New Jersey Department of Health (NJDOH)

NJDOH Data Requirements related to IRB Submissions

If acquiring data from NJDOH, then investigators must identify the data elements to be obtained in the conduct of the research. Investigators can review documents with the various data elements on the NJDOH website or sending an email requesting data elements that can be collected in the conduct of research. After identifying the data elements, a data collection sheet must be created and included in Cayuse IRB.

Investigators should review the Additional Guidance, Step 2 - #3 to review NJDOH information and guidance related to the acquisition of NJDOH data.

New Jersey Department of Health Employee and Staff Principal Investigator Guidance

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.

Principal Investigator Eligibility Guidance

• Principal Investigators requesting NJDOH data must be:
  • 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
• Private citizens and residents that want to gain access to NJDOH data must request data through the State of New Jersey Open Public Records Act (Click here to go to NJ OPRA)

NJDOH CIRB SUBMISSION DOCUMENTATION*

• Investigator Financial and Other Personal Interest Form
• 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
• 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 Pat Gessner with any questions regarding NJDOH submissions

New Jersey State Psychiatric Hospital Research

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

Submission Guidance New Submissions - Initial Submissions

1. Review the NJDOH Decision Tree for CIRB Submissions.pptx to gain a better understanding of the IRB review process. Please note that Rowan University IRB will determine if a study requires IRB review. This determination is made through a CIRB submission, and Rowan's IRB will communicate with you via email. 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. If unsure of the training, please contact the Rowan University IRB office at (856) 566-2712.

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 Conflict of Interest (COI) and Significant Financial Interest (SFI). NJDOH and non-NJDOH investigators listed on an IRB submission should identify that their institution is and will be responsible for reviewing conflicts of interest and significant financial interests, and any restrictions/management plans imposed by their institutions communicated to and included in the Rowan NJDOH IRB submission to ensure that IRB approval can include and incorporate any restrictions/management plans imposed by their institutions, if applicable. Complete the form and save it in a folder titled “CIRB” on your computer.
2. Download the NJDOH Protocol Template. When completed save it as a separate file and save it on your computer in a folder corresponding to your proposed application. 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.
3. If obtaining data from NJDOH, contact New Jersey Department of Health to obtain information about the data that can be used in the research proposed. Create a data collection sheet based upon the data elements to be obtained from NJDOH and upload the data collection sheet as a separate document in section 8 of the CIRB application.
4. Draft and save all surveys, data collection sheets, questionnaires and/or other research instruments in the. Use your in the computer folder you just created.  Use your institutional or company logo on top of the documents and include a version date and page numbers on the left-hand side of footer.
5. Download and save all advertisements, flyers, and/or letters into your folder. Use your institutional or company logo on top of the documents and include a version date and number.
6. Download the consent template from the following site: https://research.rowan.edu/officeofresearch/compliance/irb/submissions/consenttemplates/index.html. Or, download the consent template approved by your institution.  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.
7. When drafting the data to be acquired from NJDOH, please include the data elements as a separate document and save to your folder.
8. Download the Principal Investigator and Investigators CV's/resumes named on the IRB application to your folder.
9. Download the Agreement for Ethical Conduct of Human Subjects Research for NJDOH Submissions-(Formerly NJDOH OC-41) and save the agreement to your folder. Please make sure to fill-in the document, then print and have all investigators sign the form and then obtain the investigator's Direct Supervisor signature.

Step 2

1. The Principal Investigator will need to go to CAYUSE IRB, log in the system, and create a new IRB application - Select "NJDOH" as the IRB
2. Upload the documents as follows:
   1. Financial Conflict of Interest Form: Upload into Section "Conflict of Interest" in Section 3 of the application
   2. Protocol: upload the completed NJDOH protocol template in Section 8.0 of the application
   3. Research instruments such as surveys, questionnaires and spreadsheets: upload into section 8.0
      1. The Data Collection Sheet should also be uploaded in section 8.0 of the Cayuse submission
   4. Consent form: Upload into Section 7 in the Cayuse submission
   5. Detailed description of data handling procedures, security measures and disposition into Section 11.0
   6. Any miscellaneous document(s) and Investigators and Collaborators CV's/resume's: Upload into Section 13.0

Step 3

1. After the PI completes the CIRB application and uploads all documentation, the PI can submit the study by selecting Study completion

Submission Guidance for Modifications and Continuing Review/Final Report

Modifications:

For NJDOH transferred IRB applications and new IRB applications a modification must be submitted in Cayuse IRB. For new protocols, please click here to review the Modification webpage. All modifications must be reviewed and approved by the IRB before implementing the changes.

Select the IRB Studies tab (next to the Inbox tab). Locate and open the study you would like to create a modification. To the left of the screen, select “New Modification”, this will bring you to the Modification application. Complete the Modification and submit for IRB review.

Please see https://support.cayuse.com/hc/en-us/categories/115001977467-Cayuse-IRB additional guidance, or call IRB Administration at (856) 566-2712.

Continuing Review / Final Report/Study Closure:

Cayuse IRB will send automatic email notifications 90, 60, and 30 days prior to the expiration date of the study. The Principal Investigator is responsible for ensuring that the Cayuse IRB protocol is either continued or closed. Recruitment and data collection can not occur for an expired protocol. All activities must cease on the date of expiration. Please click https://support.cayuse.com/hc/en-us/categories/115001977467-Cayuse-IRB to review the Continuing Review / Final Report webpage.

Select the IRB Studies tab (next to the Inbox tab). Locate and open the study that requires a continuing review. To the left of the screen, select “New Continuing Review”, this will bring you to the Continuing Review application. Under “Review Type” select either continuing review or Final Report. Complete the continuing review or final report and submit for IRB review.

Please see https://support.cayuse.com/hc/en-us/categories/115001977467-Cayuse-IRB for additional guidance, or call IRB Administration at (856) 566-2712.

Relying upon another institution’s IRB for NJDOH studies

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 being obtained and 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.

New Jersey Department of Health (NJDOH) - Data Use Agreement

NJDOH requires a fully signed Data Use Agreement when accessing or obtaining NJDOH data. Investigators must provide in detail the specific data and the period of the data to be reviewed in the CIRB application and include the data elements as a separate data collection sheet in section 7 of the CIRB application. This is important and must be done accurately.

New Jersey Department of Health - Request for Data

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.

Exempt and Non Human Subject Review Policy

Research in exempt and non human subject research categories are approved for one time. Any request for subsequent modification to exempt and non human subject research requires submission of a new application. 

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, click here - Fee Schedule

NJDOH Cayuse IRB Documentation and Information Quick Links:

Protocol Template and Investigator Financial and Other Personal Interest Form webpage

Consent Forms webpage

CITI Training webpage

FAQ (Word)