title: An audit of consent refusals in clinical research at a tertiary care center in India.
abstract: OBJECTIVE
  Ensuring research participants' autonomy is one of the core ethical obligations of researchers. This fundamental principle confers on every participant the right to refuse to take part in clinical research, and the measure of the number of consent refusals could be an important metric to evaluate the quality of the informed consent process. This audit examined consent refusals among Indian participants in clinical studies done at our center.
  
  
  METHODS
  The number of consent refusals and their reasons in 10 studies done at our center over a 5-year period were assessed. The studies were classified by the authors according to the type of participant (healthy vs patients), type of sponsor (investigator-initiated vs pharmaceutical industry), type of study (observational vs interventional), level of risk [based on the Indian Council of Medical Research (ICMR) "Ethical Guidelines for Biomedical Research on Human Participants"], available knowledge of the intervention being studied, and each patient's disease condition.
  
  
  RESULTS
  The overall consent refusal rate was 21%. This rate was higher among patient participants [23.8% vs. healthy people (14.9%); P = 0.002], in interventional studies [33.6% vs observational studies (7.5%); P < 0.0001], in pharmaceutical industry-sponsored studies [34.7% vs investigator-initiated studies (7.2%); P < 0.0001], and in studies with greater risk (P < 0.0001). The most common reasons for consent refusals were multiple blood collections (28%), inability to comply with the study protocol (20%), and the risks involved (20%).
  
  
  CONCLUSIONS
  Our audit suggests the adequacy and reasonable quality of the informed consent process using consent refusals as a metric.
authors.forename: S J
authors.initials: SJ
authors.lastname: Thaker
authors.forename: B H
authors.initials: BH
authors.lastname: Figer
authors.forename: N J
authors.initials: NJ
authors.lastname: Gogtay
authors.affiliation: Department of Clinical Pharmacology, Seth GS Medical College, King Edward Memorial (KEM) Hospital, Mumbai, Maharashtra, India.
authors.forename: U M
authors.initials: UM
authors.lastname: Thatte
mesh_terms: D000368:Aged; D035843:Biomedical Research; D002986:Clinical Trials as Topic; D006801:Humans; D007194:India; D007258:Informed Consent / Q000706:statistics & numerical data*; D008297:Male; D035842:Research Subjects; D062606:Tertiary Care Centers