• How different groups understand and experience clinical practice and research in cancer genetics? 
• Do those interviewed see there being a clear distinction between what is clinical practice and what is research?
• What ethical issues or practical difficulties do these different groups see as arising from the way in which clinical practice and research are organised/regulated?

Fifty-nine patients from the genetics clinic in Southampton were interviewed between March 2006 - 2007. Also interviewed were 30 healthcare providers / cancer genetics researchers and 20 people who have an interest in cancer genetics or medical research (e.g. work in cancer charities or patient support groups or sit on ethics committees or government bodies).

 

 

Most interviewees regarded research and clinical care as different activities which have very different motivations. Research activities were described as looking for the causes of disease focussed upon finding a cure for cancer and therefore, oriented to the future and for the benefit of the wider society.  Clinical care, on the other hand, was described as treating patients.

 

However, many interviewees said they experienced difficulties in distinguishing research and clinical care at times, and commented that they experienced problems in identifying whether some of the procedures they had undergone were carried out for research or clinical purposes. These difficulties were increased in research studies that included DNA (genetic) analysis, in these cases research based DNA testing was often seen as a clinical service.

 

Many interviewees thought that there should be a greater amount of communication between researchers and the clinical staff. They believed that research is very important because it enables medical knowledge to progress and because the results can be used to inform patient care.

 

 

Most interviewees had been invited to take part in at least 2 research projects in the past, and 48 people who had previously been involved in research projects recalled one or more aspects of these research studies (e.g. the aims, procedures or outcome of the study).  Interviewees; recall was influenced by the type of research concerned, for example, screening (e.g. MARIBS) and clinical trials (e.g. CAPP2) were recalled in more detail than epidemiological studies (e.g. EMBRACE) or questionnaire studies.

 

 

The reasons given for participating in research varied. They included both a) personal reasons: looking for answers about the family history of cancer and/or to receive personal health benefits e.g. greater monitoring, cancer screening or DNA (genetic) testing and b) social reasons: finding out information for other family members, paticularly children, helping future generations of one's family or society in general, having an interest in the research project and/or wanting to help science/medicine progress.

 

Many people said they would be less inclined to take part in research which involved the testing of new drugs because of the risks, unless they thought there was a potential health benefit for themselves.

 

 

Most interviewees said that their consent to take part in research should be sought, as they believed they had a right to say what happened to them. In relation to this, they believed they should be informed of risks involved in research participation. In general, the interviewees thought that obtaining a broad consent to use blood samples in research was adequate.

 

Maintaining privacy and confidentiality were regarded as very important. However, this did not mean that interviewees were regarded as very important. However, this did not mean that interviewees thought research samples/data should be irreversibly anonymised, for they saw their data as family property and believed it should be stored in such a way that it could be used to benefit their family in the future.

 

The interviewees thought feedback of research results, either personal results or general findings, was important. Finally many interviewees commented that they would like to receive updates about the ongoing projects they were involved in

 

RECOMMENDATIONS FOR CLINICAL SERVICES

 

• Keep research participants updated with research results and the progress ongoing projects.
• If a DNA test or screening test (blood test/mammogram) is undertaken as research, ensure that research participants are aware that this is not a clinical service.
• Make sure research participants are informed of the risks of their research participation.
• Do not be afraid to offer patients the chance to participate in research.

 

Staff involved in the project have attended several medical conferences both within the UK and mainland Europe to present the results of the project. They were also invited to give simnars to clinical and academic audiences. A number of geneticists and gentic nurses/counsellors attended a workshop in London to receive the results of the research.  In addition, the finding are currently being written up as a series of academic papers.