Affiliated Health Systems and Performance Sites

Rowan University faculty, staff and students should read the information below when conducting research at affiliated health systems and performance sites below. Conducting research at the sites below may require additional forms to be submitted and reviewed by the Institutional Review Boards (IRB) of those sites or approval, procedures to be followed for the use of data about a living individual for research purposes. Faculty, staff and students can contact the Rowan IRB office related to any questions or consultation related to conducting research at the sites below. 

Virtua Health

Rowan University Virtua Health College of Medicine and Life Sciences represents schools and institutes, dedicated to improving health for all. The college will transform the practice of medicine using an approach that treats the whole person, not a disease. Driven by world-class physicians and researchers on the leading edge of science, the college aspires to become a national leader in health care education, discovery and innovation. The College has 3 schools and various institutes and centers.

Faculty and staff of Rowan University that propose human subjects research projects involving Virtua Health locations/sites, employees or patients must submit an Engagement Assessment form for review by the Rowan IRB and Virtua IRB. This engagement form will allow the Rowan and Virtua IRB’s to determine which IRB should be the IRB of record and review the human subjects research project. Please download, complete and submit the Engagement Assessment form below to the Rowan and Virtua IRB general email accounts.

Engagement Assessment Form should be completed when:

• Virtua Health clinics and sites will be used in the conduct of research
• Virtua Health patients will be recruited and enrolled in a research project
• Virtua Health patients will be involved in an intervention or manipulation of their environment
• Virtua Health patient medical records and HIPAA/PHI will be used or accessed in the conduct of research
• Virtua Health employees are identified as researchers or enrolled as subjects

Engagement Assessment Form

Rowan University faculty and staff and Virtua Health employees will still be required to submit the project to the relying IRB for local context review. Local context review may require additional changes to approved IRB submissions to ensure the research can continue at the relying site. Additional changes required by the relying IRB via the local context review must be shared and provided to the IRB of Record. Changes may include but are not limited to use of Virtua Health HIPAA authorization and consent form when accessing and using protected health information. Principal Investigators or a research team member must submit the changes required via the local context review to the IRB of Record.

Virtua Health, being a covered entity, according to HIPAA regulations, may require additional training prior to release, access and/or use of HIPAA/PHI data for research purposes. Researchers will have to follow Virtua Health policies and procedures related to the release, access and/or use of HIPAA/PHI data for research purposes. Data Use Agreement - Please note that to obtain protected health information and limited data sets, a Data Use Agreement will be required. If only obtaining de-identified health and medical information, past, present, or future, a Data Use Agreement will not be required.

Engagement Review - Once the completed engagement assessment form is sent to both IRBs, the IRBs will review and identify the IRB of record. Principal Investigators (PI) will receive notification of the IRB of Record and instructions what submissions, forms, and applications should be submitted to the IRB of record and relying IRB. Relying IRB will conduct a local context review, and changes required as a result of the local context review must be reflected in the IRB of Record protocol.

For assistance with Rowan-Virtua engagement, contact Katelynn Huff. 

Cooper University Health Care

Rowan University and CUH have an IRB reliance agreement governing human subjects collaborative research projects when the research project involves both institutions. This agreement reduces administrative burden for Rowan University faculty and staff, as well as ensuring CMSRU students can participate and be engaged in human subjects research projects, whose PI's are employees of CUH.

Any Rowan University faculty and/or staff conducting research in collaboration with CUH employees, access and use of CUH data for research purposes, or conducted at CUH facilities should complete and submit a Cooper Rowan Engagement Assessment form for review by the Rowan and Cooper IRBs. This assessment form is necessary to help and guide faculty and staff research to identify the IRB they should submit to for a review of their research project.

Question: When is a Cooper Rowan Engagement Assessment Form necessary?

Answer: When a Principal Investigator or research/study staff do not hold a dual appointment and the proposed research activities are conducted at both insitutions.

Example 1: Rowan PI faculty, who does not have an appointment with CUH, wants to conduct recruitment and enrollment activities at CUH locations/sites.

Example 2: Rowan PI faculty, who does not have an appointment with CUH, wants to access and use patient medical chart data or enroll CUH patients as research subjects.

Example 3: CUH PI, who does not have an appointment with CMSRU, wants to access and use student educational records and class/course information or enroll CMSRU students as research subjects.

Example 4: CUH PI, who does not have an appointment with CMSRU, wants to conduct research activities at CMSRU sites and locations.

Cooper Rowan Engagement Assessment Form

CMSRU students that participate in human subjects research conducted at CUH facilities or when the Principal Investigator is a CUH employee, that does not have a dual appointment at CMSRU, or involves use of CUH data may participate in research as a researcher. Such projects, including all participating in research, must be submitted to the CUH IRB. All policies and procedures of CUH and the CUH HRPP/IRB must be followed by all engaged in the above scenario. CMSRU students may not be PI at CUH.

CMSRU students conducting human subjects research where there is no involvement of CUH employees, CUH locations or use of CUH data must find a Rowan/CMSRU faculty to be the Principal Investigator project and submit their propsed study to the Rowan IRB. 

Click here to contact Cooper University Hospital IRB

For assistance with Rowan-Cooper engagement, contact Katelynn Huff. 

Cooper Medical School of Rowan University (CMSRU) - Office of Medical Education (OME)

When submitting a Cayuse IRB application where educational data and records will be used, please contact Office of Medical Education Administration to discuss the project and data that is available. The contact for the Office is Dr. Susan Perlis.

Use the form below to review data that the Office of Medical Education can provide in relation to a Rowan Cayuse IRB submission. The data to be obtained should also be listed as a separate document and attached in the Rowan Cayuse IRB submission as a data collection sheet.

Available Data from OME - Click here to view data.

Jefferson Health New Jersey/Thomas Jefferson University (TJU)

To review detailed guidance and directions related to submitting a Rowan Cayuse IRB submission when the research will include TJU, click on this link: Rowan IRB and Jefferson Health IRB Guidance

Rowan IRB and Jefferson IRB Determination Form