March 18 2025
Written by Jamie Saunders, M.S., Research Program Manager, MaineHealth Cancer Care Network NCORP
Obtaining informed consent is the process by which a study team member, knowledgeable about the research, thoroughly reviews with the potential participant all aspects of the trial. This is done to ensure the participant is fully informed and can make a well-considered, voluntary decision about research participation. The consent discussion should be conducted in clear and easily understandable language so that the participant can process the information. The discussion should also minimize the possibility of coercion and avoid any language that may suggest (or appear to suggest) the participant is waiving their rights.
Per CFR 50.25 the necessary elements of informed consent include:
- Study involves research with an explanation of the purpose and approximate duration of participation, a description of the procedures involved, and identification of any experimental procedures.
- Risks or discomforts
- Potential benefits
- Alternative procedures or other courses of treatment
- Confidentiality
- Compensation for participation
- Medical care/compensation for research related injury & contact information
- Contact information for questions.
- Participation is voluntary, there is no penalty nor loss of benefits for refusal, and the participant has the option to discontinue participation at any time.
Added elements when applicable include:
By the end of the discussion the participant should have all the information necessary to make an informed participation decision. Those performing the review can help ensure genuine consent by using easily understandable language, avoiding medical terminology, engaging with the participant in a manner that encourages questions, and using the teach back method to determine and assess understanding. Sufficient time should be allowed for participants to further review, discuss with family and/or friends, and ask questions prior to agreeing to take part in research.
Documenting informed consent takes place after explaining the research and assessing the participant's understanding but before any study related procedures/activities are conducted. Documentation of consent requires obtaining the signatures of both the participant, or legally authorized representative (LAR) and the individual who obtained consent. The participant or LAR must sign and date the consent document followed by the signature and date of the person obtaining consent. A witness signature may be required in situations where the participant is unable to sign due to physical or cognitive impairments, or when the legally authorized representative signs on behalf of the participant. Additionally, a witness may be necessary if the consent process is conducted remotely or in a language other than the participant’s primary language. The inclusion of the witness’ signature on the consent form is dictated by local institutional policy.
Once the discussion has been completed and documentation (signatures/dates) has been obtained, the participant must be given a copy of the completed ICF, and the original must be kept in the participant’s research folder.
Stay tuned for Part II which will highlight the various options for obtaining informed consent. Part III will highlight consent waivers and Part IV will highlight how to document the informed consent process.