Policies & Procedures

Policies & Procedures for TC IRB

Federal Regulations & Ethical Foundations

TC IRB policies are guided by federal regulations and ethical principles that protect the rights and welfare of human research participants. Researchers are encouraged to review the following resources:

Teachers College's agreement with the Federal Government that allows it to conduct research involving human subjects is known as a Federal Wide Assurance (FWA). In that agreement, Teachers College agrees to abide by the Department of Health and Human Services' (DHHS) regulations for the protection of human research subjects, 45 CFR Part 46. Those regulations are based largely on the Belmont Report, a statement of ethical principles in human subjects protections published in 1979. The terms of the FWA at Teachers College apply to all research conducted by its faculty, staff and students, funded or unfunded. This includes doctoral research.

The FWA also requires Teachers College to provide comprehensive, ongoing training in human subjects protections for all investigators and research staff.  This training is currently available online through CITI, provided by the Collaborative Institutional Training Initiative.  In order to register for the training, go to the CITI website.  You can see more information about this by visiting our Training & Certification page.

The federal agency responsible for oversight of human subjects research is the Office for Human Research Protections (OHRP). Its website contains a wealth of materials covering the full spectrum of issues in human subjects protections, including the DHHS regulations known as 45 CFR Part 46, and the Belmont Report. 

The federal Office of Research Integrity (ORI) oversees the responsible conduct of research at institutions that receive federal funding.

Public Responsibility in Medicine and Research (PRIM&R) is an organization of researchers, ethicists, and IRB professionals committed to improving human subjects' protections and all other aspects of the responsible conduct of research. They hold ongoing conferences and workshops and are an important resource to the research community.

Investigators who will be collecting private, identifiable health information (PHI) as part of their research are subject to the privacy requirements of the Health Insurance Portability and Accountability Act (HIPAA). Click here for more information on HIPAA.

Certain projects that gather highly sensitive data may wish to obtain a federal Certificate of Confidentiality (COC) for their project. Among other benefits, a COC prevents investigators, research teams, and/or data from being subpoenaed. Thus, a COC is most appropriate for projects where a breach of confidentiality could lead to legal difficulties for a subject. A project need not be federally funded to be awarded a COC.

TC IRB Statement of Compliance

Teachers College maintains a Federal Wide Assurance (FWA) with the Department of Health and Human Services (HHS), ensuring that all research conducted by TC faculty, staff, and students adhere to federal regulations (45 CFR 46). This agreement applies to all human subjects research conducted at TC, whether funded or unfunded, including doctoral research.

Our compliance commitments include:

  • Ensuring comprehensive, ongoing training in human subjects protections.

  • Requiring CITI Training for all investigators and research staff.

  • Adhering to institutional and federal requirements for ethical research conduct.

Download our Statement of Compliance.

TC IRB Policies & Standard Operating Procedures (SOPs)

Accessing TC IRB SOPs

The SOPs below describe the Teachers College Institutional Review Board’s current requirements and procedures for human subjects research oversight. They apply to investigators, research staff, and IRB members, and cover IRB governance and operations, investigator responsibilities, reporting requirements, and special topics such as transnational research and privacy laws.

Modular release approach

Unlike the prior single-document SOP format, TC IRB is transitioning to a modular SOP library. This improves clarity and makes updates easier to track. Additional SOPs will be added as they are finalized, and this page will remain the authoritative source for current SOPs.

Effective versions

These SOPs are the current, controlling versions as of 03/01/2026. If you previously downloaded TC IRB SOPs, please discard older copies and rely on the versions posted here.

How to use these SOPs

Use these SOPs alongside TC IRB guidance, forms, and applicable regulations. If there is a conflict between an SOP and applicable law/regulations or institutional policy, the higher authority controls.

SOP Library (Current)

General IRB Management and Authority

  1. SOP-A-001_TC IRB Standard Operating Procedure (SOP) for Establishing, Implementing, and Updating IRB Policies and Procedures
  2. SOP-A-003_TC IRB Standard Operating Procedure (SOP) for Training and Onboarding of IRB Staff and Board Members
  3. SOP-A-009_TC IRB Standard Operating Procedures (SOP) on Quality Assurance & Post-Approval Monitoring

Research Submission and Review Procedures

  1. SOP-E-005_ TC IRB Standard Operating Procedures (SOP) for Documentation of IRB Discussions, Decisions, and Findings
  2. SOP-G-009_TC IRB Standard Operating Procedures (SOP) on IRB Actions, Failure to Respond, Appeals
  3. SOP-G-010_TC IRB Standard Operating Procedures (SOP) on Transnational Research

Risk Management

  1. SOP-M-001_TC IRB Standard Operating Procedures (SOP) on Conflicting Interests of IRB Members and Consultants
  2. SOP-M-004_TC IRB Standard Operating Procedures (SOP) on Business Continuity & Disaster Recovery

Participant Enrollment

  1. SOP-P-003_TC IRB Standard Operating Procedure (SOP) for Over-Enrollment in Research Studies

Regulatory Compliance

  1. SOP-R-002_TC IRB Standard Operating Procedures (SOP) on Investigator Responsibilities
  2. SOP-R-003_TC IRB Standard Operating Procedures (SOP) on Unanticipated Problems Involving Risks to Subjects or Others
  3. SOP-R-005_TC IRB Standard Operating Procedures (SOP) on Noncompliance
  4. SOP-R-006_TC IRB Standard Operating Procedures (SOP) on Suspensions, Terminations, and Investigator Holds
  5. SOP-R-007_TC IRB Standard Operating Procedures (SOP) on Reporting to Federal Agencies, Departments, and Organizational Officials
  6. SOP-R-009_TC IRB Standard Operating Procedures (SOP) on Complaints from Research Subjects or Others
  7. SOP-R-010_TC IRB Standard Operating Procedures (SOP) on Other Reportable Information
  8. SOP-R-011_TC IRB Standard Operating Procedures (SOP) Post-Approval Monitoring and Auditing of IRB-Approved Research
  9. SOP-R-012_TC IRB Standard Operating Procedure (SOP) for GDPR Compliance
  10. SOP-R-013_TC IRB Standard Operating Procedure (SOP) for PIPL Compliance

Office Hours & Consultations

Researchers can schedule an appointment with an IRB representative by visiting our IRB Office Hours page.

Submit Inquiries via the AskIRB Ticketing System

For general inquiries, submission issues, or guidance on IRB protocols, researchers can submit a ticket through our AskIRB Ticketing System.

Contact Us

Institutional Review Board

Address: Russell Hall, Room 13

* Phone: 212-678-4105 * Email: IRB@tc.edu

Appointments are available by request. Make sure to have your IRB protocol number (e.g., 19-011) available. If you are unable to access any of the downloadable resources, please contact OASID via email oasid@tc.edu.

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