See below for common questions about research at TUSDM. For specific questions, please contact DentalResearchAdministration@tufts.edu.
Q. I have a research idea. How do I get started?
To get started, please view the annotated IRB protocol templates and study design checklists, and select that best fits your proposed study activities.
- For Student Research Fellowship Program participants, please follow the SRFP Research Approval Flow Chart.
- For MS/DSc students, please follow the MS/DSc Research Approval Flow Chart.
- For all other research, work with Biostatistics and your study team to complete the protocol template.
If you need funding for your research project, see the Funding Application Flowsheet. For general questions, contact DentalResearchAdministration@tufts.edu.
Q. For my ADEA emerging leaders program, another school received IRB approval. What is needed on Tuft’s end?
A. The Tufts IRB will also need to make their own determination. Please provide Ann-Marie Billig with further information on your role in the project, what data you will have access to (identifiable, de-identified, analyzed, aggregate), and any documents from the other school such as their IRB approval letter and protocol.
Q. Where could I find funding opportunities for a research idea I have?
A. Subscribe to our Dental Research E-list to receive research updates and funding opportunities. You can also search for funding opportunities on OVPR’s website and using the Tufts Pivot tool. When you find an opportunity of interest, submit the DRA Proposal Intake Form, and our team will assist in the application process.
Q. I was approached by a company asking to do research for them, what are the next steps?
A. All requests for research funding or donations must be tracked and accepted through the university. Our team will help determine the appropriate agreements that need to be put in place. If you plan to submit a research funding application, please complete the DRA Proposal Intake Form, and our team will assist with the budgeting and contract process.
Q. What do I do if a company offers me a product or money as a gift?
A. A gift is a voluntary transfer of money or property from the donor, where they do not expect anything of value in return. University Advancement and Corporate and Foundation Relations (CFR) is the only office able to accept gifts on behalf of Tufts University. Donations with terms and conditions are processed as sponsored awards. Please contact DentalResearchAdministration@tufts.edu if you are offered a product or money as a gift and a member of the team will follow-up about the next steps.
Q. Can I conduct research at TMC, with a TMC researcher, or access Soarian data for research?
A. Yes you can once we have the proper legal agreements in place! Please contact Ann-Marie Billig to determine what is needed. There will need to be a Principal Investigator (PI) that has an appointment at TMC on your study team (in addition to a TUSDM PI) so please identify one before contacting Ann-Marie.
Q. If I am conducting research in a lab, do I need any approvals?
A. Yes! Depending on your research, you may require biosafety approval, legal agreements if you are transferring materials or data, as well as the appropriate regulatory approvals. Please contact Ann-Marie Billig who will help determine the needed approvals. Please clarify in your outreach if you will be conducting research using samples originally derived from humans.
Q. What is a continuing review and why are they required by the IRB?
A. Per the Department of Health and Human Services (HHS) regulations at 45 CFR part 46, studies that are deemed “expedited” or are reviewed during a convened IRB meeting must submit an annual report.
to the Tufts IRB regarding the research activities that have taken place in the last year. The types of information that are required are: new COI forms from all study team members, the number of records reviewed/subjects consented within the last year, and any incidents that should be reported such as a report from the sponsor or a subject withdrew from the study. Ann-Marie Billig will help you prepare this report each step of the way!
Q. Why do I need to take CITI and GCP to conduct research?
A. Tufts University requires that all researchers involved in human subjects research must receive formal training in the protection of human subjects. Investigators and research team members conducting human subject research must complete the two mandatory trainings prior to beginning any human subjects research and must undergo continuing education.
Q. I have taken CITI and GCP training at another institution. Do I have to take the Tufts version?
A. Yes, you must take the Tufts approved CITI and GCP trainings in order to be on an IRB study team. If you have completed CITI training through another institution, you can log into your existing CITI account, and on the home page, select “add an institutional affiliation.” Once you add Tufts University/Tufts Medical Center, enroll in the Tufts Biomedical Researchers course. Oftentimes most of the modules required by each institution are the same. Any previously completed modules will transfer over to the Tufts training, and you will just need to complete any pending Tufts-specific modules.
Q. I have an appointment at another institution that has an IRB. Do I have to submit research I do at that institution to this IRB?
