAPHA), Global (roll-out), patient
Fund, and some private payments, and insurance
insurance
NIH, National Institutes of Health; NAPHA (National Access Program for HIV & AIDS); PEPFAR, Presidents Emergency Plan for AIDS Relief.
Social Studies of Science
Petty and Heimer 5
although the constraints imposed by treatment programs are also rather severe. In the
Thai clinic, care continues to be given under the umbrella of research, but that umbrella
has been enlarged to accommodate research subjects who cycle off research projects but
have no other way to access HIV/AIDS treatment.2 In US1, there was some overlap
between research and care. Both took place within the same clinic, and the research
nurses and physicians did both clinical and research work. Most research subjects were
also clinic patients. When the study subjects required HIV treatment beyond what a study
provided, they usually got that care in the clinic and it was paid for with their own insur-
ance. Whenever changes had to be made to their medications, the research staff con-
sulted with subjects HIV care providers to encourage them to make changes that
complied with the research protocol if at all possible. However, medical needs came first,
and the research staff would never discourage or prevent a subject from receiving needed
medical treatment even if that meant losing a subject from a study. In US2, research and
care were treated as discrete activities. The research and treatment units were housed in
the same building but operated separately. In fact, to prevent research subjects from con-
fusing research with treatment, the clinics policy was that study subjects were not to be
seen by their primary care physicians when they came for study visits. How the South
African clinic was going to manage the overlap between research and care was less clear,
because the clinic had not yet fully developed its research program.
In each field site, one or two members of our team conducted the bulk of the research
while other researchers visited the site, usually for a couple of weeks.3 The fieldwork in
the two American clinics was of longer duration (just short of 2 years in US1; 13 months
in US2) but was less intensive (we were not in the field every day). We spent 4 months
doing very intensive fieldwork in the clinics in Thailand, Uganda, and South Africa, with
multiple visits of a couple of weeks before and after. We first began fieldwork in US1 in
the fall of 2003 and last revisited our sites in Uganda, Thailand, and South Africa in the
summer of 2007.
Because organizing for research often leads to tension between research and clinical
staff, many topics we were interested in were rather sensitive. In our first days in each
site, staff members nervously joked about whether we were really there to see whether
they were doing things properly. As our research unfolded, we gained access to the for-
mal meetings and informal discussions that surround research and caregiving. We shad-
owed staff as they went about their work, which included study visits, clinical
examinations, phone calls, monitor visits, and meetings. We watched them complete
paperwork and requested copies of forms and policies. We attended weekly research
team meetings, training sessions, clinical care meetings, meetings about standard operating
procedures, research grant application meetings and even prayer meetings. We interviewed
and shadowed staff in a wide variety of positions at all levels of the hierarchy principal
investigators, doctors, nurses, administrators, social workers and counselors, reception
and clerical staff, data entry staff, and so forth.
How research reshapes the clinic:Three general processes

Although research findings may influence medical practice, the practice of research also
shapes the practice of medicine, largely by altering the organizations where both medical
treatment and clinical trials take place. Some of these changes are mandated by external

entities such as the sponsors of clinical trials or the scientific protocol teams that design
procedures to ensure the comparability of data collected in many sites. Other changes
arise as researchers, caregivers, and administrators attempt to balance research and care-
giving under local constraints.
Bergs (1997) studies of the rationalization of medical work offer interesting parallels
and suggest mechanisms that might account for this broad impact of clinical research on
medical practice. Although decision tools are intended to be universally applicable, in
fact they are typically only very locally useable, and then only with a lot of work to fit
them into the setting (Berg, 1997). In the course of double-fitting clinical research to the
organization and the organization to clinical research, the material environment is altered
with the introduction of new tools of research, bureaucratic relations are reorganized
with the introduction of new and retrained staff, and priorities are changed with adoption
of scientific practices. A broad correlate of these processes is standardization within and
among HIV clinics as clinics conduct studies developed and funded by a small set of
large sponsors and governed by an increasingly shared set of ethical and technical rules
(Petty, 2008). Standardization is important not only as an effect (uniformity that makes
HIV clinics all over the world mutually comprehensible), but also as a technique. Below
we examine these three general processes, observe how they vary with levels of develop-
ment and clinics existing social and technical networks, and show how research-related
changes in clinics pave the way for the adoption of research findings.
Altering the material environment of the clinic

Good laboratory facilities are crucial both to modern medical care and to clinical trials.
The comments of nurses and doctors in our field sites were peppered with references to
labs: which labs could do complicated tests required by clinical trials, which labs had
reputations for doing careful work, which facilities were especially fast, and how (in
Uganda) the absence of a stat lab (able to do tests immediately at all times) affected
treatment. Funders often pay to improve the laboratory facilities of poorer countries so
that clinics can participate in research. Once labs are upgraded, both research and treat-
ment programs take advantage of the new facilities. We introduce our discussion of the
effects of research-related modifications to the material environment with several illus-
trations from our field notes showing how the extensive improvements in the Thai clin-
ics laboratory facilities had long-term effects on treatment as well as research.
The laboratory affiliated with our Thai site is unusually well equipped, at least by Thai
standards. A member of our research team, tagging along as a visiting Vietnamese dele-
gation toured the lab, learned that this laboratory could determine drug levels in patients
blood, measure viral loads, and do drug resistance testing to see if patients had accumu-
lated any resistant mutations. At that time, only four sites in Thailand had the equipment
to do viral load testing. The manufacturer provided a viral load machine gratis because
the laboratory purchased so many viral load kits for research. Once these facilities
became available, clinic staff brought caregiving into line with the latest scientific results
by, for instance, adopting recommended schedules for viral load testing. The equipment
allowed research staff to do additional research including important pharmacokinetic
studies showing that dosages of antiretrovirals should be modified for smaller Thai

