MR. STANFIELD: In appreciation for the lateness of the hour, I will try to be brief. I just thought I would cover a few points about how NIH selects the people who serve on the peer review panels.

I should start by saying, since it has already been said a couple of times, this seems to be getting harder. Other agencies are voicing this.

From NIH's perspective, I think it is particularly getting harder in certain areas of science, particularly in clinical research.

Managed care has changed the clinical research environment. Many of our peer reviewers who are practicing clinicians, when they come to Washington, D.C. to serve on peer review for a few days, they are actually losing money out of their pocket because they are not contributing to the patient care that they would be if they were back in their hospitals.

Peer reviews aren't adequately compensated anyway, but for these folks, they are actually losing money to come and peer review for us. I think this is going to be more and more of a challenge.

I think another challenge for the future may well be not just the logisticals, but the problems associated with bringing folks together, with terrorism is so high on people's screens.

We have looked into teleconferencing. The last time we looked into it, it sort of looked like Hollywood Squares. We had about nine people on the screen. That is sort of the limit of the technology right there.

I think it is something that is seriously going to impact face to face peer review in the perhaps not-too-distant future.

If I can have the next slide, I would just remind you that each of our standing study sections has about 12 members, mostly from universities, and we have face-to-face meetings. As many as 60 to 100 applications are reviewed by each study section at each meeting.

I had some questions in the break, so let me clarify. Not all the applications are read by all the reviewers. Each reviewer is responsible for writing a critique on something like eight to 10 applications.

Then they might be asked to read another three or four, but not write anything unless they feel real excited about writing something.

The applications are provided to all the reviewers, so an interviewer who wants to, can look at any application they want to, but they don't have to review all of them.

The next slide just shows the general qualifications for a study section member. The candidate must be a recognized authority in the field. This is the number one thing. They have got to understand the science and they must be a recognized authority.

In general, we do not encourage young people to come. We like to have people who don't necessarily have NIH funding, but are at a level where they have achieved a certain success in the field and have a breadth of understanding of the field and where it is going.

Most of our reviewers are associate professors or higher. However, like I said, although they may not have NIH funding, we are certainly not going to turn down someone who is Howard Hughes.

So, the candidate usually needs to be a principal investigator on a research project comparable to those being reviewed.

Let me qualify that a bit. Now, with teams of investigators in certain aspects of science, sometimes you will have a team that is composed of folks who are really good, but really aren't the PI.

So, we are finding, especially in some areas of science, that that criteria is maybe a little too strict.

The candidate must be able to provide high quality peer reviews. You know, duh. It is certainly true that a number of people will qualify for the first two criteria, but simply aren't very good reviewers.

There must be membership diversity with respect to sex, race, ethnicity and geographic distribution.

Again, the number one thing is the science. In terms of the science and expertise, again, this is the key consideration, and the entire spectrum of science that is used must be represented by the membership.

So, many of our panels are fairly broad. So, there is a fairly broad region of science that we have to cover.

The membership must be responsive to emerging scientific areas, and shifting boundaries. Science is not static. Things are shifting and changing all the time.

Just a couple of examples. In the last couple of years, we have seen the emergence of a lot of applications using stem cells.

I can't begin to tell you the increase this year over last year, the number of applications studying anthrax, and we have had to respond to that.

Carrying over the expertise of persons rotating off the study section. Of course, you are going to have members who are leaving the study section and you need to replace their expertise. That is what the SRA has to consider when looking for new members.

The SRAs have many sources to assist them in finding reviewers. They can, of course, look at the scientific literature. We encourage them to attend scientific meetings.

At scientific meetings, you can get a one on one with an individual and begin to assess how they might fit into the dynamics of the study section.

Often, SRAs see very successful grant applicants come to their committee, and they seek those folks out as possible future members of the committee.

SRAs work with NIH program staff to try to identify promising candidates and often we get input from institute advisory councils.

We also get input from professional societies, but that is very uneven. Sometimes they just send us a list of members, and that is not particularly helpful.

The standard appointment is for four years. The chairmanship is usually the last two years of a four-year appointment. Sometimes we extend the chair for a year, so he or she has five years, serving as chair in the fourth and fifth year.

There are different rules that we have to comply with. You may not serve more than eight years on an NIH study section within a 12-year period. So, we try to not have an old girls' network.

It is important to NIH that we assure that women and ethnic minorities are represented on study sections, and we take this very seriously.

Diverse representation is required on each nomination slate that we put in and this issue is considered.

It is actually very interesting, as you go into the study section, in the behavioral arena, it is often more of a concern to make sure there are a number of men on the committee.

There is also an attempt to represent all geographical regions of the United States. Again, this is not a strict requirement. We encourage the SRAs to do this, but it is sort of down the list of things.

Folks on the Hill get very annoyed that all the reviewers come from the Boston area and the San Francisco area.

There is also an attempt to represent states that traditionally have not received a large amount of NIH funding. We call these idea states.

Actually, we have looked at this data in our reviewer pool. If you look at the idea states, there is one state that tends to be better represented than other states, and that is Kentucky.

If you look into why, it is because the University of Kentucky is very active in the university in encouraging their faculty members to do reviews. It counts as good citizenship at that university just like serving on a faculty committee or doing some other service to the university. Serving on an NIH review panel helps for research. So, that kind of approach works.

We also tried to ensure that individual research institutions are not over-represented on a study section. I won't go into detail how we do that, but we certainly don't want to have all people from Harvard on a given study section.

We are allowed to have federal employees on our committees. We have a lot of folks who are from the VA. We occasionally use NIH intramural scientists on our committees.

We are actually, by law, allowed to have as much as 25 percent of our study section members be federal employees. We never get anywhere close to that. In fact, on all committees, the median number of federal scientists on a study section is zero. At most, they will have one or two.

I should say that everything so far refers to members that are on the slate, members that are on the block, on the study section block.

In addition, in our meetings, we have a bunch of what we call temporary members who come in. They come in for a variety of reasons.

It may be that normally that study section sees 10 Parkinson's grants every round. That particular round, they have got 25. So, they need to bring in some more expertise so they don't severely overburden the two people that know about Parkinson's disease.

So, temporary members are invited to provide specific scientific and technical expertise. They are identified in the same manner as normal members, and have the same role and responsibilities.

In addition, what our SRAs use temporary members for is to try out new reviewers. Say they have identified someone, they have gotten good references from other folks. You invite them to the meeting to see how they work out. One of the criteria I had there was give a fair and a good review. Try them out and see how they work, see how your chairman thinks they worked on the committee.

In terms of reviewer preparation and orientation, I spoke a little bit about this. Again, it is similar both for normal and temporary members.

Initially, when you contact someone, we have a system where we can see if they have had review experience in the past. If they haven't, the NIH spends a fair amount of time talking with them about what their responsibilities are, what their roles are.

We provide them with a huge amount of material that they probably aren't going to read. So, it is really important that the SRA tells them what is the amount of material they need to focus on, while they are assigned to do their reviews.

This is accomplished in a variety of ways, the sort of training of the reviewers. As I mentioned earlier, often it is done with the assistance of the chairman.

With that, I think I am going to stop there, because Terry is going to tell us a little bit more about how reviewers are trained.