How do I obtain informed consent from participants?
You must describe your process for obtaining informed consent from participants for taking part in Human Research. Informed consent is an ongoing process and not just a single event or document. Informed consent allows participants to understand the nature of the research and assures that they can voluntarily and knowledgeably decide whether or not to participate. The process you employ for obtaining informed consent will depend on the research setting and your participant population. The consent process is distinct from the consent document. When written documentation of consent is a requirement for IRB approval, a participant or Legally Authorized Representative (LAR) must sign the consent document, but only after you have led them through your approved consent process. See the “Consent Process” section of “WORKSHEET: Criteria for Approval (HRP-314)” for the required elements to include in your consent process. See also Process for Obtaining Consent on the IRB website.
It is considered a best practice to document in the participant file that the informed consent process has occurred. The study team should document the consent process in the study record, such as through the documentation of the consent process form or notes-to-file.
NOTE: For FDA-regulated clinical trials, it is considered a required process to document in the participant file that the informed consent process has occurred. Lack of such documentation will result in a non-compliance finding by a FDA auditor inspecting the study.
If your research study meets the requirements for an exempt determination and there are interactions with participants, you may use an abbreviated process for obtaining consent. The abbreviated consent process must provide all of the following information to participants through an information sheet or written verbal script:
- The participant is being asked to participate in a research study.
- A description of the procedure(s) the participant will be asked to complete.
- Participation is voluntary.
- The investigator’s name and contact information.