information giving and enactment of consent in written consent forms and in participants’ talk...
TRANSCRIPT
EMPI RICAL STUDY /ANA LY SIS
Information Giving and Enactment of Consentin Written Consent Forms and in Participants’ TalkRecorded in a Hospital Setting
Marilena Fatigante • Franca Orletti
� Springer Science+Business Media Dordrecht 2013
Abstract The paper examines the attainment and adequacy of informed consent in
an ethnographic–discursive study on gynecological visits involving doctors,
patients, and nurses. Starting from a theoretical discussion on informed consent and
the principles upon which it relies, the paper highlights the changes and the
adjustments that these principle undergo in practice, from the planning of the
research till later stages of the researcher’s fieldwork and data recording. Analyses
first focus on the informed consent as a written artifact and show how the
description of the study indexes the prospective participants’ identity, as well as, it
works in favor of the researcher’s (or, other institutional representatives such as the
managers of the Hospital) accountability. Then, the authors focus on instances of
audio and video recorded doctor–patient–nurse interactions in which information is
reformulated by the doctors, in such a way as to anticipate and/or respond to the
nurses’ and patients’ concerns with regards the project (such as, the risk of exposure
to the public). The analysis of these episodes carry ethical implications, in that they
alert that patients, nurses, and doctors may be not equally knowledgeable about the
project and that they can be conceded unequal opportunities to have their inter-
pretations and identity performances acknowledged and inscribed on the tape.
Keywords Informed consent � Rhetoric � Recording � Institutional
asymmetry � Medical visits
M. Fatigante (&)
University ‘‘Sapienza’’ of Rome, Via dei Marsi 78, 00185 Rome, Italy
e-mail: [email protected]
F. Orletti
Third University of Rome, Via Ostiense 236, 00146 Rome, Italy
123
Hum Stud
DOI 10.1007/s10746-013-9303-z
Informed Consent in Theory and Practice
The debate on informed consent is huge and crosses several fields such as law,
medicine, sociology, philosophy, and more (see Katz 1984; Faden and Beauchamp
1986; for annotated bibliographies Sugarman et al. 1999, and, from 1998 to 2004,
Wiles et al. 1999, accessible at http://www.sociology.soton.ac.uk/Proj/Informed_
Consent/Resources.htm). It is in healthcare, biomedical contexts that informed
consent has developed and received the highest degree of formalization. Immedi-
ately after World War II, the main concern was to protect human beings from the
risk of being recruited as subjects in harmful experiments such as those perpetrated
by Nazis in concentration camps (Hazelgrove 2002; Weindling 2004; quoted in
Murphy and Dingwall 2007). Since then, clinical trials and biomedical research was
subjected to a strict and strongly bureaucratized ethical monitoring (Nuremberg
Code 1948; Declaration of Helsinki 1974), prescribing that the researcher explains
to the participants, as clearly and exhaustively as possible, the aims and procedures
of the study, the absence of any risks or discomforts for them, the expected benefits,
the measures to protect participants’ confidentiality and archive data in secure ways.
These principles were maintained by other codes of behavioral research, such as
the American Psychological Association’s Ethical Principles of Psychologists and
Code of Conduct (see http://www.apa.org/ethics/code/index.aspx?item=3).
Adequate information delivered to the participants by written consent forms
should ensure the respect of the participants’ autonomy, which Faden and
Beauchamp (1986: 239) posit as the encompassing principle of ethics in research,
even considering the right to privacy as ‘‘reducible to or derivative’’ (1986: 9) from
the autonomy principle. Acknowledging someone as an autonomous agent, in fact,
enables that person to exert exclusive control over personal data and any other
information that can be disclosed or used by the researcher, a problem that charges
the individual himself with the opportunity to evaluate whether or not anonymity is
a desirable aim (Hopkins 1993).
Routinely, informed consent and related issues such as, the discussion of
confidentiality, is gained ‘‘at the outset of the relationship,’’ and ‘‘thereafter as new
circumstances may warrant’’ (Code of Ethics APA 1992). Such ‘‘anticipatory’’
regulatory regime (Murphy and Dingwall 2007), poses—particularly for ethno-
graphic and observational studies—serious problems with regards to the adjustment
of the procedure to the practice, i.e., the live context in which the research takes
place. Apprehending what the research is about, and understanding the degree to
which they can perceive their private realm be over-exposed to external gaze,
cannot be limited to a single moment in time prior to the ‘‘beginning’’ of the
research. Marzano (2007) emphasizes that ‘‘by subordinating the conduct of
research to formal assent by the participants studied or by prior approval by the
committees, the proponents of deontological positions attribute to participants an
ability to make rational comparison of the costs and benefits of their involvement in
the research that is very difficult to perform at the beginning of the research (…)’’
(2007: 428).
As a matter of fact, what the participants understand and agree to regarding their
involvement in the research may be not fully apparent to them, and often to the
M. Fatigante, F. Orletti
123
researcher as well, until particular incidents happen, which threaten the relationship
of trust and respect the two parties mutually established at the start of the research
(Ellis 2007; Etherington 2007).
Furthermore, the displacement of the activity of consent—gaining at the outset of
the research course rules out the possibility to analyze how participants are
informed, how they manifest their understanding of the research instructions and
how they eventually express their agreement to participate.
Studies in Ethnomethodology and Conversation Analysis have analyzed routine
practices of gaining consent during recordings of telephone surveys (Maynard et al.
