Full Disclosure for CME Activities
The Collaborative Family Healthcare Association requires that all individuals who may affect the content of a continuing education activity must disclose any relevant financial relationships during the past 12 months with
commercial interests. Relevant financial relationships also include
relationships of a spouse or significant other.
The disclosure form must be completed by:
- CFHA Board of Directors
- Conference Planning Committee members
- CFHA staff and advisers
- Conference presenters and co-presenters
A commercial interest is any proprietary
entity producing, marketing, re-selling or distributing health care goods or
services consumed by or used on patients.
Excluded from the definition of
commercial interests are non-profit or government organizations, non-health
care related companies, liability insurance companies, health insurance
providers, group medical practices, and for-profit hospitals, rehabilitation
centers and nursing homes.
Relevant financial relationships with
commercial interests and conflicts of interest resulting from those
relationships must be revealed to the audience and resolved prior to the
Persons refusing to disclose or resolve relevant financial
relationships will be disqualified from being a part of the planning and
implementation of this CME activity.
Skip details and go directly to form
Policy and Procedures for Full Disclosure and Identification and Resolution of Conflicts
The following policy governs all Collaborative
Family Healthcare Association (CFHA) produced CME activities:
of Financial Relationships: The existence of any financial relationship
or interest an individual in a posit ion to influence/control content currently
has, or has had, within the last year must be disclosed in writing to learners prior
to presentation. Disclosure information must be received and reviewed by CFHA prior
to confirmation of the individual’s participation. Any conflicts of interest must
be identified and resolved prior to the individual’s confirmation as an activity
faculty or other content-influencing/controlling role.
The intent of this policy is not to prevent
individuals from participating, but rather is to identify and resolve any conflict
of interest. Should resolution be impossible, a replacement for the individual must
Because the review, identification, and resolution
process must take place prior to the activity, all individuals in a position to
influence/control content must return the disclosure information by the due date.
Additional clarification is asked of those who participate in Speakers’ Bureaus
to assist CFHA reviewers in understanding the nature of your Speakers’ Bureau relationship
(a list of recommended speakers acting independently of any guidance or direction
from a commercial entity versus a list of speakers who are acting as agents, or
who are contractually bound as agents of the commercial entity) in order to assure
that your participation will not be in conflict with previous commitments. The disclosure
will be reviewed and, should a conflict be identified, additional information or
dialogue may be required. Failure to disclose within the necessary timeframe will
result in withdrawal of the invitation to participate.
Acknowledgement of all disclosures—i.e.,
nothing to disclose or existence of affiliation(s), and/or financial relationship(s)
or interest(s)—for every individual who serves in a position to influence/control
content of the educational activity must be presented in writing to the learners.
2. Disclosure of Unlabeled/Investigational Uses
of Products: Faculty must disclose to CFHA and the learners
when an unlabeled use of a commercial product, or an investigational use not yet
approved for any purpose, is discussed during an educational activity. Faculty must
disclose that the product is not labeled for the use under discussion or that the
product is still investigational.
The intent of this policy is not to prohibit
or limit the exchange of views in scientific and educational discussions, including
discussions of unapproved uses, but to ensure that faculty discloses to learners
that such discussion will take place.
Should an unplanned discussion of unlabeled
or investigational uses of a product occur (usually in the course of a question
and answer session), it is the responsibility of the faculty member to inform the
learners that the use under question/discussion is unlabeled or investigational
prior to answering the question or responding to the discussion point.
Acknowledgement of planned discussion of
unapproved or investigational uses of products must be presented in writing to the
learners prior to the start of the activity, or (for enduring materials) at the
point that first mention is made of the unapproved/investigational use in the activity.
or Refusal to Disclose/False Disclosure: Failure or refusal to disclose, false disclosure,
or inability to work with CFHA to resolve an identified conflict of interest will
result in withdrawal of the invitation to participate and replacement of the faculty/planner.
Identification and Resolution of Conflicts of Interest
A. CFHA will inform all individuals who are invited
to serve in roles that may impact the content of an educational activity (faculty,
planners, authors, editors, reviewers, staff, etc.) of the CFHA Policy on Full Disclosure.
Disclosure forms and due dates will be distributed with the invitation to serve.
Confirmation of service is contingent upon return and review of disclosure information
and resolution of any conflicts of interest.
B. Each individual faculty/planner/author/editor/reviewer/staff
must complete and return his/her disclosure paperwork. CFHA will proceed through a review of the
submitted information and, should any of the disclosed information trigger a concern
regarding a possible conflict of interest, reviewers may seek input from the candidate
and/or other individuals prior to confirming the candidate’s service.
C. Should no conflict of interest be identified, the
individual may be confirmed in their role in the activity.
D. Should a conflict of interest be identified, the
individual will be contacted and asked for clarification or additional information.
Upon receipt and review of this additional information, methods of resolution will
be identified and discussed with the individual. Resolution methods may include,
but not be limited to, one or more of the following:
- Assuring valid content through:Evidence-based content using best available,
highest strength of evidence
- Peer review of content prior to the activity;
activity faculty must be responsive to revision requirements*
- Assigning a different topic for the individual
- Assigning a different faculty for a topic
- Cancellation of the faculty
E. The resolution process and outcomes will be documented
in the CME activity file.
*CFHA considers independent peer review
for evidence-based content appropriate action to resolve conflict of interest on
the part of speakers and authors.
Participant Disclosure Form
* indicates required fields