Changes

PHAC, through its Guidance Innovation Hub has developed a compendium of tools, listed on this page, that can be used by national guideline development groups to help improve their practices related to the management of COI, including adherence to the GIN principles.

PHAC, through its Guidance Innovation Hub has developed a compendium of tools, listed on this page, that can be used by national guideline development groups to help improve their practices related to the management of COI, including adherence to the GIN principles.

== PHAC COI disclosure form for guideline development ==

== PHAC disclosure of interest form for guideline development ==

Coming soon.

 

 

The disclosure of interest form is currently undergoing pilot testing, and a final form will be uploaded soon.

== PHAC COI assessment tool for guideline development ==

== PHAC COI assessment tool for guideline development ==

There is an important distinction to make between disclosed interests, and the presence of COI. Expert advisory panelists providing advice to PHAC or otherwise developing guidance (e.g., clinical practice guidelines) may have a wide variety of affiliations and interests. As noted by the World Health Organization, "''The declaration of one or more secondary interests (declaration of interests) does not automatically mean that a conflict of interest is present: there is a distinction between the two. A transparent and objective process for assessing a declaration of interests is required to determine if a conflict exists and what its effects might be, and to manage any significant conflict of interest."''<ref name=":1">World Health Organization. WHO handbook for guideline development (2nd Edition); Chapter 6 Declaration and management of interest. WHO 2014. Available from: <nowiki>https://apps.who.int/medicinedocs/en/m/abstract/Js22083en/</nowiki></ref> Figure 1 provides an overview of the link between disclosures of interests, and the identification and management of COI.

There is an important distinction to make between disclosed interests, and the presence of COI. Expert advisory panelists providing advice to PHAC or otherwise developing guidance (e.g., clinical practice guidelines) may have a wide variety of affiliations and interests. As noted by the World Health Organization, "''The declaration of one or more secondary interests (declaration of interests) does not automatically mean that a conflict of interest is present: there is a distinction between the two. A transparent and objective process for assessing a declaration of interests is required to determine if a conflict exists and what its effects might be, and to manage any significant conflict of interest."''<ref name=":1">World Health Organization. WHO handbook for guideline development (2nd Edition); Chapter 6 Declaration and management of interest. WHO 2014. Available from: <nowiki>https://apps.who.int/medicinedocs/en/m/abstract/Js22083en/</nowiki></ref> Figure 1 provides an overview of the link between disclosures of interests, and the identification and management of COI.

[[File:COI processes.jpg|center|frame|674x674px|<u>Figure 1.</u> An overview of processes involved in the disclosure and assessment of interests, and identification and management of COI]]

[[File:COI processes.jpg|center|frame|622x622px|<u>Figure 1.</u> An overview of processes involved in the disclosure and assessment of interests, and identification and management of COI]]

Individuals involved with guidance development panels (within PHAC, Health Canada, or otherwise) are regularly collecting disclosures of interests from their panel members. Groups have expressed challenges in determining if COI is present and how to best manage COI. A variety of approaches are currently being used to determine COI and associated management options, and approaches are not always well documented, leading to concerns about consistency and transparency.  

Individuals involved with guidance development panels (within PHAC, Health Canada, or otherwise) are regularly collecting disclosures of interests from their panel members. Groups have expressed challenges in determining if COI is present and how to best manage COI. A variety of approaches are currently being used to determine COI and associated management options, and approaches are not always well documented, leading to concerns about consistency and transparency.  

# Based on those factors, a judgment is made on the presence (yes/no) and type of COI (financial, non-financial) and how significant the COI is (low, moderate, high), with the aid of a rubric/algorithm

# Based on those factors, a judgment is made on the presence (yes/no) and type of COI (financial, non-financial) and how significant the COI is (low, moderate, high), with the aid of a rubric/algorithm

Figure 2 provides a conceptual schematic of the tool. '''Detailed instructions for assessing each factor and making judgments on the type and significance of COI are included in the tool.'''

Figure 2 provides a conceptual schematic of the tool. '''Detailed instructions for assessing each factor and making judgments on the type and significance of COI are included in the tool.'''

[[File:COI tool.jpg|center|frame|876x876px|<u>Figure 2.</u> Conceptual schematic of the PHAC COI assessment tool. Information that will be disclosed in the PHAC disclosure of interest form are in red. Other considerations could, for example, be whether a published article was based on opinion versus simply restating published evidence. It could also be, for example, if an honorarium or grant was paid to the individual’s institution versus directly to them. ]]

[[File:COI tool.jpg|center|frame|573x573px|<u>Figure 2.</u> Conceptual schematic of the PHAC COI assessment tool. Information that will be disclosed in the PHAC disclosure of interest form are in red. Other considerations could, for example, be whether a published article was based on opinion versus simply restating published evidence. It could also be, for example, if an honorarium or grant was paid to the individual’s institution versus directly to them. ]]

As noted in Figure 1, when COIs are deemed to be present, the next step is management of those COIs. To facilitate consistent and transparent approaches to managing COI, an algorithm has been developed (Figure 3)to help guide assessors to suggested management options taking into account:

As noted in Figure 1, when COIs are deemed to be present, the next step is management of those COIs. To facilitate consistent and transparent approaches to managing COI, an algorithm has been developed (Figure 3)to help guide assessors to suggested management options taking into account:

* Internationally recognized principles for the management of COI (e.g., GIN<ref name=":6" />)

* Internationally recognized principles for the management of COI (e.g., GIN<ref name=":6" />)

'''This algorithm to guide users on how to manage COI is included in the COI assessment tool, along with detailed instructions for users.'''

'''This algorithm to guide users on how to manage COI is included in the COI assessment tool, along with detailed instructions for users.'''

[[File:COI Tool Algorithm .jpg|center|frame|<u>Figure 3.</u> Algorithm for determining management options for COI. The management options provided herein are suggestions that take into account international standards such as the GIN principles, and can be modified to suit the individual needs of each guideline group. Where multiple options are presented, the choice may depend on the number of COI identified, the presence of COI among other panelists involved in a guideline, and how strict a stance the group wishes to take on COI.]]

[[File:COI Tool Algorithm .jpg|center|frame|<u>Figure 3.</u> Algorithm for determining management options for COI. The management options provided herein are suggestions that take into account international standards such as the GIN principles, and can be modified to suit the individual needs of each guideline group. Where multiple options are presented, the choice may depend on the number of COI identified, the presence of COI among other panelists involved in a guideline, and how strict a stance the group wishes to take on COI.|852x852px]]

The full COI assessment tool is currently undergoing pilot testing, and a final tool will be uploaded soon.

The full COI assessment tool is currently undergoing pilot testing, and a final tool will be uploaded soon.

== Guidelines International Network (GIN) Checklist ==

== Guidelines International Network (GIN) checklist ==

The following checklist was developed by PHAC to aid journals seeking to implement the GIN principles on COI for authors, or guideline developers assessing or updating their policies to align with the GIN principles.

The following checklist was developed by PHAC to aid journals seeking to implement the GIN principles on COI for authors, or guideline developers assessing or updating their policies to align with the GIN principles.

A document or link to the document will be uploaded soon.

A link to the document will be uploaded soon.

== Resources from the international guideline community ==

== Additional resources from the international guideline community ==

=== Examples of disclosure of interest forms: ===

=== Examples of disclosure of interest forms: ===