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Human Subjects HSPP documents forms

Human Research Protection Program Toolkit

A comprehensive set of forms, templates, policies, procedures, and guidance topics to support the ethical and compliant conduct of Human Subject Research and its oversight.

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What's New?

What’s New: AI Consent Guide — New plain-language examples aligned with Rutgers IRB templates to help researchers develop clear, ethical consent language for studies using or developing AI.

General Consent Templates

What are Consent Templates? Consent templates and passages found below provide language to use when obtaining informed consent or assent from individuals to take part in human research. Choose the template and passages that best reflect the research and subject population to be enrolled.

General consent templates contain all required informational elements when a study poses greater than minimal risks of harm or plans to enroll a vulnerable population (i.e., children, adults lacking decisional capacity, etc.)

AI Consent Guide

AI in Human Subjects Research: Rutgers Consent Guide - Download the AI Consent Guide

Surrogate Consent Process

When the research plans to enroll adults who lack decisional capacity, follow the Surrogate Consent Guidance. Use the appropriate Surrogate Consent Template (above) and applicable worksheets (below).

Special Consent Passages

Special consent passages must be added to the body of the consent document when specific laws or regulations apply to the research.

Consent Addenda

When a study plans to offer/enroll subjects in optional research activities secondary to the main study, append the appropriate addenda to the end of the consent document for the main study.

Non-English Documents

When the research plans to enroll individuals who cannot read or write, cannot see, cannot hear, or who do not speak/read English well, follow the instructions below to include the services of an interpreter, witness and/or translator, as applicable. 

When the Short Form of Consent Process will be used to enroll individuals who cannot read/write English well, use TEMPLATE HRP-507.

External IRBs

A collection of different toolkit documents used for studies involving External institutions. The Human Research Protection Program Toolkit contains documents required to establish a reliance agreement when an External Institution is relying on Rutgers University to serve as the IRB of Record.

What are Standard Operating Procedures (SOPs)?

SOPs are similar to instruction manuals as they detail steps of the IRB review process and policies that guide human subject research review.

Standard Operating Procedures

What are Manuals & Handbooks?

Manuals and handbooks contain required reading for researchers looking to learn about the main aspects of Human Subjects Research.

What are Checklists?

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

What are Worksheets?

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

Worksheets

Performance Site Forms

Letter of Cooperation Overview

When a study team intends to conduct research involving staff, students, patients, or individuals from external sites—without engaging them as research personnel—use the HRP-504 template (below) to document the agreement between the parties.

Performance Site Overview

When research plans to conduct or engage sites in human research, the forms below are a requirement to utilize the sites for research purposes. Examples of research activities requiring Performance Site documentation:

  • Recruiting on-site;
  • Using hospital staff to provide a service;
  • Using hospital staff as study personnel;
  • Using a room;
  • Using equipment;
  • Accessing medical records (including chart reviews), etc.

Robert Wood Johnson University Hospital, New Brunswick

For all research activities conducted that involve the use of the RWJBH hospital and/or accessing electronic medical records, extracting patient medical records or screening medical records for recruitment of study, must reference both performance sites below in the eIRB+ application:

  • Robert Wood Johnson University Hospital (RWJBH)
  • EPIC System-wide (RWJBH)
    1. Complete the IRC form (formerly RUG) online printable form (Rutgers VPN required if accessing outside the Rutgers network). For questions, email RUG Support.
    2. Submit your completed IRC Form online. It does not have to be approved before your eIRB+ request is submitted for review.
    3. Upload your IRC application or IRC email receipt within your eIRB+ submission.

University Hospital UHNJ, Newark (affiliated with the New Jersey Medical School)

For all research activities conducted that involve the use of UH and/or accessing electronic medical records, extracting patient medical records or screening medical records for recruitment of study, must reference both performance sites below in the eIRB+ application:

University Behavioral HealthCare UBHC (Various Locations in New Jersey)

  1. For the use of any UBHC locations, please obtain the site approval form before submitting your study to the Rutgers IRB.
  2. Please complete the UBHC Human Subject Research Form to add a site. The form is required each time a new UBHC site is added. For questions, contact UBHC.
  3. Complete the following actions when you submit your study in eIRB+:
    • Add the UBHC as a performance site.
    • Upload your approved UBHC Human Subject Research Form within your eIRB+ application.

Research Protocol Templates

What are Research Protocol Templates?

Research Protocol Templates serve as a starting point when crafting a Research Protocol document. Templates contain all required elements for Rutgers IRB approval and detailed instructions.

15.301 (HRP-503a) Interventional Research Protocol
This template should be used by biomedical and social-behavioral researchers conducting research in which subjects are assigned to receive one or more interventions so that the researchers can evaluate their effects (e.g. clinical trials, CBT, Behavioral Modification studies, or randomized outcome studies.

15.302 (HRP-503b) Non-Interventional Research Protocol
This template should be used by social-behavioral and biomedical researchers to prepare a protocol document for any research involving various types of interactional or observational methodologies: observations, interviews, focus groups, surveys, program evaluations, quality of life or interactional research.

15.303 (HRP-503c) Secondary Research with Data or Biospecimens Protocol Template
To be used by biomedical and social-behavioral investigators proposing secondary research with data—which may include written text, images or audio-/visual-recordings—or biospecimens that were or will be collected for other purposes. This template replaced the Retrospective Chart/Record Review Protocol.

15.304 (HRP-503d) Data/Tissue Repository SOP
For investigators who wish to develop standard operating procedures in order to establish a research [tissue or data] bank, otherwise known as a repository. This SOP template may be submitted to the IRB instead of the applicable Rutgers IRB Research Protocol Template.

15.305 (HRP-503e) RCI Application and Protocol for Exempt Research
This template must be used by RCINJ Investigators submitting proposed exempt research in eIRB through the Fast Track Exempt Review Process.

15.306 (HRP-503f) Humanitarian Use Device Protocol Template
This template should be used by clinicians planning to provide patients access to a Humanitarian Use Device (HUD) in the clinical context. If the HUD is being used in a clinical investigation to evaluate its safety and effectiveness, either for the HDE-approved indication(s) or for a different indication, please use HRP-503a Interventional Protocol Template instead.

15.307 (HRP-508) Local Context Supplement
A Local Context Supplement (LCS) must be completed and submitted to the IRB when a Rutgers Investigator proposes to collaborate with one or more other institutions and Rutgers is not the lead site. In such cases, the Rutgers Investigator must disclose in the LCS what specific research tasks s/he will perform, where the tasks will be performed, and what/how data will be held by Rutgers and/or transferred between collaborating institutions. Other information may be requested by an IRB to learn more about the local context.

15.308 (HRP-503Plus) Research Protocol Guide for eIRB+
This document is intended to help you prepare your eIRB+ application. This document does NOT need to be uploaded/submitted in eIRB+. You may use this as a worksheet as you prepare your application narrative. When ready, you may copy and paste your responses into the eIRB+ application

Paper Forms

These documents are used for active paper studies only.

General Paper Forms