Page 11 - Research Compliance Welcome Package (1.4.19)

• If your financial relationship with the company disclosed meets the threshold of 12 month period:
$25,000 in a rolling
• Another member of the research team must be included when obtaining Informed Consent on this study. You may be involved to answer questions about the study and give an overview about the study, but another individual (without a potential conflict) is to be responsible to: (1) go over the Informed Consent document in detail with the subject, (2) explain the nature of the financial relationship with the study, and (3) verify that the patient
understands the risks and voluntarily agrees to participate in the study.
This research team member is the person responsible for signing the consent form as the “person obtaining
informed consent.”
• Individuals will
not be allowed to serve as Principal Investigator for studies that are subject to the Food and
• You are
situations where the data collection is required due to your role as the clinician involved in the care of the patient.
not to be responsible for the collection of research specific data, except for those • An independent monitor will provide detailed reports of data safety findings to the IRB as deemed
necessary.
• Upon review of financial relationships related to a Principal Investigator's research responsibilities, the BSWH Research Institute Conflict of Interests Committee may deem an industry relationship to be a Financial Conflict of Interest and disallow the investigator from serving as Principal Investigator.
The following paragraphs are provided for your information:
The Research Conflict of Interests Committee has sought to establish consistent standards by which it finds a financial interest to be significant such that there can be a reasonable presumption that a conflict of interests
exists. These standards were set with utmost care to recognize the importance of industry interactions to support research activities, regulatory considerations for government-funded research, and public perceptions. Investigators who exceed these threshold standards may be restricted in performing as Investigators on studies where their financial interest is with an organization/company related to the study (i.e. study sponsor or manufacturer of study product). In a few cases, where the Investigator is associated with an existing study and where the integrity of the study would be affected by removing the Investigator, the individual has been allowed to remain as Investigator when they have agreed to follow other stipulations that have been applied to protect the study. It is anticipated that these adopted standards/thresholds may change as regulatory limits are lowered and other influences create more changes in this arena. It is in this context that the following stipulations are made:
Drug Administration regulations or supported by any other sources (including BSWH- or Investigator- supported funding) when their financial interests with an organization/company are related to the study (i.e.
$50,000.
PHS-funded studies, the Research Conflict of Interests Committee will determine relatedness of
study sponsor or manufacturer of study product) and are greater than
• Regarding
financial interests greater than
$5,000 with organizations/companies that sponsor or manufacture products used in the study. This determination will guide the Committee in deciding whether individuals will be
allowed to serve as Principal Investigator on the study.
Research Integrity Officer Contact Information
Please contact the Research Integrity Officer with questions regarding Research Conflict of Interests Management.
Stephanie Worley Research Integrity Officer (254) 215-9025 Page 3 of 3 10/30/18