Petty and Heimer 7
patients and for children. With this evidence about levels of drugs in patients blood,
clinicians lowered doses, saving valuable medicines and reducing side effects. As one of
the lead researchers emphasized though, it would have been inappropriate to lower doses
without the data from the research.
These synergies between laboratory facilities, research, and caregiving also showed
up in decisions about pap [cervical] smears, which were initially added to improve one
study but later became standard of care for all research and treatment programs in the
Thai clinic. When researchers wanted additional ways of measuring disease progression
in one long-term study, one researcher suggested in the weekly doctors meeting that
annual pap smears for the women would provide another clinical end point (cervical
cancer is a correlate of HIV infection). As they discussed whether and how to provide
pap smears, clinic staff worried both that they could not offer the test at their sub-sites
and that Thailand might actually be behind the Western sites if all of the other countries
are doing annual pap smears, and [we] are not. Noting that Latin American sites had not
been doing pap smears, they decided to tell the research sponsor about their plan and to
suggest that other countries like the Latin American ones might wish to follow
Thailands example. In a project meeting later that day, they debated whether to do
cheaper conventional or more expensive, but more accurate, liquid pap smears, set-
tling on liquid smears for initial examinations and conventional smears for subsequent
examinations. The same schedule was later adopted for the observational study that the
Thai clinic used as a vehicle for providing care to patients who did not qualify for other
studies.
In addition to wanting to keep up with wealthy countries and be a role model for other
research clinics, the Thai clinicians were clearly pleased to provide high quality care to
their patients. In the clinic meeting mentioned above, one caregiver readily agreed to
write up notes from the examinations and track any necessary follow-up; because pro-
viding this care is very important to her ... she was willing to take on quite a bit to be able
to do it. During clinic hours, another caregiver seemed pleased about providing this
service, even though it makes the visits very long for the patients. Improved laboratory
facilities and findings from research studies created opportunities for providing better
care. Indeed, once a higher standard of care became possible, one staff member argued,
they were required by GCP [good clinical practice] to provide the best care for the
patient including pay[ing] for all the tests.
In exploring the relationship between research and the material environment of the
clinic, we make two related arguments. First, research entails importing new technolo-
gies or using old technologies in new ways. These technologies include medications,
tests, equipment, paper or computerized forms, and even exam rooms. In our study, we
observed that research-mandated technologies have bigger immediate effects but smaller
long-term consequences in poorer clinics. Second, researchers make non-mandated
changes to the material environment of the clinic to ease the enactment of study proto-
cols. According to Berg (1997: 93), materializing a tools demands or in this case,
materializing researchs demands requires that those advocating the use of a tool
change the material environment so that the decision technique becomes an unavoid-
able (and often unnoticed) part of daily practice. Both of these processes adopting
research-mandated materials and changing the material environment to facilitate the

enactment of research protocols require and increase standardization in the clinic. We

have illustrated the effects of new equipment and drugs on the clinic, focusing particu-
larly on the Thai clinic. We now turn to a discussion of the ways that researchers succeed
and fall short in re-making clinics so that protocols become unavoidable and
unnoticed.
Local researchers adopted pap smears and viral load tests because they viewed pro-
viding the tests as essential for a good research clinic. These Thai examples thus illus-
trate normative and mimetic isomorphic pressures (DiMaggio and Powell, 1983). Other
changes to the material environment are more coercive. For example, the adoption of
viral load testing was motivated in part by the publication standards of top tier medical
journals. Material changes were sometimes less about achieving accuracy than about the
uniformity required by multi-center clinical trials. The American clinics as well as the
Thai and Ugandan clinics conducted multi-center clinical research funded by the Division
of AIDS (DAIDS) at the US National Institutes of Health (NIH). Such trials, which
facilitate the collection of data from large, representative samples in dispersed sites,
place a premium on standardization. The central means of ensuring that similar proce-
dures are performed on every subject at each site is the study protocol, a recipe for the
conduct of a study, including inclusion and exclusion criteria, randomization procedures,
schedules of interventions, and lists of tests to be performed and documents to be cre-
ated. Moreover, research funders provide equipment needed to standardize results and
also supply more common equipment not otherwise available in poorer clinics. Whether
clinics use their own or research-provided equipment, they are expected to use it in
study-specific ways to standardize results. Differences among sites are further reduced
through training of staff, testing and re-testing of equipment, and using specialized cen-
ters for such technical functions as performing laboratory tests and reading x-rays
(Friedman et al., 1998). In fact, in order to become a part of a DAIDS funded network,
clinics establish ties to laboratory facilities with particular certifications and capacities.
Research-provided equipment often duplicated equipment already available in
American clinics; in poorer countries, medical equipment was often in short supply.
Indeed, the Ugandan site lacked some very basic medical equipment. Doctors were urged
to share because there were too few instruments for each doctor to have his/her own set
or even to supply each examination room. The adult wing of the clinic had only one
working blood pressure machine; research funds were used to supply a blood pressure kit
for the maternity ward. In poorer clinics, research materials are especially valuable
because they are less likely to be duplicates of existing materials. But, because materials
are less easily replenished or replaced, the overall effect of altering the material environ-
ment is smaller in poor countries. Because it is hard to get equipment repaired, Ugandan
staff revert to older practices when equipment breaks. In fact, the maternity units blood
pressure machine was already broken at the time of our fieldwork.
A particularly important and controversial technology in HIV/AIDS research is the
protocol-defined medication regimen. Commentators have observed the ethical difficul-
ties that arise when research protocols conflict with clinical judgments and when studies
provide medications that are otherwise unavailable. The impact of the research-provided
medication is greatest where access to expensive HIV medications is limited and where
research staff and participants have no options beyond study-provided antiretrovirals.

Petty and Heimer 9
Indeed, it is debatable whether research participation can be fully voluntary in places

where antiretrovirals are largely unavailable. Furthermore, in the Ugandan clinic, even
more than in our other sites, there was concern about how to provide patients with treat-
ment and expensive antiretrovirals after studies were completed. A similar concern in the
Thai clinic led to the creation of observational studies.
A less obvious consequence of research-provided drugs is the construction of knowl-
edge and routines regarding new therapies. Pharmaceutical companies are aware of this
effect and even conduct multi-center seeding trials more to encourage physicians to use
their drugs than to collect data (Sismondo, 2010). By conducting research, physicians
and nurses learn firsthand about new drug regimens; for instance, they learn what side
effects to watch for and how to treat them. Research is also an opportunity to create the
organizational routines needed to use a new drug. For example, in conducting a study of
an immune booster that is infused in newborns to reduce the odds that they will acquire
HIV from their mothers, the Ugandan hospital trained staff members and devised rou-
tines for moving HIV-exposed newborns to the special care unit (to receive the immune
booster intravenously) and hospitalizing them for 48 hours rather than the usual 24 hours.
Thus, if the research results confirmed the immune boosters efficacy, the Ugandan hos-
pital would be well positioned to implement the technique. But it is not just staff mem-
bers who adopt new routines. Through participating in research, patients also learn new
skills that enable them to take new medications and use new medical devices.
Beyond the transformations brought by the importation of research-mandated materi-
als, in all of the clinics in our study, we also observed research staff changing the material
environment of the clinic in order to decrease the work of meeting research require-
ments. Altering clinical materials so that they overlap with the demands of research is a
strategy for making such demands unavoidable and unnoticed. Indeed, when pap smears
became standard of care in the Thai clinic, doing them for research was no longer extra
work. Similarly, US1 and the South African clinic altered their clinical records to meet
the demands of research. US1 revised its subjective form to fit the needs of an observa-
tional study in which more than 500 of the clinics 2025 patients were enrolled. Labeled
subjective because it contains patient-reported information, such as fatigue and nausea,
that is not easily measured, the form is filled out at every patient visit (regardless of
whether the patient is a research subject) and becomes part of the medical chart. When
research forms are mandated, standardization of clinic activities becomes very attractive
and the easiest way to standardize is in favor of the most rigid requirements. Standardizing
up saves time, but it also means that staff members collect data that are not needed and
with a specificity that is not relevant for caregiving. But recreating information after the
fact from inadequate records is such a burden that people accept the lesser burden (the
tax) of routinely collecting a bit extra. Similarly, as we discuss more below, when the
South African clinic computerized its medical records, it organized the records with an
eye to future use in research. This affected both the kinds of information staff gathered
and how they collected and recorded it.
Reorganizing the material environment is more difficult in poor settings for obvious
reasons. Both American sites had access to the full range of technology for HIV care at
the American standard, although US2, the public clinic, sometimes struggled to find
funding for antiretrovirals. Resources were at an intermediate level in the Thai clinic

