title: Insurance in clinical research.
abstract: OBJECTIVE
  Sponsors need to pay for management of all serious adverse events suffered by subjects in a clinical trial and to compensate for injuries or deaths related to the trial. This study examines if insurance policies of trials, cover all contingencies that require reimbursement or compensation.
  
  
  METHODS
  Insurance policies of trials submitted to Sahyadri Hospitals between January 2013 and December 2013 were studied, with respect to the policy period, the limit of liability, deductibles, and preconditions if any.
  
  
  RESULTS
  All the policies studied had some deficiencies, in one respect or the other and none had a provision to pay full compensation if required. Some insurers have put in preconditions that could jeopardize the payment of compensation to subjects.
  
  
  CONCLUSIONS
  Insurances are complicated documents, and need to be critically examined by the ethics committee before approval of the study documents.
authors.affiliation: Sahyadri Clinical Research and Development Centre, Erandwane, Pune, Maharashtra, India.
authors.forename: Ravindra B
authors.initials: RB
authors.lastname: Ghooi
authors.affiliation: Sahyadri Clinical Research and Development Centre, Erandwane, Pune, Maharashtra, India.
authors.forename: Deepa
authors.initials: D
authors.lastname: Divekar
keywords: Compensation; insurance; preconditions; trial injuries