Questionable requirement for consent in observational research in psychiatry.
ABSTRACT Informed consent represents a cornerstone of the endeavours to make health care research ethically acceptable. Based on experience of qualitative research on power dynamics in nursing care in acute psychiatry, we show that the requirement for informed consent may be practised in formalistic ways that legitimize the researcher's activities without taking the patient's changing perception of the situation sufficiently into account. The presentation of three patient case studies illustrates a diversity of issues that the researcher must consider in each situation. We argue for the necessity of researchers to base their judgement on a complex set of competencies. Consciousness of research ethics must be combined with knowledge of the challenges involved in research methodology in qualitative research and familiarity with the therapeutic arena in which the research is being conducted. The article shows that the alternative solution is not simple but must emphasize the researcher's ability to doubt and be based on an awareness of the researcher's fallibility.
- SourceAvailable from: Jenni Burt[Show abstract] [Hide abstract]
ABSTRACT: The equitable provision of care is a core principle of the NHS. Previous research suggests that older cancer patients may be less likely to use specialist palliative care than younger patients, but studies have failed to fully define and measure clinical need. The aim of this study was to examine use of specialist palliative care in relation to age, after controlling for need. I used a mixed methods approach, grounded in a pragmatic philosophy and drawing upon a health capability account of equitable healthcare. I undertook a focused ethnography of three specialist palliative care services, using documentary evidence, observation of meetings, and interviews to investigate conceptualisations of need for care. I derived two models of need. The first ‘aspirational’ model encompassed physical, psychological, social and spiritual care for patients and carers. However, with limited resources, a predominantly physical model of need was applied. Additionally, observations suggested that care may vary in relation to patient characteristics including age. To locate a suitable measure of need, I conducted a systematic literature review and critical and content appraisal of health-related quality of life instruments. I chose the EORTC QLQ-C30 instrument as the indicator of need in a cross-sectional survey of patients and carers, conducted to measure use of specialist palliative care in relation to age. 252 patients and 137 carers attending four outpatient lung cancer clinics participated. 39% received specialist palliative care. Age was not associated with use of specialist palliative care; metastatic disease, global quality of life (‘need’) and the clinic where treatment was provided were. These findings suggest equitable use of specialist palliative care. However, a comprehensive account of equity must consider both use and quality of care. There were some suggestions that, within a resource-limited context, the quality of care may vary. Future equity research should prospectively consider variations in use and quality of specialist palliative care for different patient groups across all care settings, and from diagnosis to death.
- [Show abstract] [Hide abstract]
ABSTRACT: To summarize important recent contributions to the literature on the subject of ethics in psychiatric research. Current literature reflects an expansion in the range of psychiatric research on ethics topics. Articles continue to appear on core ethics subjects such as informed consent, but many recent contributions focus on diverse issues such as third-party privacy, the ethics of Internet-based research, revisiting the wisdom of imposing medical ethics requirements on observational research, and psychiatric research ethics as applied to special populations such as children or older persons. Psychiatric research is critical for the elucidation, prevention, and treatment of mental diseases. Increased attention and novel approaches taken to obtain informed consent, correcting therapeutic misconception, and guarding privacy will advance the research enterprise and continue to ensure that the subjective experiences of participants in psychiatric research remain positive.Current opinion in psychiatry 12/2008; 21(6):572-7. · 3.57 Impact Factor
- [Show abstract] [Hide abstract]
ABSTRACT: Qualitative research is largely dependent on building good interpersonal relations between researcher and participant. This is necessary for generating rich data, while at the same time ensuring respect is maintained between researcher and participant. We argue for a better understanding of researcher-participant relations in research practice. Codes of ethics, although important, do not address these kinds of ethical challenges. Negotiating the ethical relations between researcher and participant is paramount in maintaining ethical rigour in qualitative research. In this paper we propose concepts that can assist in understanding how the ethics of research relations are negotiated in practice; the 'zone of the untouchable' from the Danish philosopher, Løgstrup, is combined with the notion of 'ethical mindfulness'. We argue how and why these concepts in tandem can heighten awareness and offer ways to address the ethically important moments in research.Medicine Health Care and Philosophy 11/2008; 12(3):291-9. · 0.91 Impact Factor
QUESTIONABLE REQUIREMENT FOR
CONSENT IN OBSERVATIONAL
RESEARCH IN PSYCHIATRY
Marit Helene Hem, Kristin Heggen and Knut W Ruyter
Key words: acute psychiatry; informed consent; participant observation; power dynamics
in nursing care; psychotic patients; research ethics
Informed consent represents a cornerstone of the endeavours to make health care research
ethically acceptable. Based on experience of qualitative research on power dynamics in
nursing care in acute psychiatry, we show that the requirement for informed consent may
be practised in formalistic ways that legitimize the researcher’s activities without taking
the patient’s changing perception of the situation sufficiently into account. The presenta-
tion of three patient case studies illustrates a diversity of issues that the researcher must
consider in each situation. We argue for the necessity of researchers to base their
judgement on a complex set of competencies. Consciousness of research ethics must be
combined with knowledge of the challenges involved in research methodology in
qualitative research and familiarity with the therapeutic arena in which the research is
being conducted. The article shows that the alternative solution is not simple but must
emphasize the researcher’s ability to doubt and be based on an awareness of the
Informed consent represents a cornerstone of ethically acceptable health care research.