A. Yes, only if you are engaging Tufts in the research. Researchers affiliated with TUSDM/TMC must submit for Tufts IRB review any human research project they will be involved in if it will be conducted at Tufts or on behalf of Tufts somewhere else. Please also refer to OHRP’s guidance on engagement in research for more information: http://www.hhs.gov/ohrp/policy/engage08.html.
Q. Can someone from another institution be on my study team?
A. Yes! To determine if a data sharing agreement will be needed or if they must be added to the Tufts IRB registration for this study, please share the following information with Ann-Marie Billig: 1. What institution are they affiliated with? 2. What will their role be in the study (protocol development, recruitment, consenting, data analyses, manuscript writing, etc.,)? 3. What kind of data will they have access to (identifiable, de-identified, aggregate, analyzed)?
Q. Do I need IRB approval for a case study?
A. If your case report will be for 3 or fewer cases and the data will be de-identified, it is not considered research that must be approved by the IRB. However, it will need to be internally approved by Dental Research Administration. First, please complete the case report template, and send that to Shruti Jain for her review. She will then connect you to Ann-Marie Billig for the next steps.
Q. Can I look at records in AxiUm to see if there’s data I can use for research?
A. Yes, with IRB approval. Complete the review preparatory to research form with your statistician and send it to Shruti Jain. She will then work to review it, and share it with Ann-Marie Billig who can prepare the IRB submission necessary to review AxiUm for preparatory research purposes.
Q. Do I need IRB approval if I’m working with faculty from another institution?
A. Your colleague at the other institution will first need to verify with their IRB what is required to have you be a part of their research team. Next, we will need to submit to the Tufts IRB for a formal determination. Please provide the following information to Ann-Marie Billig so she can determine how to best proceed: your role in the study, what data you will have access to (identifiable, de-identified, analyzed, aggregate), and any documents from the other school such as their IRB approval letter and protocol.
Q. Can I share research data with collaborators at other institutions?
A. De-identified data can be shared with collaborations at other institutions after a data sharing legal agreement has been executed. Please share the following information with Ann-Marie Billig so she can begin working on the agreement: a copy of the Tufts IRB-approved protocol and Tufts IRB Approval Letter, the names and emails of the collaborators, and what their role will be (are they conducting statistical analysis, will it be jointly analyzed, will they conduct their own research and jointly analyze it with the tufts de-identified data)?
Q. I have a research idea. How do I get started?
A. Please refer to the getting started study design checklists found here. Please then contact Dr. Shruti Jain to begin the study design and protocol development process. If your project requires funding, see the Funding Application Flowsheet.
Q. What constitutes Human Subjects research?
A. Human subject means a living individual about whom an investigator (whether professor, staff, or student) conducting research: (1) obtains information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens; or (2) obtains uses, studies, analyzes or generates identifiable private information or identifiable biospecimens. Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Q. When is IRB approval needed for research?
A. The IRB is federally mandated to review, monitor and approve biomedical and social, behavioral, and educational research involving human subjects. Some projects may be research studies that do not involve human subjects or research as defined by the Federal Final Rule. The PI can not make the final determination as to whether a project constitutes human subject research or not; that determination may only be made by the Tufts IRB. In addition, many journals and/or national organizations require a formal determination letter from the IRB in order to submit a manuscript or abstract. Please contact Ann-Marie Billig to start the IRB submission process.
Q. I want to present or publish the results of a sponsored project. Do I need the sponsor’s approval?
A. The sponsored research agreement includes details on the sponsor’s requirements. Often, sponsors require that a copy of the proposed presentation or publication be submitted to them for review 30-60 days prior to submission to ensure no confidential information is disclosed. Please reach out to your Research Administrator to confirm the sponsor’s terms and conditions.
Q. What equipment and resources are available for my research?
A. Basic Science Research: A variety of equipment for in-vitro research is available in the Dr. J Murray Gavel Center (DHS833). Contact Mona.Patel@tufts.edu with any questions.
Clinical Research: The 14th floor Clinical Research Center has 7 fully-equipped dental bays for clinical research. Contact Joseph.Cimmino@tufts.edu with any questions.
Core Facilities: The university also has core facilities available to Tufts researchers. See information about Tufts Core Facilities here.