2010; Maynard and Schaeffer 2002), sociolinguistic observational studies (Mondada
2006), calls to services and organizations (Speer and Stokoe 2012), and face-to-face
interaction in a psychiatric setting (Speer and Stokoe 2012), all done while the
recording devices (as well as the data collection itself) were already ongoing. These
studies have explored how practices of gaining consent are handled in the
interaction in ways that may markedly differ from idealized protocols. Analyzing
the design of consent-gaining turns (typically formatted as announcements rather
than requests), Speer and Stokoe (2012) show how they ‘‘tilt research participants
towards assent’’ (2012: 15), something that holds true also for written forms of
requesting consent.
By opening the ‘‘methodological black box of informed consent’’ (Speer and
Stokoe 2012: 3) to overt investigation, these studies demonstrate the unavoidable
gaps between theoretical principles and actual practices of behaving ethically in
research.
Participants’ Concerns Arising in Audio and Video-Assisted Research
Studies that have analyzed participants’ orientation to the recording tools (Gordon
2012; Lomax and Casey 1998; Monahan and Fisher 2010; Speer 2002; Speer and
Hutchby 2003) have been revealing about both methodological and ethical aspects
embedded in giving consent to video- or audio-assisted research.
Aimed to contest the old prejudice about the non-naturalness of behaviors
produced when participants know they are being recorded (the observer’s paradox;
Labov 1972), these studies have turned the participants’ reactivity to the tape into an
analytical and hermeneutical resource for understanding what the participants treat
as morally relevant for them. Speer and Hutchby (2003) label as ‘‘tape-affected
speech’’ (2003: 321) sequences occasioned by the presence of the recording,
including episodes in which participants orient to the ‘‘inappropriateness of certain
kinds of talk’’ (2003: 325) and/or overtly express negative reactions (such as,
annoyance) to the recording technology. Rather than discarding these episodes, or
treating them as evidences of data contamination, these authors advocate the need
for analyzing them as ‘‘the situated ways in which research ethics and the morality
of recording are played out as participants’ concerns’’ (2003: 321).
Over the long-term audio recordings of American couples talking at home,
Gordon (2012) found how participants may comment about, through, or to the
Information Giving and Enactment of Consent
123
recorder, in both literal and non-literal ways. Similarly to Speer and Hutchby,
Gordon includes instances in which the recording is glossed as a burden or, within a
non-literal frame, as a spy-bug, a wire capable to exhibit sensitive aspects of
personal and family identity such as, political orientations.
If, on one hand, these instances may be heard to question the grounds upon which
the participants have expressed their consent at the beginning of the research, on the
other they show to be treated by participants themselves as interactional resources to
perform identity work, in Monahan and Fisher’s terms (2010), staged performances,
‘‘deeply revealing of how individuals perceive themselves and would like to be
perceived’’ (2010: 363). In this perspective, comments addressed to or about the
recorder, which make relevant its risky consequences for the morality of the
participants, are ways to inform the researcher about the participants’ reflexive
awareness of the research instruments; another tool by which informants exercise
their agency ‘‘to make sense of and influence researcher and research results’’
(Monahan and Fisher 2010: 362).
Participants though, may differ in their reactions to the tape or, as regards the
extent to which they can make their reactions evident and influential on the research
results.
Relevant to our topic, studies on the influence of videotaping in medical
consultations different, and sometimes inconsistent, results. Redman et al. (1989)
highlighted that doctors and patients markedly differ on a measure of perception
of behavioral efficacy when they were video recorded. Notably, the doctors
reported the feeling that their behaviour had been affected by the observation
more than patients did. Another study showed that in GP consultations, patients’
refusal to be video recorded was mainly accounted for reasons such as worrying
about being watched by others and embarrassment about the specific health
problem reported (Martin and Martin 1984). The same study also revealed how
patients were more willing to sign the consent form when they are ‘‘in the
territory of the doctor’’ rather than when the researcher handles the form to them.
Furthermore, patients who accept and sign the consent form, may still report
feeling uncomfortable by video recording afterwards (Coleman and Manku-Scott
1998; Coleman 2000).
These latter results hints to the fact that institutional hierarchy and power can
affect, and shape toward certain directions, what is otherwise expected as a
voluntary, autonomous choice of the individual (Katz 1984; Bain and MacKay
1995).
Grounding on the literature examined so far, the study discusses the process of
attainment of informed consent during an ethnographic research project carried out
in a gynecological unit of a public hospital in Italy, focusing on how aspects of the
consent were recalled and re-enacted during the recordings of the gynecological
consultations, involving patients, doctors, and nurses.
M. Fatigante, F. Orletti
123
The Study: Aim and Methodology
The study was carried out over the course of 1 year (2009–2010) in a Gynecology
Outpatient Department in an Italian public hospital. Data included the collection of
audio- and video-recorded gynecological visits with (mostly) pregnant patients.
For the aim of this paper, we examine two different kinds of data:
1. in the first section, we analyze written consent forms of the study, examining
how they were written and revised in consecutive versions;
2. in the second section, we analyze episodes from audio and video recorded
medical visits, in which the different participants (doctors, nurses, and patients)
make relevant issues associated with informed consent; this corpus includes
episodes in which participants refer to the loss of confidentiality that the audio
(or video) taping of their behavior can entail. As regards these episodes, we
particularly aim to examine what are the problems to which the participants
orient when they display attention to the research tasks and the recorder, and
how they deal with them.