and scarcer in the African clinics. Researchers in Uganda, particularly, were keenly
aware of the material barriers to complying with research protocols. Internet connections
were unreliable in Uganda, making it difficult to file serious adverse event (SAE)
reports in a timely way.4 The lack of reliable medical records in the Ugandan hospital
sometimes meant that more leg-work was required to track SAEs. When the Ugandan
clinic instituted a quality assessment/quality control (QA/QC) program (described more
fully below) to reduce protocol violations and documentation errors, the trainer
instructed QA/QC reviewers to pay attention not just to documentation but also to the
conditions that make it possible to do documentation:
If people dont have any place to sit while they do their work, they are less likely to fill out
forms correctly or to check them. If there is not a clock, they cant document the time if they
dont themselves own watches. If there is not a locking cabinet, they cant store their work
securely. You cant tell people not to leave forms in the pocket of the binder (as they have) if
you dont supply them with a hole punch so that they can prepare the forms to insert in the right
sections of the binder.
The QA/QC program provided what equipment it could. Where rule infractions were
related to working conditions that could not be changed, QA/QC reviewers were to docu-
ment the local working conditions for external monitors. In contrast to the subjective
form in US1, much of the work of implementing research protocols is never made
unavoidable and unnoticed in poor settings.
When routines have already been reconfigured to accommodate research protocols,
the subsequent work of implementing research results, now translated into new tools
(such as clinical practice guidelines), is likely to be less onerous, less noticeable, and less
avoidable. The ratcheting up of rigor, detail, and pace that comes with research may thus
make the subsequent implementation of research results, which requires some of this
same extra work, seem relatively easier. Some costs of implementing research results
have merely been displaced into the research phase. Research may entail more work than
simply caring for patients, but taking on board new therapies and administering new
drugs also entails extra work unless, of course, one has already learned appropriate
practices by participating in the research on those therapies and drugs.
In materializing the clinics environment, research projects alter the way that people
interact with objects and so make it easy for them to continue to use those new tools and
technologies even after research projects end. Healthcare institutions that have not partici-
pated in the research have to bear the start-up costs of acquiring and learning to use the
technologies required to implement research results. The rapid adoption of research results
in research clinics is thus partly accounted for by the continuing presence of the tools,
technologies, and infrastructure of research, as well as the staffs recently acquired skills
for using the new materials. Techniques and skills, as Knorr Cetina (1999: 220) has noted,
travel not just through laboratory protocols, but through packages of arrangements that
incorporate scientists and material objects and that need to be recreated in local contexts.
Reorganizing bureaucratic relations

As they alter skills and tasks, the technologies of research, including protocols, paper
forms, equipment, and techniques, also alter the patterns of interaction and the content of

Petty and Heimer 11
relationships, sometimes supporting and sometimes challenging existing hierarchies. As

Barley (1990: 67) observes, Technologies are depicted as implanting or removing skills
much as a surgeon would insert a pacemaker or remove a gallbladder. Rarely, however,
is the process of technical change so tidy. We open our discussion of this untidy process
of reorganizing relations among staff with an extended illustration of how concerns
about data quality reshaped staff relations in the Ugandan clinic.
Now therere some violations you can be gentle about. But some violations are so
no-no that you have to stop right there and not accept it in any form. There is no excuse
that can justify that. And source documentation is one of them, the regulatory specialist
emphasized, explaining why medical hierarchies sometimes had to be challenged in the
Ugandan clinic. The data for a research project are extracted from source documents
often medical records and transferred to a projects case report forms (CRFs). In an
extended interview, the regulatory specialist described the elaborate QA/QC program
that she had helped develop to ensure the quality of the data and to complement and
prepare for the external monitoring that occurs on a regular schedule in research studies.
You shouldnt wait for someone else to come and tell you what youve done wrong, she
said in describing a program of records reviews, unannounced visits to clinical sites
where source documents were produced, formal monthly reports and discussions of sys-
temic issues, and retraining on good clinical practice (GCP).
Before the development of the new QA/QC system, the clinic had done internal moni-
toring on a very loose basis. The new formality was important because it facilitated the
reorganization of bureaucratic relations. Discussing cultural differences, the regulatory
specialist explained that because of the big gap between doctors and nurses in Uganda,
a nurse will never tell the doctor, Well, what you wrote is not correct. Or, You havent
completed this portion. She had noticed that the QA forms were typically filled out
correctly up to the point where the reviewer was supposed to supply the name of the
person who had made the error and who therefore needed to correct it. When she asked
why the names were omitted, staff members asked, If we identify, what will happen to
this person? Staff were worried about embarrassing people and about jeopardizing their
own and others jobs. To empower staff to point out the errors of their peers and superiors
while preserving cordial work relations, the regulatory specialist made three changes.
First, she modified the forms so that reviewers recorded ID numbers rather than names
of people making errors. Next she ensured that in the first couple of layers of the three-
part QA/QC system, nurses monitored the work of nurses and doctors inspected the work
of doctors. Where that was not practical, she made sure that the unmatched pairs trusted
each other and were comfortable with the assignment. Finally, she adjusted descriptions
of jobs and responsibilities. Now when the top QC staff member inspects others work,
[E]veryone knows what she has to write up. ... She has a right to yell. She has a right to
question. And yell you know what I mean strongly.
We were able to see how this new system was working some months later in QA/QC
meetings and in several of those unannounced visits. One unannounced visit to the hos-
pital special care nursery, where some of the research was being conducted, was nearly
aborted when there were no records to be checked. Defining their job as checking source
documents, the QA/QC site team initially wanted to leave because there [was] nothing
for us to do here. The regulatory specialists interpretation of the situation was quite

