How do I submit a new study for review?
New studies must be submitted by the deadlines for inclusion at the scheduled IRB meetings. The new study application form identifies what documents must be submitted for review. Be sure all consent and assent forms adhere to Informed Consent Requirements.

What other documents should be submitted with my new study?

• 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.

What if my study is eligible for expedited review?
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. If you believe your study qualifies, submit the expedited review application, and if approved, it will be reviewed by designated IRB reviewers, without waiting for the next full IRB meeting. The IRB reserves the right to request full committee review at any time.

What needs to be submitted to request an 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.

What is informed consent, and what must be included in it?
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.

What if I cannot obtain informed consent, or need a HIPAA waiver or Other Informed Consent Alteration?
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. Submit the Waiver or Alteration of Informed Consent or HIPAA Authorization form with the study application when requesting any consent waiver alteration (including verbal consent), or waiver of HIPAA authorization.

Summary of Data Covered by HIPAA

What do I need to submit with revisions or other review requests for an approved study?
Revisions to an Already Approved Study form.

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