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Policy on Academic Exercises Designed for Teaching Students Research Techniques

Research as defined in the Code of Federal Regulations (45CFR46) and conducted by any member of the Tufts University community is subject to federal regulations that require that all research protocols involving human subjects be reviewed by an Institutional Review Board (IRB) for the protection of human research participants (Federal Wide Assurance 00002603). However, these regulations allow certain types of course-related studies to be conducted without IRB review. Since course-related studies are generally not designed or developed to contribute to generalizable knowledge, but are designed to provide students the opportunity to practice various research methods, they do not fit the federal definition of research requiring IRB review. The purpose of this policy is to clarify when student research projects and activities must be submitted to the SBER IRB for review. In some cases, the best circumstances for learning to conduct research are those that closely resemble situations that would be faced if actually carrying out a research project. This can result in the need for the same real world protections for human research participants, including review by the SBER IRB, if the project meets the definition of human subject research in the Code of Federal Regulations.

The following definitions guide the development of the policy regarding academic exercises designed for teaching students research techniques:

  • Research is defined as any systematic investigation, including research development (pilot testing), designed to develop or contribute to generalizable knowledge. (Title 45 Code of Federal regulations (CFR) part 46.102(d))

  • Generalizable knowledge refers to any systematically gathered data which is intended for dissemination through various means (e.g. publication by paper or electronically, conference presentation, poster presentations, internet postings, and presentations to outside constituencies) and which might reasonably be generalized beyond the research sample.

  • A human subject is a living individual about whom a researcher (faculty or student) obtains data through intervention or interaction with the individual (including from interviews and surveys) or identifiable private information.

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Research Practica/Educational Inquiry/Practice

These are usually in the form of course-related research projects and/or directed studies and are designed to provide students an opportunity to practice various research methods. These methods may consist of interviews, observations, survey techniques, measurements of behavior and data analysis. Typically such projects are quite limited in scope, do not lead to generalizable knowledge and are not undertaken with that goal in mind. Therefore, these projects are considered "classroom exercises" and are not subject to review by the SBER IRB. Presenting results to the class for which the project is carried out or for a departmental research presentation event does not constitute public dissemination or contribution to generalizable knowledge.

It is important to note that data collected as research practica cannot be used at a later date for presentation at conferences, publications, theses or doctoral dissertations and will not be approved by the SBER IRB for use in any way other than as a class exercise. If there is any possibility that the student will ultimately have the opportunity to publish the results of the project, the best course of action is to request IRB review and approval. Many publications ask for proof of this approval before accepting a manuscript and the SBER IRB cannot provide retroactive approval.

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Potential Practicum Problems

tudents engaged in the process of learning research techniques understandably want to focus on compelling or real-life issues. Some of these topics raise concerns for the well-being of the subjects and the students themselves. Projects that would place either the students conducting the research or their subjects at risk if confidentiality were breached must be constructed with special care. Projects conducted in hospitals or other health care facilities must also be designed to not violate federal health care privacy regulations (HIPAA) and will normally require approval of the hospital’s IRB.

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IRB Assistance

While research practica are not under the purview of the SBER IRB, the IRB Administrator and IRB Chair for the SBER IRB are available for consultation with students and for class presentations regarding the protection of the rights and welfare of human subjects.

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Faculty/Instructor Responsibilities

  • To register the appropriate course work as "research practica" with the SBER IRB.

  • To ensure that research practica exercises are conducted with careful attention to the ethical standards according to the relevant discipline (e.g. American Psychological Association, American Anthropological Association). This may include the use of a written consent form, debriefing, confidentiality procedures, and other practices that would be appropriate if the exercise were an actual research study.

  • To ensure that the research projects are appropriate and that participants are not exposed to more than minimal risk.

  • To carefully consider research projects that potentially address sensitive topics and should discuss such issues with his/her students.

  • To advise students to identify the project as a class assignment or research practica. Labeling such projects as “research” is inaccurate and misleading for others with whom the students may interact as a necessary component of completing the assignment.

  • To ensure that written consent clearly states that the study is being conducted for educational and not research purposes.

  • The instructor must have completed IRB training.
    http://www.tufts.edu/central/research/IRB/HumanEducation.htm

  • Instructors must discuss research ethics and at the very least, incorporate protection of human subjects as part of the educational process. Ideally students should all complete the online CITI training.
    http://www.tufts.edu/central/research/IRB/HumanEducation.htm

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Responsibilities of Student(s) in Conducting Research Practica

  • Students are responsible for conducting research practica exercises with careful attention to the ethical standards according to their relevant discipline (e.g. American Psychological Association or American Anthropological Association).

  • Students are responsible for understanding the protection of human subjects and correct consent procedures.

  • Students should pay particular attention to issues of confidentiality, and should ensure that participant names (e.g. from consent forms) cannot be linked to data.

  • Students engaged in research practica cannot use data collected as part of research practica at a later date for presentation at conferences, publications, theses or doctoral dissertations. It is important to note that data collected as part of a research practica will not be approved by the SBER IRB for use in any other way.

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Special Considerations

  • All research for doctoral or masters work and senior honors theses projects cannot be registered and must be reviewed by the IRB.

  • Any student research that does not meet the criteria for research practica requires IRB review. An SBER IRB protocol must be completed for each unique research project by the student investigator(s).These research projects require review and IRB approval before proceeding. The SBER IRB application forms and instructions are available at
    http://www.tufts.edu/central/research/IRB/Forms.htm

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Additional Information

Tufts University, Office of the Vice Provost for Research
Health Sciences Campus: (617) 636-6550
Medford Campus: (617) 627-3417
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