Initial Submissions

Initial Submissions

Initial Submissions to the IRB

If you have general questions about the IRB processes, procedures, or other questions, please use this FAQ (Word). eIRB FAQ's and assistance is located on the eIRB homepage. You can also find detailed eIRB User Manuals and Quick Reference Guides Here

SUBMISSION GUIDANCE:

  • Step 1: Identify all Co-Investigators, Study Coordinator, and Study Staff that will be involved in your research. Request that all individuals go to the eIRB live site and register/create an account in eIRB. To create an account, the individuals just need to input their Rowan University Network username and password to go to the registration screen and complete all information with a red asterisk. eIRB IT will approve the registration and create an account in eIRB.
  • Step 2: Make sure all personnel identified as a researcher on your study have completed the appropriate CITI human subjects training.
  • Step 3: Download the Protocol Template and complete the sections as necessary and as it relates to your research. It is recommended to complete this first, as it will help with completing and inputting information into the eIRB application
  • Step 4: Download the appropriate Investigator Financial and Other Personal Interest Disclosure Form (find below) related to your campus and IRB submission. Complete the sections as necessary and obtain all signatures
  • Step 5: Prepare applicable Consent Forms, interview script, questionnaires/surveys, data collection instruments, advertisements, bulletin board announcements, email language, external study site approval letter and other research instruments to upload
    • Note: Retain all documents, instruments and forms in one folder on your desktop or flashdrive so you can upload the documents when prompted in eIRB. It is good practice to update all documents with version dates in the footer and on Rowan Letterhead/Logo if possible
  • Step 6: Log into eIRB and begin filling out the eIRB application

If an investigator will be assigned to an eIRB application and that investigator is not a Rowan University faculty, staff or student and the investigator's institution does not have an IRB that has a Federalwide Assurance (FWA), then the external investigator needs to read, review and sign an Individual Investigator Agreement (Word).

All new, initial applications must be submitted electronically via eIRB.

eIRB Checklists:


Protocol Template:

The study protocol template below is required when submitting an IRB application via eIRB. All researchers and investigators are encouraged to use this template as a guide to develop your research protocol.

  • Study Protocol Template - Example (Word) - This template includes examples of what some research studies may include in a protocol. If this template is used in a formal eIRB submission, then the first page of instructions and all instructional text and examples should be deleted. The protocol that is uploaded into eIRB should only include the investigator input and directly relate to the proposed research study.
  • Study Protocol Template (Word) - This template includes instructional text. When using this template in a formal eIRB submission, please delete the first page and all other instructional text. The protocol that is uploaded into eIRB should only include the investigator input and directly relate to the proposed research study. Recommended for experienced researchers.

Will your research include Rowan University faculty, staff and students as subjects who are being recruited to complete an electronic survey?

Qualtrics Site

If so, University Information Resources and Technology Policy requires that you use Qualtrics to administer the electronic survey. Any questions about the survey policy and conducting surveys using Rowan faculty, staff and/or students should be discussed with a representative from Rowan's Office of Information Resources and Technology. IRT - University Policy Webpage


CONSENT FORMS:

Depending on your study and who your subjects are, your study may require the use of consent forms. We have created consent form templates that are required to be used when submitting eIRB applications.


INVESTIGATOR FINANCIAL AND OTHER PERSONAL INTEREST DISCLOSURE FORM:

The Investigator Financial and Other Personal Interest Disclosure Form and Study Protocol are required for every eIRB submission. A study specific Investigator Financial and Other Personal Interest Disclosure Form is required for all research personnel.

Any significant financial interest must be reported to the Institutional Review Board (IRB) via the eIRB application. The Conflict of Interest Committee (COIC) associated with your Home Department organization's campus - RowanSOM or Glassboro - will conduct a review of the significant financial interest.. Any Glassboro/CMSRU financial or other personal interest disclosed must be reported to the Office of Research. Conflict of Interest Committees review disclosures of significant interests and determine if these constitute a conflict of interest, and, if so, to decide how such conflicts will be managed, reduced or eliminated.


IRB submissions of Research Conducted Outside of Rowan University:

To assure the protection of human subjects and to comply with Federal regulations, the Institution requires IRB review and approval whenever biomedical or behavioral research projects are undertaken by the Institution's faculty, staff, employees, agents, or students which, in whole or in part, involve human subjects or human material or records and surveys. Therefore, if studies are conducted wholly outside of Rowan University by faculty, staff or students an eIRB submission is still required.  Review may require a Facilitated Review or normal initial submission review from one of Rowan University's IRBs. Please reach out to the IRB if you have any questions regarding your outside research IRB submission. 

APPENDICES:

Appendices for guidance and assistance in your IRB application submission can be found here