Yes, the NIH’s Office of Research Integrity (ORI) system is broken. I know this from personal experience. ORI is broken from the 6 year statute of limitations that just happens to coincide with the median time it takes a PhD student to graduate, to the way ORI shrugs off complaints made by grad students. (A grad student who rocks the boat has a hard time graduating.) ORI is broken in the way that it allows universities to self-police, despite an absolute conflict of interest there. I saw first hand how a whitewash panel is put together. A professor from a poorly funded department is put in charge. He knows his job and has no problem lying through is teeth, since the backdoor deal is that he gets some money if he does what the administration wants. And, if he has an inconvenient finding, his department will be retaliated against by cutting funding. (No auditable relation between those things of course.)
University administrations don’t want anything to get out for a very simple reason. Research universities get hundreds of millions in funding from NIH and they keep about 25% of what they get for admin needs. It is supposed to be roughly 50% of the grant amount is admin overhead cost. What that means is that a $1 million grant is supposed to give the university another $500 thousand. So the total is $1.5 million. Thus the admin’s cut should be about 33% of the total payout on the grant. But in practice, a typical big research university will collect 25% or so for itself.
So if someone comes forward and says a scientist has lied, that means the university will have to do two things: A. Darken their reputation. B. Give back the admin money on that grant.
Trust me on this – university administrators do not want to give back money on big grants. That’s one reason why you are more likely to see a university ORI office be zealous going after a scientist with a small budget or a couple of MDs doing a small independent clinical study. It doesn’t cost them much and it makes them look like they are doing their job. Just like the mafia does, they need to feed the small fry to the lions to protect their operation.
(A side effect of this pattern is that some professors learn they can steal the grant ideas of other professors, lie to NIH and represent them as their own. A university will do nothing to them if they get the grant – because the university needs the money. If they don’t get the grant, hey, no harm done. I know one of those professors.)
Universities do have a huge problem with financial conflict of interest. That conflict of interest needs to end. It can only be ended by making ORI a Department of Justice (DOJ) office and having universities host that office. The ORI also need manpower to do its job. It doesn’t have anywhere near enough.
However, the cure is not eliminating apparent conflicts of interest in scientists. (Universities are pushing this angle – go figure.) All that does is tilt the playing field more steeply toward the corrupt. Those scientists who are corrupt will not stop being so, they will just go underground. That will mean they will continue to have money when others don’t. Going underground means the intentionally corrupt will develop even stronger backdoor connections to get ahead. This is Gresham’s law in medical research.
Science is not like politics. Politics is inherently corrupt, and truth is a propaganda commodity. That is why we see climate science lose in politics despite overwhelming evidence. But in science, there is an testable standard of truth and falsehood. So the cure for medical research is laws that require data transparency. Give any researcher with a PhD access to the data for any scientific paper that receives federal funding. All any credentialed scientist the right to trace that data back to its sources. (That will, by the way, lead to publication of base data to accompany scientific papers.)
In other words, introduce auditing into science. We do it in finance. Science needs it too. Indications are it is sorely needed. But science is an independent enterprise. It isn’t necessary to create audit bureaus. Independent scientists would be happy to tear into the sausage that has been faked, baked and cherry picked. They get publication rights to that. The con-men of science (could throw a few names out) will fight this, get huffy and blather loudly.
Inability to produce the data and allow it to be traced back (in its entirety) should be grounds for prosecution. So should it be grounds for prosecution to refuse access to contact information of personnel in the lab. Grad students, the lowly ones, know what’s going on. So do SRA’s (senior research associates) and post-docs.
Additionally, the ORI should leave NIH and go under DOJ. Universities should not be allowed to self-police – period. (I have personal experience with the outrageous whitewash that passes for ‘investigation’ by universities.) All reports (the vast majority are from lowly grad students who are tasked with lying, or figure it out) should be routed directly to an ORI office.
That will work. Science is not like other professions.
The problem with the conflict of interest proposal is that it unreasonably cuts into the rights of scientists (most of whom work extremely hard for low salaries) to profit from their rare expertise. As long as that profit is done honestly, there should be no problem. Most are honest.
Most in research are not MDs either, and much of the discussion that happens assumes everyone is an MD. The vast majority in research are PhD’s. Those are the people who do a lot of teaching of MD’s. Research PhDs can spend 10 years in grad school. The median is 6 years to a PhD, and 60% don’t make it. Then they work for years in post-doc positions. Maybe, if they are lucky (including having a mentor who helps them) they will get a ‘real job’ making decent money by the time they are 40. Those people deserve to profit from their hard won expertise.
Forget about the conflicts of interest by scientists themselves. Enact legislation that forces transparency, eliminates the ridiculous 6 year statute of limitations at ORI, move ORI into DOJ, and take enforcement and reporting away from universities.