Guidelines on conflict of interest

Prologue

Circumstances create a conflict of interest (COI), when an individual has an opportunity to affect CPEcontent about products or services of a commercial interest with which he/she has a financial relationship.

Organizers must place a higher priority on the health and well-being of the public than on individuals’ personal economic interests.

Some people in CPE have personal economic interests derived from financial relationships with commercial interests that create a personal sense of duty or loyalty to the commercial interest.

Some financial relationships with commercial interests are important enough to conflict with the person’s responsibility to CPE learner sand to conflict with the public interest.

If a person in CPE has a conflict of interest,the DCPE must manage the conflict ina manner that is in the best interest of the public.

Relevant Financial Relationships

Financial relationships are those relationships in which the individual benefits by receiving a salary, royalty,intellectual property rights, consulting fee,honoraria, ownership interest (e.g., stocks, stock options or other ownership interest. Financial benefits are usually associated with roles such as employment, management position,independent contractor (including contracted research), consulting, speaking and teaching,membership on advisory committees or review panels, board membership, and other activities from which remuneration is received, or expected.It also considers financial relationships of a spouse or partner.Relevant financial relationships are financial relationships in any amount occurring within the past 12 months that create a conflict of interest.There is no minimum amount for relationships to be significant. Inherent in any amount is the incentive to maintain or increase the value of the relationship.

Disclosure

Department of Continuing Professional Education, Ziauddin University requires written, signed disclosure of the existence of relevant financial interests or relationships with commercial interests from any individual in a position to control the content of a CPE activity. Individuals whorefuse to disclose relevant financial relationships will be disqualifiedfrom serving as aplanning committee member, a teacher, a speaker, a moderator or an author of the educational activity nor will such individuals have control of or the responsibility for the development, management, presentation or evaluation of the CPE activity. The purpose of the Disclosure of Educational Planners/Organizers and Commercial Entity Relationships is not to prevent an individual with relationships with or interests in commercial entities from participating in an educational activity, but to help identify and resolve any potential conflicts of interest and to inform the participants thatsuch relationships exist. Variation from the above policy will be considered on a caseby-case basis by the chair in conjunction with the DCPE committee.

Identifying and Resolving Conflicts of Interest in Continuing Professional Education

The DCPE requires and expects that planners/organizers should themselves identify and resolve conflicts of interest (COI). DCPE establishes mechanisms that go beyond simple disclosures to resolve conflict of interest prior to the education activity being delivered to learners.

  1. In order to begin the process of managing COI, the organizer must know about relevant financial relationships prior to the activity being developed and delivered to the learners. DCPE must obtain from the planners,speakers or authors written disclosures of their financial relationships that are relevant to the content being considered or planned for the activity. This disclosure information is so important to the CPE process, that individuals who refuse to disclose relevant financial relationships are disqualified from having a CPE role that will otherwise give them the opportunity to affect the development, management, presentation or evaluation of that CPE activity.
  2. A COI is present when a planner, speaker or author has both a current financial relationship with a commercial interest and the opportunity to affect content relevant to products or services of that commercial interest.Conflicts of interest can be identified through an analysis of the information disclosed and an understanding of the planned content of the CPE.Circumstances create COI. Context counts. However, “A conflict of interest occurs when there is a divergence between an individual's private interests and his or her professional obligations to [the institution] such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal gain,financial or otherwise. A conflict of interest depends on the situation, and not on the character or actions of the individual.” When a person has divested themselves of a relationship any associated conflict of interest is resolved. However, the relationship must be disclosed to the learners for the next 12 months, as part of demonstrating compliance.
  3. In CPE there are two components to conflict of interest – a current financial relationship with a commercial interest and the opportunity to affect content relevant to products or services of that commercial interest. So, as long as the relationship is current, managing or resolving the COI must involve the content of the CPE. This is where the DCPE intervenes to identify safeguards that can be, or already are, incorporated intothe process to prevent the insertion of commercial bias.

The following approaches can be used to resolve conflict of interest.TheCPEmechanism involves specifying, “Who does what?” within an activity:

a) Ask the person with the conflict of interest to limit his or her presentation to the areas of unconcern i.e. pathophysiology, so that his or her financial relationships were not relevant to the educational event, and by asking someone else, without a COI, to evaluate and discuss the clinical implications ofthe primary speaker’s discovery for us.

b) When a proposed speaker has a conflict of interest related to content change the focus of the activity so that the content is not about products or services of the commercial interest that are the basis of the conflict of interest.

c) When an individual has been the principal investigator on a project funded by a commercial interest, choose to limit the individual’s presentation to thedata and results of the research. Someone else could be assigned to address thebroader implications and recommendations for clinical care.”

Epilogue

Describing and Documenting Conflict of Interest

The organizer needs to document the implementation of the safeguards for COI in the activity proposal. The DCPE expects that the organizers will demonstrate compliance with the accreditation requirement.That is,performance-in-practice will serve to verifycompliance;

  1. Filling of the Disclosure statement.
  2. All who are in a position to control content have disclosed relevant financial relationships.
  3. Individuals who refuse to disclose are disqualified from any role involved in planning, management, presentation, or evaluation of that CPE.
  4. That disclosure of relevant (or no) financial relationships of those with control of content was made to learners prior to the beginning of activity.
  5. That signed written agreements documenting terms of commercial support exist between DCPE & commercial supporter.
  6. That disclosure of source of commercial support was made to learners prior to the activity.
  7. Costing and Approval of budget of thatCPE from office of finance.