2014-12-23

Meeting Information

Please note the following comments from Heather:

“…when we get into the weeds of each element and start talking about critical dates, there may be more than one date field for most types of interests (start and end dates for consulting, attendance date and payment date for advisory board meetings, etc.).  If possible, I’d like to get the group to agree upon the key reporting date for each.  So, for example, if an organization wants someone to disclose all relevant interests from the past 12 months, which is the date that matters?  It is always just the latest date, or can we specify which field would be used to determine if any one interest should be disclosed?" 

Attending: Ross McKinney, Co-Chair; Mike Champa, Betty Harvey, Pamela Miller, Heather Pierce, Bill Sacks, Cory Schmidt, Steve Singer, Valerie Smothers, John Sweeney, and Gary Wimsett.

Agenda Items

1 Review minutes

The minutes were accepted as submitted.

2 Discuss glossary

Valerie explained the genesis of the glossary and the need for a common understanding of terms to develop specifications.  She mentioned some terms were from the IOM report on Conflict of Interest, and Ross proposed several as well.  Gary questioned what source the IOM used to populate definitions. Heather answered it was from several different places.  Valerie agreed some definitions could use some greater rigor.  Pam asked if the definitions would be used in outward facing documents.  Ross answered yes.  Valerie added the definitions could be a prologue or appendix to the specification once developed.  Ross added the definitions could be used within the convey application as well.  The group decided to send comments on definitions to Valerie.  Valerie will follow-up with Ross after the call to determine other people who should weigh in on the definitions. 

3 Discuss revised form and comments from Ross

Ross began the discussion of what kind of data should be included on the form.  Several fields were listed under identification of the person.  Bill Sacks asked whether these fields are going to be mandatory or optional; if they are made mandatory, he recommends thinking about people who don’t have anything to say in those fields.  Heather reminded the group the task here is to come up with specifics of any field that organizations use for disclosure.  Each organization will define what components to include.

The groups discussed whether Education was necessary and concluded that it was not; degree will be removed. Ross added the importance of capturing when data is submitted by a designee. The form will be edited to clarify that. Ross noted we would need similar identifiers for designees.  Ross asked how to best identify companies.  Valerie asked what information would be captured.  For the company, Ross recommended capturing email address, phone, postal address; profit vs. non-profit; a description; and whether the company is publicly held or privately traded. Valerie commented that on the last call David described Form of business as pharmaceutical company, IT company, device company, etc. Type of entity would indicate publicly traded or privately held. She will add those descriptions to the form.

For the subsidiary question, the name might be the parent company.  Ross mentioned subsidiary should be able to be populated automatically, stating for example if it’s a subsidiary of Johnson and Johnson.  Pam expressed concern of the burden of maintaining that going forward.  Heather will investigate that. 

The third section described who has the relationship you are disclosing.  Pam commented the most broadly proscriptive institution is the FDA; they include spouse and some form of family and required the most information.  Corey commented some state-run institutions have broader requirements. Ross suggested the need for a field for other family.  Valerie will add sibling and parent and then “other.”  Valerie will follow-up with Monika and Susan regarding family relationships in state institutions. 

Pam noted journals moved from a relationship-based strategy and switched to an entity-based model.  A discussion followed about entity relationships.  Based on the definition of partner Valerie provided, the group decided that Owner/Co-owner/Partner of non-incorporated entity would suffice.  Mike asked if there was a need for a field for additional comments, open ended question.  Valerie will add additional comments for all relationships. 

Ross suggested adding a description for owner or co-owner of non-incorporated entity and removing the question regarding private equity, options, and promissory notes.  The group recommended removing the questions regarding monetary value of equity, options, or promissory notes and having a questions that asks for the estimated value as of a specific date, allowing for the option “Unable to include estimate.” Ross mentioned this relationship would be applicable to people who are doing consulting as a business.  Heather thought estimated value would be useful. 

Valerie reviewed the questions/fields for equity owners. Bill noted when someone is going in for a particular purpose such as a new grant, they say as of today this is still accurate and that would be the date used.  Pam added the date of disclosure and date to which it refers. Steve expressed ACCME’s concern was with any relationship that has existed in the past 12 months.  The end date for them is critical.  Valerie clarified the end date as what date relationship began and what date did it ended.  If a relationship ended three months ago (still within last 12 months) accredited provider would need to consider that relationship in making decision.  Heather mentioned the system will link to latest known financial interest automatically.  Ross thought we need to be careful about dates because some relationships are ad hoc.  Valerie informed the group that the next call would be January 13^th at 11:00 a.m. Eastern time. 

Decisions for the form

• Education will be removed from the available answers to “Who are you?”
• The form language will be modified to make it clear when data is submitted by a designee.
• We will clarify what identifiers would be used for designees.
• Company/Entity contact information will be replaced by email address, phone number and postal address.
• Add Description.
• Add publicly traded or privately held next to type of entity to clarify.
• Add a field for profit vs non-profit.
• Add possible values to Form of Business: Pharmaceutical Company / Device Manufacturer / Medical Supply company / Health care delivery entity / IT company / other
• For “Who has the relationship you are disclosing,” Valerie will add sibling, parent and then “other family.” 
• Owner will be changed to Owner/Co-owner/Partner of non-incorporated entity. The separate entry for Partner will be removed.  
• We will add additional comments for all relationships. 
• For Owner/Co-owner/partner of non-incorporated entity, the question regarding the nature of the ownership relationship will be removed as will the question regarding monetary value of equity, options, or promissory notes.  We will add a question that asks for the estimated value as of a specific date, allowing for the option “Unable to include estimate.”
• For Equity Owner, Valerie will add “On what date did the ownership relationship end?”

Action Items

Valerie will follow-up with Monika and Susan regarding which family financial relationships to disclose.