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

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

Teaching Research Teaching Research MethodsMethods

(Classroom Protocols)(Classroom Protocols)

Boston University Charles River Campus

Boston University Medical Center Mary A. Banks BS, BSNIRB Director

Page 2: Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director

““Classroom Protocols”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)

Page 3: Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director

Faculty person Faculty person Principal Investigator (PI)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 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

Page 4: Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director

Classroom ProtocolClassroom ProtocolProtocols 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definition of “human research” because, while they involve human subjects, the activities are intended for teaching, not for publication.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)

Page 5: Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director

Human Subjects 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” (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.

Page 6: Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director

ResearchResearchClassroom activities usually do not meet

the 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 knowledgeIntent is NOT to publish any of the data Intent is NOT to present any data

collected at any scientific meeting

Page 7: Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director

Requirements for AllowableRequirements for AllowableClassroom ProtocolsClassroom 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”

Page 8: Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director

Requirements for Allowable Requirements for Allowable Classroom Protocols (cont.)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)

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

Page 9: Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director

Requirements for Allowable Requirements for Allowable Classroom Protocols: Vulnerable Classroom Protocols: Vulnerable

PopulationsPopulationsNo 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

Page 10: Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director

Consenting subjectsConsenting subjectsStudents 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

Page 11: Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director

Permission to conduct activities not Permission to conduct activities not otherwise allowed under these otherwise allowed under these

guidelinesguidelinesIf 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.

Page 12: Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director

PI ResponsibilitiesPI ResponsibilitiesMust be a faculty memberMust take responsibility for the student

researchAgrees to report any violations to the

IRBReviews all questions on surveys and

questionnaires for sensitive onesReviews study populations and excludes

studies involving vulnerable subjectsReports to the IRB any subject

complaints, unanticipated problems or adverse events related to the student research

Page 13: Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director

Process to obtain IRB Process to obtain IRB ApprovalApprovalFaculty/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

Page 14: Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director

Additional itemsAdditional itemsApproval 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.

Page 15: Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director

Separate IRB submissionSeparate IRB submissionIf 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