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All investigators

All investigators who are conducting research using human participants have the following responsibilities

General Responsibilities
  • To comply with the Code of Federal Regulations regarding the protection of human subjects.
  • To protect the rights and welfare of all human subjects, and to conduct all research according the IRB approved protocol.
  • To retain all data and signed consent documents for at least 3 years beyond the completion of the research.
Informed Consent Responsibilities

Prior to beginning participation in research, participants must give their informed consent. Informed consent is obtained by explaining the nature of the research and participation. There are generally EIGHT REQUIRED ELEMENTS OF INFORMED CONSENT that must be conveyed to participants. Click here for more information on informed consent requirements, researcher responsibilities, federal regulations and samples.

  • To ensure that each potential participant understands the nature of the research.
  • To ensure that the correct procedures are followed to gain informed consent from each person prior to participation.
  • To provide each participant with a copy of the IRB approved consent document unless waived by the IRB.
Educational Responsibilities
  • To ensure that all study team members, including Faculty Advisors, have completed the CITI online training and that the certification is current. Certification is valid for a period of 4 years.
Procedural Responsibilities
  • When submitting to the SBER IRB, be sure to use only the most updated version of the required forms. They will always be posted on the website under ‘Forms’.
  • To not initiate any changes to the protocol without IRB review and approval, unless it is necessary to eliminate an immediate hazard. Submit the Request for Protocol Modification
  • To submit a Request for Continuing Review form at least 6 weeks prior to the expiration date of the protocol if the research is going to continue past the expiration date.
  • To promptly report any unanticipated problems to the IRB by submitting the Unanticipated Problem Report
  • To promptly report any adverse events to the IRB by submitting the Adverse Event
  • To officially close the study once completed by submitting the Request for Study Closure
Principal Investigator Responsibilities

Click here for information on eligibility to be a Principal Investigator

A Principal Investigator (PI) is the individual responsible for carrying out a scientifically sound, ethical research study consistent with the research plans approved by an IRB. The PI must possess the expertise, time and commitment to conduct and provide the necessary oversight for all aspects of the study, and must be willing to accept full responsibility for the study, including the supervision of any co-investigators, research staff and students. Any co-investigator appointed to act on behalf of the principal investigator (acting in the absence of the PI, for example) must meet all institutional requirements to act as a principal investigator. As an integral part of Tufts’ Human Research Protection Program, PIs share in the responsibility for protecting the rights, safety, and welfare of subjects who participate in research.

Tufts IRBs recognize only one principal investigator per human subjects research study. Other individuals may be named co-investigators. In multi-site studies for which Tufts acts as the coordinating institution, the principal investigator assumes the responsibility for the conduct of the study at each performance site and by each site-specific principal investigator.

Faculty Advisors, Student Researchers, and International Researchers

There are additional responsibilities for the following groups:

  • Faculty Advisors
  • Student Researchers
  • International Researchers
Faculty Advisors

All Faculty Advisors who oversee undergraduate and graduate student research have the following responsibilities:

  • To ensure that the Principal Investigator and additional research staff abide by all Investigator Responsibilities
  • To meet with the Principal Investigator to monitor study progress and ensure that the procedures outlined in the IRB protocol are followed.
  • To be available to the Principal Investigator to supervise and address problems should they arise.
  • To arrange for an alternate Faculty Advisor to assume these duties when unavailable (vacation or sabbatical).
  • To oversee the prompt reporting of any adverse events or unanticipated problems to the IRB.
Student Researchers

Important points for student researchers:

  • Students can serve as Principal Investigators as long as certain requirements are met.
  • There must be a Faculty Advisor.
  • Projects that may require IRB review include, but are not limited to: Undergraduate research projects, honors theses, masters’ theses, and dissertations.
  • Both students and Faculty Advisors must complete the CITI Training. There are additional educational/training requirements for students.
  • Student research is subject to the same regulations as other research. To ensure a timely and efficient review, it is recommended that students contact the IRB Office as soon as possible.

All undergraduate and graduate student researchers have the following responsibilities:

  • Any student engaged in human subjects research is directly charged with protecting the rights and welfare of participants. This includes upholding the three ethical principles of Justice, Beneficence, and Respect for Persons.
  • Conduct all research procedures in accordance with the protocol that has been reviewed and approved by the SBER IRB.
  • Submit and receive approval for a request for protocol modification before enacting any changes.
  • When applicable, students must apply for continuing review of approval.
  • When applicable, students must report any adverse events or unanticipated problems.
  • All study data including consent forms must be stored in compliance with Tufts University’s Record Retention Policy.
International Researchers

All researchers who intend to conduct research on the ground in a country other than the United States have the following responsibilities:

  • Be aware of and follow all human subjects regulations in the country(ies) in which research will be conducted.
    • If IRB/ethics review is required in the country, you must submit a copy of an approval letter from a local IRB/ethics review board with your application.
  • If local IRB/ethics review is not required in the country, you must submit a letter/email of confirmation from a knowledgeable person stating that this is the case. Researchers must also provide a letter of support from an individual in the host country stating that the research is acceptable according to local context.

For more information, see Tufts policies.