different: As a quality management team, you see that the problem is there is no form.
That is a major problem! So they waited until the unit doctor arrived and then discussed
the situation. To make the doctor see the problem, the regulatory specialist role-played
with him, asking him to pretend that she had failed to record the data and he was inspect-
ing her work. Watching his reaction to the error he was actually harsher than I was,
the regulatory specialist confided made things click for her team. They now understood
that they were evaluating the job, not the person, and that poor work sometimes required
harsh assessments. The special care nursery team ultimately proposed some recommen-
dations on their own and warmly welcomed the QA/QC group on a follow-up visit,
consolidating the QA/QC teams emerging sense that it really was acceptable to be criti-
cal when making inspections.
A few days later, another documentation problem turned up in an unannounced site
visit to a post-natal ward. This time, a confession occurred quickly. As they discussed
the problem that the doctors sometimes forget to summarize the case in the discharge
section at the bottom of the form ... [the lowest level QA/QC staffer] tells them that actu-
ally the nurses end up writing the discharge summary even though it is supposed to be
the doctors who do it. ... [They all agree, though] that the nurse cant sign the form once
she has filled it out because the line for the signature clearly indicates that it is supposed
to be the doctors signature. The professor (QA/QC team member and also a doctor)
seems baffled that about why it should be a problem for the doctors to write given that
all they have to do is say things like the sex of the child, that it was a simple vaginal
delivery, the date and time, and so on [He runs through the couple of sentences that
would be required.]. In this reordered workplace, the lowest level QA/QC staff members
are now quickly reporting errors or violations of protocol, even when it is their hierarchi-
cal superiors who are not correctly and fully documenting.
As it shapes their activities, these examples show, research also reshapes relationships
among colleagues. The non-relational parts of work (skills and tasks) nearly always spill
over into the relational aspects of work (Barley, 1990): the QA/QC tasks changed the
relations between research staff inspecting medical and research records and the nurses
and doctors who write those records. When they take up QA/QC work, nurses, who cus-
tomarily follow doctors orders, must learn to correct the doctors whose medical records
are being used for research. Research inevitably confers new duties on clinical staff, as
nurses become study nurses and physicians become physician-investigators. Some of
the changes required by research are superficial, as Fisher (2009) showed in her study of
pharmaceutical clinical trials conducted by non-academic physicians, but many are not.
Research has led to the creation of wholly new job categories, including study coordina-
tor, data monitor, and regulatory affairs coordinator. Although new staff members were
hired and existing staff retrained and redeployed in order to conduct clinical research in
all five of the clinics we studied, the wealthier clinics were better able to meet staffing
requirements.
Nurses, doctors, and administrators compete for authority in a clinic; the introduction
of new tools shifts the kinds of capital that are valued, fostering interpersonal conflict as
some seek to conserve the current authority system while others attempt to subvert it
(Bourdieu, 1975; Hong, 2008). Bergs work (1997) emphasizes that tools reinforce
bureaucratic hierarchies. Support of the established medical hierarchy is particularly

Petty and Heimer 13
salient during the backstage work of clinical research when protocols are written by
experts (Mueller, 1997). Study protocols reinforce established clinical jurisdictions by
dictating that certain categories of professionals be represented. For example, because
ACTG research units are required to have on staff experts in a long list of fields, includ-
ing virology and immunology, primary care clinics are unlikely to be selected as research
units. Other sites are excluded from particular studies because they lack relevant exper-
tise. US2 ruled out some studies because it had no on-site hepatologist. Within clinics,
research protocols support the established medical hierarchy by defining who is allowed
to examine patients, prescribe and dispense drugs, and interpret diagnostic tests.
These professional jurisdictions and other procedures of the organization are codified
in standard operating procedures (SOPs), which are required for participation in research.
According to the DAIDS ACTG, SOPs spell out exactly how you are expected to do
things.5 SOPs define how procedures, examinations, and measurements are to be done
and who should do them; they dictate how to manage samples (for example, how to array
blood samples in a box for shipment, as we learned in Thailand). They lay out procedures
for filling out case report forms and laboratory requests, for correcting errors, and for
quality assuring forms. When monitors inspect a research sites work, they routinely
verify that the site has SOPs and then sometimes check whether the site is actually fol-
lowing its SOPs (Heimer and Gazley, 2010).
Although the imposition of SOPs can be experienced as a hassle, SOPs can also be
welcome infrastructure, particularly when they clarify relations among staff and do not
simply duplicate or supplant existing infrastructure. During our fieldwork, the Ugandan
clinic conducted a big SOP writing program as it launched a large study, funded by the NIH
and the Ugandan Ministry of Health. It was a moment of liberation when the Ugandans
realized they could write their own SOPs rather than adopting the NIH templates. It is one
thing to be expected to follow a regular procedure, but quite another to be expected to fol-
low an American procedure in a Ugandan environment. SOPs must actually fit the site, and
lengthy weekly meetings were required to craft workable SOPs. But once these jurisdic-
tional and procedural issues were worked out, the SOPs were adopted for general clinic
use, reshaping relations well beyond the project for which they were originally created.
Although SOPs and research protocols reinforce some authority relations, they recon-
figure others. Conducting research disrupts established relations when local research
staff members follow research protocols and perform work they are not usually autho-
rized to do. Protocols require that research staff perform particular tests at specified
study visits or in specified situations, much like nurses are required to follow the stand-
ing orders written by doctors. A simple example is the standing order to give an analge-
sic if a patients oral temperature rises above 101F (38C). The distinction between
standing orders and research protocols is distance. Research protocols are written by
experts who may live and work far away from those implementing the protocol. As with
the standing order, the authority of a research protocol formally arises from the expertise
of those who wrote it. Nevertheless, because of the distance between the authors and
implementers of the research protocol, the apparent authority of local implementers
increases. Thus, established notions of medical authority are called into question in the
implementation of research protocols when, for instance, nurses are asked to do work
usually performed by physicians.