Research participants in the field of psychiatry are often particularly vulnerable and
much thought must be given to research ethics.1?5In this article we will highlight
problematic aspects of the requirement for informed consent in acute psychiatry. We
will use empirical data from a study conducted in an acute psychiatric department to
discuss how to understand and cope with the dilemmas that inevitably arise in such a
challenging research field.
The study in question was conducted in a locked ward of an acute psychiatric
department in a city in Norway. (The main author (‘I’/‘me’/’my’/‘MHH’) performed
most of the empirical work as part of a PhD thesis. The terms ‘we’/‘us’ refer to the
main and secondary authors or to all three authors.) The study focuses on how nurses
Address for correspondence: Marit Helene Hem, Section for Health Science, Faculty of Medicine,
University of Oslo, PO Box 1153 Blindern, NO-0318 Oslo, Norway. Tel: ? /47 22 85 84 20;
Fax: ? /47 22 85 84 11; E-mail: firstname.lastname@example.org
Nursing Ethics 2007 14 (1) # 2007 SAGE Publications10.1177/0969733007071357
use power in their interaction with psychotic patients in ways that either promote
patients’ dignity or have a degrading effect. The study has an ethnographic design and
data were collected by participant observation over a period of 30 weeks and by
interviews with nurses and psychotic patients.6?11
This article was occasioned by an injunction from a supervisory body that
demanded informed consent to be acquired at all times from all patients admitted
to a locked psychiatric ward. It has proved impossible to comply with this injunction.
After several weeks of compliant, doubtful and somewhat unsuccessful attempts to
follow the consent rule, we reached a point where we had to make a choice: the study
would either have to be abandoned in its current form as a research project based on
empirical data, or the method would have to be changed. We chose the ‘non-
compliant’ alternative after consulting the National Committee for Medical Research
Ethics, which is an advisory and co-ordinating body for the regional research ethics
committees,12and after gaining the support of the hospital and the university institute
management for our decision. The project was continued with the requirements that
general information on the project be made available and that respect be shown for any
patient reservations about being observed.
The empirical basis for the discussions in this article was derived from the ‘non-
compliant phase’ of the project. The purpose is to show why a practice that is governed
by rules, and which has the objective of acquiring consent for research from psychotic
patients, is inappropriate. We also wanted to demonstrate how and with what
problems and misgivings an alternative and more flexible, situation-orientated
practice was developed.
Before we present empirical data in the form of the case studies that constitute the
basis of the discussions, we will first give more details about the reasons for the
injunction we were obliged to contravene.
In Norway there are three bodies that are ascribed the task of supervising health care
research. First, there are the Regional Committees for Medical Research Ethics13that
function as independent advisory and guiding bodies. Second, we have the
Norwegian Social Science Data Services14that assess aspects of privacy protection in
particular. Neither of these two bodies made any comments on this study. The third
body, the Directorate for Health and Social Affairs,15takes decisions on cases that
involve access to information that is subject to confidentiality and on dispensations
from the duty to observe confidentiality.
The reason we had to contact the Directorate for Health and Social Affairs was
because health care personnel are obliged to prevent unauthorized persons from
gaining access to confidential personal information with which they become familiar
in the course of their work. In this context a researcher is considered an unauthorized
person. In a letter dated 8 September, 2003 (reference 03/3889T7TS LRH), the
Directorate therefore concluded that, pursuant to the Norwegian Health Personnel
... on the basis of a total assessment of the project as a whole and since Section 29 of the
Health Personnel Act does not provide justification for permitting observation, a
42 MH Hem et al.
Nursing Ethics 2007 14 (1)
dispensation for conducting this project cannot be granted. In the opinion of the
Directorate, any performance of the project must be based on consent from all patients
attached to the hospital ward involved.
Three case studies to illustrate reasons for
Below we present data that describe in some detail the relationship of the main author
(MHH) to three patients, Ida, David and Tom. It was not possible to acquire explicit
and informed consent to my presence from any of these three. The use of discretionary
judgement from one situation to another was a common feature of the relationships.
Ida: ‘Oh, please! Don’t make me ... ...!’
Ida was acutely psychotic and had delusions and paranoid ideas. She was cautious,
did not say much, and was polite and pleasant. I found her somewhat guarded in her
contact with co-patients and employees and with me. To a certain extent she kept to
her room, frequenting the common rooms for only short periods. However, after two
weeks a form of contact had been established between us. I wanted the best for her: she
was fragile and this was her first hospitalization. I also thought that Ida could be a
significant participant. She was intelligent and reflective. When we came across each
other in the corridor or when Ida came into the sitting room to chat with her co-
patients, nurses and/or me, there was an instant rapport between us. Two days before
she was to be discharged I asked her if she would consider being interviewed. She
consented, and we made an appointment for the following day. Ida said she thought
she had something important to tell me about her very first frightening experience of
being psychotic and being admitted to an acute ward.
