Fall Semester Campus Re-opening FAQS - June 15
Obtaining informed consent is, first and foremost, the Investigator's responsibility. Lack of informed consent will expose the Investigator to a claim of medical malpractice (and in some settings, possibly to a claim of assault and battery). In the research arena, however, the IRB is also charged with oversight responsibility for the consent process, which is exercised by (i) approving the informed consent documents to be used, (ii) obtaining the Investigator's certification that informed consent will be obtained and documented in every case, and (iii) reserving the right to audit the consent process and documentation in any case. In addition, for studies involving federal funding or FDA drugs or devices, federal regulations define the necessary elements of informed consent for human research, and require a much more extensive consent document than typically used for non-research medicine and surgery. Consent documents which meet the federal regulatory requirements are generally expected by the IRB, even for studies which are not subject to the regulations.
All Informed consents, whether to be signed or as recruitment letter 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 (ask to speak to the IRB Chair).
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
If the study qualifies for a waiver of documentation (signed) Consent form, a Recruitment Letter with the same information must be provided to participants. The signature lines are then removed. All documents may be modified to meet the needs of the study.
Use this consent form for exempt research in which you are not required to obtain a signature.
You may also use this form for research in which a Waiver for Documentation of Consent has been submitted for approval
Use this form if the investigation is non-research.
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.