Monday, February 11, 2013

Writing a consent document for a clinical trial or for a survey requires the investigator to ensure that all legally required elements are contained in the document. As defined in 45CFR46 (the Common Rule), these elements include:

  1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any products which are experimental. This is critically important in human subject research because research is not the same as therapy; the involvmeent of a researcher is different from that of a patient’s physician, and this may lead to what is known as therapeutic misconception.
  2. A description of any reasonably foreseeable risks or discomforts to the subject. In the case of adjustment, this may require referral to risk of musculoskeletal pain, or in the case of cervical adjustments for research purposes, to the exceedingly small risk of stroke.
  3. A description of any benefits to the subject or to others which may reasonably be expected from the research. Typically, there is no specific benefit to the patient in terms of improvement of a condition. We cannot guarantee that research subjects will improve. Usually, this is couched in terms of the knowledge that will be gained.
  4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. This is part of informing the participant so he or she can make an informed decision.
  5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that external regulatory agencies, such as the Food and Drug Administration, may inspect the records. Also, that HIPAA will be followed.
  6. For research involving more than minimal risk, an explanation as to whether any compensation and/or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
  7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
  8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. People need to know they are free to leave a study. However, in large-scale investigational new drug studies, there may be problems if people do leave the study, and this would need to be disclosed as well.


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