When Students Do Human Subject Research

Any research conducted by students, graduate or undergraduate, that does not fall under the definition of a research practicum, that involves human beings as subjects, and that is intended to contribute to generalizable knowledge must be reviewed and approved by one of the two Tufts Institutional Review Boards (IRBs) prior to the start of research. The Social, Behavioral & Educational Research IRB (SBER IRB) works with faculty and students based on the Medford/Somerville campus; the Health Sciences Campus and Tufts Medical Center IRB (HS IRB) works with faculty and students based on the Boston and Grafton campuses. Research subject to IRB review includes, but is not limited to, all independent undergraduate research projects and honors theses, master’s theses, and dissertations.

Because of the time required for IRB review (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 project to be completed during that semester. As a result, the IRBs recommend that faculty advisors require submission of IRB protocols within the first three weeks of the semester. Additionally, both the student researcher and the faculty advisor need to undergo training prior to conducting human subject research, so time for completing training should also be taken into consideration. Please note that educational requirements differ depending on which of the two Tufts IRBs are involved. Details can be found on the websites listed below.

Research conducted by students is subject to the same IRB rules and regulations as research conducted by faculty. The student researcher and the faculty advisor are expected to work as a team to ensure the protection of the rights and welfare of human research subjects and compliance with all applicable university and federal regulations. A reliable and robust communication plan should be arranged among team members before the study starts. It is especially important that student researchers and faculty advisors understand and acknowledge their roles and responsibilities, which differ for the two Tufts IRBs (see below). For example, student researchers may be principal investigators of research projects under the purview of the SBER IRB (Medford/Somerville campus) but they may not be principal investigators of research projects under the purview of the HS IRB (Boston and Grafton campuses). The principal investigator is the primary contact with the designated IRB.

Responsibilities of faculty advisor and principal investigator for research projects under the purview of the SBER IRB (Medford/Somerville campus)

The faculty advisor is responsible for

• developing a robust plan for overseeing and monitoring a student-run project
  
• reviewing and ensuring the appropriateness of the student’s SBER IRB protocol application
  
• signing the student’s SBER IRB protocol application
  
• ensuring that SBER IRB–authorized protocols are followed
  

The principal investigator (faculty advisor or student researcher) is responsible for ensuring that

• all researchers in the study have the appropriate training and comply with SBER IRB–approved conduct for the research
  
• each potential subject understands the nature of the research
  
• all SBER IRB–mandated procedures are followed, including informed consent, progress reports, and reporting of unanticipated problems
  
• the SBER IRB protocol is not changed in any way without SBER IRB review and approval, unless it is necessary to eliminate an immediate hazard

Responsibilities of faculty advisor (who is the principal investigator) for research projects under the purview of the HS IRB (Boston and Grafton campuses)

The faculty advisor/principal investigator is responsible for

• developing a robust plan for overseeing and monitoring a student-run project
  
• reviewing and ensuring the appropriateness of the student’s HS IRB protocol application
  
• obtaining the signature on the HS IRB protocol application of the chief or chair of the principal investigator’s division
  
• ensuring that HS IRB–authorized protocols are followed
  
• ensuring that all researchers in the study have the appropriate training and comply with HS IRB–approved conduct for the research
  
• ensuring that each potential subject understands the nature of the research
  
• ensuring that all HS IRB–mandated procedures are followed, including informed consent, progress reports, and reporting of unanticipated problems
  
• ensuring that the HS IRB protocol is not changed in any way without HS IRB review and approval, unless it is necessary to eliminate an immediate hazard

For more IRB information, please go to

• the Social, Behavioral & Educational Research (SBER) IRB website (student-conducted research policies can be found at http://www.tufts.edu/central/research/IRB/StudentPolicy.htm)
  
• the Health Sciences Campus and Tufts Medical Center IRB website