title: Recruiting terminally ill patients into non-therapeutic oncology studies: views of health professionals.
abstract: BACKGROUND
  Non-therapeutic trials in which terminally ill cancer patients are asked to undergo procedures such as biopsies or venipunctures for research purposes, have become increasingly important to learn more about how cancer cells work and to realize the full potential of clinical research. Considering that implementing non-therapeutic studies is not likely to result in direct benefits for the patient, some authors are concerned that involving patients in such research may be exploitive of vulnerable patients and should not occur at all, or should be greatly restricted, while some proponents doubt whether such restrictions are appropriate. Our objective was to explore clinician-researcher attitudes and concerns when recruiting patients who are in advanced stages of cancer into non-therapeutic research.
  
  
  METHODS
  We conducted a qualitative exploratory study by carrying out open-ended interviews with health professionals, including physicians, research nurses, and study coordinators. Interviews were audio-recorded and transcribed. Analysis was carried out using grounded theory.
  
  
  RESULTS
  The analysis of the interviews unveiled three prominent themes: 1) ethical considerations; 2) patient-centered issues; 3) health professional issues. Respondents identified ethical issues surrounding autonomy, respect for persons, beneficence, non-maleficence, discrimination, and confidentiality; bringing to light that patients contribute to science because of a sense of altruism and that they want reassurance before consenting. Several patient-centered and health professional issues are having an impact on the recruitment of patients for non-therapeutic research. Facilitators were most commonly associated with patient-centered issues enhancing communication, whereas barriers in non-therapeutic research were most often professionally based, including the doctor-patient relationship, time constraints, and a lack of education and training in research.
  
  
  CONCLUSIONS
  This paper aims to contribute to debates on the overall challenges of recruiting patients to non-therapeutic research. This exploratory study identified general awareness of key ethical issues, as well as key facilitators and barriers to the recruitment of patients to non-therapeutic studies. Due to the important role played by clinicians and clinician-researchers in the recruitment of patients, it is essential to facilitate a greater understanding of the challenges faced; to promote effective communication; and to encourage educational research training programs.
authors.affiliation: Centre of Genomics and Policy, Faculty of Medicine, Dept of Human Genetics, McGill University, 740 Dr, Penfield Avenue, 5th Floor, Suite 5200, Montreal, (QC) H3A 1A4, Canada. erika.kleiderman@mail.mcgill.ca
authors.forename: Erika
authors.initials: E
authors.lastname: Kleiderman
authors.forename: Denise
authors.initials: D
authors.lastname: Avard
authors.forename: Lee
authors.initials: L
authors.lastname: Black
authors.forename: Zuanel
authors.initials: Z
authors.lastname: Diaz
authors.forename: Caroline
authors.initials: C
authors.lastname: Rousseau
authors.forename: Bartha Maria
authors.initials: BM
authors.lastname: Knoppers
mesh_terms: D000533:Altruism; D001291:Attitude of Health Personnel; D026686:Beneficence; D003219:Confidentiality; D028744:Ethics Committees, Research; D005190:Family; D006801:Humans; D033181:Information Dissemination; D007258:Informed Consent; D008495:Medical Oncology / Q000941:ethics* / Q000379:methods / Q000639:trends; D009369:Neoplasms / Q000378:metabolism / Q000473:pathology; D033281:Nontherapeutic Human Experimentation / Q000941:ethics*; D018579:Patient Selection / Q000941:ethics*; D026684:Personal Autonomy; D010817:Physician-Patient Relations / Q000941:ethics*; D036301:Qualitative Research; D035844:Researcher-Subject Relations / Q000941:ethics*; D012935:Social Justice; D012944:Social Support; D019452:Terminally Ill