As for the analysis of the letter accompanying the consent forms, we rely on the
theoretical and methodological framework of Discursive Psychology (Potter and
Wetherell 1987) and, particularly, on its recognition of the rhetorical ground of
descriptions (Billig 1987, 1991; Edwards 1994).
Transcripts of the video and audio recorded interactions in medical visits were
analyzed according to the principles of Conversation Analysis (Sacks et al. 1974;
Schegloff 2007), thus privileging in-depth analysis of the sequential structure (turn
by turn) of the event.
The Corpus
A total of 35 doctor–patient–nurse audiotaped interactions and 10 videotaped
interactions of gynecological visits were collected. The group of patients were either
expectant mothers or mothers who have just delivered their baby. Half of the
patients were native speakers of Italian, the rest were non-native speakers (coming
from different countries including Bangladesh, Morocco, Philippines, Peru,
Ecuador, India, Romania) talking fluently and understanding Italian in all cases
except three of them. Three different doctors (two men and one woman) participated
in the study. Medical visits lasted on average 180. Almost 25 % of the visits were
check up consultations conducted with the same patient. Informed consent was
collected before the beginning of the visit with only one exception, in which the
patient expressed her consent verbally prior to the visit and only signed the form
after that. When used, the video camera was oriented toward the desk, placed
sideways; given its position, it was able to capture the interaction as the doctor
interviewed the patient, in the front part of the room; the physical examination
(including weight measurement and body inspection) occurred instead in the back of
the room, separated by a curtain and invisible to the video camera.
Information Giving and Enactment of Consent
123
Prior to the collection of recordings of gynecological visits (which were only
allowed by the Director of the hospital few months later the admittance of the
researcher to conduct observations in the ward), the methodology included
fieldwork done by the researcher.
Analysis Section 1: The Crafting of the Consent Form
Some information on how the researcher (one of the author) had access to the
research site will provide a background to understand how the consent letter was
planned and its language formulated.
One of the doctors working in the hospital (kin-related to the researcher)
mediated access to the institution and brought the project to the attention of the
Head of Gynecology and Obstetrics. An appointment between the researcher and the
Head followed in July 2009. During this meeting, the overall objective of the study
was presented as follows: it was stated that we (researchers) wanted to examine
doctor–patient interactions as they would naturally develop during the gynecolog-
ical consultation in order to observe the communicative processes and find any
possible flaws, with particular regard to interaction with foreign patients. Due most
likely to the professional and personal trust between the Head and the doctor who
mediated the exchange, the proposal was immediately accepted and the Head
showed himself willing to help develop the project and facilitate communication
with the other institutional representatives (colleagues in the Ethical Committee of
the Hospital and the Administrative Manager), who were required to express formal
approval of the proposal.
As Pope (2005:1182) states, ‘‘ethical issues are magnified in medical settings, not
least the informed consent’’. As a matter of fact, a provisional draft of the informed
consent was the first document that the Department Head requested. A letter stating
the aims and procedures of the study and the request for authorization were then
prepared. We opted for an identical formulation of the consent form for both doctors
and patients, in that we chose to stress the ‘communication’ between them as the
focus of the research, not favoring either of the two sides. Informed consent forms
were translated into 9 languages, after considering the different ethnic and linguistic
backgrounds from which the patients participating in the study may plausibly
originate (according to reports by the Department Head and the other doctors):
English, French, Romanian, Tagalog, Chinese, Arabic, Spanish, Bangla, and Hindi.
Below is the informed consent form in its original format.
We numbered each paragraph in order to aid recall of the specific parts that were
later modified:
M. Fatigante, F. Orletti
123
Although designed merely to inform the participants about the scope and
procedures of the study, it is immediately apparent that the letter does much more
than this. First of all, the letter frames the interlocutory context and indexes the
identities of the interlocutors: i.e., who is the author and who is the addressee. The
pronoun we, used at the very beginning (point 1), identifies the researchers as a
group, thus diffusing the responsibility of authorship and action over a plural
subject, of which the researcher present is thereby only a representative. This may
work as a rhetorical device that strengthens the likelihood that the addressee may
trust the interlocutor as a spokesperson (or partner) of a more authoritative subject.
Also, at point 3, there is a reference to the researchers’ knowledge and to previous
studies on the topics. Both these elements cast the researchers’ identity and
enterprise as a professional, scientific one, working again to enhance the reliability
of their proposal. As a matter of fact, science is commonly conceived as an
enterprise worthy of consideration and respect in its own right (Ziman 1978).
Furthermore, despite being addressed to doctors as well as to patients, the letter
displays the researchers’ efforts to take the patients’ perspective into particular
account and acknowledge the patients as the ultimate beneficiaries of the research
results. This is particularly evident in the wording of the last parts of paragraphs 3, 4,
and 10, marked in bold. Attention to the patients’ experience, their needs and
demands is explicitly stated and presented as both the reason motivating the study
(see the expressions ‘‘we know,’’ ‘‘we believe’’) and its ultimate, beneficial goal.
Beneficence for patients is also recalled in the reference to good treatment outcomes.
Overall, it seems that the first version of the informed consent letter was aimed at
gaining, in particular, patients’—more than doctors’—collaboration and support for
the project. This preference can be easily understood if one considers that
collaboration from health professionals was provided to the researcher quite
independently of the written consent: the researcher’s access was negotiated well
before, and the researcher had several other opportunities to inform the doctors and
obtain (or fail to obtain) their availability in participating in the study. Conversely, the
process of informing the patients was much more reliant on the written instructions in
M. Fatigante, F. Orletti
123
that the researcher would only meet them once, immediately prior to the visit, when
she asked for their authorization.
