NJDOH employees/staff can be named as a Principal Investigator (PI) on IRB submissions. NJDOH employees/staff identified as a PI take on the responsibilities and duties of the PI.

Principal Investigator (PI) Responsibilities and Duties Include:

• Preparation of a research protocol and fulfillment of all subsequent obligations in connection with that protocol
• Ensuring changes in the design or conduct of the research including addition of new subjects obtains IRB approval before implementing the change. Only when to eliminate apparent immediate hazards to human subjects (to ensure subject safety) can protocols be changed without IRB approval. Such protocol deviations to the safety of subjects must be immediately reported to the IRB
• Minimize risk by using procedures which are consistent with sound research using appropriate procedures; and risks to subjects are reasonable in relation to anticipated benefit (if any)
• Selection of subject population is equitable
• Obtain informed consent in advance of research participation (if necessary)
• Ensure that privacy and confidentiality is properly maintained
• Ensuring appropriate additional safeguards are included in the study to protect the rights and welfare of human research subjects who are likely to be vulnerable to coercion or undue influence
• Properly implementing an approved protocol using good clinical and/or human subject research practices
• Coordinating, supervising and monitoring the activities of all other persons participating in the research and for assuring that all personnel are properly trained to conduct human subject’s research; and IRB documents and submissions are filed/submitted timely to the IRB
• Ensuring NO subject enrollment occurs and all research activities are stopped when a protocol expires
• Complying with all IRB decisions, conditions, and requirements and for ensuring that applicable laws and regulations are observed
• Reporting unanticipated adverse events that are also unanticipated problems involving risks to subject or others (e.g., those that are related and or possibly related to the research) to the IRB and other appropriate agencies as they occur. Further guidance on reporting external un-anticipated adverse events and local unanticipated adverse is available at: http://www.hhs.gov/ohrp/policy/advevntguid.html. and http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126572.pdf.

IMPORTANT: NJDOH employees/staff cannot be named as a PI when collaborating with external, non-NJDOH entities to avoid payment of IRB review fees.

• NJDOH Employees or Employee of a New Jersey State department, agency, or office
• Federal, state, or local government employee
• Individuals who hold an appointment or have employment with:
  • An institution of higher education
  • Academic teaching hospital
  • Medical center
  • Reserach institute that is affiliated with an institution of higher education
  • Nonprofit entity with 501(c)(3) IRS status (Other than institutions of higher education)
  • U.S. registered corporations and businesses 
  • Organization that collaborates or has a formal partnership/agreement to conduct services or participate in a project with NJDOH

• Principal Investigator institution's Institutional Review Board approval letter
• Protocol Template
• Consent Forms
• Research Materials – Data Collection Sheet, survey, interview or other instruments; screening instruments
• Advertisements, letters
• Detailed data that will be obtained from NJDOH via Data Use Agreement
• Investigators CV’s and resumes and/or training certificates/completion letters
• Any other document(s)/materials pertinent to the proposed research study
• Agreement for the Ethical Conduct of Human Subjects Research (formerly NJDOH OC-41)

* - May change depending on study design, type and purpose.

Please Contact Eric Gregory with any questions regarding NJDOH submissions

The state psychiatric hospital system is now part of the State of New Jersey Department of Health. New Jersey state has not approved state psychiatric hospitals as research performance sites, including retrospective chart reviews or observational only based research.

New Jersey State Psychiatric Hospitals

• Ancora Psychiatric Hospital
• Ann Klein Forensic Center
• Greystaone Park Psychiatric Hospital
• Trenton Psychiatric Hospital

1. Review the NJDOH Cayuse IRB Submission Workflow to gain a better understanding of the IRB review process. Please note that Rowan University IRB will determine if a study requires IRB review. The non-human subjects research determination is made through a CIRB submission. If a Data Use Agreement is required, then please review Additional Guidance - Step 1; sub-step 3 to review data that is available from NJDOH. Include the data elements in a separate document, and upload the document into the CAYUSE IRB APPLICATION in Section 8.
   
   
2. Accessing CAYUSE IRB - All investigators, staff and coordinators included on the protocol must submit a CAYUSE EXTERNAL USER ACCOUNT request as directed here. Non-Rowan Users (External Affiliates): Request a New Cayuse IRB Account

3. Make sure all personnel included on the protocol have completed CITI human subjects training. You can find information about Rowan's IRB training by clicking Education and CITI Training. Click here - CITI webpage- to go to the CITI program.

