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Office of Outside Interests
Welcome to the Office of Outside Interests at Case Western Reserve University. The mission of the Office is to administer the University’s Policies on conflict of interest, to preserve the integrity of the University and its members, and to comply with applicable federal laws pertaining to individual and institutional outside interests where there could be the appearance of a conflict of interest. It is the intent of Case Policies and the mission of the Office of Outside Interests to fulfill this charge while at the same time respecting academic freedom and encouraging outside scholarly and entrepreneurial activities.
The Outside Interests Committee (OIC Page)
The members of the Outside Interests Committee (OIC), including the leadership of the Committee, are appointed by the President and include faculty, non-faculty employees, and administrators.
The Office of Outside Interests supports the OIC in:
• Identifying and responding to individual and institutional outside interests in a timely, supportive fashion
• Reviewing individual, as well as institutional outside financial interests
• Managing, wherever possible, outside interests that could give the appearance of conflict of interest.
For more information, link to the "OIC Page."
Outside Financial Interest Report
In compliance with federal regulations, Case requires all Faculty members, whether conducting research or not, as well as all
Investigators, including staff members, who work on research to complete the "Outside Financial Interest Report" at least annually. In addition, the Office of Outside Interests will collect Outside Financial Interest reports for Senior Staff. This report should be updated within ten days whenever there is a change in outside financial interests or University responsibilities that could give the appearance of a conflict of interest, or whenever a conflict of interest is eliminated. The reporting is all electronic - see below:
Submit Your Outside Financial Interest Report Online:
• Submit the Outside Financial Interest Report for Faculty and Investigators online via Spiderweb using your Case Network User ID (also known as "user name," "network ID," "Case ID," or "CWRUnet ID") and password.
• Follow the link on the left menu pane to “Outside Interest (COI).”
• If you have difficulty logging into SpiderWeb, it may be because you do not have a Case User ID--or if you have one, your Case User ID may require activation and your password may need to be re-set. To learn more about the Case User ID, please see these instructions: Case User ID Instructions.
• If you need an affiliate account sponsored by an active Case faculty or staff member, please contact your Case faculty or staff sponsor.
Other Forms
Staff and Advisee Notification Form
Case Policies
In February, 2009, Case Western Reserve University’s Board of Trustees approved revised conflict of interest Policies developed at the initiative of President Barbara R. Snyder and with extensive consultation with constituencies across the campus. The President’s leadership in updating the policy has placed the university ahead of national trends toward greater transparency in proposed federal and state legislation, voluntary disclosure by industry web sites, and anticipated changes in NIH regulations. The revised Policies apply to all members of the university community, including University leadership, faculty, researchers, staff and students. For more information, see the 2009 Case “Policies on Individual Conflicts of Interest and Institutional Conflicts of Interest.”
Please note: In June, 2009, the January 27, 2009 Policies were revised to address NIH requirements. Please see pages three-four for added language pertaining to record-keeping and NIH notification in the event of non-compliance.
COI Policies 2009
Current Events
Date: September 26, 2011
The National Institutes of Health has released a "Revised Policy: Managing Conflict of Interest in the Initial Peer Review of NIH Grant and Cooperative Agreement Applications." According to NIH, "This announcement provides revised policy for managing conflict of interest (COI), the appearance of COI, prejudice, bias, or predisposition in the NIH initial peer review process."
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-120.html
Date: August 25, 2011
DHHS Publishes Financial Conflict of Interest Final Regulation
After a process of receiving and analyzing comments to notices of proposed rulemaking over the past two years, DHHS has published new financial conflict of interest regulations. The Director of the NIH, Francis Collins, MD, PhD, said in a public telebriefing on Tuesday, August 23, that the new regulations are intended to preserve the public trust and enhance transparency and integrity of research. He noted that the previous regulations had been in effect since 1995 and needed modernization. On behalf of the Outside Interests Committee, the CWRU Office of Research Administration will notify the campus and larger research community of plans to update university procedures.
Please see below for related links:
Link to Regulation
Link to Supporting Information
Link to NIH Statement
Download a PDF of 2011 DHHS FCOI Regulation*
*Note: The PDF is 159 pages, but the Rule proper begins on page 108.
See page 108 for 42CFR50, "Promoting Objectivity in Research."
See page 133 for 45CFR94, "Responsible Prospective Contractors."
Date: April, 2010
Physician Payment Sunshine Act included in 2010 Patient Protection and Affordable Care Act (PPACA).
Academic organizations are pleased to see new payment disclosure requirements included in the recent legislation. Under the new legislation, starting March 31, 2013, any "manufacturer(s) of a covered drug, device, biological, or medical supply," is responsible for annually reporting to the secretary of Health and Human Services (HHS) "the amount of payment or other transfer of value" over $10 made to physicians and teaching hospitals. HHS will also collect "a description of the nature of the payment or other transfer of value." The legislation authorizes HHS to fine up to $150,000/year for non-compliance.
(Source: Report on Research Compliance, Vol. 7, Number 4, April 2010)
PPACA - SEC. 6002. The Transparency Reports and Reporting of Physician Ownership or Investment Interests
Read more information about the PPACA, including the entire text.
Related Case Policies
Business Policies (includes PCard)
Faculty Handbook
Human Resource Policy on COI
Human Resource Procedures for COI
Personal Use of University Property
Procurement Policy (see Gifts, Vendors)
SOM CME Forms, Policies, and Procedures
Technology Transfer Forms & Policies
Other Resources
COI Policies at Affiliate/Partner Hospitals
Government Regulations, Professional Guidances
E-mail Information for Affiliates
The Case Office of Outside Interests sends out email notifications via Case email. If you’re working at an affiliate organization (UHCMC, CCLCM, etc.), did you know you can have your Case email forwarded to your daily email account, saving you time and effort?
If you work for UHCMC, you can download this brief PowerPoint presentation that will tell you how to forward your Case email to your UHCMC account. [DOWNLOAD HERE.]
Using Yahoo, Hotmail or Googlemail? Check with your email provider to find out how you can forward email to your account.
(NOTE: We offer this email forwarding information as a convenience for you. Forwarding your Case email is not a requirement to complete your COI form.)
CONTACT INFORMATION FOR THE Outside Interests Committee
Maureen Landies, PhD
Director, Outside Interests Committee
Phone: (216)368-0838
Email: maureen.landies@case.edu
Yovonda Rease
Specialist II, Outside Interests Committee
Phone: (216)368-5963
Email: caseoic@cwru.edu
Sears Library Building Room 658
Case Western Reserve University
10900 Euclid Avenue 44106-7230
http://ora.ra.cwru.edu/research/orc/coi/index.cfm
Phone: (216)368-5963
Fax: (216)368-3737
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