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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 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.

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 Approval Forms

When research plans to conduct or engage non-Rutgers sites in human research, the forms below assist the research in documenting approval between Rutgers and the non-Rutgers sites.

General Site Approval Form

If a project plans to conduct research with staff, students, patients or members of any non-Rutgers institution/organization/school (but not engage them as research personnel), use template HRP-504 (below) to document the agreement between parties.

Performance Site Approval Forms

Performance Site approval documentation is required for all research involving any site below which includes systematic participant recruitment, research impacting site staff time, and/or research impacting site financial reimbursement. All research activity at a performance site cannot proceed until the PI receives approval from the Rutgers IRB and the performance site.

Examples of research activities requiring Performance Site Approval: 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

  1. Complete a Research Utilization Group (RUG) form Online Printable Form (Rutgers VPN required if accessing outside the Rutgers network). For questions email RUG Support.
  2. Submit your completed RUG Form online. It does not have to be approved before your eIRB request is submitted for review.
  3. Once approved by the RWJUH RUG Committee, attach your approved RUG Form to your eIRB submission and ensure RWJUH is listed as a site for your study in eIRB.

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

  1. Determine if your study requires “University Hospital Registration” and/or “NJMS Office of Clinical Research Administration (OCRA)" review.
  2. If yes, your study must have both of the following included in eIRB:
    - Add "University Hospital" as a performance site in your eIRB application.
    - Your "OCRA confirmation email" should be attached with your eIRB submission to provide proof of registration and/or review.
  3. ***Please note that University Hospital will not provide final approval for a study until after it has been approved by the IRB. You will be directed in the confirmation e-mail from NJMS-OCRA to forward your IRB approval notice once received, so that the UH registration/approval process can be completed.

University Behavioral HealthCare UBHC (Various Locations in New Jersey)

  1. Using a UBHC Human Subject Research Form, obtain site approval from UBHC before submitting your study to the Rutgers IRB.
  2. Complete the following actions when you submit your study in eIRB:
    - Add UBHC as a research site.
    - Attach your approved UBHC Human Subject Research Form in your eIRB submission.

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) CINJ 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