Page images
PDF
EPUB

ers and provide them more hands-on activity. So, would you give us a little assessment of what you think you've accomplished and where you may be headed with this program?

Dr. RAUB. The effort begins with the recognition, as you just said, that it is no longer enough for the NIH to limit itself to predoctoral and postdoctoral training and career development, that we must extend our interests further, more specifically to include the K through 12 setting.

Our initiative has many components to it. The cornerstone is the introduction this year of science education partnership awards that we are undertaking in collaboration with the Alcohol, Drug Abuse, and Mental Health Administration. These awards will be made to institutions, primarily academic institutions, that will encourage partnerships among working scientists in the universities and the industrial setting, professional educators in the school systems, and other interested members and institutions in the community. The general idea is to get young people knowledgeable and excited about science, to expose them to some role models, to the issues that face our society. While we obviously hope that many of them will be attracted into science studies and, therefore, science careers, even for those who are not, we believe it is vital that the level of public literacy about science, whatever professions they enter, be high.

Complementing that initiative, there are a number of other activities. As part of biomedical research support grants, we have a special element that encourages high school science teachers, especially those who are minorities or who teach large numbers of minority students, to have an affiliation such as a summer research experience in a research laboratory. We hope these affiliations will give them new insights, new relationships, and connections that will last them through the year, not only to keep their own literacy and motivation high, but to pass that on to their students.

NIH itself has cooperative efforts with a number of institutions in the region. One of the programs we will begin this year is the Saturday Scholars, which will provide an extended Saturday morning lecture and laboratory experience for high school students in this area. This is but the beginning of what we hope can be a comprehensive and thorough reentry into this aspect of math and science education.

RESEARCH TRAINING

Senator HATFIELD. Do you remember a year or two ago we had difficulty in maintaining a stable number of training grants? There were many reasons, but one was the inadequate levels of the stipends. And your authorized increase of the stipend resulted in a reduction of the number of grants awarded. How are we doing on training grants this fiscal year? Have you filled all of the slots in the training grant programs, say, for fiscal year 1991?

Dr. RAUB. The slots for the training grant programs continue to be actively sought after, and it remains a high priority effort for us with somewhere in excess of 12,000 trainees. We are proposing a stipend increase as part of the 1992 request, an increase of 4 percent, as a way of staying competitive in that arena. As I am sure you can appreciate, the situations vary considerably across the

country with some areas much more expensive than others. With our stipend level, we are competitive in many parts of the country, but institutions in the high-cost regions do supplement our stipend levels from private local funds as a way of making themselves competitive. We believe we have a workable, stable arrangement there, and are anxious to continue that investment in the next generation of scientists.

SLEEPING DISORDERS

Senator HATFIELD. One last question. Do you have a date when the National Commission on Sleep Disorders will be finishing up their report?

Dr. RAUB. I do not know the date exactly. I know they are looking toward possibly this fall having, if not the final report, certainly some major information available. As you know, several of our institutes have a strong research interest in various aspects of sleeping disorders.

Senator HATFIELD. Thank you, Mr. Chairman. Thank you, Dr. Raub.

DISSEMINATION OF RESEARCH RESULTS

Senator HARKIN. Dr. Raub, one item that was in the paper this morning announced a new treatment which cuts rectal cancer deaths sharply. It is not so much the substance that I wanted to focus my first question on, but rather the procedure of announcing these new findings and clinical trials.

There have been over the last year a number of situations in the press where there have been complaints raised that a lot of these scientific findings were not released early because they waited until they were published in the scientific journal, usually the New England Journal of Medicine. The charge has been too often researchers are intent on having their research work published first in medical journals and withhold information from the practicing medical community until the publications occur. This, in fact, has often been a requirement for publication.

I just wonder what policy reviews you have put in place to ensure that as soon as valid research results are available, they are released and disseminated in an aggressive manner to the medical community around the country?

Dr. RAUB. We have made that process a high priority issue during the past year. The Cancer Institute's announcement yesterday, that appears in the newspaper today, was developed with what is emerging as an NIH-wide approach for selective, rapid dissemination of that kind of information.

In the past, many institutions, including NIH, have been frustrated by the delays associated with the journal review process. While delays are individually understandable, when the subject matter of the finding involves something that could be immediately applicable, especially in life-threatening situations, we feel it incumbent upon ourselves to do something to make the process faster and more efficient without compromising the critical review that is needed to protect the patients and the practicing physicians and ensure that the information is valid.

Our efforts culminated in a special meeting this past January of leading scientists, journal editors, and other interested members of the community. This workshop, held at NIH, was partly retrospective and partly prospective. The retrospective part was to look at five case histories, individual clinical trials, where the results either had or had not been disseminated rapidly. We tried to understand what had worked and what had not worked in each of those individual instances, and then synthesize that information into some common ideas.

A critical part of that meeting was the participation of several leading journal editors who indicated their willingness to take special steps to expedite their peer review whenever a finding affecting a life-threatening disorder occurs. The journal editors also agreed to be more tolerant with respect to situations in which some publication has occurred before a full scientific manuscript exists.

We will continue to refine this model, but we believe we are on the right track and have the means within the NIH to be selective in identifying those clinical trials that have this kind of result that demands rapid dissemination. Associated with each clinical trial is a solid review system of independent scientists, so we have a builtin peer review. Wherever practical, we will seek a further external peer review, either associated with a journal or an ad hoc one that we could assemble on our own. We will continue to work to make the entire process run faster. I am optimistic that the journals are with us on this. No doubt we will learn and further refine the procedure, but I think we have turned the corner with respect to having a means to deliver validated results into the hands of the practicing community and thus available to patients.

