510. New Projects: Submission Requirements for Full Committee Review
Updated Oct. 4, 2019
The following requirements apply to each New Project submitted in IRBNet for Full Committee Review. (For information about when projects require Full Committee Review, see IRB Policy Manual for review types.)
Research Integrity (RI) staff assess new projects submitted for Full Committee Review for completeness. Investigators are encouraged to plan appropriately to allow time for this assessment when submitting new projects for IRB review. Incomplete submissions are not assigned to a meeting agenda regardless of the submission date.
Mandatory Submission Requirements for Full Committee Review of New Projects
Complete the following steps for each new project submitted for Full Committee Review.
- Confirm the PI and all members of the study team have completed the required training
- Create a New Project in IRBNet
- AddPart I, Cover Sheet
- Add Part II Application
- Add recruitment materials
- As applicable, (1) use the Consent Form Checklist to revise the sponsor consent template to include University and Affiliate requirements; or (2) use a University consent template for other greater than minimal risk research; add the Consent Form Checklist.
- Add the informed consent documents.
- Add study materials: assessment instruments, surveys, questionnaires, data collection logs, procedural protocols
- As applicable, Add mandatory materials/documents for clinical investigations and study-specific materials/documents (from the itemized lists below)
- Share IRBNet access for all study personnel and the Responsible Official
- Obtain the PI’s signature electronically through IRBNet.
- Obtain the Responsible Official’s signature electronically through IRBNet.
- Submit the project for Full Committee Review.
Mandatory Submission Requirements for Clinical Investigations
The following additional mandatory requirements apply to new clinical investigations submitted for Full Committee Review:
- AddClinical Research Protocol (AKA: Sponsor Protocol) or its equivalent (e.g., investigational plan)
- Add device manual (for research involving investigational devices)
- AddInvestigator Brochure for investigational drugs or devices, or justification for exemption from IND or IDE regulations from FDA or device manufacturer
- Add Investigator form 1572
- Add documentation of FDA, study sponsor, or device manufacturer determination of significant or nonsignificant risk device study (required for investigational device research conducted without IDE)
Study-Specific Submission Requirements for Full Committee Review of New Projects
For new projects submitted for Full Committee Review, additional materials are required as follows:
- AddProtocol Review Subcommittee review: Required for VA research
- Add grant proposal, contract, or scope of work: Required for federally sponsored research
- AddResearch: Investigational Drugs or Research: Investigational Device researcher form: Required when research activities involve investigational/experimental drugs/devices or when drugs/devices are used for off-label or unapproved purposes.
- AddResearch: Blood or Biological Specimens researcher form: Required when research involves the collection of human blood or biological specimens.
- AddHIPPA Authorization Template: Required to obtain written authorization from participants for research involving disclosure of protected health information (PHI).
- AddHIPAA Waiver of Authorization researcher form: Required for the IRB to waive the requirement for written authorization for research involving disclosure of PHI.
- Add vulnerable population researcher forms: Required for research involving pregnant women, fetuses, or neonates; prisoners; children; or adults with cognitive impairment.
- Add Research: International researcher form: Required for research involving culturally sensitive or foreign populations
- Add agency-specific researcher forms: Required for research conducted or supported by the DOD, DOE, DOJ, or EPA.
- Add Education Records/Classroom Survey researcher form: Required for research invoking FERPA or PPRA (e.g., research conducted in schools that receive funding from the DoEd)
- Add documentation of regulatory committee approval: Required for research that is subject to approval from regulatory committees responsible for biological, radiation, or environmental safety
- Add documentation of external scientific, safety, or institutional approval: Required when approval from an external body is necessary for the research to proceed.
NOTE: In some cases, external bodies require IRB approval before approving the research or research components (e.g., recruitment). Contact Research Integrity with questions about obtaining approval from external institutions.
IMPORTANT NOTE REGARDING THE CONSENT WAIVERS FORM:
The Consent Waivers form is required for research requiring Full Committee Review under the following two circumstances:
- For FDA regulated research, to request IRB approval for a waiver of informed consent to review medical records to identify eligible patients, or for a waiver of documentation of consent to complete minimal risk components prior to enrolling a participant in the study (for example, pre-screening interview) (i.e., minimal risk components of greater than minimal risk research).
- For greater than minimal risk research when the only record linking the participant and the research would be the consent document and the principal risk is the potential harm resulting from a breach of confidentiality, that is, to request IRB approval for a Category 1 waiver of documentation of consent. Such research may also be reviewed by expedited procedure if the risk of breach of confidentiality is sufficiently mitigated.
For more information, see IRB policy for waiver/alteration informed consent and waiver of documentation of consent.)
Additional Requirements for Independent or External Investigators Using the University IRB
Review IRB policy for independent or external investigators to use the University IRB and complete the following steps:
- Add principal investigator curriculum vitae.
- As applicable, confirm an Independent Investigator Agreement or IAA is attached by RI staff. In the latter case, AddExternal Investigator Request to Use University IRB.