Informed Consent
Requirements

Student Investigator




Research News @ Tufts


Policy on Student Conducted Research

Research Projects, Directed or Independent

Any research conducted by students, graduate or undergraduate, that does not fall under the definition of a research practicum, which uses human beings as subjects, and which is intended to contribute to generalizable knowledge, must be reviewed and approved by the SBER IRB prior to start of the research study. This includes, but is not limited to, all independent undergraduate research projects and honors theses, masters' theses and dissertations. A faculty advisor signature is required as part of the submission process.

Recognizing the time constraints imposed on projects that must be begun and completed within a single semester, the SBER IRB will make every effort to work with faculty members to process proposals promptly. However, faculty advisors must plan for and allow adequate time for the review process to occur (approximately two weeks to a month, depending on the particular human subject issues raised by the proposed research). The later in the semester a proposal is received, the more difficult it will be to accomplish the review in time for the projects to be completed during the current semester. It is very strongly urged that faculty advisors require submission of IRB applications/protocols within the first three weeks of the semester for projects that must be completed during the current semester.

Like all submittals to the SBER IRB, student research projects will be reviewed on a rolling basis and may qualify for exempt or expedited review procedures if risks to subjects are no greater than minimal risk and meet other federal criteria. In the event the submission requires full review it will be placed on the agenda for the next available convened SBER IRB meeting. SBER IRB approval of a research protocol can not be granted retroactively under any circumstances.

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Responsibilities of Faculty Advisors for all Student Conducted Research Projects

 

"Faculty advisors of both undergraduate and graduate students working with human subjects must be currently certified to conduct research with human subjects, hold a terminal degree, and have conducted research culminating in peer-reviewed articles. Certification to conduct research with human subjects is attained by completion of the CITI online tutorial. The certificate of completion for the tutorial must then be submitted to the SBER IRB."

  • It is the responsibility of faculty advisors to determine when an undergraduate or graduate student project does not meet the definition of a research practicum and must be reviewed by the SBER IRB.
  • When student research activities are not research practica, it is the responsibility of faculty advisors to assist students in preparing and reviewing materials for the SBER IRB and to ensure that the research is conducted in accordance with Tufts University’s federal wide assurance for the protection of human subjects and with applicable university policy.
  • Faculty members are also responsible for the review and approval of the scientific integrity of the proposed research project, including assessing the scientific rigor and merit of a study.

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Responsibilities of Student(s) Investigators in Conducting Research 

  • Both undergraduate and graduate students working with human subjects must be certified to conduct research with human subjects. Certification to conduct research with human subjects is attained by completion of the CITI online tutorial. Completion of training is automatically recorded and reported to SBER IRB.
  • The investigator(s) has primary responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable provisions of Tufts’ Federal Wide Assurance (FWA).
  • The investigator(s) conducts all research according to Institutional Review Board (IRB) approved protocol and complies with all IRB determinations.
  • The investigator(s) does not initiate any changes without IRB review and approval, unless it is necessary to eliminate an immediate hazard. Changes can include, but are not limited to, the following examples: changes in principal investigator, in approved number of participants, in procedures or methods, in recruitment methods or materials. Click here for a copy of the Request for Protocol Modification form.
  • The investigator(s) ensures that all researchers in the study have the appropriate training and comply with IRB approved conduct for the research. Click here to view the training requirements.
  • The investigator(s) ensures each potential subject understands the nature of research.
  • The investigator(s) provides a copy of the IRB approved consent document to each subject, unless waived by the IRB. Click here for a copy of the Request for Waiver of Consent form.
  • The investigator(s) retains (in the manner specified in the protocol) all signed consent documents and research evidence for at least 3 years beyond the completion of the research.
  • The investigator(s) retains (in the manner specified in the protocol) all submission documents with signatures, all approval documentation, including signed approval letter, stamped interview/survey/questionnaire protocols, and all approved modifications for at least 3 years beyond the completion of the research.
  • The investigator(s) reports progress to the IRB annually through continuing review or earlier (if required by the IRB) if recruitment of subjects, data collection, or contact with subjects will continue. Click here for a copy of the Request for Continuing Review form.
  • The investigator(s) promptly reports any unanticipated problems to the IRB. Click here for a copy of the Adverse Event Reporting form.


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