In the past several months, the NIH has been dealing with various scientists who have not disclosed payments to them by outside companies for doing research. The ethical rules guiding whether researchers had to disclose money they made from outside research were rather obtuse. Last September, Dr. Elias Zerhouni, the director of the NIH, imposed a one-year moratorium on receiving an honoria by NIH scientists for any outside research, because the NIH has to conduct an across-the-board investigation into the scope of the problem. Recently, the NIH opened an investigation into a particular researcher who allegedly received over $500,000 from Pfizer for collaboration in doing research regarding Alzheimer's disease as well as for representing Pfizer at certain conferences.
The researcher's defense seems weak at best.
Much of this starts last year when then-Rep. James Greenwood (R-PA) started looking into various payments that had, supposedly, been paid to about 20 NIH scientists. Rep. Greenwood believed that these scientists had not disclosed the arrangement with outside companies to the NIH, in violation of regulation. One of these scientists was Dr. Trey Sunderland, the scientist who allegedly received over $500,000 from Pfizer.
Now, people are up in arms about the amount of money, but mostly they're upset about the lack of disclosure of this arrangement. Disclosure would mean, one would suppose, that the scientist would have submitted some sort of paperwork or form to disclose this - verbal disclosures are pretty rare when it comes to ethical rules. So what puzzles me is his big defense (according to a letter written by his attorney to the NIH, and as reported by the LA Times):
"Dr. Sunderland has committed no unethical acts," Muse wrote. "His failures have been in the context of not keeping and filing proper paperwork."
Er, um ... right. So he didn't file proper paperwork. You're saying that there is proper paperwork to be filed. And he didn't. So he didn't actually disclose it in the way he should have. Sunderland's lawyer goes in this letter to try to blame the NIH for his client's lack of disclosure:
Throughout the NIH, Muse wrote, the monitoring of financial relationships between the government scientists and their outside employers has been characterized by "indifference, lack of enforcement and administrative shortcomings."
Ahhh. Soooo ... your client didn't file proper paperwork because it looked like they weren't going to enforce it? What? If he really thought that there was a lack of enforcement, shouldn't he have gone ahead and just filed it, figuring they'd never read the form or care? At least then he would have filed the proper paperwork and complied with his ethical obligations.
This one will be decided by the OIG, so no need for me to rant on and on about it. It's at least good to know that someone in NIH is now paying attention to the rules. Unfortunately, this is one way that company policy change is often created - someone in the company does something screwy or shady, so the company finally revisits the policy(ies) and decides whether the policy still works as it is or if it needs some tweaking to reflect the current realities. Don't let your company be like the NIH is this regard - implement clear policies that guard against conflicts of interest and other wrongdoing, and put it on the 'to do' list of the COO or other officer to revisit those policies every year and seriously consider whether the policy needs to be updated, or at least recommunicated to the employees.
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