However, Ida seemed evasive the following day. When I cautiously reminded her of
our appointment, she said she thought other patients would have more to contribute
than her. I felt intuitively that I should keep my distance and leave her alone. She was
discharged shortly after this encounter. The doubt about what had happened in my
relationship with Ida preoccupied me. I recognized my eagerness to obtain informa-
tion from her, information that I presumed would be extremely valuable, although
there was something in her obvious vulnerability and withdrawal that made me also
withdraw. I constantly consulted the nurses about those I was planning to recruit as
participants; they gave me the impression that Ida would prefer to forget the entire
psychosis, get out of hospital and carry on with her life. I did not find this
interpretation convincing and I was left with no good explanation or advice about
what was the ‘right’ action for a researcher.
Ida was re-admitted two weeks later. She seemed very ill. She talked incoherently
and walked restlessly and unsteadily back and forth. She was unkempt and could not
manage to dress herself or eat without help, but she remembered that I was a
researcher in the department. I did my best to keep my distance at the same time as I
tried to send her positive glances that were intended to signal: ‘I’m still here, but I
won’t force myself on you.’ I was in doubt about whether my message was
understood. Maybe Ida thought I was keeping my distance as a sign of my
disappointment over her previous refusal to be interviewed? It could also be that
Questionable requirement for consent in observational research43
Nursing Ethics 2007 14 (1)
my presence in the unit disturbed her. I felt uncertain about how to understand and
tackle the situation.
One day Ida came up to me and said clearly and urgently, almost shouting and
imploring: ‘Oh please! Don’t make me take part in the research project!’ This episode
made a deep impression on me, but it was also a relief. The uncomfortable situation
was resolved. Her outburst was overheard by a nurse who told me that Ida was
struggling with numerous voices and that she had the feeling of being under
surveillance and steered by strong powers. Among the struggle and chaos, the nurse
had realized that Ida was also fighting against ‘tests’ and being the victim of an
experiment. I was grateful for the nurse’s explanation and Ida’s demonstration. The
situation was also relevant to the question of whether participant observation poses
an unacceptable additional strain on psychotic patients in an acute psychiatric
David: ‘Will I get royalties from the book sales?’
David was a mature man who had been admitted involuntarily for psychosis. He had
a long record of illness with several admissions. He functioned relatively well for
periods and managed to use his creative abilities in his job. He had seen the notice
about the research project and immediately made contact when he saw me. I perceived
David’s willingness to participate in the project as unusually intense. I tried to calm
him down and to take the consent proceedings slowly. David became irritated and told
me loudly and clearly that he really had a lot to contribute to the research. He almost
ordered: ‘Write down everything I say!’ He was restless in his movements and
disturbed many of the other patients.
I experienced many dilemmas resulting from his intense wish to take part in the
project. I tried to withdraw by sitting elsewhere or talking to others, but he followed
me and urged me once again to listen to everything he said about Norwegian
psychiatry and his experience as a patient. I tried to keep my distance and reminded
him that it was not primarily the patient’s life I was focusing on but the nurses’ work
with patients. Aggressive and forthright, David replied: ‘Them ? / the nurses ? / they
don’t work at all.’ It was without doubt an interesting patient experience, and I
followed it up in different ways that provided valuable data about David’s experience
of being pathologized and ignored.
Some days later he was again excessively eager about his commitment to the project.
I now noticed that his interest was more positive and more factual. Applying the
consent I had obtained, I started a new conversation with him. He proved to be skilled
in writing and he had several intelligent questions about the research project. We sat in
the common room in the unit and chatted for almost half an hour about psychiatry,
nurses and research. He wanted to discuss how the doctoral thesis was to be written.
He visualized a best-seller that would bring in a large income. I explained that I was
going to write articles. He saw that as a poor solution and argued strongly for a book in
which his experience could be given focus. When he had decided that a book must be
published, he suddenly asked in total seriousness: ‘Will I get royalties from the book
sales?’ My attempts to correct him seemed only to reinforce his opinion and he
repeated it continuously. He became more insistent in his arguments and did not let
me out of his sight. His behaviour towards me illustrated the problem of power
dynamics and setting limits in psychiatry (the actual subject of the research project).
44 MH Hem et al.
Nursing Ethics 2007 14 (1)
His ‘quest’ for the researcher’s attention provided me with valuable data while also
making me uncertain about whether it was right to include him in the research out of
consideration for his own good (he was in a locked ward in order to regain his peace of
mind). It was also annoying to be exposed to David’s intense and persistent interest. It
was a relationship from which it was almost impossible to escape. I noticed that to
cope with the situation I activated the knowledge and experience I had acquired as a
psychiatric nurse. My role varied between that of therapist and that of researcher. I
activated a knowledge base that gave me power in the situation and that also enabled
me to handle David’s persistence. For a person researching the power dynamics of
nursing care, this mixture of roles provided data and was interesting in itself, but it
was also unpleasant and problematic.
Tom: ‘Damn nosey status seeker!’
Tom was also very interested in the research project that he had read about on the
notice in the corridor. His interest developed differently. I had heard at the morning
meeting that Tom was unstable and that his behaviour towards women often
emphasized sexual aspects. Tom appeared as I entered the sitting room. We introduced
ourselves, and he said that the research project looked interesting and he would like to
participate. He thought he had experience to contribute as he was older than me. He
gradually became more interested in me than in the research. He was seeking contact.
One day when we sat in the corridor he stroked my arm gently and made a comment
about the jacket I was wearing. Suddenly he said, ‘You really are nice-looking!’ I
thanked him for the compliment, sat there calmly and did not regard his interest as
disagreeable or sexual, but rather as his way of making contact. We talked a lot, and he
told me about his difficult life in and out of psychiatric institutions. He told me about
his sadness at not fulfilling his own and others’ expectations of his career. He appeared
to be a gifted man with artistic talents. This changed shortly afterwards.
For some days there was considerable unrest in the department, with several new
admissions, aggression, piercing screams and vandalism in the sitting room. Tom
could not tolerate the changes in the environment and became disturbed and very
anxious. One day when I entered the unit he shouted: ‘You just walk around here
snooping. Damn nosey status seeker! You don’t know anything! You’re a careerist! Just
keep away from me with your research!’ I was upset because the accusations were
crass and I found them unreasonable, but I did not have the ‘right’ to argue. My task
was to observe, converse and make notes. I was there primarily to do a job rather than
to take on the function of therapist, even though I once again experienced that it was
difficult to make a distinction between the roles. I thought Tom’s reaction should be
understood in the light of my having unlimited development opportunities while
he had ended up fighting for his mental health and regretting an abandoned career. He
saw that I was upset and suddenly expressed concern about having been so angry.
He apologized again and again; he assured me that the project was important and that
he would do all he could to support it.
This episode was a new challenge for me. I wondered how to handle Tom, the course
of his illness and his consent to the research. Should I take into account the fact that at
his most anxious and insecure time he had turned his back on me and withdrawn his
consent? Could I regard it as an episode and an exception that confirmed his ‘yes’ to
the consent? Was his consent to participation merely a fulfilment of his wish for contact
Questionable requirement for consent in observational research45
Nursing Ethics 2007 14 (1)
with a person who had time to sit and listen? Was this an ulterior motive that was
acceptable from the viewpoint of research ethics?
I was present the day Tom was discharged. He felt calmer and was ready to leave.
He shook my hand and thanked me politely for the time and attention I had given him
and hoped that his contribution would be useful for my research.
The case histories leave an impression that the research was conducted in a field where
both the patients and the ambience are characterized by great despair, sadness, rapid
changes in atmosphere, insecurity and aggression, but also by pleasure and new
opportunities. The unreliability of informed consent is clear and the patients’
fluctuating capacity2to assess what they are being asked about is striking. The above
descriptions show how demanding it was to relate to these patients and how I
repeatedly had to activate my skills as an ethically conscious researcher, participant
observer and psychiatric nurse. My doubt about what was right and what was wrong
is clearly conveyed.
With empirical data on problems concerning research ethics as our starting point, our
discussion will now cover three different standpoints. We start with the most extreme
solution to the dilemma facing us: that the project should not be carried out because it
was impossible to obtain informed consent. We then discuss the practice that was
established and study more closely the research ethics issues that arose, particularly
the consent problem. In the third and final part of the discussion we outline and argue
the necessity of the researcher applying discretionary judgement and a flexible, more
situation-orientated approach to the ethical challenges linked to vulnerable patients’
No research without consent
One consequence of the injunction to obtain consent and the subsequent problems in
the research field was the conclusion that the injunction from the supervisory body
(the Directorate for Health and Social Affairs) made correct practice impossible and
that the project would therefore have to be terminated. The Directorate underlines the
importance of protecting psychotic patients owing to their vulnerability. This is a
standpoint we support. Furthermore, the Directorate claims that psychotic patients are
so vulnerable that it is unacceptable to involve them in schemes in which a researcher
participates in the field for a long period. Does the patient’s vulnerability therefore
preclude the researcher being integrated into the therapeutic arena? The practice that
was developed in this research project indicates a negative reply to this question.
The descriptions of Ida, David and Tom show, as the Directorate points out, that
psychotic patients are vulnerable owing to their vague and to some extent flawed
understanding of reality. They are afraid, and they probably experience existence as
unpredictable and fragile. The descriptions, however, likewise show that, despite their
vulnerability, they are brave and ‘strong’: they interact with the people around them,
46 MH Hem et al.
Nursing Ethics 2007 14 (1)
they are humorous and they dare to express their opinions, often with great force. The
descriptions also show that the researcher was in doubt when she met both the
patients’ strength and their vulnerability, and she activated different types of
competence to handle the situations. We consider the doubt to be positive, and so
far have restricted ourselves to stressing that vulnerability is a complex phenomenon.
