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June Tip

Friday, June, 30th, 2017 Previous Tips Tip of the Month

Tufts Health Sciences IRB does not distribute the IRB membership roster.  If your Sponsor requests this information, provide the Sponsor with a study-specific Federal Wide Assurance letter instead. Type in the study information and print a study-specific letter. The letter will serve as an assurance statement that you can provide to your Sponsor in lieu Read More

May Tip

Tuesday, May, 30th, 2017 Previous Tips Tip of the Month

There are special requirements for enrolling wards of the state in a research study.  If your study may enroll wards of the state, provide a plan in your protocol that describes how they will be enrolled. Refer to the IRB’s Wards of the State policy for additional information.

April Tip

Wednesday, May, 3rd, 2017 Previous Tips Tip of the Month

The IRB does not provide verbal approval, (e.g. over the phone or during an in-person conversation). Any new study or modifications to an existing study that you wish to implement must be submitted to the IRB office as a paper copy. After being reviewed, a formal signed IRB approval letter will be sent to the Read More

March Tip

Tuesday, April, 4th, 2017 Previous Tips Tip of the Month

New research team members cannot participate in research activity until you receive a formal acknowledgment from the IRB office. To add a new research team member, you can submit a cover letter using the template located on the IRB Website. A research team member is defined as a person who has direct contact with subjects, Read More

February Tip

Thursday, March, 9th, 2017 Previous Tips Tip of the Month

Study documents should always be organized and available for inspection by the IRB, the institution, sponsor, or regulatory authority (FDA, OHRP). All research records must be accessible for inspection and copying by authorized representatives at reasonable times and in a reasonable manner.

January Tip

Wednesday, February, 22nd, 2017 Previous Tips Tip of the Month

Do not engage in research activity that involves human subjects or specimens until you have received a formal IRB approval letter from the IRB. Quality improvement projects, secondary data analysis and review of medical records are often human subjects research activities as well, so please contact the IRB to discuss your project and any submission Read More

December Tip

Tuesday, January, 3rd, 2017 Previous Tips Tip of the Month

Ensure that all hard copy and electronic copies of signed ICFs are securely stored to prevent unauthorized access, disclosure, or loss. Paper copies should be stored in a manner that limits access to only authorized individuals (filing cabinets/areas should be locked and placed in secured/locked rooms). Electronic copies should be saved on a device that Read More

November Tip

Friday, November, 4th, 2016 Previous Tips Tip of the Month

The IRB counts any subject that signs an Informed Consent Form (ICF) as enrolled in the study.  To avoid over-enrollment, when proposing the total number of subjects you want to enroll in your study, take into account subjects that may be lost to screen failure, disqualification, drop-outs, etc.  And if your study is reaching the Read More

October Tip

Tuesday, October, 4th, 2016 Previous Tips Tip of the Month

Only the current, IRB approved and validated ICF can be used to enroll subjects.  Therefore you should: Make sure all members of the research team who consent subjects have access to the most recently approved ICF. Discard all older or expired paper versions so they aren’t used by mistake. Check to make sure the IRB Read More

September Tip

Sunday, September, 4th, 2016 Previous Tips Tip of the Month

Ensure that all hard copy and electronic copies of signed ICFs are securely stored to prevent unauthorized access, disclosure, or loss. Paper copies should be stored in a manner that limits access to only authorized individuals (filing cabinets/areas should be locked and placed in secured/locked rooms). Electronic copies should be saved on a device that Read More