General information for submission of EIRB documents

General information for submission of EIRB documents

A major operational goal of the human subject protection program at the USU is to minimize, if not eliminate, the need for passbacks by establishing processes, including training and advice, that result in the submission of high quality documents.

To achieve that goal, the Office of the Vice President for Research (VPR) designed a multistep program.

  1. Flagging submissions that are candidates for exemption determination with a prefix code of EXM before the protocol title.
  2. Preparation of instructional material to provide a high quality submission for various use cases. The instructional material will be available on the upcoming revised USU VPR website
  3. In person teaching sessions for the USU community to be held quarterly.
  4. Identification, training, and support for IRB submission enablers distributed across the programs and departments to function as the first line for preparation of submissions, to respond to questions, and to provide initial support.
  5. Shifting the USU IRB Analysts to function as second level support for IRB submission preparation so that they will devote most of their time to processing submissions, teaching, and quality improvement.

On an operational basis, the general problem is mapping information from often multiple sources into a structured document. The mapping is neither simple nor straightforward. The process has a learning curve and USU VPR encourages limiting the number of people in a given program, department, or center who perform the mapping and data entry to increase the proportion of people with sufficient experience and expertise by fostering a system where fewer people do more submissions.

The IRB submission process begins with a study team entering data into the EIRB system.

A more comprehensive checklist for the study team to follow in preparing a new submission follows in Table 2 entitled "Detailed Generic Checklist for study team initial submission of EIRB documents".

Table 2

AdministrativeUSUHS Form 3208 (for faculty) and Form 3202 (for students)Linkage with USUHS VPR research project tracking system
AdministrativeSummary of Grant ApplicationIf applicableIs protocol aligned with goals of funded project?
AdministrativeVerification of Scientific ReviewDocumentation of who, when, where, outcome, if applicable. Members of study team cannot participate in scientific reviewIRB will only review protocols that have undergone competent scientific review
AdministrativeDocumentation of local command pre-IRB reviewIf applicableAssure local command at Department of Defense study sites is aware and accepts protocol participation
Study TeamConflict of Interest StatementUse version from March 2016Assure quality and integrity of study team
Study TeamResearcher Responsibility StatementUse version from October 2015Assure quality and integrity of study team
Study TeamVerification of relevant CITI Training for all members of Study TeamAssure quality and integrity of study team
Study TeamCurriculum Vitae for all members of Study Team, relevant licensesAssure quality and integrity of study team
ProtocolProtocol documentIf requesting or anticipating that the project will be exempt from IRB review and oversight, include the letters “EXM” as the first letters of the titlePrimary review document
ProtocolSample Informed Consent FormPrimary review document
ProtocolData Collection Forms (Case Report Forms), survey instruments, questionnairesPrimary review document
ProtocolAdvertising materialPrimary Review Document
ProtocolHIPAA Waiver of AuthorizationIf applicableData custody and privacy
AgreementsCopy of MOUs and Partnership AgreementsIf applicableData custody and privacy
AgreementsData Sharing AgreementsIf applicableData custody and privacy
AgreementsLetters of SupportIf applicableSupporting document
Product SafetyInvestigator’s BrochureIf applicableSupporting document
Product SafetyApproved Product Package InsertIf applicableSupporting document
Product SafetyFood and Drug Administration IND or IDE number. If study under IND, Principal Investigator must be an MD.If applicableSupporting document