Conference on Human Subject Protection and Financial Conflict of Interest, August 15-16, 2000
The NIH advances science to improve human health. But the NIH is truly only an instrument – a public entity endeavoring to serve the public good. It is the public, the citizens and taxpayers of this country, who support our goals and, with their money, support science.
The NIH is a steward of public money and has, therefore, a real obligation to protect the public investment in science. This means that we must work with many partners to develop policies that assure the ethical conduct of research and to remain vigilant so that the policies are followed.
Frequent reference today to conflict of interest may cause us to forget that NIH's policy, as published in the Code of Federal Regulation, is actually about Objectivity in Research. It is a real distinction. Objectivity is a broader term. By a standard dictionary definition, what is objective is based on observable phenomena, presented factually, and without bias--and I think you'll agree this applies well to science. In fact, objectivity lies at the heart of science. It must not be compromised by financial considerations. Nor for the pursuit of fame. Nor for the desire to produce an insight into the processes of life.
The last two – pursuit of fame and the desire to produce an insight – are familiar to us in the sciences. If anything historically has been a threat to objectivity, it has been these things. Why not win a Nobel Prize? Why not astound the world with a fresh – and freshly published – insight? In some measure, such pursuits and desires are present and always have been in scientists, perhaps all of us, and in moderation may inspire us. But good researchers know how to control the desire, how to mitigate the passion, and always have.
Financial considerations are newer. It has only been in the last 10 years or so that substantial consulting fees or equity interests in a new company became widely available to scientists. It has usually been the case that researchers have hoped for a favorable outcome from their work followed by wide recognition. It is only recently that immediate – and quite possibly substantial – financial gain also became a possibility for scientists. The world is changing, and we are not going to stop the way the world changes.
But we can pose blunt questions. First, how can we distinguish the financial interests that may compromise a scientist=s objectivity? It is possible that some will not. Second, how do we make sure that all scientists understand the risks that financial consideration can raise? Some transactions may appear innocent and in fact may be innocent. And finally, how do we make scientists understand the importance of declaring those risks?
This last question is important because the heart of the matter is disclosure by individuals. It takes more than one person – especially one interested person – to decide on the innocence of a transaction. That is, disclosure is part of a process. While protecting an individual's privacy is an absolute requirement to make the process of disclosure work, the core of disclosure is that it is public. In a limited way to be sure, but disclosure is carried on not in the privacy of one's own conscience, but in a discreet and confidential public forum. To be precise, it must be carried on in many forums. The NIH has its own responsibilities, but so equally have professional associations, universities, and other institutions because all of us want to assure objectivity.
How do we going about this now?
We concede that this is not always enough. Therefore, we also rely on Institutional Review Boards and we require data and safety monitoring boards for studies where risks to objectivity are high. To complement these institutional protections, we also have education requirements for investigators and we require them to send us monitoring plans.
This is what we have been doing. But how do we do it better? This year the NIH began proactive compliance site visits. These are different from the site visits we conduct when we have reason to suspect there is a problem. The proactive site visits are not for cause and not punitive. The reason for them is to acquire a better understanding and appreciation of how NIH's policies work and what difficulties implementing and observing them present to researchers and their institutions. They make us ask significant questions, for example: Have we focused on the most important issues? Have we missed something? Have our policies enabled institutions to monitor financial activity that could interfere with objectivity? And are these policies working?
These visits give us the knowledge of the daily experiences and business of both the individuals and the institutions that implement and observe our policies. Without that direct knowledge, the odds that our policies will be reasonable – that is, will cover the areas that need to be covered without creating needless red tape – diminish greatly. I said the NIH is a steward. A good steward must know when something is amiss and know how to fix it – thus the site visits. But a truly good steward most know when things are working as they should or, better, know how to make things work as they should. If we visit when there are no problems, we will be able to be a partner, as well as a steward, and to develop the best policies and the best strategies for making them work. Such visits also allow us to learn by seeing how others grapple with the same issues that engage us here. That truly is a partnership, and the proactive compliance site visits will continue.
We have only completed a few such visits, so it is premature to draw hard and fast conclusions, but we do have some insights already:
First, that some institutions develop a culture of compliance, which I believe is absolutely necessary for the effective day-to-day working of objectivity policies.
