The entity that normally is supposed to determine whether an academic researchers conflict

Conflict of Interest (COI) Overview

Conflicts of interest in research occur when university members are in a position to influence research and their extramural activities are such that they or their family may receive a financial benefit or improper advantage from the research.  Conflicts of interest have the potential to inappropriately influence many aspects of research - from how a study is designed, how data is collected, analyzed and reported, to what individuals/suppliers are involved in the work.  In a university setting, especially one that promotes technology transfer and entrepreneurial activity, conflicts of interest are inevitable.

Examples:

Dr. Karl is a founder of a non-publicly traded company that utilizes technology developed in her lab at CMU. She has an equity interest in the company. This must be disclosed and may or may not constitute a financial conflict of interest.

Dr. Smart is an economist at CMU. Dr. Smart consults for a bank, assisting with economic forecasting. Dr. Smart received $8,000 in payment for his consulting services last year. This must be disclosed and may or may not constitute a financial conflict of interest.

Dr. Singh patented technology he developed at Great Eastern University. Dr. Singh is currently on faculty at CMU doing similar work. Dr. Singh has received royalties from Great Eastern University exceeding $5,000. This must be disclosed and may or may not constitute a financial conflict of interest.

Dr. Bing is a founder of a non-publicly-traded company that utilizes technology developed in her lab at CMU. Dr. Bing receives federal funding at CMU for further development of the technology. Dr. Bing would like to issue a subcontract to the company for a portion of the work to be done. This must be disclosed. It may constitute a financial conflict of interest and a management plan may be required

Management of Conflicts

In some instances it is necessary to manage, reduce or eliminate conflicts of interest. CMU works with Investigators to explore whether there are structures that would allow research to continue when there is an appropriately-avoided or managed conflict. Examples of mechanisms that are used to avoid or manage conflicts include:

• Public disclosure of financial interests (e.g., when presenting or publishing research);
• Monitoring of research by independent reviewers;
• Modification of the research plan;
• Change of personnel or personnel responsibilities;
• Divestment of the financial interest;
• Severance of relationships that create the conflict (e.g., consulting);
• For research projects involving human subjects research, disclosure of conflicts directly to human participants; or
• Written disclosure of the conflict to all individuals working on the research project.

ORIC will communicate its determination regarding a management plan to the Investigator in writing. The Investigator may not commence or participate in the research until the Investigator agrees to and complies with a management plan imposed to manage a conflict of interest. Once agreed to, ORIC works with departments to monitor compliance with the management plan. Management plans are sometimes updated to reflect changes in research personnel, financial interests or other factors.

Review of COI Certifications and Disclosures

CMU uses an electronic system (SPARCS) to collect and store certifications.

ORIC will review certifications to determine if a conflict exists, and ORIC may contact the Investigator for additional information. The objective of ORIC’s review is to determine whether an Investigator’s disclosed intersts are related to the Investigator’s research activity, and if so, whether the interest poses a perceived or actual conflict.

A conflict exists when ORIC reasonably determines that the financial, personal, or other interest in question could directly and significantly affect the design, conduct, or reporting of the Investigator’s research activity. ORIC will consider several factors in determining whether a conflict exists, including:

• The nature and extent of the research and an Investigator’s role on a project;
• The nature of the Investigator’s research activity, including whether it relates to basic or fundamental research directed at understanding basic scientific processes;
• Whether the research involves intellectual property linked to the investigator's interest;
• Whether the research could affect the value of an Investigator's financial interest;
• The amount of a financial interest; and
• Where the Investigator holds a financial interest in another company, whether the Investigator’s interest could result in the Investigator influencing company decisions, or whether the research could have a significant impact on the company’s business or financial outlook.

In conducting its review, ORIC may call upon subject-matter experts as needed with respect to any particular project, such as division management and others with relevant expertise. If it appears that a conflict may exist, further review is required. This review may be conducted by ORIC staff, the relevant department head, dean, OVPR, and/or their designees.

Reporting to Federal Agencies and the Public

CMU is required to notify NSF's Office of General Counsel in the event a financial conflict of interest related to an NSF award is identified and CMU finds that is it unable to appropriately manage the conflict.  Some other sponsors require similar notifications.

In the event an Investigator has a financial conflict of interest related to PHS or DOE funding, CMU is required to report certain situations to the funding agency. These reports are made by staff in ORIC.  Investigators do not need to report directly to PHS or DOE.

In the event it is determined that a researcher has a financial conflict of interest as it relates to PHS or DOE funded research, the regulation requires that certain information be made available to the public about the Investigator's signifiant financial interest (SFI).  The information that CMU is required to release includes:

• Investigator's name;
• Investigator's title, and role with respect to the research;
• Name of the entity in which the SFI is held;
• Nature of the SFI (stock, income, etc.);
• Approximate dollar value of the SFI in dollar ranges ($0 - $4,999, $5,000 - $9,999, $10,000 - $19,999, amounts between $20,000 - $100,00 by increments of $20,000, amounts above $100,000 by increments of $50,000), or  if the interest is one whose value cannot be readily determined through reference to public information, a statement to that effect.  

In these cases, the PHS and DOE regulations provide the university with a choice between posting information about financial conflicts of interest on the internet and making the information available within five (5) days of a written request.  CMU has chosen to make information available upon written request to the Office of Research Integrity and Compliance. Requests can be made by submitting the FCOI Request form  [DOC].

Information Specific to Investigators Seeking or Receiving Public Health Service Agency Funding

The Public Health Service includes the following agencies:

• Administration for Children and Families (ACF)
• Agency for Health Care Research & Quality (AHRQ)
• Agency for Toxic Substances and Disease Registry (ATSDR)
• Centers for Disease Control and Prevention (CDC)
• Food and Drug Administration (FDA)
• Health Resources and Services Administration (HRSA)
• Indian Health Service (IHS)
• National Institutes of Health (NIH)
• Office of Global Affairs (OG)
• Office of the Assistant Secretary for Health (OASH)
• Office of the Assistant Secretary for Preparedness and Response (ASPR)
• Office of Public Health and Science (OPHS)
• Substance Abuse and Mental Health Services Administration (SAMHSA) 

A number of other sponsors have adopted the PHS COI standards. 

Who determines whether an academic researchers conflict of interest can be managed?

Which of the following most accurately describes an institutional conflict?

Which of the following is true about conflicts of interests?

Which of the following most accurately describes a conflict of conscience?