Human Subjects Protection Program & IRBs

An Institutional Review Board (IRB) ensures the protection of the rights and welfare of human research subjects based on the rules and regulations of the Food and Drug Administration (FDA) and Department of Health and Human Services by approving, requiring modifications in (to secure approval), or disapproving Human Subject Research projects.

Active Studies
7,900+
Clinical Trials
350
Active Human Subject Researchers
3,400+

Rutgers HSPP Toolkit

A comprehensive set of documents to support the ethical and compliant conduct of Human Subject Research and its oversight.

View a List of All Toolkit Documents

Select Topic "Human Subject Research"; Then Enter A Topic Keyword: e.g. Consent;

Templates

Serve as a starting point when crafting a required document which contain all required elements that may needed in an approved format with instructions.

Checklist

Used to document regulatory decisions by IRB Board and the IRB Office. Researcher can review these documents to see how their project will be evaluated and ensure all elements are addressed prior to the initial review.

Worksheets

Used by IRB staff and researchers to assist in regulatory decisions. Researcher can review these documents to see how their project will be evaluated and ensure all elements are addressed prior to the initial review.

Forms

Contains Forms to provide required information to attach with your eIRB application.

Manuals and Handbooks

Required reading for Researchers looking to learn about all the main aspects of Human Subjects Research.

Standard Operating Procedures

Similar to “instruction manuals”, they detail the steps of the IRB review process and policies that guide human subject research review.

External IRBs

Learn More

*When a Non-Rutgers IRB is used to oversee a research study.

*When Rutgers IRB is collaborating with another Institution or Investigator.

 

Rutgers HSPP Toolkit

Review External IRB related Toolkit documents.

Independent / Commercial IRBs

Information about using a Non-Rutgers IRB for approval.

Reliance Agreements / Single IRB

Required agreement to set the terms of IRB Approval between the Rutgers IRB and another Institution(s).

SMART IRB Portal

Use the SMART IRB platform to request, track, and document study-specific reliance arrangements using a national master agreement that allows institutions to avoid having to negotiate individual agreement per study or group of studies. SMART IRB a web platform, not an IRB.