For her special study module on sexual health and research, a second year medical student (RY) decided to do a questionnaire survey of access to sexual health care among attenders aged <25 years in the waiting room at a genitourinary medicine (GUM) clinic. The time allotted for the special study module was 1 day per week for 10 weeks. Her protocol, patient information sheet and questionnaire (available from the authors) were seen by the chairman of a local research ethics committee and deemed to be borderline audit/research.
The brief, anonymous questionnaire was not particularly intrusive. It asked about age, sex, ethnicity, employment, ease of finding the GUM clinic, whether they preferred coming there to seeing their GP, and two questions on knowledge of sexually transmitted infections. The patient information sheet made it quite clear that there was no obligation to complete the questionnaire and that this would not affect treatment.
The GUM physician at the clinic (at a hospital outside London) was supportive and the findings might have been useful. However he referred the proposal to the research governance manager. This was fatal. She wrote:
‘… It would not be possible to expect a student project to be approved in the time constraint you have indicated … It is likely that an Honorary Contract will be required for this study. In order for such a contract to be issued, a Criminal Records Bureau Check will be undertaken. CRB checks are currently taking approximately 6 weeks. If the study is also involving vulnerable groups, it is likely that an Occupational Health Check will also be required. Both these checks would be conducted by the relevant Human Resources department.
In my view this is research and not audit. There are no apparent standards set with which to compare. The proposed research question is dealing with a very sensitive subject on potentially vulnerable individuals. There would be serious concerns with regard to the data access, especially as the researcher does not appear to have access to this information in the course of their work at this clinic.
The research question and questionnaire have the potential of creating situations for the participants that the researcher may be unable to deal with, therefore involving other departments without their prior knowledge. Safeguards for both the researcher and research population must be in place — access to further counselling etc as a basic minimum.
Please do not hesitate to contact me if I can be of any further assistance.’ (!!!)
Need I say more?
- © British Journal of General Practice, 2006.