Authority relations are also challenged by the layers of external and internal scrutiny
introduced by research. To ensure uniformity, a protocol team reviews key site decisions,
answers questions, and decides how to manage unexpected events. Because external
study monitors regularly review the work of researchers, medical decisions must be doc-
umented in excruciating detail. Monitors appointed by study sponsors verify that study
data are accurate, complete, and verifiable, that the trial is in compliance with the proto-
col and other regulatory requirements, and that the rights and well-being of human sub-
jects are protected (International Conference on Harmonization, 1997). Unable actually
to watch the daily conduct of research, monitors primarily review records, and clinics
establish record-keeping routines to avoid getting dinged by monitors. Those whose
medical record-keeping is deemed inadequate may even receive remedial training,
quite an affront to those at the top of the medical hierarchy (Heimer, 2008).
Although the intervention of research staff in caregiving was largely about the pro-
duction of records, there were also consultations about the care itself, particularly when
local procedures would seem inappropriate to external referees reviewing the manage-
ment of serious adverse events (SAEs). Some adverse events (for example, malaria) that
are categorized as serious by the research protocols may seem routine to Ugandan doc-
tors; similarly, care that would be deemed inadequate by American researchers and doc-
tors (for example, transfusing without first doing blood tests) may be viewed as standard
in the Ugandan context. Because of these cross-national differences, the researchers in
the Ugandan clinic intervened more frequently in the work of other caregivers than did
the researchers in the American or Thai clinics. And Ugandan caregivers were generally
more willing to accept the authority of researchers, even on matters of care, than were
their American and Thai counterparts.
This was a matter of degree, however. Although Ugandan caregivers were quite will-
ing to comply with documentation requirements, where researchers had clear authority,
they were less amenable to intervention in medical decisions, where the authority of
research doctors was more precarious. For example, the Ugandan clinic staff worried
about the appropriateness of the hospital staffs admission and discharge decisions. They
were troubled that sick people were being sent home, but concerned that sending people
back to the hospital from the clinic would alienate hospital staff. Saying that the situation
made him jittery, one doctor worried that hospital staff would think here comes Dr
[name] to tell us that this patient is not ready to go home. ... Our relations with them will
deteriorate, and the patients will suffer. During our fieldwork, clinic doctors were devel-
oping a policy on when and how to intervene when they disagreed with hospitalization
decisions. Similar concerns about alienating other clinicians came up in Thailand, where
research doctors worried that less aggressive specialists in the affiliated hospital would
be irritated if clinic research doctors pushed for particular tests. To avoid conflicts, they
sometimes sent patients to private clinics for specific cultures and tests or worked through
clinic research doctors who had especially good relations with doctors in one of the uni-
versity hospitals.
The Ugandan researchers were more likely to intervene in hospital decisions than the
researchers in our other field sites because of variations in the standard of care, which we
take up now, as well as the shape and rigidity of the authority structure, which we turn to
below. HIV treatment was relatively standardized in four of the five clinics we studied.

Petty and Heimer 15
In the American clinics, clinicians were expected to follow treatment guidelines

produced by the US government or the International AIDS Society, and this was formal-
ized in US2 (the public clinic) with the adoption of clinic guidelines based on US gov-
ernment guidelines. Likewise the South African and Thai clinics had adopted formal
clinic guidelines. At the time, the Ugandan research doctors were just writing treatment
guidelines in response to what they perceived as excessive variation in the care provided
by doctors in the clinic and nearby hospital. Local treatment guidelines were a means of
improving care, but also provided a standard to which researchers could point when care
appeared inadequate to American funders. Standards can serve to defend organizations
against outsiders (Porter, 1995). Concerned that outsiders would view the care of research
subjects as inadequate, and thus unethical, the Ugandan researchers could use local
guidelines to legitimate the variation between American and Ugandan standards of care.
Local guidelines would thus reduce intra-clinic variation and improve care at the same
time that they explained and justified inter-clinic variation.
In contrast to Uganda, Thailand, and South Africa, where researchers viewed local
standards of care outside the clinic as inadequate, there was greater consensus on the
standard of care in the US and outright conflicts were rare. Moreover, in the US, inter-
vention sometimes went the opposite direction with caregivers occasionally intervening
in research to ensure that research subjects received care that met local standards. For
example, one treating physician in US1 (the private clinic) insisted that a study nurse
send a blood sample to a laboratory that produced faster results than the research labora-
tory. The treating physician worried that the study patient might go into labor before the
research laboratory provided the test results needed to determine whether a vaginal or
cesarean delivery was preferable.
The greater likelihood of the Ugandan researchers intervening in clinical care is also
a consequence of the authority structure of research. In both American clinics, nurses
implemented study protocols. It is hard for a nurse to force a doctor to perform some test.
The laboratory test for the pregnant woman mentioned above illustrates the importance
of hierarchy. In fact, the treating physician was incorrect about the duration of the wom-
ans pregnancy and the urgency of getting test results; nevertheless, the study nurse sent
the sample to the faster laboratory even though this meant missing study data and a small
slap on the wrist from the study sponsor. In Uganda, in contrast, doctors conducted study
visits under the instruction of researchers. The Ugandan researchers were typically phy-
sicians who had received advanced medical training in the US or the UK, giving them
higher status than the average Ugandan doctor, who has the equivalent of an American
bachelors degree. Thus, one reason that Ugandan caregivers were willing to adjust their
practice was that high status physician investigators were more involved in the day-to-
day conduct of research. Furthermore, research is a source of funding in a resource-poor
environment such as Uganda. In the American clinics, the infusion of research resources
was less important.
In all five clinics, research reorganized relations among clinic staff and between clinic
staff and outsiders. As their repertoires expanded with involvement in research, nurses
found that they were now expected to work more independently, to insist on the priority
of research tasks even when that made them appear to be shirking caregiving, and even
gently to remind doctors about the importance of following protocol procedures.

Participation in research raised the status of doctors, elevating them above other doctors
who still needed to be honored as equals. Often, as in South Africa, doctors from other
facilities sent their patients to the HIV experts who were also conducting research. But
caregiving is no respecter of institutional boundaries and research doctors often found
that they had to share the care of their patient-subjects with other doctors when patients
had to be hospitalized or needed treatment from other specialists. A good bedside manner
had to be augmented with strong diplomatic skills if these clinic research doctors were to
induce their colleagues to adopt the latest scientific findings rather than continuing with
business as usual. These tensions across organizational boundaries underscore the orga-
nizational accomplishment of the clinics: where work relations have been fully reorga-
nized to recognize research expertise and where staff have learned the meta-technology
of standardization, as they have in the clinics themselves, research results take root and
flourish without the aid of diplomacy.
Prioritizing the values of research