Whereas the first points of the letter appear to be inspired by the principle of
beneficence, points 6 and 7 seem to emphasize instead the autonomy principle, as
the participant is referred to as someone who authorizes and who is free to choose
whether or not to participate.
Notably, though, point 5 makes reference to the fact that the researchers themselves
have also asked for and obtained authorization from the official representatives of the
Hospital, the legitimate subject holding responsibility for the correct unfolding of the
institutional (i.e., clinical) activities of the ward. The sentence works in further
securing the researchers’ accountability (Garfinkel 1967; Heritage 1984; Buttny
1993), insofar as it declares that they have been formally entitled by the Hospital itself
to conduct their activity and, thus, they are not threatening agents.
The final section (point 8) contains a reference to the participants’ right to
privacy and to the researcher’s dutiful commitment to protect it. Interestingly,
whereas the epistemic responsibility for conducting the research has been attributed
to a collective subject, the legal responsibility for data protection is located onto one
single person, who is also the one who is materially visible to the participant. The
likelihood that someone self-nominates for a position of legal responsibility, even
accepting the risks connected to potential prosecutions if something goes wrong,
may be conceived as proportional to the likelihood that the person may be
considered responsible and trustworthy. The writing choices, then, help the
researcher to build a claim of reliability and trust, which may eventually affect the
participant’s likelihood of considering the option of authorizing the research.
Requests for permission to audio-record were prepared for doctors and patients as
follows:
Information Giving and Enactment of Consent
123
The language in the authorization forms provided above displays a particular
leaning towards the ethical concern of guaranteeing the participant enough
information for her to express free will in choosing whether or not to participate.
Information Giving and Enactment of Consent
123
The register of the authorization form is more ‘formal’ and neutral than the
summary of the project stated in the informative letter (Annex 1/a), and references
to specific laws and paragraph numbers are included. The neutral register makes
effective the attempt to avoid or reject ‘‘the rhetoric adornment’’ (Billig 1987: 4) of
communication and to forestall the risk that the recipient may lose his independence
in making a choice.
A special effort was made in order to make sure that the reader had fully
understood the information stated in the briefing. Terms such as ‘‘examine,’’
‘‘read,’’ and ‘‘understand’’ are mentioned in series, scaffolding the participant’s
attention and making sure that he only comes to a decision (as to whether or not to
participate) with full knowledge of what such consent implies.
The Ethical Committee of the Hospital gathered on October 19th 2009. Revisions
of the informed consent were requested: the Ethical Committee asked us to better
specify the research aims and describe the data collection procedures in more detail
in the informative letter (paragraphs 3 and 5); they also required that specific
reference to the Ethical Code on Personal Data Protection and a guarantee of secure
data storage be included (see paragraphs 7 and 9).
We report below the second version of the informative letter, sent after the
revision. Substantial changes to the previous version are marked in bold.
M. Fatigante, F. Orletti
123
As can be observed, in the revised version the references to the personal,
ideological commitment of the researchers (‘‘we know’’ and ‘‘we believe’’ in
paragraph 3 of the first version of the letter) have been erased, in favor of a clear
statement of the aims and objectives of the research (‘‘the aim of the study’’; the
‘‘overall purpose of the study’’; paragraphs 3 and 4 of the revised letter). Also,
procedures of data collection were described in more detail (par. 5).
In the second version of the form, the researchers also add more specificity about
the kind of analysis they will conduct on the data. They wrote: ‘‘The conversations,
collected as such, will be transcribed and analyzed with exclusive attention to their
linguistic and discursive features’’ (point 5 of the revised letter).
This is quite a critical point: what does it mean to conduct an analysis of
linguistic and discursive features exclusively? How is it possible to overlook the
content of what is said, once every single word produced by the participants has
been recorded and transcribed? The perspective followed by the researchers (trained
in Conversation Analysis) alerts them to consider the form and sequential structure
of the talk as more informative—and relevant for the analytic aims of the stated
approach—than any content analysis of the talk. Still, to look at the form cannot
M. Fatigante, F. Orletti
123
prevent them from hearing what people say. This is a dilemma that cannot be
avoided and cannot be erased by the quite vague—elliptic—expression at point 5.
Besides this specification, more details were provided with regards to the
legislation to which the researchers adhere (parr. 7 and 9).
The researchers responded in this way to the concern voiced by members of the
Ethical Committee and the Administrative Manager about the threat of procedures
that risked over-exposing the privacy of patients. Because the study involved
audio and video recordings, and given that data related to health status are among
the most sensitive data that may be collected from individuals, the institutional
representatives were particularly concerned with ensuring protective measures
against the risk of participants being identified, namely, anonymization. The
choice of a technical, procedural lexicon works here to strengthen vis a vis the
addressee the identity of the researcher as a knowledgeable, responsible, and
trustful agent.
The analysis of the written forms of consent shows, then, how giving information
is never a straightforward, neutral activity. The changes that the written letter and
authorization forms underwent during negotiations between the researchers and the
managing directors of the Hospital reveal the researchers’ attempts to strengthen
their accountability as professional members, acting ethically towards their
interlocutors, either the institutional representatives of the Hospital, and the patients
as prospected participants.
