DOH Home  >>  Institutional Review Board

Select textsizemediumlargelarger

Application Procedure

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

  1. 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.
     
  2. Complete the Application for Initial Review (IRB-1).
     
  3. Complete and attach other required components, as well as any optional documents, listed in the Initial IRB Application Checklist below.
     
  4. 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:

Box

Application for Initial Review (IRB-1)

Box

Research Protocol

Box

Data Use Agreement signed by principal investigator and NJDOH data steward(s). (Contact to request data use agreement template and samples).

Box

Agreement for Ethical Conduct of Human Subjects Research (OC-41), Federal employees submit OC-45, instead.

Box

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).

Box

Curriculum vitae or resumes for all investigators and research personnel



Plus, one copy of the following documents as applicable:

Box

Grant application and award notification

Box

Informed Consent Documents (forms, scripts, etc.)

Box

Instruments (survey, questionnaire, abstraction form, rating scale, etc.)

Box

Approval from other external OHRP-approved IRB institutions, if applicable

Box

DOH 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 NJDOH IRB Approval Letter.

Items that need to be submitted for an annual renewal:

  1. Application to Continue Human Subjects Research (IRB-2) [submit at least 45 days before your expiration date].
     
  2. Copy of most recent protocol
     
  3. Most recent approval letter from other OHRP-approved IRB institutions, if applicable
     
  4. Updated 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 NJDOH 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:

  1. Application to Modify Human Subjects Research (IRB-3)
     
  2. Updated protocol highlighting the changes made (see instructions)
     
  3. Modification approval letter from other OHRP-approved IRB institution, if applicable
     
  4. Any supporting materials that are changed such as:
  • Updated consent form
  • Updated and/or new questionnaires, surveys
  • Updated and/or new recruiting materials


Do we have the data you need?

Ask Us

 

Department of Health
P. O. Box 360, Trenton, NJ 08625-0360
Our Locations
Privacy policy, terms of use and contact form links State Privacy Notice legal statement Deparment's Feedback Page New Jersey Home

OPRA- Open Public RecordAct
department: njdoh home | index by topic | programs/services
statewide: njhome | departments/Agencies | services A to Z | FAQs
Copyright © State of New Jersey, 1996-

Last Modified: Friday, 24-Aug-12 10:39:00