There are grounds to question whether the perception of psychotic patients as
vulnerable contributes to devaluing them and deprives them of their legal capacity,
with the result that they are not expected to be able to take decisions and be rational in
certain areas.2,16,17We do not rule out that it may be a positive experience for patients
who have limited autonomy to meet a researcher who has interest in their experience
because they are then approached with expectations of having their own opinions.18
Conducting the type of research described here is closely connected with co-
operation in the workplace and gives employees an insight into how a researcher
handles situations with patients/research participants. When we decided to
continue the project despite the fact that it was not feasible to implement the
injunction, the decision was influenced by support from professional circles both
within and outside the department where the project was conducted. Solid backing
from the practice field, the university and the research ethics bodies inspired us to
continue collecting data. This meant that individuals with wide and comprehensive
expertise in research ethics, professional ethics, psychiatry and qualitative research
methods considered the research ethically acceptable and did not agree with the
public supervisory body’s instructions.
It is also worth mentioning the need to develop knowledge of what takes place in
psychiatry. For some time, acute psychiatry has been the frequent object of strong
criticism, partly because it is regarded as a field that is closed to access. Research can
help to bring to light both critical and constructive aspects of therapeutic practice.
There is clearly a need for knowledge about what happens on a daily basis in an acute
psychiatric department: what creates dignity and what degrades patients?19An
interesting example from our material that shows the ambiguity of care concerns the
setting of limits for David. Setting limits for patients’ behaviour can be degrading, even
though it is necessary to promote dignity at that moment and in the long term. The
way in which limits are set may appear demeaning, but the process can also create
dignity and must be interpreted in the light of the specific context. Knowledge of this
type of process between patients and employees cannot be acquired if the researcher
does not participate and try to understand what is happening.
Consent is not only consent
At the very first meeting with the department/research field, MHH was struck by how
data on the field flowed in continuously, even though the intention at the start was
only to obtain consent. Being shut in and locked up, hearing shouts and seeing bed
restraints etc provides information about power in therapy. The point is that collecting
data cannot be separated from requesting consent in this type of research.2,3,5,20?22
MHH’s attempts and investigation to determine how far Ida, David and Tom should
be involved in the research shows how important it is to establish a relationship that
can form the basis for assessing what is in the best interest of the participant.
Establishing relationships with psychotic persons takes time and is demanding. It is
inevitable that information is acquired in the process of obtaining consent, and in this
Questionable requirement for consent in observational research47
Nursing Ethics 2007 14 (1)
type of research it is therefore not possible to distinguish between procuring
information and being present, which entails the researcher having access to
information that is subject to confidentiality.
The fact that there is a connection between achieving information about patients and
that negotiations about consent may take time also sheds light upon another issue that
has been a focus in qualitative research for the last 10? /15 years, namely, ‘process
consent’21,23,24or ‘ethics as process’.25These concepts have been discussed in several
ways, based on different kinds of research projects.24?26A common trait, however, is
that there seems to be a growing awareness of the dynamic qualities of qualitative
research (especially participant observation). An understanding that consent is given
once and for all is both insufficient and misleading. From the stories of Ida, David and
Tom we would like to point out two issues. First, it is obvious that their consent was
invalid because of their rapid shifts of opinion about whether or not to participate in
the research project. Their consent had to be continually negotiated. Second, the
relationship and communication between the patients and MHH was at times based as
much on MHH’s therapeutic skills as on her research competence. Her professional
background in psychiatry was of vital importance for her ability to interact with the
psychotic patients and take into consideration whether or not she could rely on their
willingness and abilities to be part of her research.
The three narratives from the ‘non-compliant phase’ illustrate that, in different ways,
these patients had a somewhat unclear understanding of to what they were
consenting. Ida, for example, wanted to relate her experience even though it was
frightening for her to talk about what she had been through. However, she had
consented and MHH could have exploited the situation and maintained that ‘consent
is consent’. (Those who were interviewed signed a consent form. At that time Ida had
not given her written consent to being interviewed.) Ida was in an extremely psychotic
state on her second admission, thus research would have seemed the same to her as
‘tests’. She may also have presumed that tests and observations of her would be made
secretly. A common problem with psychotic patients is that they feel they are being
monitored and recorded. Ida was worried about having contact with a researcher she
thought would make records and carry out tests. MHH experienced ambivalence
between not burdening the patients with information and explanations on the type of
research she was conducting while realizing that patients like Ida could develop
‘crazy’ and disturbing associations such as that research in psychiatry involves tests
and perhaps manipulation. The ambivalence reinforced the doubt about whether her
daily collection of data in the department was too stressful for the patients. Would the
knowledge the project provided in the long term justify the strain expressed directly or
indirectly by the patients?
A dubious feature of researchers who comply with the rules is that they follow
standards and procedures rather than endeavouring to exercise discretionary judge-
ment in their assessments. It is tempting to simplify the complex and difficult aspects,
and thus claim that the research is safe and ethically acceptable, even though this is not
necessarily the case. How can consent show that no persuasion, inveigling or coercion
occurred?27The point of consent is that it is intended to prevent those taking part in
research being deceived or exposed to coercion; but full consent is an illusion.27MHH
felt relieved on the days she had obtained consent from all the patients (in the
‘compliance phase’), but there was still a nagging doubt because she knew that several
of them had signed a document without understanding what it implied. She therefore
48 MH Hem et al.
Nursing Ethics 2007 14 (1)
felt she had behaved unethically, even though in formal terms she was in the right. The
fact that she chose to be ‘non-compliant’ did not make her daily work less complex. On
the contrary, throughout the ’non-compliance process’ she was constantly aware that
she should check and appraise the value of any consent. Ida provides an example of
obtained consent that soon became refusal to participate.
