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» Research Bill Of Rights

Research Bill Of Rights

 Research subjects can expect:

  • To be told the extent to which confidentiality of records identifying the subject will be maintained and of the possibility that specified individuals, internal and external regulatory agencies, or study sponsors may inspect information in the medical record specifically related to participation in the clinical trial.
  • To be told of any benefits that may reasonably be expected from the research.
  • To be told of any reasonably foreseeable discomforts or risks.
  • To be told of appropriate alternative procedures or courses of treatment that might be of benefit to the subject.
  • To be told if an investigator has a financial relationship with a sponsor of the research, other than a reasonable fee for administrative work involved, that could influence his/her objectivity or behavior in conducting this research.
  • To be told of the procedures to be followed during the course of participation in the clinical trial, especially those that are experimental in nature.
  • To be told that they may refuse to participate (participation is voluntary), and that declining to participate will not compromise access to services and will not result in penalty or loss of benefits to which the subject is otherwise entitled.
  • To be told about compensation and medical treatment if research related injury occurs and where further information may be obtained when participating in research involving more than minimal risk.
  • To be told whom to contact for answers to pertinent questions about the research, about the research subjects’ rights and whom to contact in the event of a research-related injury to the subject.
  • To be told of anticipated circumstances under which the investigator without regard to the subject’s consent may terminate the subject’s participation.
  • To be told of any additional costs to the subject that may result from participation in the research.
  • To be told of the consequences of a subjects’ decision to withdraw from the research and procedures for orderly termination of participation by the subject.
  • To be told that significant new findings developed during the course of the research that may relate to the subject’s willingness to continue participation will be provided to the subject.
  • To be told the approximate number of subjects involved in the study. 

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