1) What do I do if I receive a request from the media to be interviewed about a research study (and/or for a participant to be interviewed)?
Most media requests do not constitute human subjects research, but the Principal Investigator must inform IRB so that a determination can be made.
Please provide a letter to the IRB that includes the following information:
1. Reference the IRB #, Principal Investigator, and study title. 2. Formally tell us that an interview will occur.
If a subject will be interviewed, please also address the following:
1. Explain how you will choose a research study participant for the interview. 2. Explain how you will contact the participant. (Please Note: To preserve study confidentiality, participants should not be contacted directly by the media, nor should their contact information be provided to the media, until they have consented to the interview.) 3. Confirm that participation in the interview will be optional for the participant, and will not affect the participant’s care or research participation. 4. State whether there is a form for the participant to complete from the hospital (for HIPAA, etc.).
Please also note that any media related request for Tufts Medical Center should be directed to the Public Affairs Office at (617) 636-0200, or to the Public Relations Office at (617) 627-3069 for Tufts University.
2) When do I need to send a research study involving animals to the IRB for review & approval?
Please refer to this guidance about when to submit animal studies to the IRB for human subjects review.
3) What to do if I am missing some of my study documents/Can you send me copies of my study documents?
If some study documents are missing, check with all members of the research team to check if the study documents were misplaced and can be located; if not, please submit a formal response to the IRB. This formal response should include the following:
1. A reason that these documents were not retained 2. AReportable New Information (RNI) Form signed in original ink to the IRB office (Box #817, or drop off to 15 Kneeland St., Tupper 1, 1st Floor) explaining why these documents were not retained, and outlining your corrective action plan to ensure there is a plan to avoid this from happening in the future.
a. If your corrective action plan includes providing additional education to the research team to reinforce the importance of proper record retention, please document the following details about this training for your study files, and on the Reportable New Information Form:
The date and time the training took place
Who participated in the training
A brief summary of what was discussed
b. Evaluate whether your record retention plan accounts for changes in research team, such as the study coordinator. For example, the plan should ensure electronic documents are stored in a location that is secure but also accessible in the event a coordinator (or any other person responsible for file management) leaves the institution. The plan must also ensure relevant e-mail correspondence is printed for the paper study file.
4) Are there times when I can just drop in at the IRB Office and get help with my study?
Yes, the IRB has the drop in hours every Tuesday 2 – 4 PM. The Tufts MC/TUHS IRB office is located on the 1st floor of 15 Kneeland Street (Tupper Building). If you do not have a pass card to open the door, call the Tufts MC/TUHS IRB office at (617) 636-7512 and staff can let you in. Press the buzzer on the left side of the doorway from the front of the building in order to gain entrance into the IRB. For security reasons, it is required that you show your Tufts-issued ID.