New study submissions
New studies must be submitted by the deadlines for inclusion at the scheduled IRB meetings. The new study Proposal Submission Application identifies what documents must be submitted for review. Be sure all consent and assent forms adhere to Informed Consent Requirements. Investigators must submit proof of human subjects training, taken within the last three years. If you do not have a current certificate, you may take the NIH on-line training .
Investigators must submit a conflict of interest form.
The IRB, under Department policy, will review all new, non-exempt studies at a full IRB meeting. Follow-up reviews, continuing approval and minor revisions may be eligible for expedited review.
Exemption from IRB review determination
The IRB will make the exempt study determination. Requests for exempt study determination may be submitted with the new study application at any time. It is suggested that submissions be at least two weeks before an application deadline, so that investigators have time to make a full IRB study submission if the study is not determined exempt.
Except in very rare situations, participants in research must be informed that they are voluntarily being included in research. They must receive all pertinent information about that research and about their rights. Investigators should review and include all of the legally required information in an informed consent form.
Waiver or alteration of informed consent and waiver of HIPAA authorization
Federal regulations provide limited ability to perform human subjects research without written informed consent. An IRB may approve a waiver of HIPAA authorization under specific situations. Refer to the Summary Information Sheet for information on what waivers may be permitted by the IRB, and complete section 5 of the Proposal Submission Application, as appropriate. Be sure to provide justification for any requested waiver or alteration.
When requesting waiver of parental consent for minors participating in research, it is strongly recommended that a third party opinion be obtained (from someone who advocates for children’s rights). The opinion should be from someone not involved in the project who carefully reviews the study requirements asked of the child and provides an opinion that the child is not placed at any additional risk by their participation without parental consent.
Revisions or other review requests for an approved study
Revisions to an Already Approved Study form.
Many documents are also available in MS Word format.