Ethical Principles and the Practice of Qualitative Research: Insights from a social science research project Professor Lindsay Prior School of Sociology, Social Policy & Social Work Queen’s University, Belfast March 14th 2007

Aims and Objectives of the Session To consider a ‘case study’ in qualitative research and to examine: 1. The ‘fit’ between the demands of medical research ethics committees and the practices of the qualitative researcher. 2. To highlight some common problems in ‘fitting’ qualitative research to the requirements of ethical governance. 3. To highlight the range of ethical issues that can arise in a single research project. 4. To highlight the role of ‘trust’ in research ethics.

Part of an Innovative Health Technologies Research Programme Funded by ESRC (Project L ) Links in to a parallel Wellcome funded study on the ways in which genetic risks might be calculated and used for insurance purposes. Ethics Approval sought from, and granted by an MREC and 4 LREC’s Case Study Title: The Construction of Risk Estimates in a Cancer Genetics Clinic

The broad research questions How do clinical professionals assemble cancer genetic risk assessments? What are the consequences of the risk assessment for patients/clients? How do patients/clients understand the risk assessment and its implications?

The Data Collection Methods The core design was an ‘ethnography’ of a clinical service: The key ‘site’ was an institute of medical genetics and the service covered an entire UK region.

Types of data collected: Medical Records (e.g. pedigrees) and documents of various kinds including GP referral letters. Observations in the clinic and the associated laboratory. Discussions between nurse-counsellors, clinical geneticists about risk assessment of patients. (Naturally- occurring data) Consultations between clinical professionals and patient/clients about risk assessment and its implications Interviews between social scientist and patients about their understandings of their risk assessment. (Also interviews with lab scientists and some clinical staff)

Reads referral letter from GP Discussion of the case between professionals

Pedigrees are drawn discussed and analyzed. Genetics is an affair of the family. ‘Cyrillic’ is a device that compiles essential information, draws a pedigree & calculates a risk In genetics it is possible to ‘know’ /deduce something about the health status of a specific individual if one has information about their relatives.

200 CG1:And the genes are broken up into sections and so a gene that 201 controls a protein function in a body is not just one long coding 202 instruction it is in fact broken up into sections that then get joined 203 together. And those sections you can think of them as being volumes of 204 an encyclopaedia. Basically between the two genes there are effectively volumes. And it takes our laboratory a week to check each one, 206 which you can then work out quite quickly that that is effectively a year 207 to check every single one. That is just the practicality of the time scale. 208 The other problem though, if you are dealing with something as big as 209 something like an encyclopaedia and you are looking for a mistake and 210 effectively what you’re dealing with is just a code, a series of letters, then 211 you are looking for something like a missing paragraph or sometimes just 212 a missing word, or sometimes just a missing letter. And right down to 213 just a change on one letter can be all that is needed to have disastrous 214 effects. 215 P8: Yeah. An example of clinic talk between a patient and a consultant

So what are the ethical implications of collecting these kinds of data? Consent, Anonymity, Confidentiality, Autonomy of Individuals; Data Protection … Issues …. Consent from the GP and the patient (re-the letter)? Consent from each individual at the study site, and in each discussion? Consent for access to the discussion from the patient? Consent to access of the pedigree from all concerned? Consent to the interview with the patient and participation in the study?

The Patient Sample

INT: And how do you feel about [being low risk]? Do you feel reassured? P29: No. Not at all. Its just seems to be too much co-incidence that so many people in my family all on my mum's side and all blood related, you know. My Nan, her brother and her sister died. My Mum's sister. You know there are just too many that puts things... you know reading a letter which says 'you are not in a higher risk' does not put my mind at rest at all. Not at all. (P29: Clinical assessment = low risk, ovarian/breast cancer) Extract from Patient Interview (Interviewed at home by Social scientist)

So what are the ethical implications of collecting these kinds of data? Problems with sample numbers; problems with interview schedule; problems of ‘harm’ How are the sample numbers to be justified? How is the interview schedule (open-ended questions, narratives) to be justified? What risks are involved (for interviewer and interviewee)? What is the precise role of the interviewer?

The findings Ethical issues arising out of findings that research population is not keen on Ethical issues connected to lodging data in the qualitative research data archive

Conclusions The ‘fit’ between qualitative research and ethics committees Is not an easy one… The research style and ‘ethos’ implied by the forms (at the outset) is geared to a specific (and different) form of research practice Problems justifying sample numbers – and allowing for the emergent shifts in direction that often occur in qualitative work. Problems justifying open-ended interviews

Conclusion Some social researchers often feel that ‘ethics’ is used as a form of censorship and control – rather than a means of facilitating good research. Transparency in procedures and sound governance of all aspects of social research are essential, but… On matters of practical detail one has to trust the professionalism of the social researcher – and that is what is often felt to be lacking in ethical review of qualitative research. E.G Robert Dingwall