Tutorial Chapter 15: What are researchersí obligations when cooperating institutions are involved?

Case Study:

NYU researchers are interested in conducting a study at a city dental clinic which provides primary dental care for patients who have no access to medical insurance.

The researchers aim to establish a link between inadequate or infrequent dental care and various oral diseases. As part of their study they also hope to draw a comparison between the oral health of smokers and nonsmokers.

How should the investigators obtain approval when working with this cooperating institution?

  • A: Since the research is being conducted at an independent clinic, whose IRB has already approved the study, researchers decide they do not need to submit their application to the UCAIHS and receive the UCAIHS's approval prior to beginning the study.
  • B: Although the clinic's IRB has already approved the study, the researchers understand that they must apply to the UCAIHS for approval since they are members of the NYU community. They include a copy of the letter of approval from the dental clinic IRB in their application.

Letters of approval are required from cooperating institutions or organizations when they are involved in research conducted by NYU employees or students. Approval is needed when:

  • research is conducted on their premises
  • subjects are recruited from their institutions
  • data are obtained from these institutions.

The approval must take the form of formal notification of approval from the cooperating IRB if it exists, which is the case at most hospitals and universities and in many school systems, or from the Director or equivalent administrator of an organization without an IRB.

An institution or organization is usually considered as participating in a research project when its staff, facilities, or records of individuals are used in conducting the research. A hospital would be considered as participating in research if, for example, subjects were recruited through its outpatient clinic.

Most school systems have established procedures for gaining access to their students or teachers for research recruitment. In New York City, the Department of Education has established its own IRB. University investigators doing research in NYC schools must have, in addition to UCAIHS approval:

  • Department of Education IRB approval
  • approval from the appropriate superintendent, principal and teacher, if applicable.

Chapter Review

Question 1

A cooperating institution's approval is required when (select all that apply):

  • an NYU researcher is conducting research there
  • subjects are being recruited there
  • records are being obtained there
  • none of the above

Question 2

Institutions or organizations may give investigators identifiable private information about potential subjects without prior permission if they are independent of the investigator's affiliated organization.

Question 3

Research in the NYC public schools system always requires the approval of (select all that apply):

  • Department of Education IRB
  • superintendent
  • principal
  • teacher

Next Chapter: What are researchers’ obligations when doing research in foreign countries?

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?
  • Glossary
  • References