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 New Brunswick IRB Title

Full Board Review

Any research study that is greater than minimal risk must be reviewed by the full board. Research protocols that present minimal risk to participants but which do not conform to any of the categories of expedited or exempt research must also be presented for review before the full board. Full board review requests must be completed using the Full Board and Expedited Application.

The following must be included in a full board protocol submission:

Initial IRB Submission Reminder List, Initial IRB Submission Reminder List

IRB application, 1 original and 15 copies of the IRB application

1 original and 20 copies consent and assent forms or letters, advertisements, data collection sheets, and any other study related materials, 1 original and 15 copies of the consent(s) and assent form(s) or letters, advertisements, data collection sheets, and any other study related materials

4 copies of the protocol 1 original and 3 copies of the protocol

4 copies of all study personnel Training Certificates 1 original and 3 copies of all study personnel training certificates

4 copies of Investigator Financial and Other Interests Disclosure Forms, 1 original and 3 copies of Investigator Financial and Other Interests Disclosure Forms

4 copies of UH and/or UBHC registration(s) if either is indicated as a study site, and 1 original and 3 copies of RUG and/or UBHC form(s) if either is indicated as a study site

4 copies of UH and/or UBHC registration(s) if either is indicated as a study site, and1 original and 3 copies of SRB, Radiation Safety and/or Biosafety approvals, if applicable

4 copies of the full grant and/or contracts 1 original and 3 copies of the full grant and/or contracts. Note: the IRB will accept draft versions of contracts for review.

Protocols which require full board review are assigned to a full board meeting based upon date and time of submission to the IRB office.

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