Institutional Review Board Template Library | NYU Langone Health

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Institutional Review Board Operations Institutional Review Board Template Library

Institutional Review Board Template Library

NYU Grossman School of Medicine’s Institutional Review Board (IRB) has created the following standard templates, forms, waivers, and guidance for human subjects research.

Please note that some forms and guidance documents have been impacted by changes to federal regulations that are also known as the Common Rule. Please pay careful attention to which form you use or whether your study was approved by the IRB before January 21, 2019 (old rule) or after January 21, 2019 (new rule).

Protocol Templates

Protocol Builder® is a first-of-its-kind solution that makes writing investigator-initiated protocols faster and easier, and helps to ensure that protocols meet IRB and regulatory standards. You may choose from 18 cloud-based protocol templates to create your protocol (Kerberos ID and password required).

A user guide is also available. For Protocol Builder account issues or inquiries, please contact the Help Desk at 844-563-1042 between 9:00AM to 9:00PM. You may also contact Matthew Larkey, administrative coordinator, at matthew.larkey@nyulangone.org.

You may also use one of the templates below.

COVID-19 Research Template for Interventional Research Protocol Synopsis
COVID-19 Research Template for Observational/Non-Interventional Research Protocol
Protocol Template for Interventional Clinical Trial Protocol (old rule) (new rule)
Protocol Template for Interventional Behavioral Study (old rule) (new rule)
Protocol Template for Observational Study (old rule) (new rule)
Summary of Exempt Research (old rule) (new rule)

Consent Forms

You may need one or several of the following forms as you obtain informed consent or assent from subjects.

Key Information Template (new rule)
Biomedical Consent Form Template (old rule) (new rule)
Nonbiomedical Consent Form Template (old rule) (new rule)
Standard Consent Language: Biomedical (old rule) (new rule)
Standard Consent Language: Nonbiomedical (old rule) (new rule)

Other Consent Forms

Audio Video Consent (Release)
Pregnant Partner Contact Sheet
Emergency Use Consent Form
Full Telephone Consent
Humanitarian Use Device Consent Form
Specimen Banking Consent Form
Expanded Access of Investigational New Drug/Investigational Device Exemption Consent Form
Research Authorization Form

Consent Templates Short Forms

These forms are for use with non-English–speaking persons who are going to be asked to participate in research. Use a short form written in the subject’s native language in order to record consent. The English version of the short form is available here for your reference, although English speakers will be able to read and consent using a regular consent document.

Short Consent Form (English)
Short Consent Form (Albanian)
Short Consent Form (Arabic)
Short Consent Form (Armenian)
Short Consent Form (Bengali)
Short Consent Form (Bosnian)
Short Consent Form (Brazilian Portuguese)
Short Consent Form (Farsi)
Short Consent Form (French)
Short Consent Form (Greek)
Short Consent Form (Haitian Creole)
Short Consent Form (Hindi)
Short Consent Form (Hungarian)
Short Consent Form (Italian)
Short Consent Form (Korean)
Short Consent Form (Japanese)
Short Consent Form (Mandarin)
Short Consent Form (Mongolian)
Short Consent Form (Polish)
Short Consent Form (Romanian)
Short Consent Form (Russian)
Short Consent Form (Spanish)
Short Consent Form (Thai)
Short Consent Form (Turkish)
Short Consent Form (Urdu)
Short Consent Form (Vietnamese)

Standard Consent Language for Special Cases

If your study involves a CT scan, chest X-ray, or other radioactive medical imaging study, please use the language found in the standard consent language: biomedical template.

Assent Templates for Children

NYU Grossman School of Medicine’s institutional review boards (IRB) have been working closely with researchers who have specific expertise in working with children. The result is clearer guidelines for working with minors and more detailed assent of minor forms.

Whenever children or minors (less than 18 years of age) are involved in research, federal regulations require the assent of the child or minor. Out of respect for children as developing persons, a detailed written assent document provides the child with information that they can take home. The signature allows the child to feel that their decision matters, and including him or her in the process enhances the ethical principal of respect which should be present in all human subjects research.

Please consult our guidance on assent forms and use these templates with all new research proposals involving children. Should you have any questions, contact the IRB at irb-info@nyulangone.org.

Assent for children ages 7 to 11 years for biomedical studies
Assent for children ages 7 to 11 years for nonbiomedical studies
Assent for children ages 12 to 14 years for biomedical studies
Assent for children ages 12 to 14 years for nonbiomedical studies
Assent for children ages 15 to 17 years

Waivers of Consent

Request for Waiver of Authorization or Consent Form (old rule) (new rule)

Recruitment Templates

When using direct patient contact as a recruitment method, you need to include information in your proposed protocol to the IRB. Once you have IRB approval you may then contact DataCore to obtain a list of patients.

Please use the following templates for recruiting participants for human subjects research:

Recruitment Phone Script Template
Recruitment Physician Letter Template
Recruitment Patient Letter Template
Recruitment Sample Subject Direct Mail Notification Template
Standard Protocol Language—DataCore Epic Recruitment

Guidance Documents

You may find the following guidance documents helpful as you create a new protocol and submit to the appropriate review boards.

IRB Policy Documents

Lapsed Study Policy

New Protocol Guidance

COVID-19 Specific Participant Letter Regarding Limited Liability
IRB Guidance for Obtaining Informed Consent During COVID-19 Research
Requirements and Tools for New COVID-19 Human Subjects Research
Protocol Builder® NYU Langone–Specific Biospecimen Protocol Addendum
Review Preparatory to Research and Recruitment
Guidance on Investigator’s Responsibilities (old rule) (new rule)
Writing a Research Protocol (old rule) (new rule)
Required Elements of a Protocol
International Conference on Harmonization Good Clinical Practices, Applicability to Human Subjects Research
Research Data Compilations
Protocol Development for Genetic Research Studies
Community Engagement Research
Special Considerations for the Oversight of Research Protocols Using an FDA-Regulated Product
Required Documents Checklist
Requirements of the Sponsor and the Investigator as a Sponsor
Data Safety Monitoring
Conducting Research Outside of the United States (old rule) (new rule)

Subject File (Binder)

Subject File Guidance Document

Recruitment, Consent, and Waiver of Consent and Authorization

Guidance on Electronic Informed Consent
Creating a Consent Process and Documentation (old rule) (new rule)
Creating a Verbal Consent and Template
Recruitment Guidance (old rule) (new rule)
Assent of a Minor Form and Process Preparation
Advertisements for Recruiting Subjects
Obtaining and Documenting Informed Consent of Non-English–Speaking Subjects (old rule) (new rule)
Informed Consent for Non-English Speaking Participants
Requests for Waiver of Consent (old rule) (new rule)
Waiver of Parental Permission (old rule) (new rule)

Research Involving Vulnerable Populations

Research Involving Cognitively Impaired Subjects
Research Involving Students or Employees
Research Involving Prisoners
Research Involving Pregnant Women, Fetuses, and Neonates
Research Involving Children (old rule) (new rule)

Types of IRB Submissions and Reviews

New and Continuing IRB Review (old rule) (new rule)
Emergency Use of an Investigational New Drug or Investigational Device Exemption
Compassionate Use Emergency Device Policy

Research Navigator Appendices

Almost all appendix forms related to study submissions are available electronically in Research Navigator. The only paper forms you may need to fill out and upload to your study profile are the appendices listed below:

Other Submission Forms for Upload to Research Navigator

Disclosure of Financial Interest Form

There are three easy methods that can be used to complete your research financial disclosure forms (Kerberos ID and password required for login).

For more information, contact the Conflict of Interest Management Unit.