Comment from Arthur Caplan, University of Pennsylvania

Sirs: The proposed regulations do a commendable job of calling for more transparency and assigning clear responsibility to recipients of federal funds to identify and manage COI. I do have some comments to offer that may prove useful. 1. I do not think the case for moving from !0K to 5K is well made. I worry that there is a burden at the 5K level since most travel costs will push toward this number having to be declared and open to management. 2. I think income from academic activities from not for profit entities ought not be subject to disclosure 3. I think however that reimbursement from non academic not for profits should be. this is because patient advocacy groups and other entities can shape collection and interpretation of data and because there may well be a proliferation of not for profit entities to shield COI from disclosures if this loophole is allowed. 4. I think the emphasis on management plans and monitors is appropriate in handling COI but more examples of what each might actually involve are needed to help guide institutions 5.I do not think regs are ready in any way to handle institutional COIs. I think these do exist but urge that more resources be devoted to conducting research and symposia to explore the geography of COI in this area. 6. I think it may well be useful to spell out certain types of relationships that are red flags for elimination such as studying a drug or vaccine in which an investigator has a direct financial interest. Transparency and management are fine but some relationships need to be identified as triggering the need for elimination or reduction. 7. I am not clear whether institutions will be expected to disclose COIs as well as their management plan responses? This may need to be clarified further in the regs. On the whole I support these revisions. Thank you for the opportunity to comment