The data we have are really a goldmine, the head of the South African HIV clinic
explained with some pride. The data she referred to are the clinics medical records. She
and the other staff members came to think of their medical records as a big cohort of
HIV patients whose records might tell us something useful when someone trawled
through the data. This re-conception of medical records as data led staff to worry about
the comparability of records across patients and over time. As the clinic drafted new
clinical guidelines in 2003, it had occurred to her that if they stopped doing some of the
things they had been doing previously, they would not have baselines for comparison.
This ethos has also shaped the hospitals decisions about computerizing their medical
records, with the HIV clinic leading the way, as well as a multitude of smaller decisions
about which data to collect, how to enter them into the system (a complicated matter for
family histories or doctors notes, for instance), and the sequence in which to back enter
older records into their database. Outsiders seemed to agree that they had done a master-
ful job. Informing her staff that a group of researchers would be visiting to look at the
adult patient charts, the clinic head added that they looked at our peds [pediatric] charts
last time and were very complimentary, saying that they had never seen such good
documentation.
When patients become data, clinics adopt more objective measurements of symptoms
and standardize record-keeping (even harmonizing record-keeping with clinic guidelines
in the case of the South African clinic) to ensure commensurability. Research protocols
redefine what counts as good data and this is translated into the organizational routines
and the embodied expertise of the clinic. Moreover, this sensitivity to data made the doc-
tors in our field sites especially critical and responsive consumers of research.
As we noted, the South African clinics re-conception of its medical records arose in
part from the discussion about computerization of files. Uniform, computerized record-
keeping makes it easier for investigators to compare the outcomes of similar groups of
patients who received different treatments. Indeed, one objective of the general move-
ment in the US toward computerizing medical records is to increase comparability and
facilitate research. In US1, several staff members were responsible for computerizing

Petty and Heimer 17
records and for reviewing the information, for instance to help locate potential research
participants (with unusual mixes of characteristics).
In response to the requirements of specific research projects and funding agencies,
clinics developed practices for ensuring the comparability of records. For example, the
Ugandan clinic brought in a consultant to help them make their records useable by the
US Food and Drug Administration (FDA) because they anticipated that the data from
one study would be used as part of an FDA approval process. The Ugandan manager of
the health visitors (outreach workers) described how the new standards of record-keep-
ing increased and changed her work. Before the consultants visit, they used index cards;
afterward, they used forms. They had to legalize everything, including even the writing.
If someone scribbled, they now had to cross out the illegible inscription, correct it, date
it, and sign it. Research staff in American clinics, indeed in all the clinics, also com-
plained about these nit-picky research requirements. However, in the US similar stan-
dards of record-keeping are defined and enforced by non-research entities such as the
Joint Commission. Although pre-existing rules increase the potential for conflicting stan-
dards, they also increase the odds that the organization will be able to follow additional,
similar rules.
Multi-center research spreads Western expectations about medical record-keeping.
The practice of recording medical information to share across locations is less routine in
Uganda or Thailand than in the US. Implementing a standard medical record in early
20th century American hospitals required constructing a network of doctors, administra-
tors, and buildings (Timmermans and Berg, 2003). Similarly, maintaining research
records requires a network of personnel, objects (binders, file cabinets, computers), and
locations (laboratories, work space for completing forms and entering data, storage
rooms). While participating in treatment programs such as the US Presidents Emergency
Plan for AIDS Relief (PEPFAR) also increases record-keeping duties, as we saw in sev-
eral of our clinics, evaluations of treatment programs are typically less deep than corre-
sponding evaluations of research. Indeed, the extra documentation work required for
research compared with treatment was a source of tension among the Ugandan staff.
Donors funding treatment programs certainly expect reports and often give exceedingly
elaborate instructions for the preparation of those reports, but unlike research monitors,
donor staff and site visitors rarely review individual medical records. Research encour-
ages a legalistic orientation to medical record-keeping because of the anticipation that
outsiders will use the record to make judgments about work quality. This orientation is
already common in the US, where the audience for medical records has expanded beyond
local caregivers (for example, in the same clinic or hospital) to include outsiders who use
the records for non-caregiving functions, such as justification for payment or evidence of
malpractice.
Medical research entails a reorientation toward patient information. Numerous schol-
ars have observed the objectification of patients in medical care. During a medical exam-
ination, an individual is subjected to the clinical gaze and established as an analyzable
object, a case (Foucault, 1973). Clinicians depersonalize patients by treating them as
biological processes (Anspach, 1988). Research goes even further, because transforming
patients and their complaints into data requires removal of identifying and extraneous
information. Depersonalization conflicts with the ethos of nursing. As one US1 study

nurse pointed out, nurses are charged all the way through their training with the obliga-
tion to think of Mrs Jones in room 235, rather than depersonalizing her.
Through a process of reshuffling spokesmanship (Berg, 1997), research shifts what
kind of information is relevant and trustworthy. In particular, quantitative data are privi-
leged over qualitative data. An important example of quantification is the grading of
symptoms on a four-point severity scale to make symptoms ranging from nausea to
blood pressure comparable (DAIDS/RSC, 2004). Although symptoms are graded in
research records, they often are not graded in ordinary clinical records. Research staff
drawing on clinical records to fill out case report forms often had to ask clinical staff to
grade symptoms after the fact.
Research also tends to privilege machine measurement. As Anspach (1988) observed,
different levels of authority are attributed to technology, professional staff, and patients;
the x-ray shows but the patient alleges. The measurement of fat redistribution, a side
effect of antiretrovirals, elucidates this privileging of machine measurement. Fat redistri-
bution (lipodystrophy or lipoatrophy, in medical terminology) can radically alter a
patients appearance, resulting in sunken cheeks, extra fat on the neck and/or abdomen,
the buffalo hump, or skinny legs. Yet patient reports that they look different often seem
imprecise or inaccurate to clinicians and are insufficient for the purposes of research.
Instead, data collectors are trained in anthropometrics so they more precisely can mea-
sure fat loss and gain. Even this method is suspect, though, and some protocols insist on
the use of expensive DEXA scans to measure changes in fat distribution.6
In many medical settings, preference for precise, machine-produced measurements
has transformed the way people work. In poor countries, such expensive substitutions are
less common and when they occur, it is often through the largesse of research projects.
Thus in the Ugandan clinic, it was a research funder that supplied the mercury manom-
eter blood pressure kit for the maternity ward. Mercury manometers are used in clinical
trials because they have usually been thought to be more accurate than aneroid manom-
eters. Although this blood pressure kit brought Ugandan practices into line with research
standards, the effects of research were short-lived. As we noted above, before the arrival
of the new kit, blood pressure measurements were not made in the maternity ward. Nor
were they measured after the kit broke. If the aneroid manometers were in fact sturdier,
the choice of greater accuracy came at a high cost. Large leaps in technology often have
less long-term impact than shorter leaps when sustainability is an issue.
Most remarkably, though, participating in research changed how clinic staff thought
about scientific and medical knowledge. The doctors in our study critically evaluated
published research, taking on what Timmermans and Berg (2003) call a researcher ori-
entation. Because most medical research is oriented toward answering questions impor-
tant to wealthy countries, doctors in Uganda, Thailand, and South Africa were especially
critical consumers of research. In Uganda, clinic staff discussed research on mother-to-
child transmission of HIV, asking penetrating questions about when antiretrovirals had
become common in the research sites. Noting that elective cesareans reduced transmis-
sion, they were troubled that such procedures were not possible in their own facility,
where staff shortages meant that any elective cesarean section was inevitably delayed
until it became an emergency. What would the research findings predict about Ugandan
outcomes under these conditions? In Thailand, clinic staff were intensely aware that

