2015-01-13

Meeting Information

Attending: David Blake, Ross McKinney, Co-Chairs; Mike Champa, Luke Diorio, Susan Ehringhaus, Betty Harvey, Norman Kahn, Monika Markowitz, Heather Pierce, Bill Sacks, Cory Schmidt, Valerie Smothers, Steve Singer, John Sweeney, and Radu Vestemean, 

Agenda Items

1 Review minutes

The minutes were accepted as submitted.

David mentioned as a follow-up on the action items, there were edits to the form, but discussions will be limited until glossary terms are clarified.  Susan connected Valerie with the general counsel at UNC, and she indicated that they they collect data on spouse or equivalent, then dependent child; no one was looking at parent, sibling, or non-dependent child relationships.  Monika commented in Virginia they are permitted to look at spouse only, not equivalent or domestic partner.  

2 Discuss glossary

Pam and Heather suggested proposed changes to the glossary.  Pam emphasized the need to include all views, and Heather agreed.  Heather mentioned the first initial glossary was pulled from the IOM discussion paper. Additional information came from the preamble on the Sunshine Act.  They tried to determine which terms were not included in the glossary that would be beneficial and which were just statements.  Any overlap or definitions not discussed were taken out. David asked whether every data item will have a single definition consistent for all uses in the repository.  Heather confirmed that and added the terms would be used consistently from disclosure to disclosure. Valerie noted there will be detailed definitions in the specification and will need agreement in the glossary on the conceptual pieces.  Those definitions can be embedded in the data fields of the specification.  Heather commented if there are nuances about the definitions a detailed description is needed.  Steve recommended referencing sources when possible.

The group agreed to delete the following definitions:

• Award
• Authorship
• Consulting fee and all other terms qualifying a kind of fee
• Employee
• Faculty
• Ownership (verify)
• Review activity (verify)
• Travel (verify)

The group modified the definition of Consulting to:

Payment for providing advice to another entity. This may be through mechanisms like an Advisory Board, individual relationship, speaking, or teaching.

 Ross recommended that Data Safety Monitoring Board be its own category. David commented that they always ask for more details on consulting work. Pam commented that the New England Journal of Medicine treats work on Data Safety Monitoring Boards differently than other types of consulting. Valerie recommended revisiting the form to establish sub-categories for consulting/independent contractor.

The group discussed distinguishing consultant from employee.  Pam mentioned a Consultant is somebody who gets a 1099; employees get a W-2 form. Susan commented it is a factual determination for them.  David commented that term doesn’t provide much information that is meaningful.  Steve commented that ACCME Standards of Commercial Support do not allow an employee of a commercial interest to participate in CME.  David asked Steve if they had a formal definition for consulting because it could be based on all kinds of activities. Steve will find out and report back.  Valerie added the IRS has clear definitions as well.  Monika asked if it would be better to broaden that and talk about employment on an hourly basis so it includes compensation.  Heather agreed; she will come up with more specifics on employment and employee.  Valerie will look for the ACCME and IRS definitions.

Equity owner was used in the draft form but not in the glossary. At some point, it should be defined.  David commented Expert Witness is an important thing to include under consulting.  Heather agreed to clarify consulting is a broad category and define the sub-categories. The group agreed with edits to the  definition of expert witness to be:

An individual hired for his or her special training, education, knowledge, skill, or experience  to  provide expertise in a matter  involving the legal system.  Expert witness services include providing a written report, appearing for a deposition, or otherwise providing information, including testifying under oath.

Cory asked where adjunct appointment would fit given the removal of faculty.  Heather answered it could be a subset under employment for voluntary affiliation. 

Steve commented we are assuming this system will include more information than what is needed by the ACCME. The ACCME is not concerned when an individual is paid by an educational entity such as a medical school or university to teach or be part of CME.  Is speaking directly paid for by a commercial interest delineated separately?  Heather mentioned the definition of an activity should be consistent across entities.  Relationships may be disclosed differently depending on the type of activity and the requirements. 

Ross noted more people’s comments would be useful.   David was unclear whether working on the glossary is best done when we’re finished flexing out sequence of questions.  Heather thought it was helpful in reframing the discussion to see which definitions no longer makes sense and see what pieces are missing when we built out sub-categories and categories.  David encouraged identifying high level relationships with company such as consultant, employee, owner, partner etc.  Pam assumed the first stab at the glossary was for our use not for others.  The financial terms, such as bond, convertible security, etc. should be standard definitions from some legal source.  The group agreed. 

(Note: The US Securities and Exchange Commission defines many investment terms. See: http://www.sec.gov/answers/convertibles.htm for an example.) 

Decisions

Action Items

The group will revisit the form to establish sub-categories for consulting/independent contractor.