Social, Behavioral & Educational Research IRB
All investigators who are conducting research using human participants have the following responsibilities and certain groups have additional 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.
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.
- 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.
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.
- 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 & Templates".
- Do not initiate any changes to the protocol without IRB review and approval, unless it is necessary to eliminate an immediate hazard. Submit a Modification in eIRB.
- Submit a Request for Continuing Review in eIRB at least 6 weeks prior to the expiration date of the protocol if the research is going to continue past the expiration date.
- Report issues, adverse events, or other developments that occur in the course of your research to the SBER IRB by completing the “Report New Information” activity within eIRB. Reportable information should be sent to the IRB within 5 business days.
- Use the Departing Principal Investigator Checklist when leaving Tufts University 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.
- Officially close the study once completed by submitting a Study Closure Request.
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. This is outlined in the Principal Investigator Eligibility Policy.
Faculty Advisors, Student Researchers, and International Researchers
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 by completing the “Report New Information” activity in eIRB within 5 business days.
Important points for student researchers:
- Students can serve as Principal Investigators as long as they have training and/or experience in research methodology to be eligible to serve as Principal Investigators on research studies.
- 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.
- 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.
- Report issues, adverse events or other developments that occur in the course of your research by completing the "Report New Information" activity in eIRB within 5 business days.
- All study data including consent forms must be stored in compliance with Tufts University’s Record Retention Policy.
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.
- Undergo review by the Integrative Safety Committee (ISC) if the international research will involve face-to-face procedures. The ISC review process can be started by submitting a complete Ramp Up Request Form to your respective Research/School Dean or Designee, who will then forward the request to the ISC for review.
For more information, see Tufts policies.
The General Data Protection Regulation (GDPR) law requires the protection of privacy and security of data collected about people while they are within the European Economic Area (EEA).The law applies based on the location of the participant at the time they provide data, not the researcher’s location. If you plan to conduct research with people in the EEA, your research is subject to GDPR requirements. This includes research conducted via survey, phone, or videoconference, when participants are in the EEA or could be in the EEA. All studies subject to GDPR regulations must be reviewed by the Tufts GDPR committee. This is a separate review process than the IRB review, but our office will help coordinate with the GDPR committee. Please plan on an addition 1-2 weeks for this ancillary review process. Review the European Economic Area General Data Protection Regulation website for additional information about GDPR.
To avoid GDPR implications, you can design your study to exclude participants in the EEA.Take steps to prevent surveys from being taken by participants in the EEA (e.g., using GeoIP in Qualtrics to exclude EEA IP addresses; limiting eligibility on MTurk or other platforms.)In the protocol, describe your plans to avoid recruiting participants in the EEA for interviews or other research activities.Including exclusion criteria in the study, reflected in recruitment materials and procedures.