• Step 1: Identify all Co-Investigators, Study Coordinator, and Study Staff that will be involved in your research. All internal/external individuals new to Cayuse IRB request an account at Accessing Cayuse IRB. Complete the New IRB User Request Google Form and submit that to create the individuals' Cayuse IRB account (Can take 24 to 48 hours to have the account created once the Google Form is submitted). 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. Rowan University faculty, staff or students accessing, using or storing HIPAA/PHI, training in HIPAA Compliance will 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 Conflict of Interest (COI) and Significant Financial Interest (SFI) Disclosure Form. Complete the sections as necessary and obtain all signatures.
• Step 5: Prepare applicable Consent Forms, interview scripts, questionnaires/surveys, data collection instruments, recruitment documents, external study site approval letter, and other research instruments. Note: Retain all documents, instruments, and forms so you can upload the documents when prompted in CIRB. Update all documents with version dates in the footer and on Rowan's Letterhead/Logo.
• Step 6: Log into Cayuse IRB and begin filling out the CIRB application

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 are general, not Rowan University Cayuse IRB
specific. Individuals will have to create a Cayuse account, separate 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. 

Cayuse Support

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.

• CLINICAL/CLINICAL TRIAL Protocol Template (Word)
• MEDICAL CHART REVIEW Protocol Template (Word)
• NJDOH USERS Protocol Template (Word)
• SOCIAL BEHAVIORAL EDUCATION RESEARCH Protocol Template (Word)
• SECONDARY USE OF BIOSPECIMENS Protocol Template (Word)

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:

• Recruitment Flyer Template
• Recruitment Rowan Daily Mail or Listserve Template
• Recruitment Email and Letter Template

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.

•  Electronic, Anonymous Survey Recruitment Template

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.

• Consent Form Templates

When conducting research at a non-Rowan study site, permission from a representative at the site is required prior to the recruitment of subjects. The permission letter should include the following: 

• Name of study
• Study site letterhead
• Principal Investigator and/or student's full name
• Purpose of study
• What resources/sites/rooms will be provided to the researchers
• Statement and understanding that human subjects will be recruited at the site, and human subjects will undergo research experimental procedures
• Signature, title, and contact information of the individual providing approval

The above bulleted items should be included in the study site permission letter and uploaded in the Cayuse IRB application.

A study-specific Conflict of Interest (COI) and Significant Financial Interest (SFI) Disclosure Form is required for research personnel listed on a study as Principal Investigator (PI), Co-Investigator (Co-PI), and/or Primary Contact. Research personnel listed on the study as Other Study Staff are not required to complete the form.

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.

If an investigator will be assigned to a 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).

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 a Rowan CIRB submission may be necessary. IRB review may require a rely on non-Rowan IRB or research/protocol 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. 

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

If you are conducting a retrospective chart review or require access to RowanSOM 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 & Corporate Integrity. A completed Preparatory to Research form must be attached in the IRB submission to ensure the Privacy Office is aware of and approves release of PHI- protected data and your proposed project can be completed. After completing the form, please review the Rowan University Office of Compliance & Corporate Integrity webpage and submit to the office for review and signature. Upon obtaining the completed and signed form, the Preparatory to Research fully completed and signed form should be attached in the Cayuse IRB submission.

• Click here to download the Preparatory to Research form 

If your research will access and/or use patient HIPAA/PHI data, whether it is from a RowanMedicine clinical practice or external, non-Rowan entity, in a prospective or retrospective chart review IRB study, then HIPAA training must be completed and certificate/evidence of completion included in the Rowan Cayuse IRB submission. 

More information about HIPAA and HIPAA Medical Research Training for Rowan University faculty, staff, and students can be found Here. 

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