1.       Disclosure not received

A.       Prohibited from participating in any capacity in activity

 

2.       Disclosure received

A.       No relationships disclosed

1)       participation in activity can take place

 

B.       Relationship disclosed

1)       Review must occur by course director or chair/co-chair

2)       Resolutions  to be reached

a.       Participation permitted—COI deemed not possible source of bias.

b.       Participation permitted—with implementation of established “Mechanisms Used by CME Providers to Validate Course Content and Assure Lack of Commercial Bias” (see C,2 below)

c.       Unacceptable— unresolved conflict, participation prohibited

3)       Report to CVSC using the Conflict of Interest (COI) Assessment Form which includes:

a.       disclosures from all faculty

b.       any ‘B’ or ‘C’ rated COI requires identification of specific resolution action.

 

C.      Decision-Making Guidance in COI Review

1)       Are there any:

a.       questions that full disclosure has not been made

b.       indications that the clinical information is misleading

c.       indications that the individual improperly favors any outside entity or appears to have an incentive to do so

 

2)       Mechanisms to employ:

Use mechanisms a-f for every occurrence of any conflict of interest

a.       Peer review by course leadership

b.       Evaluation of commercial bias

c.       Attestation forms

d.       Disclosure of off-label /unapproved uses

e.       Disclosure of mechanisms to validate content

f.         Disclosure of commercial relationships

Use mechanisms g-l as needed for conflicts rated “B” or “C”

g.       External content reviewers (CVSC)

h.       Encourage changes in commercial relationships

i.         “Reaction Panel” as an onsite review process

j.         Objectivity training for moderators

k.        Reassign Faculty, if necessary

l.         Encourage Faculty to use best available evidence