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 identifiying the data elements, a data collection sheet must be created and included in the eIRB application.

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

 

NJDOH eIRB 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.



Submission Guidance New Submissions - Initial Submissions

  1. Review the NJDOH Decision Tree for eIRB Submissions to gain a better understanding of the eIRB review process.
    Please note that Rowan University IRB will determine if a study requires IRB review. This determination is made through an eIRB submission, and Rowan's IRB will communicate with you via email. If a Data Use Agreement is required, then please review Addtional 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 eIRB application - section 7.
  2. All investigators, staff and coordinators included on the protocol must submit an eIRB Guest Account Registration by submitting a request to eIRB IT using eIRB@rowan.edu. You can view the eIRB homepage and guest account registration instructions here- eIRB Homepage. All investigators and personnel named on the eIRB application need to request their own guest account. Follow registration instructions and select your role as Investigator/Researcher.
  3. Registration may take approximately 24 to 48 hours after submitting the registration form. You will receive an email from Rowan's IRB indicating that your eIRB account has been created.
  4. 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 the Education & CITI link above. Click here -CITI webpage - to go to the CITI program.
  5. 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. Please use matching emails in CITI and eIRB when registering with both CITI and eIRB
    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 15 of the eIRB application. 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.
  6. 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 eIRB submission, and general guidance to navigate and complete an eIRB application can be found on this webpage: Investigator / Researcher eIRB Manual webpage

Step 1

  1. Download Investigator Financial and Other Personal Interest Disclosure Form. Complete the form and save it in a folder titled “eIRB” on your computer.
  2. Download the Protocol Template. When completed save it as separate file and save it in “eIRB" folder. 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 7 of the eIRB application. - Click here to view information on New Jersey Department of Health - Data Use Agreement
  4. Draft and save all surveys, data collection sheets, questionnaires and/or other research instruments in the “eIRB" folder. 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 in the “eIRB" folder. Use your institutional or company logo on top of the documents and include a version date and number.
  6. Download the consent template that is appropriate for the study. When completed save it as separate file and save it in the “eIRB" folder. 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 the "eIRB" folder.
  8. Download the Principal Investigator and Investigators CV's/resumes named on the eIRB application to the "eIRB" folder
  9. Download the Agreement for Ethical Conduct of Human Subjects Research for NJDOH Submissions-(Formerly NJDOH OC-41) and save the agreement to the "eIRB" 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 the eIRB system, log in the system, and create new eIRB application - Select "NJDOH" as the IRB
  2. After the eIRB application is created, the PI can notify all Co-Investigators to log into the eIRB system, open up the eIRB application and click on the “Accept Participation” button under "My Activities". After the PI includes all the Co-Investigators in the eIRB application, the PI can use the eIRB email function to notify the Co-Investigators to accept participation.
  3. Upload the documents as follows:
    1. Financial Conflict of Interest Form : Upload into Section 1.3 "Conflict of Interest" in the eIRB application
    2. Protocol: upload into Section 7.0 "Study Summary" in the eIRB application
    3. Research instruments such as surveys, questionnaires and spreadsheets: upload into section 7.0 "Study Summary" in the eIRB application
      1. The Data Collection Sheet should also be uploaded in section 7.0 of the eIRB application
    4. Consent form: Upload into Section 13.2 "Consent Forms & Process of Consent" in the eIRB application
    5. Detailed description of data handling procedures, security measures and disposition into Section 15.0 "Additional Supporting Information" in the eIRB application
    6. Any miscellaneous document(s) and Investigators and Collaborators CV's/resume's: Upload into Section 15.0 "Additional Supporting Information" in the eIRB application

Step 3

  1. After the PI completes the eIRB application and uploads all documentation, the PI can submit the study by selecting "Submit Study" under "My Activities".

 

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 eIRB. 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 Investigator / Researcher eIRB Manual webpage for additional guidance, or call IRB Administration at (856) 566-2712.

Continuing Review / Final Report:

The eIRB system 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 eIRB 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 here 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 Investigator / Researcher eIRB Manual webpage for additional guidance, or call IRB Administration at (856) 566-2712.

 

Facilitated Reviews and When does a research study proposed meet the requirements for Facilitated Review?

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 eIRB application and include the data elements as a separate data collection sheet in section 7 of the eIRB 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 eIRB application.

 

Fee Schedule

All non-NJDOH 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

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NJDOH eIRB Documentation and Information Quick Links:

Protocol Template and Investigator Financial and Other Personal Interest Form webpage

Consent Forms webpage

CITI Training webpage

Rowan University Guidelines

Appendices to Guidelines

FAQ