Where I've been

I spent most of the past week in Bethesda as a member of a proposal review panel for the National Institute of Minority Health and Health Disparities. I'm not allowed to say anything about the proposals, but the fact that the meeting happened, and my participation, are a public record, as is the announcement for the proposals we reviewed.

I thought people might be interested in how the various components of the National Institutes of Health (NIH) go about spending your money. It's too complicated to go into all of the details, but I'll hit the highlights. NIH consists of several different so-called Institutes and Centers (I/C), of which NIMHD is one. Other examples are the National Cancer Institute; National Heart, Lung and Blood Institute; and the Fogarty International Center. Congress allocates money to the various components, and may establish some priority issues for them, but beyond that they have considerable discretion.

Each I/C has a national advisory council which sets general priorities and has final approval power over funding awards (a general term which includes grants, cooperative agreements, and contracts, each of which work a bit differently). Awards to external researchers -- mostly in universities -- are called "extramural" funding. In addition, most of them have some intramural funding in which they run their own labs and employ their own scientists,  but most NIH-funded research is extramural.

Based on congressional mandates, national council guidance, and staff decisions (with occasional requests for additional public input), the I/Cs issue so-called "Parent Announcements" which invite ideas for research projects from investigators and are completely open; and so-called "Program Announcements" and "Requests for Applications," which have increasing degrees of specificity. (They also make awards for training and career development, which I'll only mention here.)

The main kinds of research awards with "parent announcements" are called R03s, which are small awards for preliminary work, usual using already available data, to figure out what it would take to do a study and to generate hypotheses. It isn't necessarily expected to result in scientific findings, other than perhaps a paper on methodology or suggestive observations. The R21 is an "exploratory and developmental" award. It is enough money to do some real science, but isn't necessarily expected to have enough statistical power to draw definitive conclusions. Rather, it is preparatory to an R01 which is a full-scale research project. The R21 might yield methods and measurement instruments, or demonstrate the feasibility and safety of an intervention. In terms of clinical drug trials, it is equivalent to a Phase 2 study.

Investigators who win these awards are given the money and they just run with it. NIH doesn't get involved except to require annual progress reports. However, if you don't end up with publications they aren't likely to fund you again.

The proposals we reviewed this week were for so-called U01 awards, which are cooperative agreements, That means NIH staff will work with the investigators to implement the projects. That makes our job as reviewers slightly different because it means we don't have to assume that the project will be implemented exactly as proposed. If there are "addressable" weaknesses, which could be fixed in cooperation with NIH staff, but we like the project otherwise, we can still give it a good score.

Next, I'll explain the review process and exactly what the heck I did.