Petty and Heimer 19
some side effects of antiretrovirals were more common among Thai patients than among
Westerners, perhaps because of some combination of genetic factors and lower body
weight. They were also unhappy that the local government-produced generic GPOvir
often could not be included as a comparison point in multi-site studies. To answer their
questions, they would need to conduct their own research. The South African clinic, an
early participant in the government antiretroviral roll-out, questioned some components
of the government first-line regimen. In particular, staff were deeply worried about the
danger of lactic acidosis (a life-threatening condition) when patients with a high body
mass index were given stavudine, one of the drugs included in the first-line regimen. But
what made this clinic so confident that stavudine was the problem? Well, they had done
what proper scientists do, keeping good records and analyzing their data to see what was
going on. As a result of their early findings, they purchased a machine to make more
accurate and more rapid measures of lactic acidosis so they could protect their patients.
Eventually the government agreed that the rates of lactic acidosis had been unexpectedly
high and agreed to carry out an audit (Wilson, 2006).
This impulse to do some research is quite fully institutionalized in the two American
clinics, where staff fairly often conduct small research projects using existing medical
records (chart reviews) and even carry out rather substantial investigator-initiated stud-
ies. Often these studies are either required or strongly encouraged for staff on certain
career paths or enrolled in degree programs. All five clinics welcomed outside research-
ers (including us) and felt obliged to assist them in their work. But the enthusiasm about
research described above goes well beyond this essentially routine endorsement and sup-
port of research. What we are describing is instead a habit of noting where the uncertain-
ties lie and a deep commitment to scientific inquiry as the way to answer open questions.
This lesson was brought home to us when the Ugandan staffs immediate response to an
early presentation of our research (where we hazarded an explanation about why one of
their guidelines was not working as intended) was to propose a research project (subse-
quently funded and carried out). In addition to turning clinic staff into enthusiastic
believers in science, participation in clinical research also made them eager to adopt the
results of the enterprise that they so whole-heartedly endorsed.
Conclusion
How institutions organize care and research is consequential because the more care and
research overlap, the more each is altered in the course of double-fitting the clinic and the
research protocol. Conducting clinical research is not only a means for testing new treat-
ments or a means for poor patients to get access to drugs and therapies; it is also a way to
increase the likelihood that new therapies will fit local conditions. Translating clinical
research into medical care involves complex articulation (Epstein, 1996; Rosengarten et al.,
2004) because new therapies enter a full world (Lwy, 1996) of constraining routines,
practices, and knowledge. However, this articulation occurs not only after the research is
complete, but also while it is being conducted. Even before the results of clinical studies
are announced the full world of medicine has intruded on clinical research and vice versa.
If clinical trials shape organizational routines as much as they shape medical routines,
this may help explain why scientific knowledge penetrates other arenas with more

difficulty. If one of the main routes of influence is the indirect one through organizational
practices, then less elite organizations that do not also conduct research may be less able
to adopt scientific knowledge because they lack the organizational and material cultures
that support such knowledge. This is not to say that clinics that are not engaged in
research provide poor care. What it means is that clinics that segregate research and, to
an even greater extent, clinics that do no research will have much more infrastructural
work to do before new research results can be implemented. In US2, the director had
strong ties to the research community; he also required clinic staff to follow treatment
guidelines that were updated regularly. Staff members were required to discuss certain
kinds of treatment decisions in a group meeting. In other words, mechanisms were in
place to distribute and enforce the use of new clinical tools in a way that compensated for
the partial wall between research and treatment. Given these mechanisms, what US2
mainly had to worry about was getting the other parts of its network, namely state
funders, to keep up.
How, when, and whether technologies affect the content of work is an empirical ques-
tion. In order to meet research requirements, clinics create new routines, hire new staff,
retrain existing staff, adopt new technologies, and establish new relationships with tech-
nicians and experts. The extent and permanency of these effects varies. Some research
procedures, such as the exceedingly cumbersome technique for taking blood pressure
required by some ACTG protocols, are learned only temporarily.7 A procedure that
makes nurses feel like Catholic nuns (keep both feet on the floor) is unlikely to be
widely adopted.
During the course of a study, research protocols are resources for action, but once the
study is over, clinic staff have no reason to use these protocols, except perhaps as tem-
plates for future studies. The techniques as well as the norms of research, such as the
commitment to standardization, quantification, and even the rights of individual partici-
pants, are potentially ephemeral. In the language of Sewell (1992), such schemas only
become structural when supported by human or non-human resources. Although the
effects of some protocols are fleeting, other protocols are built into the structure of the
clinic through paper and computerized forms, machines, and employment categories.
Because it is labor intensive to modify forms and job categories, once altered, they are
unlikely to be changed back.
If research and the adoption of research results are really two parts of the same enter-
prise, as our findings indicate, those eager to diffuse research results more quickly might
consider a different strategy. Rather than diffusing results, they should instead try diffus-
ing research. But although research transformed clinics in both rich and poor countries,
the effects varied, as we have noted. In effect, standardization, learned as meta-strategy
in research, is often redeployed to treatment. Clinics that do research have mastered the
standardization necessary for reworking research templates for treatment. But the effect
of standardization as a meta-strategy was larger in poorer sites where standardization of
medical care was less common and where it brought considerable legitimacy (especially
in the eyes of donors).
We also argued that research expertise is more readily accepted and drawn upon in
facilities conducting research, where bureaucratic relations have already been reconfig-
ured to recognize that new expertise. The effects of reorganizing bureaucratic relations