Descriptions of the study aims and procedures are inevitably constructed as
rhetorical discourses, allowing the researchers to perform identity work and pursue
particular social, interpersonal aims: while emphasizing the expected beneficial
outcomes of the study, the researchers attempt to enhance affiliation with the
interlocutors and make them part of a shared enterprise that would be equally
profitable for the participants and for themselves; while referring to legal articles on
privacy, the researchers attempt to secure themselves as trustful interlocutors, aware
of the judicial value of their assertions and commitment they make with the
participants.
Both strategies work to build and maintain a relationship of overall solidarity and
trust between the researchers and the participants, which may favor the opportunity
that these latter, at least, consider authorizing the study as an option.
Analysis Section 2: Informed Consent in Action
As Faden and Beauchamp (1986) stress, ‘‘[s]ubstantial understanding demands
apprehension of all the material and important descriptions—not all the possible
descriptions…’’ (1986: 304). By ‘‘material’’ the authors indicate that information
which is considered relevant according to a subjective criterion of the participant,
that is, according to the set of norms, preferences, and values which constitute the
moral framework of that particular individual.
A series of episodes selected from the audio and video recorded interactions
show how the participants express their concerns about their talk being recorded.
Information Giving and Enactment of Consent
123
These episodes show that not all material descriptions were provided in the
informed consent by the researcher.
In the following excerpt from an audio recorded interaction, the patient, the
doctor, and the nurse have engaged in a sequence of ‘‘small talk’’ (Coupland 2000)
regarding the advantages and disadvantages of delivering the baby at the end of the
current year or at the beginning of the next (the patient’s pregnancy’s full term falls
exactly on December 31st). The nurse, in particular, had voiced her opinion that to
deliver at the end of the year would be a definitive misfortune in that the newborn
would be doomed to be attributed 1 year more when in fact he is only a few days or
even a few hours older than people who are attributed 1 year less. That comment
had solicited the doctor’s amused reaction. At this point, the nurse expresses her
wish that the researcher would ‘‘cancel’’ parts of the data.
The nurse’s comment opening the exchange is an example of what Speer and
Hutchby (2003) call as ‘‘tape-affected speech’’. These authors looked at the precise
ways in which participants react to being recorded and consider them as instances of
‘‘situated morality,’’ defined as the set of ethical preoccupations (such as, concerns
related to rules of proper demeanor in public) which cannot be formulated in
principle but, rather, emerge as participants’ concerns are made relevant in talk.
Coming immediately after the sequence of small talk in which she has engaged,
the nurse’s formulation marks the recorder as a risky tool in revealing awkward
performances—in that they depart from an expected professional demeanor—to a
wider audience. Her turn reveals her orientation regarding the extent to which the
anonymity of their data and talk will be preserved.
M. Fatigante, F. Orletti
123
Underlying the nurse’s comment, though, is not only a concern regarding her
public image as a sensitive issue. There is also her interpretation that only certain
data are good and useful for the research purposes; mundane assessments, personal
opinions, and, generally, talk that is not professionally relevant seems to be
considered negative and trivial, such that it needs to be removed from the ‘‘official’’
data that will constitute the object of the research.
The doctor responds to the nurse’s comment with extended laughter (line 2);
treating it as a laughable, she soothes the seriousness of her claim. Further, she
contrasts the nurse’s interpretation, maintaining that the sequence that the nurse is
referring to is still part of communication and in this sense it needs not be discarded.
The negotiation between the doctor and the nurse ends quite rapidly: the doctor puts
the argument to a close (alright, line 4), normalizing the episode as something that
can be expected (after all) and pursuing the nurse’s agreement by means of the tag
question at the end of the turn (Heritage and Raymond 2005). We do not have
access to possible multimodal displays of the nurse’s agreement or disagreement,
but we know that she does not continue, accepting the doctor’s turn as a termination
of the topic. The patient too, orients to the closing of the activity by initiating the
greeting exchange, and thanking the doctor for the visit. In the way in which the
doctor cuts short the nurse’s concerns, and the nurse does not insist, this episode
makes relevant the institutional distribution of entitlement to action among the
participants in the medical visit. As a matter of fact, the nurse’s wish cannot be
satisfied, insofar as the participants consented to the video recordings of the ‘‘visit’’.
The doctor’s response defends the procedure, and aids the researcher’s interest of
saving as much data as possible and avoiding data deletion, which the nurse’s wish,
inscribed on the tape, would entail.
This can be discussed as evidence that the doctor, in the absence of the
researcher, acts as her ally, employing rhetorical strategies to face the other
participants’ concerns.
In the next excerpt, the doctor anticipates and neutralizes the concern that may
(potentially) arise from a patient, about being subject to the researcher’s external
scrutiny. The researcher has momentarily left the room1 in order to recruit patients
who were expected to arrive later in the morning, and inform them about the
research.
1 Once the data collection started, it was decided that the researcher would stay in the room while the
consultation was recorded. This condition was negotiated between the researcher and the doctors, as these
latter expressed their preference for having the researcher physically identifiable by and accessible to the
patients.
Information Giving and Enactment of Consent
123
a
a meaning, the researcher
The excerpt originates from a case in which the participants
interpreted differently some of the information given by the researcher: the
researcher had mentioned to her informants (both doctors and patients)
M. Fatigante, F. Orletti
123
the possibility that she could recruit the same patients across consecutive
visits.2
The doctor (not shown in the transcript) interpreted these as part of the research
protocol and delivered this information as such to the patient in the room. The
sequence opening between lines 1–5 casts the researcher as someone who
apparently did not understand or fully acknowledge what the participants told
her. The doctor’s turn ‘‘the lady has given the consent but’’ (line 1) makes clear that,
in the doctor’s understanding, the formal authorization is only a partial
accomplishment, in that further events will prevent the researcher’s aims (as
interpreted by the doctor) from being properly fulfilled. The patient aligns to this
version, as she underlines that she had informed and warned the researcher about the
fact that she was about to deliver, so she would have not been available a second
time to contribute to the research project as a pregnant patient. Note that the
patient’s choice of the word warned to refer to what she told the researcher implies a
certain degree of complaint from her part, toward the researcher’s inability to
understand or inattention.
