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). FAQ's for IRB process and assistance is located on the Rowan University IRB Homepage. You can also find detailed guidance to IRB submissions provided in the following link: Cayuse Help Center

SUBMISSION GUIDANCE:

  • Step 1: Identify all Co-Investigators, Study Coordinator, and Study Staff that will be involved in your research. Request that all internal/external individuals new to Cayuse IRB request an account at Accessing Cayuse IRB. Once an account has been created, go to Cayuse IRB Login and sign on with your Rowan University Network ID and password. 
  • Step 2: Make sure all personnel identified as a researcher on your study have completed the appropriate CITI human subjects training. For Rowan University faculty, staff, or students submitting human subjects research projects through the RowanSOM IRB additional training in HIPAA Compliance (OCC103) and HIPAA Privacy and Security Medical Research Compliance (OCC-109) may be required.
  • Step 3: Download the Protocol Template appropriate for the type of research you are conducting (SBER, Medical Chart Review, Biospecimens, Clinical Research/Clinical Trials, and NJDOH). 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 CIRB 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 CIRB. 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 Cayuse IRB and begin filling out the CIRB application

Student Submission Checklist - Students can use the Student Submission Checklist to use as a guide to accomplish the basic steps needed to use the Rowan Cayuse IRB (CIRB) submission and review system, high-level review of the review and approval process and other helpful hints and notes about the Rowan CIRB

Non-Rowan University Investigator Named in Rowan CIRB Submission - If an investigator will be assigned to an CIRB 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).

Non-Rowan Performance Sites - If your research will be done in collaboration or at Cooper University Hospital or Jefferson Health New Jersey/Thomas Jefferson University, then click on the following link to view guidance and information about submitting a Rowan CIRB submission. Rowan Performance Site Webpage

Cayuse IRB Website - Cayuse offers training guides and user manuals to all end-users of their product. These guides and user manuals provide information about using their product and is general, not Rowan University Cayuse IRB specific. Individuals will have to create a Cayuse account, seperate from your Rowan Cayuse IRB account, to enter this website and view the training guides and user manuals. Note that in the Rowan CIRB submission, an orange question mark is available in the submission that will bring up some of the guidance and training materials found on the Cayuse IRB website. Click on the link below to go to the Cayuse IRB website.

Preparatory to Research - If you are conducting a retrospective chart review or require access to HIPAA/PHI data to determine that you can acquire an adequate sample of subjects from the RowanSOM patient population, then click on the link below to complete and submit a Preparatory to Research form that will have to be reviewed and approved by the Rowan University Office of Compliance & Privacy. Preparatory to Research form is required when access to HIPAA/PHI data in electronic medical records (EMR) is required to ensure the Privacy Office is aware of and approves release of EMR protected data.

Protected Health Information (PHI)/HIPAA Data - If you will access and use RowanSOM patient PHI/HIPAA data in a prospective or retrospective chart review, then use of PHI/HIPAA data in medical research training must be completed. This training is managed by the RowanSOM Compliance Office and additional training may be required by that office for use and access of PHI/HIPAA. Faculty and staff training can be completed via Healthstream, and student training can be completed via KnowBe4. Links for information and access to training applications are listed below.


Protocol Templates:

The study protocol templates below are required when submitting an IRB application via CIRB. All researchers and investigators are encouraged to use one of these templates as a guide to develop your research protocol.

Qualtrics Site

If your research includes surveying Rowan University faculty, staff and students as subjects you must conduct the survey in Qualtrics.

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 CIRB 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 CIRB 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 CIRB 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.

 


Recruitment Flyers, Postings, and Announcements 

Subject recruitment is an important part of most human subject research studies. All human subject recruitment must also be reviewed and approved by the IRB prior to implementation. All appropriate recruitment documents, tools, and methods should include the following: 

  • Name of study
  • Indication of "Research Study" and statement of voluntariness  
  • Time commitment and study location
  • Subject enrollment requirements (i.e. 18 and older, students, subjects with "x" condition etc.) 
  • Primary Investigator contact information
  • Statement that study has been approved by Rowan's IRB

The above bulleted items should be included in advertisements and other recruitment instruments.

Below are some templates to use for flyers, listservs or letters/emails:

Social Media Advertisements with Limited Character Space

For research that only utilizes an electronic, anonymous survey and researchers will not access, use, or collect subject identifiable information, the template below can be used. For research studies that include research procedures other than or in addition to electronic, anonymous survey, but will use social media advertisements should include the advertisement content requirements listed above.

 


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 CIRB 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. 

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