RFMH Financial Conflict of Interest Policy
  Effective Date 8-24-2012, revised 12-14-2012
 


Research Foundation for Mental Hygiene, Inc. (RFMH)
Financial Conflict of Interest Policy

 

     

RFMH is committed to carrying out its functions in a manner that promotes confidence in the integrity of the organization. No officer, director, employee or agent of RFMH shall have any interest, financial or otherwise, direct or indirect, or engage in any business or transaction or professional activity, or incur any obligation of any nature that is in substantial conflict with the proper discharge of their duties in the best interest of RFMH. RFMH’s Conflict of Interest Policy can be found in the RFMH Corporate Policy Manual Section 2.2 available at:  http://corporate.rfmh.org/corporate_info/corporate_policy_manual.pdf
This RFMH Financial Conflict of Interest Policy provides more detailed requirements for addressing issues relating to potential Financial Conflict of Interest in research. It incorporates the provisions of:

 
  • 42 CFR Part 50 and 45 CFR Part 94 which were issued by National Institutes of Health (NIH) to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under NIH grants, cooperative agreements  or under PHS contracts will be free from bias resulting from Investigator financial conflicts of interest; and


  • 21 CFR Part 54 which was issued by the Food and Drug Administration (FDA) to ensure that financial interests and arrangements of clinical investigators that could affect reliability of data submitted to FDA in support of product marketing are identified and  disclosed by the sponsor of any drug, biological product, or device marketing application. The sponsor of any drug or device marketing application must submit for all clinical investigators who participated in the study, a certification that no financial conflicts exist or a disclosure of the existing financial conflicts.  The Investigator and Institution are required to provide the sponsor with the information needed to complete certification and disclosure statements. The FDA policy encourages Applicants and investigators to minimize such financial arrangements or to ensure that studies are well designed and managed in such a way, as to eliminate the possibility of bias due to the existing financial arrangements.

  Table of Contents
  1 APPLICABILITY
  2 DEFINITIONS
  3 TRAINING
  4 SUBRECIPIENTS
  5 SUBMISSION AND REVIEW OF DISCLOSURES
5.1 Submission Prior to Application for Funding or Negotiation of an Agreement
5.2 Submission of Updated Reports
5.3 New Investigators and New Disclosures
5.4 Review of Disclosures
  6 FAILURE TO TIMELY DISCLOSE OR REVIEW OR  FINDING OF NON COMPLIANCE WITH A FCOI MANAGEMENT PLAN
  7 MANAGEMENT OF CONFLICTS OF INTEREST
  8 RECORD RETENTION
  9 PHS CERTIFICATION
  10 PUBLIC ACCESSIBILITY
  11 REPORTING – INITIAL REPORTS
  12 REPORTING – ANNUAL REPORTS
  13 REMEDIES
  14 ADDITIONAL REQUIREMENTS FOR FDA REGULATED COVERED CLINICAL STUDIES
14.1 Definitions under FDA Regulations 21 CFR 54
14.2 Additional Disclosure Requirements for Covered Clinical Studies
14.3 Reporting for Covered Clinical Trials
  15 EFFECTIVE DATE
  16 PROCEDURES AND FORMS
 
 
   
 



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