Soon after this sequence, the doctor, unsolicited, adds in a formulation of the
nature of the study (line 6). Several adverbs she uses (by the way, actually) display
her attempt to reassure the patient about the non-harmfulness of the recordings (and
the research overall), and normalize the effects of the study on the patient’s
experience.
As a matter of fact, she had solicited the patient’s complaint that the researcher
had not attended to what she told her. Now, she orients instead toward a
minimization of the implications of this failure, emphasizing that the interest of the
study is only restricted to the limited, and local sphere of the communication they
have (lines 6–8).
The use of the extreme case formulation (Pomerantz 1986; Edwards 2000) at line
7 (‘‘it has nothing to do’’) is also interesting. It appears quite similar to that
employed in the informed consent discussed earlier, when the form referred that the
analysis would be conducted ‘‘with exclusive attention to linguistic and discursive
features’’ (paragraph 5 of the revised letter). In rephrasing the study details, then, the
doctor seems to use the same argumentative move, aimed at reducing the
threatening quality of the research as a self-exposing and possibly exploitative
activity.
The way in which the doctor frames the researcher’s analysis is also interesting.
She labels it in terms of a ‘‘communicational analysis’’. The adjective communi-
cational is quite rare in ordinary language and there is a lack of consensus as to
whether it can be considered a correct Italian word at all. When used, it is associated
with a specialized register, such as certain theoretical and practical approaches to
communication in sociology or psychology, or bureaucratic and administrative
language (Fortis 2005). Viewed as such, the doctor’s choice of communicational
2 According to the hypothesis of the researcher (not mentioned to the patients), which guided the design
of the study, collecting data over an extended period of time from the same patients would provide the
possibility to compare and analyze possible changes and developments in the patient’s communicative
and health literacy skills, as the pregnancy unfolded and the chances to discuss pregnancy-related matters
with the doctors improved.
Information Giving and Enactment of Consent
123
instead of the more common communicative would place the researcher’s interest at
such a high, ‘‘technologized’’ level of specialization that the chances that her actions
may overlap or impinge effectively on the patient’s experience would be
diminished. This is further stressed at line 7, as the doctor asserts that what the
analysis will target ‘‘has nothing to do with what we do’’. In this way, she rules out
the hypothesis that the researcher is interested in the effective medical practice the
doctor and the patient are engaged. By displacing the interest of the researcher onto
the level of ‘‘communication’’ only, the doctor addresses—and attempts to
prevent—the patient’s potential concern of having her health and her body exposed
to an external gaze; this would imply an harm to her right to confidentiality.
The patient, similarly to the nurse in excerpt 1, ratifies the doctor’s interpretation,
without pursuing the argument further. By repeating twice that she was informed by
the researcher herself, she concurs to repair the breach in the researcher’s
accountability and trustfulness that the event recounted has generated.
To sum up, we have seen in both excerpts how participants recall, during the
audio or video recorded visits, the conditions they have stipulated in the informed
consent.
When made relevant, it was the doctor who reasserted the aims and procedures
implied in the research instructions, anticipating and reassuring the other
participants about the benignity of the research.
The management of research-related tasks and activities (for which the
researcher, and not the doctors, should be held accountable) among participants,
then, indexes the asymmetrical, institutional distribution of roles and authority
between doctors, the nurses and the patients in the medical visit.
The episodes analyzed so far raise a double concern for the researcher: first, one
may question to what extent the participants have been made aware about the kind
of use (e.g., analysis, dissemination) that the researcher will make of the data. The
nurse’s comment in excerpt 1 reveals that she had imagined that only work-related
talk would be taken as object of analysis whereas, as scholars in the analysis of
doctor–patient interactions (among others) know, small talk or other ‘‘non-
instrumental’’ sequences of actions regularly provide the basis for relevant
analytical claims (see, among others, Maynard and Hudak 2008). In the consent
letter, the restriction of the research’s interest to ‘‘doctor-patient’’ communication
and the emphasis devoted to the efficacy of the communication may have
legitimately obscured the likelihood that any instance of talk, also including the
nurse or other participants who have delivered their consent, would be observed and
analyzed. Secondly, the excerpts show evidence that in both cases the doctor, in the
absence of the researcher, acts as her ally, reassuring about the non-harmfulness of
the recordings (and the research overall), strengthening then the likelihood that the
participants would not express resistance to—or simply doubts about—the use of
data, and eventually repairing (excerpt 2) to momentary breaches in the researcher’s
accountability.
Given that the doctor’s behavior has an influential character on the other
participants’ responses (Martin and Martin 1984), this raises a doubt with regard to
the likelihood that all participants in the medical visit can be given equal
opportunities to consent to research in full autonomy and with no external influence.
M. Fatigante, F. Orletti
123
Another set of episodes, regarding the participants’ orientation to the recording
device, shows how doctors entitle themselves to engage with the researchers and the
research apparel in a different, more authoritative way, as compared to nurses, and
patients.
