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Required Elements of Informed Consent


Please refer to the informed consent document format guide when completing your consent form.

The information in the consent form must be presented in a language that is understandable and at a level that is comprehensible to the participant or their legal representative. For information being distributed to the general public a 6th grade level is recommended.

Guidance from our federal oversight office, OHRP, states that "Use of the first person (e.g., "I understand that ...") can be interpreted as suggestive, may be relied upon as a substitute for sufficient factual information, and can constitute coercive influence over a subject." Based on this, the IRB requests that consent documents use second person if at all possible.

All consent forms must contain the basic elements described in the federal regulations found in 45 CFR 46.116 (a) & (b) and listed below.

  • An explanation of the purpose of the research, the duration of participation, a complete description of the procedures to be followed and identification of any procedures which are experimental.
  • Description of any foreseeable risks or discomforts;
  • Description of any benefits to the subject or others;
  • Disclosure of appropriate alternative procedures, if any, that might be advantageous to the subject;
  • Explanation of procedures to maintain confidentiality;
  • For research that involves more than minimal risk, an explanation whether compensation or medical treatment will be available if the subject is injured and where to get further information about this;
  • Whom to contact for answers to questions about the research and research subject's rights;
  • A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits and the subject may discontinue participation at any time without penalty.

Additionally, the consent form cannot ask the participant to waive or appear to waive any of their legal rights or release the investigator, sponsor or Oklahoma State University or its agents from liability for negligence. Special care must be taken when dealing with illiterate participants.

 

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