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REMARKS BY:	DONNA E. SHALALA, SECRETARY OF HEALTH AND HUMAN SERVICES
PLACE:		NHRP Advisory Committee Swearing In
DATE:		December 21, 2000

Building Trust and Confidence in Human Subject Research

Thank you Dr. Koski for your gracious introduction.

Let me start by simply congratulating and thanking all of the members of the National Human Research Protections Advisory Committee.

As all of you know, I am in the final weeks of an eight-year run as Secretary of Health and Human Services. In joining you here this morning, I won't say that I've left my most important secretarial act for the end. But that's only because if I do, other people in the department will get mad at me.

The fact is: Attending this swearing in of the National Human Research Protections Advisory Committee - and giving my charge to the Committee - is a milestone that I felt compelled to reach before my tenure as Secretary is over. So, today, while I'm happy to see many old friends one more time, my real purpose is to make sure we're on a path of building trust and confidence in human subject research.

It's hard to imagine a higher calling for those of us dedicated to public health than to make sure we protect people who put their lives and trust in our hands. If we can't do that, then we have no business being researchers - or those who fund, supervise and review their work. Let me be clear: I take this issue very seriously, and my expectation is that you will too.

None of us - public servants, scientists, research institutions, IRBs - can be proud of human subject research unless it is done in a way that fully protects the public. Now, the vast majority of researchers do not cut corners when it comes to protecting human subjects and fully informing them of the risks they face. But we've also learned that our system of patient protection is not as good as it could be - or should be.

So here's my message: Researchers seeking only to make a name for themselves. Researchers seeking only to unmask a discovery. Researchers seeking only to secure some kind of financial reward - are researchers whose priorities are wrong, and who need to find another line of work.

As for the rest of us: We too must do better. It is our duty to do better.

That's why the FDA, NIH, AHRQ, CDC, as well as the other 16 federal departments who are signatories to the Common Rule, have been working together to make sure that their rules for protecting research subjects - and their procedures for carrying out those rules - are as mistake-free as humanly possible.

That's why I named Dr. Greg Koski to lead the Office of Human Research Protections. As I said in June when I first appointed Greg: He is the right person, with the right experience, at the right time to take on this challenge.

That's why last May I announced new steps to strengthen the way we protect people who volunteer for clinical trials, steps that include better education and training, improved monitoring of investigators, tougher standards against conflicts of interest, civil penalties, new guidance on informed consent, and other important issues that you will be working on during the life of this Committee.

Finally, that's why this morning we swore in the National Human Research Protections Advisory Committee.

To each member of the Committee I want to say this: We need you help us set priorities.

We need you to provide Dr. Koski, his colleagues at the Office of Human Research Protections, and indeed all of us, broad scientific and ethical guidance for investigators and institutions.

We need you to use the depth of your experience to support OHRP's oversight role, to answer the tough questions, and to voice your skepticism when you think there's been a rush to judgment.

We need you to offer continuity between this administration and the next - because there can be no partisan divide when it comes to protecting human research subjects.

We need you to work together with your colleagues - not only on the Advisory Committee and at OHRP, but at academic health centers, businesses and government at all levels.

We need you to help make this an international movement, so human subjects are not only protected here - they're protected everywhere.

And most important - we need you to hold our feet to the fire.

Today is not the end of a long road. It is only the beginning. We have a moral responsibility to fix problems in human subject research, to end financial conflicts, to refuse to tolerate those who undermine public trust, and to build a system that not only produces the best science in the world, but is supported by the highest ethical standards in the world.

None of us can do that alone. Not investigators. Not great public servants like Greg Koski, Ruth Kirchstein, Jane Henney and Bill Raub. Not IRBs. Not even all of the agencies within HHS that are so committed to improving patient protection. But we can achieve that dual world of great science and great ethics - if we work together, and if every member of this Committee serves as our nation's conscience. That means committing yourself to being the guardians of human research subjects, and the voice for a course of conduct on research that is as tough as it is wise. Thank you.

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