B5 - Conflict of Interest - Management Strategies

STRATEGIES TO MANAGE IDENTIFIED CONFLICTS OF INTEREST

In compliance with the MOPH DHP standard for support of accredited CPD activities, Element 3 - Standard 3.2: The scientific planning committee (SPC) is responsible to have processes/strategies in place for managing and mitigating any conflict of interest (COI) identified prior to, or during the CPD activity. 

The SPC must review the completed disclosure forms of all scientific or organizing planning committee members, speakers, facilitators, and other involved persons. The SPC must also have procedures in place to follow if a conflict of interest comes to their attention prior to, or during the CPD activity to ensure appropriate COI management, compliant with CPD standards

What is conflict of interest?

Conflict of interest exists when an individual, whether a member of a planning committee or a presenter, has an opportunity to influence the content of an educational event through the mentionor promotion of products or services of a commercial interest with which he or she has relationship,or through the omission of mentioning competing products or services. 

The purpose of identifying and addressing potential COIs is to ensure proper balance, independence, objectivity, and scientific rigor for educational activities. When actual or potential COIs are identified, organizers and presenters must ensure that they are appropriately addressed.

Who should disclose conflicts of interest? What should be disclosed?

Anyone in a position to control the content of a CPD activity should disclose all potential conflicts ofinterest that are relevant to the content of the presentation and resolve them prior to the CPD activity. HMC CPD requires all members of planning committees and all presenters to complete the Declaration of Conflict of Interest.

Organizers of CPD activities can prevent or reduce the risk of conflict of interest by selecting planning committee members and presenters who do not have relationships to commercial interests related to the content. They may also assign to the presenter aspects of the content that do not place the presenter in a position of potential conflict of interest

How to manage an identified conflict of interest

Once a conflict of interest is identified, organizers of a CPD event must determine if it can be practically managed. If it cannot, organizers will need to select another presenter; in the case of a planning committee member, he or she will need to be replaced.

Appropriate mechanisms for resolution can include a) altering control over content or b) independent content validation.

a. Altering control over content

• choose someone else to present the part of the content that is problematic
• change the focus of the CPD activity so that the content is not about the products or services of the commercial interest, if that is the basis of the conflict of interest
• limit the content presented by the person in question to a report of the data without providing recommendations; another presenter can be assigned to address broader implications and recommendations
• limit the sources for recommendations. Limit the role of the presenter with potential COI to reporting recommendations based on formal structured reviews of the literature, along with a clear statement of the inclusion and exclusion criteria. That way they present information that is explicitly “evidence-based” rather than reporting personal recommendations or selecting the evidence to be presented.

b. Independent content validation: Conflict of interest may be resolved if the CPD material is peer reviewed, all the recommendations involving clinical medicine are based on evidence that is accepted within the profession, and all scientific research referred to in the CPD activity in support or justification of patient care recommendations conforms to the generally accepted standards.

Determining the right course of action can be facilitated by asking a few useful questions:

• How were the topics and the presenter for the activity determined?
• What content is expected to be included in the presentation?
• Will the presenter be making clinical recommendations?
• What sources of evidence will support the presentation?

A few examples of strategies considered to be adequate to manage identified conflicts are: 

1. The speaker could be required to alter the focus of the talk to limit the areas where conflict of interest is significant.
2. The topic selected could be changed, but the same speaker be used.
3. The Scientific Planning Committee (SPC) could ask for a peer review of the content to ensure that the principles of scientific integrity, objectivity and balance have been respected.
4. Both topic and speaker could be excluded from the activity. This is rarely needed, but it can be a last resort if a significant COI cannot be managed.
5. If a COI is identified for one or more SPC members, the conflict should be declared to others on the committee and the member could excuse himself or herself from planning decisions relevant to their area of conflict.

Transparency to learners

CPD event organizers and presenters must take steps that would allow participants to make independent judgments on the relationships identified and management strategies employed to deal with any conflicts of interest

At the start of each activity, a conflict of interest declaration must be presented:

Slide 1- Presenter must disclose: Personal relationships with commercial interests. Specific outline of connections/support for development/presentation of the program from commercial entities or organizations including educational grants, in-kind services, AND specific aspects of the faculty/presenter connections that a program participant might consider relevant to the presentation. 

