Informed Consent Form Checklist

Elements of an Informed Consent Form

The following items must be included on all consent forms involving Agnes Scott researchers engaged in research involving human subjects (and by all outside researchers using members of the Agnes Scott community as human subjects).

  1. A statement that the study involves research.
  2. Purpose(s) of the research.
  3. Expected duration of the subject's participation.
  4. Explanation of the procedures to be followed.
  5. Attendant risks or discomforts.
  6. Expected benefits (money, course credit, free physical examination).
  7. Alternate procedures that would be advantageous to the subjects (if applicable).
  8. Extent (if any) to which confidentiality of records identifying the subject will be maintained.
  9. An offer to answer any inquiries concerning research procedures, the subject's rights, and whom to contact in the event of a research-related injury. For student research, the instructor/advisor must be the primary contact listed for inquiries.
  10. An instruction that the subject is free to withdraw his/her consent and to discontinue participation in the research at any time without penalty to the subject.

Other Elements of Informed Consent

When applicable, the principal investigator must provide the following to each subject:

  1. If more than minimal risk is involved, an explanation as to whether any compensation and any medical or psychological resources are available if injury occurs (and if so, what they consist of).
  2. A description of circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
  3. A description of circumstances under which the subject's participation may result in monetary costs to the subject.
  4. A description of the consequences, if any, of a subject's decision to withdraw from the research and procedures.
  5. A statement of significant new findings developed during the course of the research, which may affect a subject's willingness to continue participation.
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