Tutorial Chapter 6: What process does the University use for implementing the regulations?

Case Study:

A senior investigator in the social sciences who is also a Dean of Students is concerned about the growing caseload of students at the school's clinic showing signs of serious anxiety. She is interested in the relationship between depression and increases in anxiety and in particular in whether depressed individuals more easily experience increased anxiety levels than those who are less depressed. Her previous work has indicated quite strongly that anxiety can make depression significantly worse, but the findings in the reverse are less clear. This work could help clinicians at the school determine improved treatment for the students.

The investigator submits an Application for Review to the institution's IRB for a pilot study, proposing to recruit as subjects students at the end of their first year of college who had, in their first semester, in an introductory social science class, taken a battery of psychological tests, including ones for levels of depression and anxiety.

The investigator plans to select from among those students who had shown no more than moderate anxiety levels in the testing but who also scored either very high or very low on an index of depression. She will show the members of both groups a series of upsetting images - war, famine, earthquake, automobile accidents and the like - mixed in with other, more neutral, material, and then retest them for anxiety levels. Subjects will be told only that the investigator is interested in personal preferences for visual material, i.e., which images they like and which they don't.

The IRB defers the project, expressing serious concern that the potential benefits of the study are far outweighed by the possible risks of psychological harm to those subjects already showing signs of serious depression, particularly since they will have no warning of the type of images they will view. The researcher must now determine what to do.

What course should the investigator follow?

  • A: Since any decision made by the UCAIHS is final and cannot be appealed, the investigator decides to contact the UCAIHS to discuss how to modify her proposal to make it more acceptable to the UCAIHS.
  • B: The investigator decides to appeal the decision by approaching the institution's Vice President for Research to plead her case and ask the Vice President, himself an established researcher, to override the IRB's decision.

The human subjects review and approval process at the University is administered by the UCAIHS. The UCAIHS acts as the Institutional Review Board (IRB) for all University divisions, exclusive of the Medical School and many of the human subjects projects at the College of Dentistry. This process meets the requirements of Federal regulations that protect human subjects.

The UCAIHS is composed primarily of faculty members from disciplines in which research involving human subjects is integral to the discipline's work. These include psychology, sociology, anthropology, education, nursing, social work, and dentistry. The UCAIHS also includes a community member with no affiliation with New York University.

The UCAIHS meets bimonthly (except August) to review applications for projects involving human subjects. It has the authority to (but not limited to):

  • review and approve applications
  • require modifications and revisions
  • defer or disapprove research activities covered by this policy.
  • observe the consent process and the research
  • audit all activities involving human subjects
  • suspend or terminate activities involving human subjects.

With the exception of applications that have been approved with Exempt status, the UCAIHS also requires that all projects be reviewed at least annually (depending on the degree of risk, more frequent review may be deemed necessary). Modifications to existing studies also require review and approval by the UCAIHS prior to being implemented.

Approval is conveyed by a memorandum to the investigator from the UCAIHS and accompanied by stamped consent and/or permission forms, when such are required, indicating the dates of the approval (up to one year from the meeting date). Copies of the stamped consent and/or permission forms must be used to obtain consent or permission from all subjects for their participation.

No research involving human subjects may be initiated without prior review and approval by the UCAIHS. There is no appeal process for final decisions rendered by the UCAIHS.

Chapter Review

Question 1

The UCAIHS is governed by procedures and regulations established by (select all that apply):

  • University policy
  • the American Medical Association
  • the American Psychological Association
  • the Federal government

Question 2

The UCAIHS has the authority to:

  • approve or disapprove a research activity
  • require modifications or revisions to a research activity
  • suspend or terminate activities
  • audit the research
  • all of the above

Question 3

Researchers can appeal decisions made by the UCAIHS to the Dean of their school or unit.

Question 4

With the exception of applications approved with Exempt status, review of already approved projects by the UCAIHS must be conducted:

  • never
  • at least annually
  • when a substantive modification is made
  • at least annually or when a substantive modification is made

Question 5

Research in human subjects may begin when:

  • the researcher files an application with the UCAIHS
  • written notification of final approval has been received from the UCAIHS
  • a UCAIHS meeting has taken place
  • the subjects are available

Next Chapter: What are the investigator’s responsibilities?

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

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