Staged Performance in the Hearing Space of the Tape
We found a few number of episodes, in different visits, in which participants overtly
gloss the presence of the recorder. Consistently, it is the nurse, rather than the
doctor, who makes this concern explicit.
We show only one of these instances.
The episode starts as the pregnant patient reports a ‘‘bad experience’’ that she had
with a certain doctor working in the hospital, whose name is ‘‘Marini’’ (fictional
name). Specifically, the referred doctor gave her a wrong diagnosis and made her
feel very anxious, so much that she could not sleep, for several days. The patient is
Ecuadorian and she mispronounces the doctor’s name converting the original name
‘‘Marini’’ into ‘‘Marines’’ (accordingly to the Latin habit for which many names
terminate with an ‘‘s’’). This error is repeatedly recalled in the interaction in favor of
the possibility that the participants can tease the absent party, i.e., the doctor whose
name has been transformed.
Information Giving and Enactment of Consent
123
Recycling the patient’s mistake as a ‘‘prior laughable’’ (Glenn 2003:82), the
doctor hooks the opportunity for launching a joke: he ironically suggests to modify
the name of another colleague, in the same fashion in which the Ecuadorian patient
had modified the name of doctor Marini (line 3). At this point, a scene is constituted,
in which the doctor, the nurse, and the young trainee present in the consultation
room talk behind someone’s back. Parody and tease are ‘‘improper’’ and tactless
moves with regards to the tacit assumption and ethical expectations that members of
the same professional community behave fairly towards co-members. The nurse’s
comment, at line 12, ‘‘we’re recorded’’ provides evidence that she interprets the
current exchange as vulnerable to the public scrutiny, alerting the co-participants
about the threat that the recorder could make upon the confidential nature of the
gossiping exchange. The trainee also refers to the recorder (line 13), probably
M. Fatigante, F. Orletti
123
commenting on how it is presently conditioning the context, in which he is only
temporarily present.
In the turns that follow (lines 15, 18), the doctor makes the implications of the
threat explicit: the recorder is qualified as a spying device (Gordon 2012) able to
publicly reveal opinions that would be otherwise concealed to the external audience.
Contrary to the previous turns, the doctor’s move is uttered at a normal volume of
voice; in this way, it appears to be overtly heard by the recorder (and, thus, by the
researcher who will later transcribe the tapes). Whereas the nurse commented about
the recorder, the doctor, comments to the recorder (Gordon 2012), making explicit
the risky consequences that the recording of their behavior can have for their
professional identity and career (‘‘he will report me’’). In so doing, he not only
displays (as the nurse did) a reflexive awareness of the research device, but he also
entitles himself to stage an identity performance—at the thresholds between the
literal and non literal meanings—in which he plays as someone who might
potentially be prosecuted for misbehavior in the professional context. In so doing,
he also implicitly addresses the issue of whether or not the researcher can fully
respect what he stated in the informed consent, i.e., protection of participants’
confidentiality. As a matter of fact, in cases such this one, the only measure to
protect participants from being recognized would be never playing the data (voices
could be identified) or even deleting them. Our choice, as analysts, was to keep this
extract, given that the participants neither chose to stop the recorder, nor asked us to
do. Still, the option (methodologically valid) favoring the analytical treatment of
such instances, is done at the cost of behaving ‘‘indifferently’’ with regards to what
the participants mark, in the hearing space of the recorder, as strictly confidential
and morally sensitive.
Looking at the three excerpts altogether, we are able to better understand how
issues related to informed consent on one hand, and concerns about recordings on
the other (mutually dependant in this study) are dealt with as participants’ matter,
and how they solicit particular actions by the different parties involved in these
triadic (doctor–patient–nurse) institutional encounters.
The excerpts showed how participants, in the institutional setting of a medical
visit, may have differential access to information and experience different degree of
understanding of the aims, procedures, interests, and identity of the researcher.
Ethnographers working in settings such as hospitals or hospices, claim in fact that to
ensure all participants an equal knowledge about the research project is impossible
(Marzano 2007), and that a ‘‘hierarchy of consent’’ (de Laine 2000) needs instead to
be anticipated.
All excerpts make clear how participants orient to the recordings as something
that may impinge over either the integrity of their professional demeanor (excerpts 1
and 3) or the meaning of the institutional transactions between the doctor and the
patient, which powerfully involve in this case the inspection of the body.
Excerpt 2 and 3 in particular, show that nurses oriented to the recording device as
a threatening device. Having examined a larger set of instances in which
participants address the recording instruments, we have observed that comments
directly addressed to the recorder or the researcher about the arrangement and the
effects of the recording instruments are explicitly formulated by nurses only and, in
Information Giving and Enactment of Consent
123
few cases, keyed as ironic comments by doctors. Patients may join comments by
professionals but they do not initiate them (see excerpt 1). Once in the consultation
room, the patients seem to act in conformity to their institutional role, adhering to
the tacit script prescribed by the observational research frame: ‘‘act spontaneously,
as if you were not being recorded’’. In this fashion, they do ‘‘being patients’’. How
this relates to autonomy in expressing consent, and implications for building consent
with the participants is what we address in the conclusions.
Conclusions
We have presented in the introductory section how respect for the autonomy and
self-determination of participants relies on granting them full information on the
process in which they will participate.
However, we have seen in the practical delivery and enactment of informed
consent that information given to participants can be far less neutral, exhaustive,
and relevant to them.
Rhetorical Pitfalls of Information-Giving
In the analysis of the written consent, we have seen how information about research
aims and procedures always conveys the researchers’ preferences and assumptions.
