Tutorial Chapter 9: What information must investigators give to the UCAIHS?
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.
Next Chapter: What criteria does the Committee use when evaluating applications?