The whole question of consent seems strange in a department where limits are strict
and clearly defined by the staff and where the patients are largely deprived of the
authority to decide for themselves. Ida’s reactions illustrated that the practice created
anxiety and insecurity among the patients. Tom’s frequently ambivalent attitude to the
project also shows that he was not competent to give informed consent because he
regarded MHH as ‘damn nosey’. Both the employees and MHH found such conduct
unnecessarily disturbing for a treatment unit where the key concepts were security,
calmness and structure. David was unambiguous in his desire to participate and he
undoubtedly had extremely valuable experience to contribute. The reason MHH was
reticent was that she did not consider him competent to give consent. His interest in
the project also faded as he became less psychotic and regained greater control over
himself, but MHH could have taken his consent as given and thus placed less
emphasis on his failing competence.
Flexible and extended perception of consent
So far our discussion has focused on a dual standpoint: ‘yes’ and ‘no’ to consent. The
message is that it is important to consider psychotic patients’ vulnerability and
consent, but this must be negotiated depending on the situation and by using a
complex knowledge base. It is neither feasible nor acceptable to found actions only on
Several authors have disputed the view that qualitative research methods are
‘harmless’ compared with research that involves trials of new types of treatment,
and that the rules for consent are less stringent for this type of research.3,28Research
involving the researcher participating actively in the field/department poses a major
risk of offending the patient’s integrity. For example, the concept of a mutual
relationship between researcher and patients conceals the fact that research exploits
others for the purpose of creating knowledge.29,30Ida is an example of a participant
who agreed to be interviewed only to withdraw her consent vigorously later. She
appeared to be troubled by MHH’s presence and by her possible participation in the
research. Indeed, she misunderstood the type of research involved and refused
corrective information. MHH was in doubt about whether Ida was harmed by her
presence. Similarly, one can also question whether David and Tom (who were
respectively indiscriminately persistent and ambivalent to the project) were so
disturbed by MHH that their disquiet and insecurity increased. We are left with
doubt, and we give the researcher the benefit of the doubt. Here, as well,
assessments from the staff were critical for MHH remaining in the field. We believe
that MHH’s knowledge of psychiatry and her experience with psychotic patients’
insecurity were of help and ensured respect for the patients’ integrity. We believe
that in general the risk of distress was low.2,31,32Nonetheless there is a danger of
following the customary power patterns that can degrade patients. Contact with
patients/participants constitutes a continuous challenge that must be interpreted and
Questionable requirement for consent in observational research49
Nursing Ethics 2007 14 (1)
handled according to the situation, and it demands ‘a wide and robust concept of
reflexivity’ (p. 134).22
We argue that it is appropriate not to view research ethics in isolation but to consider
which other sources of knowledge a researcher can use to ensure good and acceptable
research practice. Further discussion therefore includes professional knowledge and
qualitative research competence as relevant knowledge bases.
Clinical competence and research ethics
Requirements regarding ethical awareness and safeguarding patients’ integrity are
basic concepts in psychiatry. MHH’s professional background enabled her to behave
with sensitivity and respect. For instance she withdrew (not exerting pressure on
Ida when Ida retracted her consent to the interview) or accepted verbal attack
(‘damn status seeker’, ‘you just walk around here snooping’) in a matter-of-fact way
and calmly. MHH’s response was founded on clinical experience from psychiatry,
where developing skills in accepting what patients express represents a major form
of competence. Managing specialized knowledge is ultimately dependent on the
person in question. The researcher’s individual aptitude ? / and ability to exercise
good professional judgement ? / is therefore vital for participant observation to be
carried out in an ethically acceptable manner. However, professionals with a high
degree of ethical awareness may still behave unethically in their research.
Researchers with qualifications in psychiatry who are accustomed to frequenting
the power structures of an acute psychiatric arena may be blind to their own
exercise of power and offensive behaviour. This is a major argument against the
importance of specialist knowledge. Nonetheless, MHH’s clinical experience and
theoretical knowledge of psychosis may also have been an advantage in enabling
her to manoeuvre her way around the acute ward in the best possible manner.
Several authors have maintained that treatment providers have relational skills that
can be used in research.33,34
Considerations concerning how close or distanced MHH was to be at any time are
expressed in the descriptions and analyses of Ida, David and Tom. One example is her
anxiety about having threatened Ida on the question of her being interviewed.
Managing knowledge of psychosis includes attempting to interpret patients’ state-
ments ? /both spoken and unspoken ? /about how much close contact they can handle. It
was also necessary to check one’s personal interpretations by talking to the employees
and listening to the professional discussions they held. Even if specialist knowledge
and clinical experience are important, thoughtful researchers should also have a
conscious relationship with the psychiatric context of which they are part. The
knowledge one acquires is developed in a certain area and has certain assumptions
about the person and the mental disorder. However, it is difficult to imagine that a
project such as ours could have been carried out if MHH had too greatly disregarded
the prerequisites on which her work was based.