Compliance is not a single event. It is a way of life or, more accurately, a way of doing business and thus must become both a habit of mind and a habit of work since it is continuous. Everyone must be aware of what is required, must understand the importance and seriousness of individual requirements, must understand how in the practical sense a requirement is implemented, and must understand that awareness of and compliance with the requirement must be habitual.
The second insight is that some institutions promote a culture of compliance.
This also implies that some have not – or not yet developed and promoted such a culture or climate. So NIH requires each institution to have a policy and to make the policy available to everyone. It is impossible to promote such a culture of compliance if requirements are not widely understood and if the practical demands of the requirements are not clear to everyone.
A third insight is that sharing the lessons learned from compliance site visits will be both essential and valuable.
Everyone has a place at the table. If we are truly partners, we need to work together, to communicate our experiences – and especially the good ones or those that show the way to improving our policies and their implementation – with one another. If there are gaps in our methods, it is better to have more eyes looking for them. If one institution implements policies more effectively than others, then we should all learn from that institution. Are our policies capturing real risks or are they squandering time that would be better spent on research?
This is not to imply that we should be casual in our observations or turn a blind eye. Our requirements assume the possibility that an investigator can have financial activities that could compromise objectivity. In such cases, the institution must eliminate, mitigate, or manage that conflict. Some financial activities may be managed merely by making them – and especially their extent – public. Some other forms may be managed in other ways, and it might be useful if you considered this in your deliberations.
There are other things you also might want to consider. We require, through 45 CFR, that no IRB may have a member participate in its initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. While we all might agree that having a financial interest in a study could compromise an IRB member, we do not have a specific regulation relating to the financial interests of IRB members. That is, I believe, also worth your consideration.
Institutions, no less than individual researchers, accept responsibilities when they conduct research. Like individuals, their reputations are in play and they risk liabilities if they do not comply with federal regulations and policies as they conduct research. And also, like individuals, institutions have financial interests in the outcomes of research – with the same problems. They too have had more time to deal with the problems of pursuing fame and producing grand results than of dealing with financial ties.
We know what this means today. Biology is fueling the biotech industry. The Bayh-Dole Act has given incentives to those best able to commercialize biotechnology. And the likelihood that a scientific finding will quickly produce a usable – and salable – product has increased amazingly.
As I said, the world is changing, and we are not going to stop the way the world changes. But we must find the ability and the will to see that the opportunities to bring science to market do not jeopardize the objectivity that has fueled scientific discovery.
What can institutions do to avoid that jeopardy? To preserve the public trust in their objectivity? Even if no institution today is violating that trust or putting profit above discovery, we know the risk is real. That risk, moreover, could affect individual researchers should they lose confidence in the institution where they work. We are, after all, taking about motives, human motives. And some motives, sometimes, are unspoken.
And some we do not really like to speak about. For some scientists and others interested in science, "profit" is a tainted word. Yet the truth of the matter is that profit is what operates a market economy like ours and produces the wealth that supports the NIH. It also is the prime motivation for producing the drugs that improve human health and reduce human suffering.
Profit – or making money generally – is not the problem, nor will it ever be. The problem is the collision of financial considerations, including a desire for personal or institutional profit, with the essential objectivity of science.
That collision, I believe, is avoidable. Financial interests and objectivity in science can be managed. Over the next day and a half, I hope we can get some sense of how we can go about this management and avoid the collision. We all have different understandings of risks and many of us have specific knowledge of risks and problems not known to others. This is an opportunity to share them. You can help us state the questions – finding and asking the right question is never easy, but always important. You can help us find the answers to the questions. Or you can share some best practices you are familiar with.
We need to listen and to make sure that our ethics and our science are equally strong. "Equally" is the operative word, for otherwise we may erect protections that hamper the scientific enterprise and its discoveries. Or worse, we may weaken or neglect protections in the name of letting science go where it must go and turn a magnificent enterprise into a suspect operation. The possibility that either could happen is real.
I have not given you a technical address with long quotations from regulations or policy papers. Nonetheless, what we are dealing with is not abstract. The problems of objectivity and profit, of the equal strength of science and protection are daily realities in research. Thus we need realistic and practicable methods to promote science in an atmosphere of objectivity and trust.
I mean we. We are all in this together. This is grand partnership on behalf of the future of science – and so we will be acting on behalf of our own futures and the future trust of the public which has supported science. This is important work, and I am glad to be in such good company as we get started on it.