The first step is for the PI to determine if the study is minimal risk or greater than minimal risk. The type of review is based on risk – minimal risk or greater than minimal risk – to the study participants. If the study qualifies for exemption, an Exempt Status Application is to be completed and submitted to the IRB office. If the study qualifies for expedited review an Expedited Review Application is to be completed and submitted to the IRB office. If the study is greater than minimal risk a Convened Committee Review Application is to be completed and submitted to the IRB office. Researchers are encouraged to call or email the email@example.com if guidance is needed.
IRB meeting dates and submission deadlines are posted online. In general, applications for convened IRB review are due on the 2nd Wednesday of each month prior to the meeting; the IRB is scheduled to meet on the 1st Wednesday of each month. Both dates are subject to change. Submission deadlines do not exist for submission of exempt and expedited new studies; they are reviewed in the IRB office in the order of receipt.
The original signed hard copy documents are to be submitted to the IRB office. They can be sent by interdepartmental mail or dropped of at the IRB office. To help facilitate and expedite the review process, the documents may be emailed to the CHAIRBOffice@challiance.org.
Yes, all research team members must complete human subject training. CHA defines “research team members” as people who contribute to the design, conduct, or reporting of a research study, have direct contact with study participants, contribute to the research in a substantive way, have contact with a study participant’s identifiable data or biological samples (e.g., tissue, blood, urine, plasma, saliva), or uses participants’ personal information. Please refer to the research education webpage for more information.
Principal Investigators and research team members must complete a mandatory training program prior to beginning research and must undergo continuing education every 3 years. The CHA research education requirements are detailed online. Each individual is to keep a copy of his/her documentation of completion from the “CITI gradebook.”
Principal Investigators are to retain a copy of education certificates for all research team members; these documents are subject to audit. A copy does not need to be submitted to the IRB office.
Yes, if the CHA researcher is the primary grant recipient a complete copy of the grant, not including the budget, is to be submitted to the IRB office. If CHA is a sub-contract or sub-award site of a federal grant, a copy of the grant does not need to be submitted to the IRB. Please call the IRB office with questions related to funding information that needs to be submitted with an IRB application.
Research, including advertising, etc., cannot begin until the PI receives the signed approval letter from the CHA IRB.
In general, to comply with Massachusetts laws on contract and tort claim requirements, most study records need to be kept for 7 years after a study is terminated with the IRB. The Department of Health and Human Services regulations specify that records must be kept for 3 years after completion of all research activities. If a study is regulated by the US Food and Drug Administration (drug/device/biologic study) research records must be kept for 2 years after a marketing application is approved. The Health Insurance Portability and Accountability Act requires records to be retained for up to 6 years after the last subject has completed study activity.
A case report or a case series is a retrospective analysis of 1, 2, or 3 clinical cases intended to broaden information for medical or educational purposes. Generally, reporting on up to 3 cases does not strictly meet the federal definition of research.
CHA does not require IRB review and approval if 3 or fewer patients’ records will be accessed; however, the authors of a case report/series are reminded that the HIPAA Privacy Rule applies. Please see the CHA policy statement about case reports for more detailed information and specifics about requirements.
CHA doesn’t provide a list of IRB member names. Instead the institution has a statement of attestation that CHA has a FWA, which can be printed and given to the sponsor.