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Components of an Informed Consent Letter

Components of an Informed Consent Letter

General Informed Consent Considerations

An investigator may involve a human being as a subject in research after informed consent has been obtained from the subject or the subject’s legally authorized representative. This consent is sought under circumstances that provide the prospective subject sufficient opportunity to consider whether or not to participate, and that minimize the possibility of coercion or undue influence. Information provided to the subject should be in language that is understandable to the subject.
The following is a description of the main components included in an informed consent letter. If your research involves children under the age of 18, assent from children may be required in addition to parental permission. Contact the Director of Institutional Research at (865) 354-3000, ext. 4816 if you have questions.

Basic Components of Informed Consent

As you develop your consent form, please include the following information.

  1. State the title of your research, and provide the contact information for the primary investigator.
  2. Explain the purpose of the research.
  3. Describe the procedures that directly involve human participants, and identify any procedures that are experimental.
  4. Describe any foreseeable risks or discomforts to participants.
  5. Describe any benefits to participants or to others that may reasonably be expected from the research.
  6. If applicable, disclose alternative procedures or courses of treatment, if any, which might be advantageous to participants.
  7. Describe the extent to which confidentiality of records identifying participants will be maintained, where the records will be stored, and who will have access to the records.
  8. For research involving more than minimal risk, explain whether any compensation or medical treatments are available if injury occurs. If compensation or treatments are available, they should be described. The procedures for obtaining additional compensation/treatment information should be stated.
  9. Identify the person(s) who participants can contact for answers to pertinent questions about the research, participants' rights, and/or in the event of a research-related injury to the subject.
  10. State that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which participants are otherwise entitled, and also that participants may discontinue participation at any time without penalty or loss of benefits to which they are otherwise entitled.

Additional Components of Informed Consent

The following additional elements of informed consent may be required.

  1. A statement that the particular treatment or procedure may involve risks to the participant which are unforeseeable.
  2. Anticipated circumstances under which a participant's participation may be terminated by the investigator without regard to the participant's consent.
  3. Any additional costs to the participant that may result from participation in the research.
  4. The consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation by the participant.
  5. A statement that significant new findings developed during the course of the research that may relate to the participant's willingness to continue participation will be provided to the participant.

Contact for Further Information

If you have any questions about preparing an informed consent letter, please check with the Director of Institutional Research, (865) 354-3000, ext. 4816.


Jeffrey J Tinley • (865) 354-3000 ext. 4816 •

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