Human Participants Training (CITI)
Policy and Procedures on Research Involving Human Participants
The protection of human participants in research is paramount. All research on humans must employ procedures designed to minimize the risk of physical, psychological, social, or economic harm. The ultimate responsibility for assuring such protection resides with the Project Director (PD). Responsibility also resides with the investigator's faculty supervisor in the case of student projects, the PD's Department Chairperson and the Institutional Review Board for the Protection of Human Participants (IRB).
All research projects involving the use of human participants must be registered with the IRB. Furthermore, research projects involving the use of human participants, including ones that are conducted in conjunction with a college class may require review by the IRB before it can be conducted. The responsibility for determining the need for IRB review of a research project resides with the Chair of the IRB. Research protocols submitted to the IRB are classified as belonging to one of three categories: exempt, expedited review, or full review. If a project is classified as exempt, no review occurs. Questions concerning the classification of a particular study into one of these three categories should be directed to the chair of the IRB.
For the purposes of this policy, the meaning of the term research is limited to activities designed to develop or contribute to "generalizable knowledge (45 CFR part 46)." Such activities, in general, do not include surveys done for the purpose of program evaluation or quality assurance. For example, use of a questionnaire for the purpose of obtaining feedback from the participants in a program or for the purpose of monitoring how well a service is delivered would not be considered a research activity and would not require either registration or review under this policy. The term research also does not apply to the practice of journalism or, in general, routine activities typically associated with the preparation of reports, such as interviewing public figures or authorities on a topic under study. Ordinarily, the information one obtains when practicing journalism is not considered data that has been collected for the purpose of testing a hypothesis. In contrast, when interview responses are treated as data, as in many types of qualitative research, the project must be registered with the IRB and may require review (see criteria for exempt research).
The question of whether class projects are subject to review has no simple answer. Most class projects that involve students within the same class testing themselves using well-established techniques do not need to be registered with the IRB. Projects that involve data collection outside of class are more likely to qualify as a research activity. If the class project involves the use of new data collection techniques or is designed to test an original hypothesis, then it counts as research. In addition, class projects that involve, for example, the collection of personally sensitive information about others or that pose more than minimal risk of harm (see definition of minimal risk under Expedited Review) to the participants in other ways are considered research activities by the College and must be registered with and possibly reviewed by the IRB. Questions about the applicability of this policy to a particular project should be directed to the chair of the IRB. In many cases, instructors can obtain a single approval for the range of projects conducted as part of a class.
All researchers, including faculty supervisors and student assistants, who intend to conduct research that requires either expedited or full review by the IRB must also complete the Protecting Human Research Participants module developed by the National Institutes of Health and available on the Internet at http://phrp.nihtraining.com/users/login.php. The Completion Certificate must be on file for all project personnel before the research can commence.
I. Exempt Research (must be registered with IRB)
II. Research Activities Subject to Expedited Review
The project does not meet the criteria for Category I and involves no more than minimal risk to the participant. Minimal risk is defined as "the risks of harm, anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (HHS regulations)". Common types of projects that are eligible for expedited review include the following:
III. Research Activities Subject to Full IRB Review
If a PD believes a proposed research project meets the criteria for exempt research, then the PD must register the project with the IRB in the Office of Sponsored Research. Registering the proposal involves completing the application form for an IRB review and submitting a brief explanation of the project and the reasons it should be considered exempt (see application form for specific instructions). The IRB chair will review the submitted project and decide if the project meets the criteria for exempt research within a reasonable amount of time (usually three working days). If the IRB chair finds that a submitted proposal is exempt, the PD may begin it immediately. In reviewing protocols registered for exempt consideration, the IRB chair will evaluate the effectiveness of procedures designed to maintain the anonymity of the participants. If these procedures are not deemed adequate, then specific changes for improving the protection of anonymity may be requested before a finding of exempt is rendered. If the IRB chair finds that the proposed research is not exempt, the investigator will be instructed to submit a research protocol for IRB review.
If a project requires expedited or full review by the IRB, the PD must submit an application and a protocol describing the proposed research (see application for details on submissions). Projects found by the IRB chair to require expedited review will be processed using a mail ballot procedure. In this procedure, each member of the IRB receives a copy of the application form and research protocol to review. IRB members are allowed 2 weeks to register with the IRB chair concerns or objections they might have to the manner in which human participants will be used. The IRB chair then acts on the application either by approving it, by requesting amendments to it based on the review by IRB members, or by calling for a full IRB review.
If a project requires a full IRB review, a formal hearing on the research proposal is held. At this hearing, the PD will be asked to make an oral presentation of the research plan and may be asked questions pertaining to the planned use of humans. The IRB chair will make a reasonable attempt to inform the PI prior to the hearing about the nature of the concerns likely to be raised at it. During the hearing, investigators may amend their proposal in response to concerns of IRB members. After the conclusion of the hearing, members of the IRB vote on whether or not to approve the proposed project. This vote may be taken in the absence of the PD.