Page 10 - Research Compliance Welcome Package (1.4.19)

• Requires BSWH to make a determination of whether or not a Financial Conflict of Interest exists for the research (significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research)
• Basic threshold for what constitutes a significant financial interest (SFI) is set at $5,000 (with other considerations such as intellectual property rights, etc.) for researcher/their spouse/dependent children
BSWH CONFLICT OF INTERESTS PROGRAM
• Managed by BSWH Corporate Compliance via the COI-Smart web-based system for COI disclosure, management, and tracking (https://baylorhealth.coi-smart.com/login.php)
• Annual program launch currently based on BSWH fiscal year (July 1st - June 30th) for managers and above as well as other designated roles, including all research KSP
• Focused on activity during the prior 12 months but updates are required as potential conflicts are identified
• Includes standard resolutions for conflict management based on system policies and restrictions approved
by the BSWH Corporate Compliance Committee and Research COI Committee
• Any researcher with an outside industry relationship should at least have the standard research resolutions included in their management plan
OPEN PAYMENTS PROGRAM
• The Affordable Care Act requires information on payments and other transfers of value and ownership/investment interest be collected from industry and displayed on a public website on an annual basis
• The national program is mandated to promote transparency by publishing data on the financial relationships between the healthcare industry (applicable manufacturers and group purchasing organizations of drugs, devices, biologicals, and medical supplies) and healthcare providers (physicians and teaching hospitals)
• The searchable data was first displayed in September 2014 (for the last 5 months of calendar year 2013 data) and is published again on June 30th each year (for the previous calendar year data and updates to previously published data)
• This publicly available resource may be used by BSWH to monitor industry payments to our physicians and may be compared to their BSWH COI disclosure
• Further information and the searchable database may be found here: https://openpaymentsdata.cms.gov/ CURRENT BSWH STANDARD RESEARCH MANAGEMENT PLAN RESOLUTIONS
Regarding your role on current and future clinical studies, when [Name of Disclosed Company] is associated with the study as either study sponsor or manufacturer of products used in a clinical trial study with which you are a principal or co‐investigator role, you will be required to:
• Disclose the financial relationship on the Baylor Scott & White Health approved Research Informed Consent document.
• Retain Informed Consent documentation for each study participant.
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