Informed consent is the most fundamental condition for the conduct of research involving human subjects & is the Investigators responsibility. The IRB is charged with oversight responsibility for the consent process, which is exercised by (1) approving the informed consent documents to be used, (2) obtaining the Investigator's certification that informed consent will be obtained, and (3) reserving the right to audit the consent process and documentation in any case.
Informed Consent is a process of communication between the Investigator and potential participants.
There are 4 principles of informed consent:
- The potential participant must be able to make a decision
- There must be an explanation of information about the research provided to the potential participant before a decision is made
- The potential participant must understand the information given about the research
- The potential participant must understand their decision is voluntary.
Informed consent does not always mean the investigator must obtain a signature (documentation of informed consent) from the participant. For more information, see the section on “Waiver of Documentation of Informed Consent”
NMC IRB Position on Participant Agreement for Non-Research Activities
The NMC IRB has taken the position that any exempt or non-research projects that intend to recruit participants specifically for such projects, must provide a consent form or agreement form/letter. Documentation of consent in the form of participant signature may not be needed.
The information provided to participants must include at minimum 1) the purpose of the project, 2) a general description of the project (procedures to be followed and expected duration, 3) a description of how confidentiality will be maintained, 4) explanation of who to contact for questions, 5) statement that participation is voluntary, and 6) any other information that a reasonable participant would want to know before participating in the project.