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. 

Cayuse IRB (CIRB) Submission Guidance

Individual Investigator Agreements

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).

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

Preparatory to Research

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.

Health Insurance Portability and Accountability Act (HIPAA) Data / Protected Health Information (PHI)

If your research will access and/or use patient HIPAA/PHI data, whether it is from a RowanSOM clinical practice or external, non-Rowan entity, in a prospective or retrospective chart review IRB study, then HIPAA training must be completed and included in the IRB submission. Certificates for {101 and 109 HIPAA/PHI-for students} and {113 and 109 HIPAA/PHI-for employees} compliance training must be attached in the IRB submission, and the Rowan University Office of Compliance & Corporate Integrity is the office responsible for oversight related to use of HIPAA/PHI data and information. Any HIPAA/PHI data that will be used for research purposes and coming from a non-Rowan, external institution may require a Data Use Agreement. Access, use, storage and disposal of HIPAA/PHI data governed by a Data Use Agreement between Rowan and the non-Rowan, external institution must be incorporated into the IRB protocol and submission.

Faculty and Staff Training

Faculty and staff can complete HIPAA 113 and 109 training via Healthstream. Certificates, indicating HIPAA training was completed, must be attached to the IRB submission.

Student Training

Student HIPAA 101 and 109 training can be completed via KnowBe4. For student training, the Rowan faculty Principal Investigator(PI) or designee of PI must submit a list of students that will be identified as research personnel in an IRB submission to the Rowan IRT - Information Security Office (ISO). Emails listing the students must be sent to Information Security Office staff Eric Wilson and/or Michael Davie, and Rowan University Office of Compliance & Corporate Integrity staff, Kathy Alburger, should be cced in the email request. Rowan IRT ISO will assign HIPAA training to the students (101 & 109), and the student will be able to use the KnowBe4 application and complete the training. Student certificates, indicating HIPAA training was completed, must be attached to the Rowan IRB submission.

To open a ticket with the Information Security Office you can email ISO@rowan.edu

If 1-5 students need to be added, write the following in the ticket:

Please assign <Name> <Email> (<BannerID>) (Enrollement Year i.e 2022) to KnowBe4 HIPAA OCCI109 training

If there are more than 5 students that need to be added please attach an Excel sheet with the student's information and write the following in the ticket:

Please assign students to KnowBe4 HIPAA OCCI109 training. Attached is an Excel sheet with the student's information.

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.

  

Non-Rowan Study Site Permission Letter Guidance 

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.

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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