Consideration of knowledge interests can also obscure the researcher’s ethical
awareness. The compromise between knowledge acquirement and personal protection
is demanding. Good management of specialized knowledge is therefore hardly a
satisfactory prerequisite for ethically acceptable research.
50 MH Hem et al.
Nursing Ethics 2007 14 (1)
Methodology competence and research ethics
Research methods are related in complex ways to research ethics and professional
practice.35Qualitative approaches are often justified by an interest in researching for
meaning, subjectivity and experience. Qualitative methods are characterized as
phenomenological and sensitive to context. The distinctive characters of various
research methods are connected to positions of scientific theory, where the relationship
between researchers and the persons and contexts to which they link their research is
perceived as mutual and dynamic. Emphasis is given to the researcher as a creative
person. Researchers’ reflectivity is connected to their consciousness of how they create
themselves through interaction with the field in which they are conducting research.
The perception that the relationship between the researcher and those researched is
intersubjective breaks with the norm of researchers’ neutrality.6?11,36,37
The shift in method towards the dialogical relationship between participant and
researcher is of importance for research ethics. The requirement for researchers to have
reflected on their own self-awareness can promote a clearer consciousness of their
responsibility to take care of the research participants’ well-being. In our project,
MHH’s self-reflection and consideration for the participants were expressed in several
ways. She tried to be aware of the impact her presence had on the patients. With David
and Tom it seemed that the expectations they created as participants were exaggerated
compared with MHH’s intentions. The extent to which her awareness of how they
perceived her should have guided her towards assuming a more distanced position
can be discussed. The main reason for being in the common rooms with them was that
she felt she was not harming them. When they were anxious and afraid, MHH ? /just
like the employees ? /was given a misunderstood role. It may well be that the patients
were exposed to no greater ‘risk’ through MHH’s presence than that they would have
experienced anyway as a result of their current state.2,38When they improved, their
reactions were somewhat different: David was no longer particularly concerned about
her, while Tom continued to be curious, perhaps because of his great need for contact,
which was largely satisfied by MHH. This shows that, through being part of what they
are studying, researchers take on a normative role. The role of researchers is not
objective; they therefore bear a special responsibility.
In this article we have shown that the principle of obtaining informed consent is
extremely problematic and does not guarantee ethically acceptable research practice.
One-sided monitoring of the requirement for patients who participate in research to
give informed consent can appear directly opposed to the good intentions and can give
the researcher an unjustified free hand to collect data. Based on experience of
qualitative research in acute psychiatry we have shown the ways in which psychotic
patients daily challenge researchers to take responsibility and to think carefully about
the extent to which patients can and should be included in research.
We conclude that a reasonable criterion is that those involved are given information
and have the right to refuse. This is not sufficient, and researchers must take
continuous responsibility for assessing what is in the best interest of patients. The
assessment is demanding and has no standard solution. Good research judgement is
Questionable requirement for consent in observational research51
Nursing Ethics 2007 14 (1)
needed and this must be exercised in the context of each situation. Discretionary
assessments require the researcher to possess high ethical awareness, good insight and
experience of qualitative research methods, combined with specialist therapeutic
competence. This is no simple prescription. It rests on an awareness that doubt must be
respected and that researchers’ assessments and their understanding of situations may
We would like to thank the hospital administration for permitting us to carry out our
study. We also thank the nurses and the rest of the staff who allowed us to observe
them and the patients who accepted our presence. The Ethics Programme at the
University of Oslo allocated research funds. We are grateful to Professor Ulla Schmidt
and post-doctoral research fellow Henrik Syse, who commented on earlier drafts of
Marit Helene Hem and Kristin Heggen, University of Oslo, Oslo, Norway.
Knut W Ruyter, National Committee for Medical Research Ethics and University of Oslo,
11Fluehr-Lobban C. Informed consent in anthropological research. We are not exempt. In:
Fluehr-Lobban C ed. Ethics and the profession of anthropology. Dialogue for ethically conscious
practice, second edition. Altamira Press, 2003: 159? /77.
12O’Mathu ´na DP. Ethical issues surrounding the conduct of research with decisionally impaired
adults. Res Pract 2003; 4(2): 42? /50.
13Richards HM, Schwartz LJ. Ethics of qualitative research: are there special issues for health
services research? Fam Pract 2002; 19: 135? /39.
14Shaw IF. Ethics in qualitative research and evaluation. J Soc Work 2003; 3(1): 9? /29.
15Usher K, Holmes C. Ethical aspects of phenomenological research with mentally ill people.
Nurs Ethics 1997; 4: 49? /56.
16Tedlock B. Ethnography and ethnographic representation. In: Denzin NK, Lincoln YS eds.
Strategies of qualitative inquiry, second edition. SAGE, 2003: 165? /213.
17Gubrium JF, Holstein JA. Analyzing interpretive practice. In: Denzin NK, Lincoln YS eds.
Strategies of qualitative inquiry, second edition. SAGE, 2003: 214? /48.