Petty and Heimer 21
also seem to be greater in poorer sites than in richer ones. Because trained staff are in
short supply, research funding alters staff composition much more in poor countries than
rich ones. Moreover, the disturbance of existing authority relations is especially pro-
nounced where research-trained workers are charged with bringing their site into confor-
mity with international standards and must instruct and correct others who may be
hierarchically superior.
In addition, we reasoned that organizations already adept at using the technologies
required by new medication regimens and new therapies face lower costs in adopting
research results. In poorer clinics, the material objects brought by research projects are
especially valuable because they are less likely to be duplicates of (or near substitutes
for) existing materials. At the same time, though, they are less easily replenished when
used up or replaced when damaged, so the overall effect of altering the material environ-
ment is likely to be modest unless the flow of research (and treatment) funds is very
stable.
Finally, we suggested that research participation makes clinic staff more sensitive to
the evidentiary basis of recommendations, and so more enthusiastic about adopting
research results. The new sensitivity to research values has a larger effect in poorer clin-
ics than richer ones because most research results can be applied off the shelf to richer
clinics but need to be scrutinized for applicability in poorer sites.
We do not wish to be too sanguine about the consequences of research participation,
particularly in poor countries. Others, especially Petryna (2009), have carefully analyzed
the risks as well as the benefits, both to individuals and to societies, that come with
research participation. Not least, the costs of new pharmaceuticals can easily overwhelm
the healthcare systems of poor countries, when investing in the lower-end of healthcare
would surely be wiser.
Conducting research is likely to have its most lasting effects when the network of ties
and the infrastructure built and reconfigured in the course of doing a research project are
later appropriated by subsequent research projects and care programs. Healthcare orga-
nizations are deeply transformed by conducting clinical research. Material environments
are changed as new objects are brought in and workers learn to use those objects. The
relations among workers are altered, with scientific workers gaining prestige and author-
ity. Staff members come to value precise measurement and reliable records. Research
extends the rails that allow scientific research results to be driven into the clinic. Of
course more rails can be laid and connected, but we should perhaps not be surprised that
the locomotives make their first trips to the places where rails have already been laid.
Nor should we be surprised that eager conductors start driving those locomotives while
the first rails are still being laid.
Acknowledgements
An early version of this article, titled How research shapes medical work: Organizational effects
of clinical trials, was presented at the 2006 meetings of the American Sociological Associa-
tion. The data for the article were collected as part of a larger research project, Clinic-Level
Law: The Legalization of Medicine in AIDS Treatment and Research (principal investigator,
Carol Heimer), supported by the National Science Foundation (NSF SES 0319560), the Russell
Sage Foundation, and the American Bar Foundation. We are grateful for helpful comments from

Rebecca Culyba, Lynn Gazley, Michael Lynch, Sergio Sismondo, Arthur Stinchcombe, and three
anonymous reviewers.
Notes
1. Because the world of HIV research is rather small in some countries, we omitted explicit
details about funding to conceal clinic identities.
2. We should not forget that research subjects are an important constituency. Their demand for
treatment, when it is not available elsewhere, creates an additional pressure for research clinics
to adopt the results of clinical trials.
3. The fieldwork was conducted by Carol Heimer (US1, Thailand, Uganda, South Africa; site
visits to US2), JuLeigh Petty (US1; site visits to US2, Uganda, South Africa), Rebecca Culyba
(US2), and Lynn Gazley (Thailand; site visits to US1, South Africa). Enid Wamani and Dusita
Pheungsamran assisted with fieldwork in Uganda and Thailand, respectively.
4. An SAE is any undesirable event, associated with a medical product, resulting in death,
life-threatening illness, hospitalization (initial or prolonged), disability, congenital anom-
aly or requiring treatment to prevent permanent damage (US Code of Federal Regulations
21CFR312.32). SAEs are tracked by funding agencies and institutional review boards (IRBs).
5. Defining the Terms: Policy, Guidelines, and Standard Operating Procedures (SOPs). 5 Octo-
ber 2006. Available at www.aactg.org/sites/default/files/definitions.pdf, accessed 19 January
2008.
6. Dual-energy x-ray absorptiometry (DEXA) scans use two x-ray beams of differing energy
levels.
7. A US1 study nurse laughingly explained that the protocol requires that the study patient raise
both arms during part of the procedure; that the nurse do a blood pressure test on each arm,
document on which arm the measure is higher, and then always do that arm first during sub-
sequent study visits; and that the nurse leave the study patient alone in the examination room
for 5 minutes between the measurements on the two arms so that he or she is relaxed. The final
requirement is that the patient keep both feet on the floor.
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Biographical notes
JuLeigh Petty is Senior Lecturer in the Center for Medicine, Health, and Society at
Vanderbilt University. Her research focuses on the standardization of medicine, the role
of epidemiological evidence in medical decision-making, and the regulation and ethics of
research and HIV/AIDS. She is the co-author of: Bureaucratic Ethics: IRBs and the Legal
Regulation of Human Subjects Research (co-authored with Carol Heimer, Annual Review
of Law and Social Science 6, 2010), Preparing Students to Navigate Cross-National
Differences in the Research Environment: The Role of Research Integrity Education
(co-authored with Elizabeth Heitman, in International Research Collaborations, edited by
M. Anderson and N. Steneck, Routledge, 2010), Risk and Rules: The Legalization of
Medicine (co-authored with Carol Heimer and Rebecca Culyba, in Organizational
Encounters with Risk, edited by B. Hutter and M. Power, Cambridge University Press,
2005), and The Ethnographic Turn: Fact, Fashion, or Fiction (co-authored with Rebecca
Culyba and Carol Heimer, Qualitative Sociology 27(4), 2004).
Carol A. Heimer is Professor of Sociology at Northwestern University and Research

Professor at the American Bar Foundation. She is especially interested in the encounters
between different regulatory systems and the standards and rules that they promulgate.
She is currently working on a book, tentatively titled The Legal Transformation of
Medicine: How Rules Work in the International World of HIV/AID, grounded in ethno-
graphic work and interviews in HIV clinics in the US, Uganda, South Africa, and
Thailand. In addition to pieces co-authored with JuLeigh Petty, her recent publications
include: The Unstable Alliance of Law and Morality (in The Handbook of the Sociology
of Morality, edited by S. Hitlin and S. Vaisey, Springer, 2010), Old Inequalities, New
Disease: HIV/AIDS in Sub-Saharan Africa (Annual Review of Sociology 33, 2007), and
Conceiving Children: How Documents Support Case versus Biographical Analyses
(in Documents: Artifacts of Modern Knowledge, edited by A. Riles, University of
Michigan Press, 2006).

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Social Studies of Science

Extending the rails: How 124

research reshapes clinics Reprints and permission: sagepub.

Conducting clinical research is an organizational accomplishment with organizational

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fieldwork in clinics in several countries, it illustrates how these organizational processes

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Data and methods

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US1 (private) US2 (public) Thailand South Africa Uganda

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How research reshapes the clinic:Three general processes

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Altering the material environment of the clinic

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enactment of research protocols require and increase standardization in the clinic. We

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Indeed, it is debatable whether research participation can be fully voluntary in places

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Reorganizing bureaucratic relations

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relationships, sometimes supporting and sometimes challenging existing hierarchies. As

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In the American clinics, clinicians were expected to follow treatment guidelines

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Prioritizing the values of research

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Carol A. Heimer is Professor of Sociology at Northwestern University and Research

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