The Following are Criteria for Which the Bulk Exemption Process Applies:
· Only applies to a specific course, or in some circumstances, multiple sections of the same course.
· Only for studies that are minimal risk
· Only for studies that are Exempt, or QI/QA
· Only for data collection that does not include personally identifiable or personally specific information. In the case of surveys or interviews, the questions should be oriented to ask the subjects their perception of what others do or think, rather than their own opinions or experiences.
EXAMPLE: Bulk Exemption form
1) Identify Topics: The instructor for the course will identify topical areas pertinent to the class and the limits to the scope of any research topic.
a. These topics, and scope, must be constrained to meeting the requirements for Exempt or QI/QA protocols. Please see the IRB website for more information.
b. Note: If QI/QA the work cannot be considered, or referred to, as research.
2) Development: The instructor may give the topics to the students to research, or may work with the students to develop the research topics.
3) Submission: Once the general outline of the research topics and their associated questions have been decided, the instructor may submit one protocol submission to cover the course.
4) Abstract: The abstract for the submission should clearly outline the course (and sections) for which the bulk exemption is being submitted, in addition to the study description.
5) Protocol: In the protocol submission form, fully describe the research, taking into account all of the variations of research to be conducted by students.
6) Informed Consent: Use the Informed Consent template to generate a template that all projects will use, with notations for appropriate spots to edit for individual projects.
7) Project Document: Provide a separate document that you submit with your protocol which clearly outlines each individual topic to be researched, with the associated questions, aims, etc.
8) Rules for Researchers: Provide an additional document that you will use to give written guidance to the student researchers. This should at minimum inform the students of the informed consent process, scope of the project, who may be recruited, how to handle adverse events, and how to properly handle confidentiality of subjects and their responses.