18Fontana A, Frey JH. The interview: from structured questions to negotiated text. In: Denzin
NK, Lincoln YS eds. Collecting and interpreting qualitative materials, second edition. SAGE, 2003:
19Angrosino MV, de Pere ´z M. Rethinking observation: from method to context. In: Denzin NK,
Lincoln YS eds. Collecting and interpreting qualitative materials, second edition. SAGE, 2003:
10Silverman D. Analyzing talk and text. In: Denzin NK, Lincoln YS eds. Collecting and
interpreting qualitative materials, second edition. SAGE, 2003: 340? /62.
11Rapley T. The art(fulness) of open-ended interviewing: some considerations on analyzing
interviews. Qual Res 2001; 1: 303? /23.
12National Committees for Research Ethics in Norway. Home page. 2006. Retrieved 31 January,
2006, from: http://www.etikkom.no/Engelsk
13Regional Committees for Medical Research Ethics, documents in English. Home page. n.d.
Retrieved 31 January, 2006, from: http://www.etikkom.no/REK/english
52 MH Hem et al.
Nursing Ethics 2007 14 (1)
14Norwegian Social Science Data Services. Home page. 1997. Retrieved 31 January, 2006, from:
15Directorate for Health and Social Affairs. Home page. 2005. Retrieved 31 January, 2006,
from: http://www.shdir.no/portal/page?_pageid? /134,112387&_dad? /portal&_schema? /
16Roberts LW, Roberts B. Psychiatric research ethics: an overview of evolving guidelines and
current ethical dilemmas in the study of mental illness. Biol Psychiatry 1999; 46: 1025? /38.
17Carpenter WT, Conley RR. Sense and nonsense: an essay on schizophrenic research ethics.
Schizophr Res 1999; 35: 219? /25.
18Dewing J. From ritual to relationship. A person-centred approach to consent in qualitative
research with older people who have a dementia. Dementia 2002; 1: 157? /71.
19Michels R. Are research ethics bad for our mental health? N Engl J Med 1999; 340: 1427? /30.
20Goodwin D, Pope C, Mort M, Smith A. Ethics and ethnography: an experiential account. Qual
Health Res 2003; 13: 567? /77.
21Miller T, Bell L. Consenting to what? Issues of access, gate-keeping and ‘informed’ consent. In:
Mauthner M, Birch M, Jessop J, Miller T eds. Ethics in qualitative research. SAGE, 2002: 53? /69.
22Doucet A, Mauthner M. Knowing responsibility: linking ethics, research practice and
epistemology. In: Mauthner M, Birch M, Jessop J, Miller T eds. Ethics in qualitative research.
SAGE, 2002: 123? /45.
23Munhall PL. Ethical considerations in qualitative research. West J Nurs Res 1988; 10: 150? /62.
24Jokinen P, Lappalainen M, Merila ¨inen P, Pelkonen M. Ethical issues in ethnographic nursing
research with children and elderly people. Scand J Caring Sci 2002; 16: 165? /70.
25Cutcliffe JR, Ramcharan P. Leveling the playing field? Exploring the merits of the ethics-as-
process approach for judging qualitative research proposals. Qual Health Res 2002; 12:
26Lawton J. Gaining and maintaining consent: ethical concerns raised in a study of dying
patients. Qual Health Res 2001; 11: 693? /705.
27O’Neill O. Some limits of informed consent. J Med Ethics 2003; 29: 4? /7.
28D’Agostino F. The ethics of social science research. J Appl Philos 1995; 12: 65? /76.
29Birch M, Miller T. Encouraging participation: ethics and responsibilities. In: Mauthner M,
Birch M, Jessop J, Miller T eds. Ethics in qualitative research. SAGE, 2002: 91? /116.
30Stacey J. Can there be a feminist ethnography? Women Stud Int Forum 1988; 11(1): 21? /27.
31Labott SM, Johnson TP. Psychological and social risks of behavioral research. IRB Ethics Hum
Res 2004; 26(3): 11? /15.
32Menikoff J. The involuntary research subject. Camb Q Healthc Ethics 2004; 13: 338? /45.
33Roberts LW. The ethical basis of psychiatric research: conceptual issues and empirical
findings. Compr Psychiatry 1998; 39(3): 99? /110.
34Lipson JG. The use of self in ethnographic research. In: Morse JM ed. Qualitative nursing
research. A contemporary dialogue. SAGE, 1991: 73? /89.
35Bell L, Nutt L. Divided loyalties, divided expectations: research ethics, professional and
occupational responsibilities. In: Mauthner M, Birch M, Jessop J, Miller T eds. Ethics in
qualitative research. SAGE, 2002: 70? /90.
36Engelsrud G. The lived body as experience and perspective: methodological challenges. Qual
Res 2005; 5: 267? /84.
37Solvoll B-A, Engelsrud G, Heggen K. Forskererfaringer og refleksjon. (The researcher’s
experience and reflection.) Norsk Tidsskrift for Sykepleieforskning (Norwegian J Nurs Res) 2005; 7:
3? /14 (in Norwegian).
38Doyal L. Informed consent in medical research: journals should not publish research to which
patients have not given fully informed consent ? / with three exceptions. BMJ 1997; 314:
Questionable requirement for consent in observational research 53
Nursing Ethics 2007 14 (1)