Ethics, Professionalism, and Interactions with Stakeholders
What this domain tests
This domain tests judgment: whether an interaction with an HCP, patient organisation or vendor withstands scrutiny under codes, anti-bribery law and transparency rules.
Core rules
- Governing instruments: PhRMA Code, EFPIA and IFPMA codes, AdvaMed for devices, Open Payments/Sunshine reporting, Anti-Kickback Statute, False Claims Act, FCPA and UK Bribery Act, GDPR and HIPAA.
- Advisory boards must meet a legitimate business need, use advisors with genuine expertise, pay fair market value for documented services, be free of promotional content, and produce the advisor's own work.
- Gifts are out; modest meals are acceptable only alongside substantive scientific content. Educational grants are independent, with no quid pro quo and no sales involvement in selection.
- Conflicts of interest are disclosed and managed; patient and trial-participant data are protected; social media and AI-assisted content follow the same review standards as other materials.
- Research integrity: no ghostwriting, no undisclosed editing, trial registration and results disclosure.
Worked example
An advisor asks the MSL to draft the slides for an upcoming advisory board and to pay the honorarium in advance. Drafting the slides yourself would make the advisor's contribution nominal, undermining the legitimacy of the meeting, so the company provides only the agenda and questions, and the advisor prepares their own content. The honorarium is paid per policy after documented services at fair market value, with the transfer reported.
Traps that cost marks
- Treating a consulting agreement as blanket permission for any interaction.
- Selecting grant recipients with sales input.
- Assuming a modest gift is acceptable because it carries a company logo.