How to submit a research protocol for IRB review

Research

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.

  1. Obtain approval or the recommendation for IRB review from the Office of Research. This requires a fully signed USU Form 3208 for Investigators (link to Assurance Forms) or a signed USU form 3202 for student research projects (link to Intramural Program Forms).
  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.
    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. 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,
    6. For research activities taking place outside of USU: Site permission letters or permission requests, Data Sharing Agreement
    7. For subject recruitment: Recruitment materials including advertisements, flyers, telephone or verbal scripts, letters or other communication directed at potential participants,
    8. For Data collection: Case Report Forms, Case History Forms, Data Collection Instruments, forms for testing tools, surveys, questionnaires,
    9. 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,
    10. 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.
    11. 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.