Insofar as they display the researcher’s commitment toward certain ‘‘desired
outcomes,’’ descriptions are rhetoric artifacts, pursuing not only understanding but
also agreement and affiliation with the speaker.
What appears as a limit here could, if properly acknowledged, be included as an
integral and legitimate part of the informative letter, insofar as a clear distinction
could be made between information about the project (and particularly, about the
kind of participation required by that project) and disclosure of the researchers’
scientific and moral positioning.
In the context of informed consent in medical treatment and research, the
disclosure of the professional’s own perspective, opinions, and recommendations
proves reasonable and less ethically debatable, if it serves the task of preserving the
patient’s health. Faden and Beauchamp favor the hypothesis that the researcher
supplies information about these topics also in order to avoid charging ‘‘the patients/
subjects as the solely responsible for processing and evaluating the information
provided’’ (1986: 308).
The ‘‘beneficial’’ outcome for participants in behavioral research is less obvious
and certainly not essential to the individual’s physical wellbeing. For this reason, the
decision about whether or not to participate needs to rely ‘‘solely’’ on the
participant’s judgment. Still, the opportunity for the researcher to disclose his own
position, including elements of the theoretical and methodological approach s/he
uses—for instance, in our specific case, in analyzing conversations—could
encourage the participant to have her/his own independent opinion about the
nature and validity of the study, and better consider whether to contribute or not.
M. Fatigante, F. Orletti
123
Rhetoric in itself does not deterministically orient the interlocutor’s judgment
but, rather, opens up a context for debate and argumentation (Billig 1987; Edwards
1994).
Recording Tools and Participants’ Concerns
The analysis of ‘‘tape-affected’’ sequences of speech (Speer and Hutchby 2003)
helped to understand what the participants orient to as matters of concern when they
exhibit their bodies and talk in front of a video camera, or in the presence of a
recording device.
As a matter of fact, the use of recording tools alerts participants about the risk
that anonymity, although promised in the written form of consent, cannot be totally
guaranteed, a possibility of which the researchers are also highly aware (Corti et al.
2000). Conversation Analysis has transformed the ethical question of whether or not
the researcher is allowed to use data that are marked as sensitive and private by the
participants, into a methodological claim and advantage, in that they can help better
understand the participants’ perspective and respect ‘‘the situated ways in which
research ethics and the morality of recording are played out as participants’
concerns’’ (Speer and Hutchby 2003:321).
Recording tools, inasmuch as they amplify—for the analysts—the possibility to
observe and deepen the understanding of the formal structure of interaction, also
enhance participants’ possibility to gain reflexive awareness of what they are doing.
Following this line, we add that the instances in which some of the participants
voiced their concerns that their behavior could be publicly observed or evaluated
can also be interpreted as the ‘‘share’’ of ‘‘instructions’’ that the participants
themselves communicate to the researcher.
By formulating their own views on the recording practices, participants display
themselves as fully entitled partners in the research process, not merely ‘‘subjects’’
being observed, but agents capable to frame events according to certain
interpretations, and thus, to intervene on the ‘‘inscriptions’’ (Latour and Woolgar
1986) that their social performances leave on the tape.
Interpreting reflexive instances of the sort we have analyzed in light of
participants’ agency (as other authors did) may constitute, we suggest, another way
to respect the principle of autonomy. In this regard, we must also consider that in no
instance these episodes have led the participants to revise their consent. Interpreting
their concerns as suggestions for the researcher to erase the data, or treat them
differently from the rest of the talk, would actually disable, without consulting with
them, the agreement that participants have formally stipulated in the signature of the
consent.
Information and Democracy of Participation in the Institutional Setting
To open up an interlocutory context in which the research plan and its antecedents
can be openly disclosed by the researcher, rather than embedded and disguised as
self-evident information in the consent letter, may also allow for information—and
Information Giving and Enactment of Consent
123
understanding—to be better negotiated, even with participants whom the researcher
meets for one time only, as in the case of patients in the present study.
We have observed how doctors, nurses, and patients were themselves able to
manage and embody part of the information delivered by the researcher. Still, these
participants exhibited unequal opportunities to voice their concerns and doubts or
interpretations with regard to the aims and procedure of the study. This was related
to the study design: the doctors, particularly, had the chance to meet the researcher
beginning with the preliminary access stage, when she was allowed to carry out
paper and pencil observations in the unit, and they also had prolonged opportunities
to have access to her and her research artifacts. They entitled themselves to
‘‘master’’ the research setting more than the nurses did, and, by declining or
neutralizing the nurses’ concerns in a playful way, more than they allowed the
nurses to do. The doctors were also able to transform the recording tools into
amplifiers of their staged performances, thus exerting an active influence on the data
and results.
As regards the patients, they only entered the scene as the recording was switched
on, and they remain mostly ‘‘voiceless’’ in the staged performances that we have
analyzed. Correspondingly, the researcher gained more knowledge about the
doctors and the professional organization of their practices than she had of patients’
experience, which, nonetheless, figured in the informed consent as a primary
concern of the researchers and a motivating force of their research activity.
Dedicating more efforts to allow participating patients and nurses as well, the
opportunity to discuss informed consent, understand the researcher’s commitment
independently from the doctor’s commitment, voice their concerns and interpre-
tations, and revise—if they feel the need—their authorization even soon after the
visit would be a proper way to respect these (apparently less noticeable)
participants’ autonomy in full awareness of what they consented to.
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