Please note: Principal investigators seeking New Jersey cancer data for their research must contact the New Jersey Cancer Registry for special IRB application instructions
Determine if your research project requires IRB approval
If you are not sure whether your project requires IRB review, please consult the decision tree [pdf 18k].
Prior to submitting an IRB application, email the appropriate Data Steward(s), who manages the dataset(s) you are interested in, and briefly explain your project and the data you will need from the Department.
After understanding the data requirements of your project, the data steward will inform the Department's IRB Administrator of your request, and you can follow the Basic Steps of IRB Application below.
If questions remain about whether your project is exempt from IRB review, or whether it qualifies for expedited or full board review, please contact the IRB office.
Basic Steps of IRB Application
Initial Review
Email your Data Steward(s) first. Briefly explain your project and the data you will need from the Department. Data Stewards are available to answer questions about the kinds of data available from the Department, as well as the data release policies for a particular dataset.
Complete and attach other required components, as well as any optional documents, listed in the Initial IRB Application Checklist below.
Please submit the application as follows:
Email a copy of the entire application, with required signatures, to
Initial IRB Application Checklist
To submit a complete protocol, your application should include the following:
Application for Initial Review (IRB-1)
Research Protocol
Data Use Agreement signed by principal investigator and NJDHSS data steward(s). (Contact
to request data use agreement template and samples).
Agreement for Ethical Conduct of Human Subjects Research (OC-41), Federal employees submit OC-45, instead.
CITI or NIH/NCI certificates for all investigators and research personnel. (CITI Basic certificates expire three years after completion date, and CITI Refresher certificates expire after two years).
Approval from other external OHRP-approved IRB institutions, if applicable
DHSS scientists or project staff only: Institutional Approval of Intramural Research (OC-37)
Continuing Review / Renewal
Federal regulations require that IRB approved protocols be reviewed and approved no less than once every twelve months. Please note the expiration date for your study listed on the latest NJDHSS IRB Approval Letter.
Items that need to be submitted for an annual renewal:
Most recent approval letter from other OHRP-approved IRB institutions, if applicable
Updated OC-41 forms with all signatures, curriculum vitae, and CITI certificates for all research personnel. (CITI Basic certificates expire three years after completion date, and CITI Refresher certificates expire after two years).
Modifications to an Approved Protocol
The NJDHSS IRB should be notified before a change is made to a protocol, including the addition or removal/replacement of research personnel. If you have a question about the need to submit a modification, contact the IRB office.
Items that need to be submitted for a modification:
