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:
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.
The consent forms have updated language for readability. If the study qualifies for a waiver of documentation (signed) Consent form, an information letter with the same information must be provided to participants. All documents may be modified to meet the needs of the study.
Use this template for all research consent forms.
All informed consents for research should include the following information:
If you have any questions about your rights as a research subject, you may contact Nebraska Methodist College’s Institutional Review Board, a group of people who are responsible to protect the rights of research subjects, by calling 402-354-7116
Use this Agreement Letter for exempt studies in which you are not required to obtain a signature. For any study determined as research, a Waiver for Documentation of Consent is required if no signature is being obtained from participants (i.e. electronic surveys).
This form is only a template and some sections may not be appropriate or additional information should be added.
Use this Agreement Letter for projects not determined to be research, whether a signature is obtained or not.
All consent forms should be written at the 5th to 8th grade reading level for adults.
Assent forms for children ages 7 and older should be at the level appropriate for the child.
A waiver for documentation of informed consent is a request whereby a signed consent document is not required. Examples include online, verbal, and implied consent. Consent will still be obtained from participants; however, they will not be required to sign the consent form. There are only three circumstances when the IRB may waive the requirement to obtain a signed consent form: