1 NJ Dept. of Health Decision Tree for eIRB Submission Revised: 06/18/2015 Is this research defined as: A systematic investigation which includes research development, testing and evaluation, designed to contribute to generalizable knowledge, i.e., publication, presentation, or achievement of a degree NOTE: Rowan University IRB will make the determination whether a proposed study is human subjects’ research or not. The Principal Investigator IS STILL REQUIRED to submit an eIRB application requesting a Non-Human subjects review. Are you using data / information about a living individual? Is there an interaction or an intervention with a living person related to this research; OR is the information individually identifiable and is the information private (is the information collected where the subject can reasonably expect that a recording is not taking place and the information was provided for a purpose where there is not an expectation that the information will be made public or used in the conduct of research)? If using confidential information or a link exists between different data sets for this research, then please follow the arrow marked ‘Yes’ Yes 1 No Yes 2 Non-Human Subjects Review Human Subjects Review

2 2 NJ Dept. of Health Rowan University eIRB Process NJDOH Principal Investigator, Coordinators, Co-Investigators, and Study Staff request a Guest Account in eIRB. Personnel receive notification of eIRB account in approx. 24 hours Principal Investigator and/or Co-Investigator creates eIRB application. Completes and uploads all applicable information listed in eIRB Application Requirements and completes eIRB application All Co-Investigators listed in the eIRB application need to Accept Participation. eIRB Application Documentation: 1)Investigator Financial and Other Personal Interest Form 2)Protocol Template 3)Consent Forms 4)Research Materials – Data Collection Sheet, survey, interview or other instruments; screening instruments 5)Advertisements, letters 6)Data Use Agreement - NJDOH 7)Any other document(s)/materials pertinent to the proposed research study Principal Investigator submits study in eIRB. If errors are noted when submitting, then specific eIRB pages noted in error message need to be corrected. If no errors occur, then the study is submitted for Department Review and Approval. 1 NJDOH Principal Investigator requests a Guest Account in eIRB Principal Investigator receives notification of eIRB account in approx. 24 hours Principal Investigator downloads and completes Rowan University Protocol and Investigator Financial and Other Personal Interest Form Principal Investigator logs into eIRB, creates eIRB application, uploads the applicable documentation, and completes the eIRB application. NOTE: needs to select the following when completing the eIRB application. On page 1.5 Review Type, the PI selects Non-Human. Complete eIRB application pages. 3

3 NJ Dept. of Health (NJDOH) Rowan University eIRB Process the data request to the NJDOH Data Privacy Officer 3 RU IRB Administration reviews eIRB application. RU IRB determines Non-Human Subjects and issues Non-Human Subjects Determination Letter to PI RU IRB Administration reviews study and identifies any changes required. IRB Administration will note the following change request in section 15 of the eIRB application: Need to upload a signed, fully executed NJDOH Data Use Agreement Principal Investigator obtains fully executed NJDOH Data Use Agreement, logs into eIRB, makes changes requested, responds to change requests, uploads fully executed Data Use Agreement in section 15 of the eIRB application and submits changes back to RU IRB for review RU IRB completes review and makes a final determination. Issues Approval Letter. Human Subjects Review Non-Human Subjects Review Principal Investigator s data request to NJDOH Data Privacy Officer