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 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.
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 report issues, adverse events or other developments that occur in the course of your research, download the Reportable New Information Form and refer to page 3 to see if this information should be reported to the SBER IRB. Reportable information should be sent to the IRB within 5 business days.
To ensure that all studies have been properly closed, modified, or transferred, and to ensure that there are adequate plans in place to retain research at Tufts, please refer to the Departing Principal Investigator Checklist.
To officially close the study once completed by submitting the Request for Study Closure
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:
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 reporting to the IRB of any issues, adverse events or other developments that occur in the course of your advisee’s research. Download the New Reportable Information Form and refer to page 3 to see if this information should be reported to the SBER IRB. Reportable information should be sent to the IRB within 5 business days.
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.
Report issues, adverse events or other developments that occur in the course of your research, download the Reportable New Information form and refer to page 3 to see if this information should be reported to the SBER IRB. Reportable information should be sent to the IRB within 5 business days.
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.