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ABSTRACT Research that involves healthy normal volunteers frequently is performed. This article examines ethical guide‐lines for the recruitment of healthy volunteers in research projects. Ethical decisions on projects that are based on patient‐volunteers or healthy normal volunteers should balance the risk to the volunteer and the collective benefit to the community. For healthy normal volunteers that risk should be minimal or trivial. Investigators should follow recruitment practices that avoid approaches to persons who are dependent upon them in some way, and should carry the day‐today ethical responsibility even after institutional ethical approval has been granted. Pilot studies and self‐experimentation readily can transgress ethical guide‐lines. Compensation for mishaps or injuries that occur during research in which there is no question of negligence (for example, an unforeseeable reaction in a phase‐1 drug trial) is an unresolved issue which should be addressed by the research community. It is recommended that action be taken to ensure that healthy volunteers who participate in approved research have redress in the rare event of an accident, whether this is a result of negligence, chance or misadventure. Hospitals/institutions or other bodies that sponsor research should extend their insurance to cover specifically such unforeseeable events in which there may be liability, and to have the facility for a payment of beneficence in the case of accidents in which liability cannot be established.

ABSTRACT Colorectal cancer in familial adenomatous polyposis is a preventable disease in at‐risk relatives of patients with primary cases. Until the recent establishment of a register in Western Australia, there has been no registration of pedigrees or central organization of surveillance in Australia. In the present study, the experience of 20 such families who were associated with The Royal Melbourne Hospital was documented, with an analysis of the reasons for any failure of management. The impact of a hospital‐based register on the management of the disease was studied. In each family, results were categorized according to whether “at‐risk” relatives had been diagnosed at surveillance examinations, and whether the Hospital register were involved. Before involvement with the register, 24 family members presented with symptomatic polyposis after the first affected case had been diagnosed. Eighteen of these had colorectal cancer at diagnosis, and 16 subjects now are dead. Identifiable reasons for the failure of surveillance were family communication failure (two cases), family denial (two cases), failure of the hospital clinic (two cases) and a failure to cover extended branches of families who were living locally (nine cases), interstate (four cases) or overseas (three cases). In contrast, only two (6%) of 33 affected cases that were identified at a planned surveillance endoscopy had colorectal cancer at diagnosis. Without the active surveillance of at‐risk family members, lethal delays in diagnosis are likely to occur. Most reasons for failure potentially are correctable by a dedicated registry that is responsible for notifying clinicians and patients about the timing of surveillance procedures.

Non‐compliance in screening programmes for colorectal cancer is likely to be the most important factor limiting the impact of screening on mortality. This study aimed to determine risk factors and correlates of compliance that could be readily identified by general practitioners. A total of 581 eligible subjects aged 40 to 75 years completed a questionnaire that covered demographic factors, personal medical history, family history of colorectal cancer and smoking status. Faecal occult blood tests were then offered by the general practitioner and compliance correlated with responses. The over‐all compliance was 44% and increased to 51% for those who accepted the self‐testing kit at consultation. For men, compliance increased with increasing level of education and was significantly greater for non‐smokers than for smokers. For women, compliance increased with increasing age, and was greater for those with either symptoms and/or a family history of colorectal cancer. A doctor group‐practice factor appeared to influence acceptance versus refusal of the test kit from the doctor. A triage approach to screening in general practice may improve over‐all compliance and the yield of tumours. With this strategy, patients at high risk (for example, those with a family history of colorectal cancer or in older age groups) are identified first. Particular attention should be given during consultation to those at high risk who have poor compliance profiles (for example male smokers with a family history of colorectal cancer). High‐risk subjects with high compliance profiles would need less attention and low‐risk individuals would need least attention.