• 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.
    • Of any benefits that may reasonably be expected from the research.
    • Of any reasonably foreseeable discomforts or risks.
    • Of appropriate alternative procedures or courses of treatment that might be of benefit to the subject.
    • 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.
    • Of the procedures to be followed during the course of participation in the clinical trial, especially those that are experimental in nature.
    • 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.
    • 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.
    • 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.
    • Of anticipated circumstances under which the investigator without regard to the subject’s consent may terminate the subject’s participation.
    • Of any additional costs to the subject that may result from participation in the research.
    • Of the consequences of a subjects’ decision to withdraw from the research and procedures for orderly termination of participation by the subject.
    • 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.
    • The approximate number of subjects involved in the study.