Senator HARKIN. Explain for me how come when I read this article it says, "according to a study published in today's issue of the New England Journal of Medicine"?

Dr. RAUB. That is an instance where the journal, recognizing and agreeing with the Cancer Institute that this is something that should be expedited, put aside its normal deadlines and made special efforts to get its review in place for this publication.

DISSEMINATION OF RESEARCH RESULTS

Senator HARKIN. In other words, you were pushing it and not them. In other words, you were in the lead in terms of getting the information out, and they decided they wanted to jump on board. Dr. RAUB. Well, the Institute had to be the one to take the initiative, but the journal certainly did not resist it. It was cooperative as well.

Senator HARKIN. In other words, you were putting the information out regardless of what they did, regardless of what the New England Journal did.

Dr. RAUB. In this instance, every effort was put into a cooperative effort. Had the journal not been able or willing, the institute and the NIH would have had to think through another scenario. But we might very well have published an alert based on our own review in that circumstance. It didn't come to that, and I don't think many will in the future.

NIH DIRECTOR

Senator HARKIN. The second area that I wanted to cover was the recommendations made by your advisory committee that included some that said that the NIH director should have substantially increased authorities, including final appointment power for senior NIH scientists and administrative staff, and for scientific appointments to NIH advisory committees, councils, and boards. It was also recommended that the NIH director's position should be a 6year term appointment.

What is the status of the recommendations made by the Secretary's Advisory Committee on the National Institutes of Health Director?

Dr. RAUB. To the best of my knowledge, Secretary Sullivan has not made final decisions about that package. I understand, though, that those issues or some of them have been central to his discussions with potential candidates for the position, including Dr. Healy. I expect that the Secretary's decisions will come forward as part of the final steps in the appointment process.

Senator HARKIN. We were going to, as you know, change the term to 6 years. It was dropped, and I'm wondering if that is something that ought to be legislatively enacted or not. Do you have any

views on that?

Dr. RAUB. I don't know the current thinking within the Department on that, sir.

ONE PERCENT TRANSFER AUTHORITY

Senator HARKIN. Just a couple more.

Congress gave the Director the authority to transfer up to 1 percent of the funds from any institute or center to any other institute or center. The authority, as I understand, has not been used yet

Dr. RAUB. That's correct.

Senator HARKIN [continuing]. Although each institute and center has the 1 percent funds in reserve for possible use. I guess this is a two-part question.

Do you expect to use this authority? And second, is this a useful tool for the director to have and should we again try to provide that authority in 1992?

Dr. RAUB. If I may, I'll address those questions in reverse order to put it in context.

In my judgment, the authorities are extremely valuable. They have been valuable, as I will explain in 1 minute, this year, and I believe they will be of increasing value when Dr. Healy assumes her post.

Actually the appropriation carried two very special authorities. One was a $20 million discretionary fund within the appropriation to the Office of the Director, and the other was the 1-percent transfer authority.

During the first 5 months of this fiscal year, I put my principal attention on the discretionary fund and, as I indicated in the opening statement, have allotted a portion of that, in total about $6 million out of the $20 million, as a way of starting selectively some of these new activities that have an NIH-wide impact.

In addition, we have solicited from the institutes, centers, and divisions their ideas as to what aspects of their program might be extended or amplified by an allocation from that discretionary fund. We will begin a review of those soon, and hope to have for Dr. Healy a set of recommendations as to how she might proceed in the last half of this fiscal year with the allocation of what remains of the discretionary fund.

I indicated in a memorandum to the institute directors that, from my vantage point, it was not likely that I would be exercising in addition the 1-percent transfer authority during this period. The money remains in their individual accounts. We have also, of course, reminded them that the incoming director may have some ideas about utilizing those funds so that they should make sure that they have the flexibility.

The language that accompanied the 1-percent transfer authority put a higher threshold on it than the discretionary fund, indicating that the transfer authority ought to be used for things that have a very special or even emergency character. In my judgment, nothing in the first few months of this fiscal year got over the threshold. But I hope we will not judge the long term on just the last few months. I think it is an invaluable tool for the management of the organization.

Senator HARKIN. We will put that authority in again then next

year.

INDIRECT COST

Might I cover with you now for just a couple of minutes the indirect costs problem? I was reading this article in the paper this morning. As I mentioned in my opening statement, it is getting more and more publicity and it almost seems like it is getting worse. I had heard about flowers and a yacht, and now I hear about charging $10,000 for a set of silverware that was donated. Now, fortunately, this was not under NIH-funded research. Right? I correct myself. It was uncovered by the Navy. Actually the lead inspection agency was the Navy and evidently they uncovered this. But I am informed that NIH has to cover the costs.

Dr. RAUB. Yes, sir.

Senator HARKIN. Well, I have a couple of questions. Is there any internal auditing agency or any internal arm that you have at NIH that could uncover these and find out what is going on? Why do we have to rely upon the U.S. Navy to go in there and find out that they are charging NIH $10,000 for a set of silverware that was donated?

Dr. RAUB. The short answer to that is no, but may I take a few minutes and explain how the system works?

Senator HARKIN. Sure.

Dr. RAUB. Indirect costs are guided by what are called the cost principles contained in Circular A-21 issued by the Office of Management and Budget. As the name implies, the cost principles are the conceptual guidance to be used in establishing indirect cost

rates.

There then is a group of individuals in the Department of Health and Human Services and certain other departments, mostly with accounting/auditing backgrounds, who review with each university,

« PreviousContinue »