Slide 2- Mitigation of Bias: Description of measures taken to deal with and mitigate potential sources of bias in the presentation.

These slides are to be visually and verbally presented to the audience. Sufficient time MUST be allowed for the audience to read and comprehend the information being shared. There must be an opportunity for the audience to ask questions about the disclosure should they arise.

6.0 (OP 4043) DECLARATION OF CONFLICT OF INTEREST

Suggested Declarations relating to Conflict of Interest for Presentations Conflict of Interest Slide

• I have no conflict of interest to declare
  
• Or (if relevant financial relationships exist, in addition to disclosure at the beginning of the presentation, faculty must discuss how the content has been adjusted to avoid the introduction of commercial bias during the presentation. For example, faculty may state that:
• I am recipient of a grant from / on the board of…/ provide advice for/ etc
  
• And perhaps something along the examples below, whichever is felt appropriate
• “I am covering topics other than those represented by my relationship with (Name of commercial entity).”
• “I will not be presenting this content in a promotional manner.”
• “I will not endorse (name of commercial entity) during this presentation.”
• “Another faculty member is covering content related to this commercial entity.”
• “There will be no case studies or activities presented that in any way represent past, current or prospective clients of (name of commercial entity).”
• Any recommendations made during this presentation are evidence‐based, or consistent with current consensus‐based simulation practice.”

Guidance on Disclosure of Relevant Financial Relationships

Hamad CPD must ensure balance, independence, objectivity, and scientific rigor in educational activities. All individuals in a position to control educational content must disclose the name of commercial interests producing, marketing, or distributing healthcare related goods or services with which the individual has had a relevant financial relationship within the past 24 months.

Please review the definitions of “commercial interest”, “financial relationships”, “relevant financialrelationships”, and “conflict of interest” to ensure compliance.

Definitions:

Commercial interest is any entity producing, marketing, or distributing healthcare related goods or services used on patients. Clinical service providers are not considered commercial interests.

Financial relationships are those in which an individual benefits by receiving a salary, royalty, consulting fee, honoraria, ownership interest (e.g., stocks), or other financial benefit, usually associated with roles such as employment, independent contractor (including contracted research), consulting, speaking and teaching, membership of advisory committees, review panels, or board membership, and other activities for which remuneration is received, or expected.

Relationships of the individual’s spouse are included as those of the individual.

Relevant financial relationships with commercial interests are any that occurred in the 24 months preceding the time the individual is involved in controlling educational content. There is no minimum payment for relationships to be considered relevant. Inherent in any amount is incentive to maintain or increase the value of the relationship.

Conflict of Interest: Circumstances create a conflict of interest when an individual has opportunity to affect educational or scientific content about products or services of a commercial interest with which he/she has a relevant financial relationship.

Required Disclosure of Relevant Financial Relationships during Educational Presentations

At the beginning of an educational presentation, both SPC members and all contributing faculty must disclose all relevant financial relationships.

Speakers with no industry involvement should inform the audience that they have no conflict of interest.

Financial relationships entirely unrelated to the topic do NOT need to be disclosed.

Any involvement should be declared with a suitable phrase e.g.

“I have/had an affiliation (state financial or otherwise) with X pharmaceutical (or medical device etc) organization”

“I am a member of an Advisory Board/ Speakers Bureau (or equivalent) with X organization”

“I have received payment from X organization (including gifts or 'in kind' compensation)”

“I have received grant(s)/ an honorarium from X organization”

“I hold a patent for a product referred to in the CPD activity (or that is marketed by X organization)”

“I hold investments in X organization”

“I am currently participating in (or have participated in) a clinical trial within the past two years”

If relevant financial relationships do exist, in addition to disclosure, faculty must declare how the content has been adjusted to avoid commercial bias. For example, faculty may state that:

“I am covering topics other than those represented by my relationship with (Name of commercial entity).” Or

“Any recommendations made during this presentation are evidence‐based, or consistent with current consensus‐based practice.” Or

“I will not be presenting this content in a promotional manner.” Or

“I will not endorse (name of commercial entity) during this presentation.”

Promotional Activity Restriction & Non‐endorsement of Commercial Entities

Endorsement of commercial entities, products, goods and services is not permitted in DHP CPDaccredited learning sessions. This will be strictly enforced.

DECLARATION SLIDES EXAMPLES: