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November 9, 2015
Dear MetroHealth Research Community,
In an effort to better serve the research community at MetroHealth, we are asking individuals to contact the IRB Professional Staff member/analyst assigned to the protocol with their questions. Unfortunately, IRB office walk-ins are not the best way to help answer your questions. To help provide timely and efficient quality advice and guidance, we are asking individuals to contact their assigned analyst (noted as IRB Administrator on your study in the eIRB system).
For short questions that can be answered over the phone or via email, please contact your assigned analyst (email preferred). When contacting your analyst, please state 1) your name and contact number, 2) protocol number (if assigned) and 3) the reason for your call. This will allow us to pull the necessary material to answer your questions.
For questions that may require additional time, please schedule a meeting with your assigned analyst via GroupWise and be sure to bring any and all materials to the meeting. We are more than happy to sit down with you to discuss your questions, and remain committed to providing excellent service to the MHS research community and exceptional protections to all human subjects at MetroHealth.
For cases where there is no IRB analyst assigned, please call the IRB Office Manager at x82021.
*Please note that currently, The MHS Human Research Protection Program is going through its reaccreditation process with AAHRPP. We will be available on a very limited basis the week of April 6th, 2015. Please plan your submissions accordingly.*
Thank you very much.
Affordable Care Act's Sunshine Law provision (aka Open Payments). The law required certain manufacturers (including pharmaceutical companies, DME suppliers, and surgical product suppliers) and group purchasing organizations to report data on payments made to physicians (excluding residents) and teaching hospitals. This included payments made for research studies. Manufacturers and GPOs have completed their reporting. The RABO office and Compliance have reviewed research related payments and reviewed payments made for research related activities. We are encouraging researchers to also log into Open Payments database and review and dispute any activities or payments made under their name.
As a reminder, MHS Providers are public employees and are subject to Ohio Ethics Commission rules. The Ohio Ethics Commission (OEC) has rather strict rules on employee-vendor relationships. The Open Payments system will make it very easy for the OEC to search and see what payments MHS physicians received from industry. As such we want to encourage all physicians to log into the system and review their data.
MHS is asking all physicians to register or commit to giving Patricia (Trish) Gallagher proxy (directions how to are attached) and she or you can report any vendor related payments to Compliance by August 29, 2014.
The Compliance Department will assist you with any disputes you would like to register. Please advise the Compliance Office of any disputes filed. The Faculty Affairs Office will make computers available and Compliance will offer assistance with the log on process. MHS will be unable to dispute any entries under your name after September 8.
Please contact Compliance (216) 778-5728 if you have any additional questions or concerns. This will need your immediate attention and computers for access if needed are in room A-107, if you need Trish's help, you can page text her at 216-210-3042 or call 8-5790.
Both Principal Investigators and Study Coordinators will now receive eIRB email notifications noting study status updates. If you would like to receive email notifications, list your role as "study coordinator" in addition to your actual role.
At the December 16th Meeting of the IRB the Board voted to update the SOPs and change the policy on expired studies as follows:
Administrative Closure: The IRB will administratively close any study that is expired for more than thirty (30) days. This research study would no longer be approved and could not continue to be conducted without submission of a new application by the investigator.
If a continuing review submission is not received reviewed and approved within thirty (30) days of the expiration date, the IRB Chair or designee will issue a letter to the investigator to inform them that the expired study has been closed and archived by the IRB Office and that in order for the research to continue, a new protocol must be submitted to the IRB for consideration. The letter will be copied to the appropriate MHS Department Chair.
All instances of lapsed approval will be reviewed as non-compliance (MHS IRB SOPs on Non-compliance will apply) and reported to and reviewed by the IRB Chair or Vice-Chair. Multiple instances of lapsed approval by an investigator will warrant review by the convened board.