Conducting Research with Human Subjects: The IRB and HIPAA

Acknowledgements

Session Objectives

What is an IRB?

Columbia University's IRB
Definition of a Human Subject

Purpose and Responsibilities of the IRB

IRB Review Criteria for
Clinical Research Studies

IRB Review Criteria (continued)

IRB Review Criteria (continued)

Research or Therapy

The Columbia University IRB
Definition of Research

"The distinction between research and therapy is often blurred" (DHHS 1991)

Research Involving Human Subjects is Regulated Under Federal Authority

Research Guidelines for Vulnerable Subjects

 Categories of Vulnerable Subjects

"All studies must continue to..."

Minimal Risk

Expedited Review May Be Available for Minimal Risk Studies

Expedited Review

Components of an IRB Submission

When Do I Submit an IRB?

IRB Amendments

When to File an IRB Amendment

IRB Renewals

Investigator Responsibilities

Activities that are Considered a Violation of Columbia IRB Policy

Potential Penalties for Violating National Clinical Research Standards

IRB Approval Does Not Offer Complete Immunity from Court Prosecution

Interpretation of IRB Regulations

Safeguarding Patient Privacy

HIPAA, “The Privacy Rule”

HIPAA Compliance and Protected Health Information (PHI)

Getting GCP Certified

Getting GCP Certified (Cont’d)

Getting HIPAA Certified

Conflicts of Interest

Rascal Testing Center

Columbia University Monthly IRB Seminars: Conducting International Research and Research at Non-Columbia Sites