Tutorial Chapter 9: What information must investigators give to the UCAIHS?

Case Study:

A researcher is working on three projects involving the same participants who will be asked about their responses to different marketing and advertising campaigns. His aim is to create a comprehensive consumer profile for different media: print, radio, and television. In essence, all three projects are the same; the research subjects will be responding to the same questions for each medium. This means each subject will be asked to complete three different questionnaires, one for each media type, in three different research sessions.

How should the Principal Investigator develop his Application for Review?

  • A: The principal investigator completes the application for the print study but since it so closely resembles the other two studies, for radio and television, he does not make specific reference to them in the Application.
  • B: Even though the researcher is essentially working on three identical projects simultaneously with the same subjects, he submits one application which includes the purpose, procedures and questionnaires for each of the media studies.

The investigator is responsible for providing the UCAIHS with the all information necessary for the Committee to review and evaluate the proposed work.

This information includes:

  • Whether the researcher believes that the proposed project may be considered for exempt review and if so, under what justification
  • The purpose of the proposed research and its possible benefits to the field
  • Procedures, criteria and materials for recruiting subjects, including how many subjects will be sought, how potential participants will be identified and contacted, and what they will be told
  • Whether subjects from any protected populations will be recruited
  • How the identity of subjects and the confidentiality of information about or from them will be protected and what possible compromises to confidentiality might occur in the course of the study or data collection
  • What risk or benefit might be derived by the subjects
  • What procedures will be followed in the course of the research: what participants will be expected to do, where the study will be conducted and by whom, how long participation will take, whether there will be any follow up, and other related information
  • Any additional procedures that may be required if there has been any deception or if a medical or psychological condition is uncovered
  • How informed consent will be ensured, including procedures, permission and consent forms
  • Whether there will be other organizations involved in the research and if so, what steps will be taken to obtain approval for the project from them
  • How potential adverse events (an undesirable and unintended effect on a subject) will be handled.

Chapter Review

Question 1

The investigator is responsible for providing all the necessary information for the UCAIHS to review and evaluate the proposed work.

Question 2

Investigators do not need to explain how they will handle adverse events until these occur during the research.

Question 3

Information about procedures to be followed during the research project includes:

  • what participants will be expected to do
  • where the study will be conducted and by whom
  • how long participation will take
  • all of the above

Question 4

Researchers must include information about possible risks or benefits to subjects when their projects are being reviewed by the UCAIHS.

Question 5

When giving the UCAIHS information about informed consent, researchers are expected to provide:

  • procedures
  • permission from cooperating institutions
  • consent forms
  • all of the above

Next Chapter: What criteria does the Committee use when evaluating applications?

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