Direct Link to Worksheet: https://cce.upmc.com/content/private-stockowner-worksheet

Background:

Owners or employees of an ineligible company must be excluded from the planning or implementation of accredited education (or qualify for an exception) if the content is related to the business lines of the company, regardless of whether the company is mentioned. Additionally, individuals who have the ability to control or influence the content of an accredited educational activity and have stock through privately held ineligible companies are considered owners or employees and therefore must be excluded from planning or implementation of the education (or qualify for an exception) if the content is related to the business lines of the company.

To help the CCEHS manage these types of financial relationships disclosed on COI Forms, the Private Stock/Owner Worksheet will need completed and submitted for the CCEHS to determine next steps. Please note, if more than one company is listed, a separate form is needed for each relationship.

Definition Reminder:

Ineligible companies are those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. The most common examples of ineligible companies are pharmaceutical and medical device companies. The ACCME also provides additional examples here: Definition: Ineligible Company - ACCME.

Please note: Bio-medical startups that have not begun a governmental regulatory approval process are not considered ineligible companies. Beginning the regulatory approval process means having submitted an Investigational New Drug (IND) application through the FDA.

When/How to Utilize the Private Stock/Owner Worksheet:

1. Review submitted COI Disclosure Forms.

If a relationship is disclosed in the “Stock (privately held):” field, or an individual discloses they are an owner or employee of an ineligible company (most commonly disclosed in the “Other” field), the Private Stock/Owner Worksheet should be utilized.

Reminder: stock through publicly traded companies, stock options, and diversified mutual funds are not private stock and do NOT require the Private Stock/Owner Worksheet.

2. Reach out to the course contact with an explanation and the link to the Private Stock/Owner Worksheet.  

The form should be completed by the individual who disclosed a relationship as an 'owner', 'employee', or 'private stockholder' in an ineligible company, NOT the course contact. It may be appropriate to communicate directly with the individual who disclosed the relationship if you are managing the activity (e.g. Ethos Administrators). Sample language for an email to the course contact is provided below.

Sample Email Language:

I am reaching out regarding a certain financial relationship disclosed by [insert individual’s name] on their COI Disclosure Form for [insert activity name].  [Insert individual's name] disclosed that they [choose the appropriate scenario: have privately held stock with a commercial interest (ineligible company) or are an owner or employee of a commercial interest (ineligible company)]. As noted on the COI Disclosure Form and COI Guidelines,  owners or employees of a commercial interest (ineligible company) or an individual with private stock in an ineligible company must be excluded from the planning or implementation of the education (or qualify for an exception) if the content is related to the business lines of the company, regardless of whether the company and/or product(s) are mentioned in the content.

That said, to help us manage this relationship, the Private Stock/Owner Worksheet will need completed and submitted for us to determine [insert individual’s name]’s ability to participate as a [insert individual’s role] for [insert activity name]. This form should be completed by [insert the individual’s name who disclosed a relationship as an 'owner', 'employee', or 'private stockholder' in an ineligible company]. Please provide them with this link: https://cce.upmc.com/content/private-stockowner-worksheet. 

Any questions related to the worksheet can be directed to [email protected].

3. Receive guidance from CCEHS as to whether or not the individual can participate in the activity.

Worksheet submissions are automatically emailed to CCEHS Support. After a submission is received, you will receive guidance on how to proceed with managing the disclosed relationship. If you have not received guidance for an individual’s worksheet, reach out to [email protected] to confirm whether a worksheet was submitted.

4. Attach appropriate documentation, as applicable.

The worksheet submission guidance will include a PDF of the worksheet and may also contain an updated COI Disclosure Form. Upload all provided attachments to the activity in Ethos.

Course: upload in the ‘Final Documents’ field under the ‘Custom’ tab.

Regularly Scheduled Series (RSS) Session: upload the worksheet PDF in the ‘Other’ field under the ‘Custom’ tab. Updated COI Disclosure Forms should be uploaded in the ‘COI Disclosure Form’ field.

Application (CCEHS application reviewer only): If the Private Stock/Owner Worksheet was utilized for a course director and/or planning committee member during the CE application process, worksheet PDFs will be uploaded to the application in the ‘Supporting Materials (optional)’ field, and updated COI Disclosure Forms will be uploaded in the ‘COI Disclosure Form(s) for Course Director and Planning Committee’ field by the CCEHS application reviewer before the application is assigned/approved.