4. Affiliate with Rowan University in your CITI account; or in your existing profile include Rowan University as another affiliated institution and select the CITI training that you have already completed - For example, if you have completed Biomedical Basic course in your institution's CITI account, then you should select the Biomedical Basic course when selecting modules/courses for Rowan University.                                                                                                      

1. 1. Please use matching emails in CITI and Cayuse IRB when registering with both CITI and Cayuse IRB
   2. If an investigator affiliates with Rowan University in CITI and their training record is not reflected in the Rowan University CITI account, investigators should print their current Certificate of Completion and upload into section 13 of the Cayuse IRB submission. The IRB will review the training and verify training is adequate, but if not, then the investigator will have to complete the human subjects research training as directed by IRB administration.
   3. Select the appropriate CITI training, for example, if only using data in your human subjects research, then you would select Rowan University Group 2: Biomedical and Basic Research - Data and Specimens Only Research. Rowan University IRB administration may request additional training as necessary and based on the research protocol.

Additional Guidance

Please note that the guidance below is specific to an NJDOH submission, and general guidance to navigate and complete an IRB application in CAYUSE can be found on this webpage: https://support.cayuse.com/hc/en-us/categories/115001977467-Cayuse-IRB under the title “Researchers: Studies and Submissions”

Step 1

1. Download the NJDOH Protocol Template. Use your institutional or company logo on top of the documents and include a version date and number and page numbers on the left-hand side of footer.
2. Review NJDOH Data request system and website here to identify data elements: Data Request Tracking System
3. NJDOH Employees - Draft and save all surveys, data collection sheets, questionnaires and/or other research instruments in the. Use your department/unit logo on top of the documents and include a version date and page numbers on the left-hand side of footer.
4. NJDOH Employees - Download and save all advertisements, flyers, and/or letters into your folder. Use your department/unit logo on top of the documents and include a version date and number.
5. NJDOH Employees - Download the consent template from the following site: https://research.rowan.edu/officeofresearch/compliance/irb/submissions/consenttemplates/index.htmlUse your department/unit logo on top of the documents and include a version date and number and page numbers on the left-hand side of footer.
6. Non-NJDOH Employees - Research instruments, documents, advertisements, recruitment and consent documents, ancillary committee review and approval, IRB approval letter, and other existing, approved PI/Non-Rowan IRB research documents and instruments can be attached to the Rowan NJDOH IRB submission, as applicable. For example, If NJDOH data only is required and recruitment, consent, and protocol/study implementation will not involve any NJDOH employee or engage NJDOH, then non-Rowan IRB approved consent documents, surveys, etc. can be attached in the Rowan NJDOH CIRB submission and the NJDOH data collection sheet with data elements will need to be drafted, made final, and attached to the Rowan NJDOH IRB submission by the research team/investigators. 
7. Create a data collection sheet as a separate document to attach in Rowan CIRB submission
8. Have the Principal Investigator and Investigators CV's/resumes
9. Download the Agreement for Ethical Conduct of Human Subjects Research for NJDOH Submissions-(Formerly NJDOH OC-41) and have the Principal Investigator and all Co-Investigators complete. Direct Supervisor signature is not required for IRB submission. 

Step 2

1. The Principal Investigator (PI) will need to go to CAYUSE IRB, log in the system, and create a new IRB submission - Select "NJDOH" as the submission type
2. Upload the documents as follows:
   1. Financial Conflict of Interest Form
   2. Site approval letters
   3. PI institution IRB approval letter
   4. Protocol
   5. Research instruments such as surveys, questionnaires and spreadsheets
   6. Consent form(s)
   7. Any miscellaneous document(s), training certifications/completion letters, and Investigators and Collaborators CV's/resume's

Step 3

1. After the PI completes the CIRB application and uploads all documentation, the PI can submit the study by selecting Study Completion in the initial, modification, renewal, or other type of Cayuse IRB submission.

All modifications must be reviewed and approved by the Rowan IRB before implementing the changes.

Please see https://support.cayuse.com/hc/en-us/categories/115001977467-Cayuse-IRB additional guidance, or contact IRB Administration.

When New Jersey Department of Health data or records is used in the research, then the study must be reviewed by Rowan University's IRB. Rowan University will not sign an inter-institutional agreement relying on another institution to conduct the review when NJDOH data is used in research.

New Jersey Administrative Law requires that certain information that will be shared or provided to individuals be reviewed and approved by the Department's Institutional Review Board to assure the protections of human subjects.

If you need to request data from NJDOH, please click here - Data Request Tracking System - and follow the instructions. The data request tracking system will allow you to identify the data you would like to use in your research and allow NJDOH to be aware of your request. The data being requested in this system must be reflected and the same as the data identified to be used in your research and will be included in your CIRB application.

NJDOH data that is Personally Identifiable Information (PII) cannot be transferred, transmitted, sent or distributed outside the United States. All research that has international collaborators must include descriptions of procedures and protocols related to the access, use, handling, transfer and storage of PII. PII data access, use, handling, transfer and storage will have to adhere and follow NJDOH Data Use Agreement terms and conditions.

Fee Schedule

All non-NJDOH/ non-Rowan investigators who use Rowan University IRB services are charged a review fee based on the level of review. For fee structure and payment, review the Fee Schedule.