Introduction

The tutorial is designed to:

  • Make the University community aware of its responsibilities when conducting research with human subjects;
  • Educate the University community in the ethical bases of the Federal and University regulations that govern these research activities;
  • Help the University community carry out its responsibilities and obligations under these regulations

Q: Who Needs to Take the Tutorial?

A: Anyone submitting an application to the NYU University Committee on Activities Involving Human Subjects (referred to as UCAIHS or the Committee) must complete this tutorial and pass the certification exam prior to review of the application. Applicants need to pass the exam once; subsequent applications to the UCAIHS do not require retesting.

Tutorial Overview

Each of the 18 chapters can be completed independently. To get the most out of a chapter, you should:

  1. Complete the case study (for certain chapters) to test your current understanding.
  2. Work through the content of the section, paying particular attention to the areas that address the gaps in your knowledge.
  3. Answer the chapter review questions to test your knowledge. Immediate feedback will be given to each answer — use this as an opportunity to review the content, especially if you were not sure of the answer.

Once you have completed all the chapters and feel comfortable with the material, take the exam. The certification exam consists of 20 primary questions and 20 secondary questions. The primary questions (worth 3 points) are always on the exam while the secondary questions (worth 2 points) are randomly selected each time you take the exam. You must receive a score of 80 (out of 100) to be certified.

Human Subjects Tutorial

  • Introduction
  • Chapter 1: Why are human subjects research regulations necessary?
  • Chapter 2: What are the basic elements of the research code of ethics?
  • Chapter 3: What are the current regulations concerning human subjects research?
  • Chapter 4: Do you need to apply to the UCAIHS?
  • Chapter 5: What do HIPAA regulations entail and how do they relate to the regulations governing human subjects?
  • Chapter 6: What process does the University use for implementing the regulations?
  • Chapter 7: What are the investigator’s responsibilities?
  • Chapter 8: What are the categories of application?
  • Chapter 9: What information must investigators give to the UCAIHS?
  • Chapter 10: What criteria does the Committee use when evaluating applications?
  • Chapter 11: How should researchers select and recruit subjects?
  • Chapter 12: What is informed consent and how is it documented?
  • Chapter 13: How must researchers deal with protected populations?
  • Chapter 14: How do researchers protect subject privacy and confidentiality?
  • Chapter 15: What are researchers’ obligations when cooperating institutions are involved?
  • Chapter 16: What are researchers’ obligations when doing research in foreign countries?
  • Chapter 17: What types of decisions can the UCAIHS make?
  • Chapter 18: What should investigators do during the application process and the course of their projects?
  • Take the Certification Exam!
  • Glossary
  • References