510. New Projects - Submission Requirements for Full Committee Review
Updated September 21, 2021
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 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 Principal Investigator (PI) and all members of the study team have completed the required training
- Create a New Project in IRBNet
- Add Part I, Cover Sheet
- Add Protocol – Social Behavioral Educational Research and Record Research or Protocol – Biomedical Research form
- 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, if applicable).
- Obtain the PI’s signature electronically through IRBNet.
- Obtain the Responsible Official’s signature electronically through IRBNet, if applicable (for all greater than minimal risk protocols, and upon request by the IRB or Research Integrity for minimal risk protocols.
- 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:
- Add Clinical Research Protocol (AKA: Sponsor Protocol) or its equivalent (e.g., investigational plan)
- Add device manual (for research involving investigational devices)
- Add Investigator Brochure for investigational drugs or devices, or justification for exemption from Investigational New Drug (IND) or Investigational Device Exemption (IDE) regulations from Food and Drug Administration (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:
- Add Protocol Review Subcommittee review: Required for VA research
- Add Research with Drugs or Research with Devices form: Required when research activities involve investigational/experimental drugs/devices or when drugs/devices are used for off-label or unapproved purposes.
- Add Research with Specimens form: Required when research involves the collection of human blood or biological specimens.
- Add HIPAA Authorization Template: Required to obtain written authorization from participants for research involving disclosure of protected health information (PHI).
- Add HIPAA Waiver Request Form: Required for the IRB to waive the requirement for written authorization for research involving disclosure of PHI.
- Add Research with Prisoners form: Required for research involving prisoners.
- Add Department of Defense Research form: Required for research conducted or supported by the Department of Defense (DOD).
- 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 IRB Authorization Agreement (IAA): University of Nevada, Reno IRB as IRB of Record is attached by Research Integrity staff.