1. Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director

2. “Classroom Protocols” Are used for research methods class or other classroom training where students conduct student “research” in order to learn about human subjects research and research methods Are intended for student learning – not for students to obtain research data that will be used to make public (publish or present at meetings)

3. Faculty person Principal Investigator (PI) The faculty person is the PI (Principal Investigator) on the classroom protocol PI takes responsibility for training the students about the ethical conduct of human subjects research PI takes responsibility for oversight of the student “research” activities PI must provide documentation that he/she has completed basic human subjects trainingbasic human subjects training PI confirms in the Application that he/she has reviewed these Classroom Protocol power-point slides Faculty PI signs an “agreement” as part of the Application for Teaching Research Methods

4. Classroom Protocol Protocols meeting the criteria of Classroom Protocols do not meet the federal definition of “human research” because, while they involve human subjects, the activities are intended for teaching, not for publication. (as described on the next two slides)

5. Human Subjects Classroom “research” activities involve human subjects because students will be interviewing or surveying people or manipulating their environment Meets the OHRP definition of “human subjects”OHRP definition of “human subjects (f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.

6. Research Classroom activities usually do not meet the federal definition of “research” federal definition of “research Definition (d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge... Intent is to teach students about research Intent is NOT to generalize knowledge Intent is NOT to publish any of the data Intent is NOT to present any data collected at any scientific meeting

7. Requirements for Allowable Classroom Protocols Student “research” activities are conducted under the supervision of the faculty PI The activities involve surveys, interviews, observations of public behavior and/or minor manipulations of the environment or taste testing of food Interview/survey questions are NOT sensitive in nature (i.e. do not ask about private health information, sexual practices, etc.) Interview/survey questions do not ask about illegal activities (i.e. drug use, alcohol abuse, etc.) Research does not involve administration of prescription or over the counter drugs or medications or any medical devices Students must be able to opt (without repercussions) from participating as “subjects”

8. Requirements for Allowable Classroom Protocols (cont.) Research activities must meet the federal definition of minimal risk (the probability and magnitude of harm or discomfort anticipated in the research activity are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests) minimal risk Student projects will not manipulate the behavior of subjects beyond the range of “normal” classroom activity or daily life Projects will not involve physically or psychologically invasive contact with subjects Projects will not involve collection of any information from any medical or school records or review of any documents protected under HIPAA or FERPA

9. Requirements for Allowable Classroom Protocols: Vulnerable Populations No research activities are permitted with children/minors (<18 years of age) No research activities involving prisoners or incarcerated persons No research on pregnant women or fetuses No research involving decisionally impaired/cognitively impaired subjects

10. Consenting subjects Students can develop consent forms as part of the student “research” project Students can consent subjects as part of their projects Faculty PI will review the consent forms Consent documents are for training purposes and therefore do NOT have to be approved or validated by the IRB

11. Permission to conduct activities not otherwise allowed under these guidelines If your instructional research activities do not meet the requirements set forth in the previous slides, you must request specific permission to conduct those activities and provide justification in your Application.

12. PI Responsibilities Must be a faculty member Must take responsibility for the student research Agrees to report any violations to the IRB Reviews all questions on surveys and questionnaires for sensitive ones Reviews study populations and excludes studies involving vulnerable subjects Reports to the IRB any subject complaints, unanticipated problems or adverse events related to the student research

13. Process to obtain IRB Approval Faculty/PI completes and signs the “Application for Teaching Research Methods” Submits to IRB for review ◦ emails PDF to IRB office OR ◦ signs and submits hard copy IRB reviews, approves, and notifies the faculty member

14. Additional items Approval is for a specific faculty member and for a given course-- if there are other or new faculty teaching the same course, they each need to obtain approval through this process. If a Faculty member teaches a second course, then a separate application is needed. Graduate assistants, teaching assistants and fellows who participate in teaching these research activities do not need separate approval provided they are teaching under the direct supervision of the approved Faculty PI and are covered by the faculty’s approval.

15. Separate IRB submission If any student in the classroom wishes to conduct any research for publication or presentation or for otherwise generalizable knowledge, OR If any student in a classroom wishes to conduct any research that doesn’t meet the criteria described in the previous slides, THEN Then a separate IRB protocol will be required to be submitted to the IRB for that project