Common Questions About New Studies
1) What needs to be reviewed by the IRB?
Any research conducted on or by faculty, staff, or students at Tufts Medical Center or Tufts University Health Sciences (TUHS), or their affiliates that involves human subjects, or human subjects’ records, requires IRB review. This is true regardless of the funding source or area of research.
In addition, any human research that is conducted at another institution or in foreign countries by Tufts Medical Center or TUHS faculty, staff, or students must be reviewed by the IRB.
2) How do I know whether my study will go to the convened IRB?
Research that presents greater than minimal risk to subjects or does not meet one of the categories for expedited review must be reviewed by a convened IRB. This determination is made in the IRB. Please contact the IRB office with any questions about whether your study requires review at a convened IRB meeting.
3) Does my study need to be reviewed by the Scientific Review Committee (SRC)?
The SRC routinely reviews greater than minimal risk protocols submitted for review by the convened IRB. The basic requisite for requiring SRC review is that a protocol has not previously undergone an independent, scientific peer review process. The types of studies that often fall under this category are investigator initiated studies, single-site pharmaceutical company sponsored studies, or early phase clinical trials. Please refer to the SRC page for more information.
You can call the IRB office at (617) 636-7512 and the SRC Coordinator or a member of the IRB office staff will help you.
4) How do I know whether my study qualifies for expedited review, exemption, or if it is Not Human Subjects Research?
The IRB makes the determination as to whether a study qualifies for expedited review, exemption, or if it is not Human Subject Research. Projects that fall into one of these three categories are reviewed in the IRB office. These studies are not reviewed at a convened meeting of the IRB; therefore, there are no submission deadlines.
In order to know which documents to submit for your study, carefully review the information about the three categories listed on our website. Please also feel free to call the IRB office with any questions.
5) What do I need to submit for a new study?
Submit ONE (1) original paper submission application to the IRB office (Box 817 or 15 Kneeland St, 1st floor). Original signatures are required on the paper submission. Please also submit all documents electronically (email the IRB Office Account or submit on a CD or flash drive – flash drives will be returned) for all studies being considered for a convened committee review or an expedited review. Email informed consent forms (ICFs) as Microsoft Word documents to the IRB office at the time of submission.
The original application will consist of the following, as needed: IRB forms, protocol, site-specific appendix (for a multi-site study), grant, and all supporting documents, as applicable (for example: surveys, advertisements, interview guides, tests or other measurement tools).
6) Do students’ academic human subjects research projects require IRB approval?
Yes. All student projects must be submitted to the IRB prior to initiation. Student research that involves human subjects, whether biomedical or social-scientific, requires approval or an exemption determination by the IRB. Please note: student researchers are required to have a faculty advisor for each research project. The faculty advisor will serve as the principal investigator.
7) What do I need to keep for my research records?
The PI is responsible retaining all documents related to a research study. The PI is to retain all original correspondence from the IRB and a copy of all correspondence submitted to the IRB. Refer to the File Review Checklist and Participant File Checklist to ensure your study files are complete.
8) I’m working on a project with faculty from another institution. If my co-investigators receive IRB approval from their university, do I still need approval from this institution?
Yes, if Tufts MC/TUHS is engaged in research. Each institution develops its own policies and procedures, and our institution’s policies and procedures may differ from other institutions. You need to submit the required forms for our institutions and should include a copy of the other institution’s IRB approval, including their approved protocol and informed consent form (ICF), if applicable. Please refer to OHRP’s guidance on engagement in research for more information: http://www.hhs.gov/ohrp/policy/engage08.html.
9) 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?
Yes, only if you are engaging our institution in research. Researchers affiliated with Tufts Medical Center and/or TUHS must submit for IRB review any human research project they will be involved in if it is conducted at Tufts Medical Center and/or TUHS. Please also refer to OHRP’s guidance on engagement in research for more information: http://www.hhs.gov/ohrp/policy/engage08.html.
10) What if I only have a draft of my questionnaire, instrument, etc., or a portion of it (i.e., the consent form or a survey)?
Submit your draft as a “DRAFT” instrument. This will allow the IRB to review what you are proposing to do. Be certain to provide information regarding your plans to finalize the instrument and a timeline for completion. The instrument may only be used after the final version receives IRB approval.
11) The study Sponsor has requested an IRB roster. Is this information available?
No, we do not release the IRB rosters. However, in lieu of a roster, you can print a memorandum: Tufts Health Sciences Statement of Compliance and provide this to your study Sponsor.
12) I plan to collaborate with another institution and send them Tufts data for research analysis. Can I submit an initial proposal to the IRB if the data use agreement is still pending?
Investigators can submit their initial IRB applications without a fully executed (signed) data use agreement (DUA), material transfer agreement (MTA) or collaboration agreement. If an agreement has not been established, confirm in your cover letter that no data and/or specimens will be transferred to another person or entity until an agreement is executed by Tufts MC Grants & Contracts or Tufts University (for MTAs)