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Tutorial Chapter 4: Do you need to apply to the UCAIHS?

Case Study:

A graduate student in the History Department at New York University plans to study the historical differences between male and female students in the past 100 years for her thesis. While doing her research, she comes across comprehensive data that was collected in the 1950s. The data could be the basis for a compelling project. She believes this will be especially interesting since she will be able to involve some of her classmates whose ages and backgrounds closely resemble those of the subjects of the earlier studies.

What course should the investigator follow?

A: Since she is a student at the University and the study is not funded, she feels confident that she can move forward with the project by enrolling her classmates in the study as soon as possible.
B: Before she starts the project she conducts further inquiries to determine whether her planned study falls within the jurisdiction of the UCAIHS.

Under the University's Federal Wide Assurance, all research activities involving human subjects must be approved by the University's IRB before the research is started, whether it is funded or nonfunded. These activities include:

Dissertations
Masters' theses
Pilot studies
Class projects
Faculty directed research.

University approval is necessary if the proposed research meets any of these conditions:

the research is sponsored by the University
the research is conducted by or under the direction of any University employee or agent (for example, faculty member, researcher, or student) in connection with his / her other institutional responsibilities, no matter where the research is conducted
the research is conducted by or under the direction of any University employee or agent (for example, faculty member, researcher, or student) using any University property or facility
the research involves the use of the University's nonpublic information to identify or contact human research subjects or prospective subjects to provide data for the research
the research involves the use of the University's students, employees, or facilities.

Oral history projects that are considered research need UCAIHS approval. For details, see Clarification on Oral History.

Use of certain data doesn't need UCAIHS review and approval:

Public Use Data
Biological Specimens and Patient Data
De-Identified Data Not Derived From Other Research Projects

For details, see the UCAIHS policy on Publicly Available Data, De-Identified Data, and Biological Specimens

There are issues that require attention when employees are used as subjects. See the UCAIHS policy on Employees as Subjects in Applied Research.

Chapter Review

Question 1

Activities involving human subjects must be reviewed only if they are funded by an outside agency.

True
False

Question 2

Research conducted by a University employee at a different institution needs to be reviewed by the UCAIHS.

True
False

Question 3

Research that involves the use of the University's nonpublic information to identify or contact human research subjects or prospective subjects must be reviewed by the UCAIHS.

True
False

Question 4

Which of the following types of activities involving human subjects need to be reviewed by the UCAIHS (select all that apply)?

Next Chapter: What do HIPAA regulations entail and how do they relate to the regulations governing human subjects?

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?
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