Research Study Development Templates

Submitting to an Institutional Review Board Research Study Development Templates
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Submitting to an Institutional Review Board Research Study Development Templates

NYU School of Medicine’s Office of Science and Research has created a list of standard protocol templates for human subjects research. Please use these templates when developing new studies. 

Protocol Template for Interventional Clinical Trial Protocol
Protocol Template for Interventional Behavioral Study
Protocol Template for Observational Study
Summary of Exempt Research

Consent and Assent Forms

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

Biomedical Consent Form Template
Nonbiomedical Consent Form Template
Standard Consent Language: Biomedical
Standard Consent Language: Nonbiomedical

Biomedical Consent Form Template (Mandarin)
Nonbiomedical Consent Form Template (Mandarin)
Standard Consent Language: Biomedical (Mandarin)
Standard Consent Language: Nonbiomedical (Mandarin)

Biomedical Consent Form Template (Russian)
Nonbiomedical Consent Form Template (Russian)
Standard Consent Language: Biomedical (Russian)
Standard Consent Language: Nonbiomedical (Russian)

Biomedical Consent Form Template (Spanish)
Nonbiomedical Consent Form Template (Spanish)
Standard Consent Language: Biomedical (Spanish)
Standard Consent Language: Nonbiomedical (Spanish)

Data Use Agreement
Audio Video Consent (Release)
Pregnant Partner Contact Sheet
Emergency Use Consent Form
Full Telephone Consent
Humanitarian Use Device Consent Form
Specimen Banking Consent Form
Treatment Investigational New Drug/Investigational Device Exemption Consent Form

Research Authorization Form
Research Authorization (Mandarin)
Research Authorization (Spanish)

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 (Bengali)
Short Consent Form (French)
Short Consent Form (Hungarian)
Short Consent Form (Korean)
Short Consent Form (Japanese)
Short Consent Form (Mandarin)
Short Consent Form (Mongolian)
Short Consent Form (Polish)
Short Consent Form (Russian)
Short Consent Form (Spanish)
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 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@nyumc.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

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

Review Preparatory to Research and Recruitment
Guidance on Investigator’s Responsibilities
Writing a Research Protocol
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
Questions to Ask Regarding Community Based 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

Subject File (Binder)

Subject File Guidance Document

Recruitment/Consent/Waiver of Consent and Authorization

Creating a Consent Process and Documentation
Creating a Verbal Consent and Template
Recruitment Guidance
Assent of a Minor Form and Process Preparation
Advertisements for Recruiting Subjects
Obtaining and Documenting Informed Consent of Non-English Speaking Subjects
Requests for Waiver of Consent
Waiver of Parental Permission

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

Types of IRB Submissions/Reviews

New and Continuing IRB Review
Emergency Use of an Investigational New Drug or Investigational Device Exemption
Compassionate Use Emergency Device Policy