How to submit a research protocol for IRB review

How to submit a research protocol for IRB review

IRB approval must be prospectively obtained prior to the implementation of any proposed research activity involving human subjects.

Human Use Protocol Submission Process:

  1. Obtain approval or the recommendation for IRB review from the Office of Research. This requires a fully signed USU Form 3208 for Investigators or a signed USU form 3202 for student research projects.
  2. The HRPP Office will accept the submission documents via the new eIRB system- iRIS. To access the system, please go to:  https://dmrncac.dhhq.health.mil (link is external)  (for new accounts, contact the HRPP office (301) 295-3303 for instructions on how to request an eIRB account) 
  3. The protocol application is a fillable eIRB form. In addition to the protocol, the following required documents may be uploaded, as applicable :
    1. For all research: Current Curriculum Vitae (CV), CITI human subjects protections training certifications, HIPAA training certification, Signed Researcher Responsibility Form, - These forms may be uploaded only once into the researcher’s eIRB profile to avoid being asked for these documents with each new IRB submission. [For help, refer to the Human Subject Research Decision Tree]
    2. For sponsored/ funded research: Financial Disclosure/Conflict of Interest Form
    3. For non-exempt studies: Proposed informed consent document (ICD) or information sheet unless a waiver of consent or a waiver of documentation of consent is being sought.
    4. For studies involving protected health information (PH): a separate HIPAA Research Subject Authorization (RSA) or a compound ICD that includes the required HIPAA elements,
    5. Request for determination of Exempt IRB Protocol: According to DoD guidelines [link]  , the determination of whether a proposed project can be exempt from IRB review is made by an independent Exemption Determination Official (EDO). Instructions on how to request an exemption determination are in the following document (link); 
    6. For exempt studies involving PHI: Request for a HIPAA Waiver of RSA, Request for Limited Data Set(LDS)/Data Use Agreement(DUA), information sheet to accompany a survey/questionnaire, 
    7. For research activities taking place outside of USU: Site permission letters or permission requests, Data Sharing Agreement
    8. For subject recruitment: Recruitment materials including advertisements, flyers, telephone or verbal scripts, letters or other communication directed at potential participants,
    9. For Data collection: Case Report Forms, Case History Forms, Data Collection Instruments, forms for testing tools, surveys, questionnaires,
    10. For studies involving external collaborators: copies of the signed or final draft or the of the Data Sharing Agreement, Material Transfer Agreement, approved Statement of Work (SOW) for studies with contracts or funded grants , Memorandum of Understanding,
    11. For studies involving School of Medicine (SOM) or Graduate School of Nursing (GSN) students: Use of SOM Students Approval Form, Use of GSN Students Approval Form.
    12. For FDA regulated research: FDA Form 1572 (for investigational new drug studies), FDA IND or IDE related correspondence, GCP certificates, current health care provider licenses, investigator's brochure (IB) or product inserts.

 

  • DoD Exemption Criteria - 45CFR46.101, 32CFR219.101[link]
  • Human Subject Research - Decision Tree [link]
  • USU eIRB Guide - Requesting for Determination of Exempt IRB Protocol [link]
  • USU eIRB Guide - Initial Submission of a Full Protocol [link]

 


USU Human Subject Protection Review Process

Summary: Document processing time for the USU Human Subject Protection Office decreased from November 2016 to January 2017 through implementation of new processes and is now at an efficiency equal to or better than published national norms. However, the total time from first submission to outcome determination for research project related documents continues to be delayed by passbacks from the analysts to the study team to address inconsistencies, deficiencies, or errors in the documents. The Office of the Vice President of Research (VPR) developed a plan to reduce passbacks and thereby eliminate avoidable delays.

Background

USUHS has a research compliance program with four components- Human Subject Protection Review, Research Animal Protection Review, Human Anatomic Material Use Review, and Biosafety. All are staffed by trained professionals whose responsibility is to review the quality of submissions prior to the formal peer review process that makes a determination on if and how a research project may proceed.

For Human Subject Protection, if a project is classified as research and if living identifiable people voluntarily provide facts, opinions, or biological material, there are three possible outcomes. [also see the Human Subject Research Decision Tree]

  1. The project is exempt from Institutional Review Board review and oversight. The determination of whether a project is exempt is made by a certified Exemption Determination Official (EDO) based on specific criteria published in the relevant regulations. USUHS currently has three EDOs to cover the portfolio.
  2. The project is non-exempt and the material in the submission is limited in scope and considered minimal risk. Such a submission will receive an expedited review meaning that the Institutional Review Board (IRB) Chair or delegate will review the material and make a determination with the time for review relative to the complexity of the material.
  3. The project is non-exempt and the submission is either for a new study or contains material that merits discussion by the full IRB at the next scheduled meeting. This type of submission is often referred to as requiring full board review.

A review of IRB submissions over the past year identifies one factor as the major cause for delay in processing- the need to passback the submission to the study team. Although there are multiple reasons for passbacks, the most common are summarized in the following table.  No matter the document type, some examples are:

  • Records without documents attached
  • Missing documents
  • Missing information within documents
  • Inconsistencies between documents

 

Table-1 Common Reasons for USUHS IRB Submission Document Passbacks

Document TypeSpecific DeficiencyComment
Submission Software SpecificFailure to attach uploaded documents to a submission.
Initial Submission for a new protocolIncomplete submission: missing entire documents
Initial Submission for a new protocolDocuments not completedfor example unanswered questions on protocol application
Initial Submission for a new protocolInformation inconsistency: a). within document b). between documentsfor example protocol and consent differ
Initial Submission for a new protocolPersonnel training documentation incomplete, outdated, or has errors
Continuing ReviewContinuing Review form incompletefor example unanswered questions
Continuing ReviewInvestigators fail to provide current study results and progress, fail to provide cited abstracts or articles, or cut and paste results from prior year
Continuing ReviewProvide literature search but do not provide summary of the current literature or indicate whether the risk/benefit of the study has changed
Continuing ReviewInconsistent reporting periods resulting in enrollment number errors between continuing review periods
ModificationsLack of identification of all requested revisions
ModificationsLack of justification for requested revisions
ModificationsIncomplete submission: missing documents (personnel or other)
ModificationsInformation inconsistency: a). within document b). between documentsfor example protocol details and consent details differ