Baruch Human Research Protection Program (HRPP) Office (formerly IRB)
CUNY Policies and Procedures, Downloadable Forms, and Reference Materials
- CUNY UI-IRB Authority
- HRPP Staff Responsibilities
- IRB Member Roles & Responsibilities
- Researcher Responsibilities
- Principal Investigator (PI) Qualifications & Responsibilities
- Faculty Advisor Responsibilities
Submitting to the IRB:
- When is CUNY HRPP or IRB Review Required?
- What to Submit?
- Where to Submit?
- Researcher Manual for Using IRBNet
Review Types and Processes:
- Exempt from IRB Review
- Expedited Review
- Convened IRB Review
- Guidance Document - Expired Studies
- Guidance Document - IRB Appeals Process
- Guidance Document - Study Closures
- Informed Consent Process and Documentation
- Tip Sheet: Informed Consent Process and Documentation
- Use of Raffles as Compensation for Participation
Types of Research:
- Internet or Mobile Technology Based Research
- FDA-Regulated Research
- Department of Defense Conducted or Supported Research
- Accounting for Total Subject Enrollment
- Children as Research Subjects
- Prisoners as Research Subjects
- Pregnant Women, Human Fetuses and Neonates as Research Subjects
- Guidance Document - Subject Pools
- CUNY College-Specific Policies Regarding Recruitment of Students as Research Subjects
- Unanticipated Problems and Adverse Events
- Disposition of Allegations of Non-Compliance
- Suspension or Termination of Human Subject Research
Education and Training:
CUNY Policies and Manual:
- CUNY Adjunct Faculty Request to Serve as PI Form
- Definitions of Anonymous, Confidential, and De-Identified
- Sample Letter - Letter of Responsibility - (For Non-Affiliated Personnel whose institution does not have an IRB) - Must be signed by supervisor.
- Sample Letter - Compliance Letter - (Non-Affiliated Personnel without Institution)
- Sample Letter - PI Letter of Responsibility - If PI is a student then faculty advisor's signature is also required.
- Informed Consent Form Template - (Adults)
- Oral/Internet Based Informed Consent Script Template
- Screening Script Template
- Addendum to Informed Consent Template
- Adolescent Assent Form/Parental Permission Form
- Child Assent Form Template
- Parental Permission Form Template
- Infomed Consent Document Development Guidance*
- Suggested Language for Informed Consent Documents*
*Please review these documents as you are creating your assent/consent forms.
- IRBNet PI Manual
- IRBNet Energizer - New User Registration
- IRBNet Energizer - Researcher 1 (Initial Submissions)*
- IRBNet Submission Instructions (Step-by-Step with screenshoots)
- IRBNet Energizer - Subsequent Submissions - (Revisions, Amendments, Continuing Reviews)**
*These instructions are for initial submissions only.
**These instructions are for previous applications submitted on IRBNet only. If you are submitting your application for the first time, please follow the IRBNet Energizer Researcher 1 instructions.
Reference/ Educational Materials:
- US DHHS Office of Human Subject Protections publications, regulations, policies and guidelines.
- NYC Department of Education Proposal Guidelines
- NYC Department of Education Frequently asked Questions
- "Research in NYC Public Schools" Presentation by Mary C. Mattis
- Code of Federal Regulations (45 CFR 46)
- International Compliation of Human Research Standards
- Belmont Report
- Issues in International Research
- Nuremberg Code
- The Declaration of Helsinki: World Medical Association Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects
- Tuskegee Experiment