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Consent Discussion Process

The consent process should allow for an exchange of information between the investigator and the subject. Even the best document is no substitute for two-way communication, interaction, and listening.

  • For complex or detailed studies, consider sending information and consent document in advance to allow potential participant time to review and think of questions.
  • Introduce yourself and take time to ask questions to assess prospective participant’s knowledge, experience, frame of mind, health literacy, motives, etc.
  • Actively listen!
  • Use plain language.  Be specific and concreate in communication.
  • Clarify what is and what is not part of the research (e.g., what will occur regardless of their participation such as standard of care procedures).
  • Describe foreign or technical concepts.
  • Use visual aids, glossary of terms, video or audio, illustrations, models or samples of interventional products.
  • Provide foundational education as needed (e.g., what is disease and standard treatment; what is a clinical trial, research purpose you are partnering with them to discover or solve)
  • If you are treatment provider, clarify that this is “research” to prevent therapeutic misconception.
  • If you are in a position of authority, reiterate that participation is totally voluntary and withdrawal is always an option (e.g., teachers, employers).
  • Use teach-back open-ended questions to assess understanding and clarify misperceptions.
  • After the study, evaluate your process by asking participant what they wish they would have known.

Documenting the Informed Consent Process

Include the following:

  • Statement that “eligibility criteria met” (or completed eligibility checklist attached);
  • Date;
  • Details of who involved/present;
  • Description of process;
  • Discussion items;
  • Questions & clarifications;
  • Any assessment used to document understanding;
  • Statement that subject voluntarily consented to participate prior to participating;
  • Copy of signed consent given to subject;
  • Any other pertinent information (witness, LAR, supplemental materials);
  • PI contact information;
  • IRB number;
  • Protocol title;
  • Version of the consent document signed.

Samples (Please note: These may not suit your protocol precisely, however, they may serve as a guide to get you started):

Template for History/Progress Note in Medical Record (UK) 

Researcher's Certification of Consent and Authorization (AHRQ)

Future Research Use

Primary Research & Future Use (Interactive Tool)
What to do and what to tell participants

Posting Federally Funded Clinical Trial Consent Forms

View PDF

OHRP Frequently Asked Questions on Informed Consent

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