NIH Extramural Nexus

Ensuring that individuals are protected when they participate as research subjects is vital to maintaining the public’s trust in the research we support. This week, the Department of Health and Human Services published a notice announcing that the federal government is considering ways to enhance the regulations that deal with the protection of human research subjects. These rules went into place more than two decades ago and many things have changed, both technologically and in the type of research that is conducted, so it is time to look at the effectiveness and efficiency of the current regulations. 

The notice describes potential changes to the Federal Policy for the Protection of Human Subjects or the “Common Rule” that are currently under consideration. This rule outlines the basic requirements for institutional review boards, informed consent, and assurances of compliance. Managing research with human participants is highly complex and affects those of you who do this research on a daily basis, thus your input into how the regulations can be updated is important to us. So, please, let us know what you think. Submit your comments to regulations.gov by September 26, 2011.

This week, members of my staff went to a meeting to kick off a project that has long been of interest to me, development of a fed-wide system for collecting professional profile information for our investigators. This concept has been an interest of the Federal Demonstration Partnership  and others for many years. I think now the time is right to begin doing the groundwork that is needed to put such a system in place. A fed-wide profile system could be used in many ways, for example, pre-populating federal forms and allowing us to more efficiently locate expertise and share data across agencies. Profiles not only will reduce the need for repeatedly entering personal information in various federal data collections it will also help scientists form networks based on  interests and expertise.  

Tools like Lattes , developed by the Brazilian government, have already proven that the technology works and acceptance for the concept. Lattes, which began in 1999, is currently in use by some 2.5 million people in 18 countries. Other profiling systems like VIVO , OSUPro , Harvard Catalyst , and Stanford CAP  may be helpful in developing the features of a fed-wide system and may, ultimately, serve as a source of information.  

This project is in the embryonic stages, so I want to be careful not to set inappropriate expectations. We have a lot to do, and it will take some time to implement such a system. At this point, we are still organizing ourselves and defining short- and long-term objectives. The next step will be to articulate the goals and explore potential benefits and uses of such a system. This will be done in collaboration with our research community to ensure we are developing a viable business model and creating a tool that will benefit us all. Then, as we move forward, we will need to research technologies and explore policy issues that might allow us to pull data from existing profile systems into a central location that could be tapped by all the federal research agencies and others. We will also begin the long process of working with federal agencies to ensure that all of our systems can handle a unique researcher identifier (a concept that is central to such a system), and that we can standardize data definitions and use the data from such a system in ways that will be useful. 

The Research Business Models interagency working group, which I co-chair, and the Science of Science Policy Working Group  are both very interested in this topic and will provide input and oversight into the group working on a potential fed-wide profile system.

I look forward to seeing this project progress. It will take us a bit of time before we are ready to fully engage the community on these issues, but I will certainly keep you updated as things move forward.

There has been much talk on the peer review process in our blog comments recently. We are extremely proud of our peer review system and its acceptance as one of the premier systems of peer review around the world. Our peer review system is based on a partnership between NIH staff and our reviewers. Each year we review about 80,000 applications with the help of tens of thousands of outside experts. I greatly appreciate those who have served and encourage everyone to participate in the process when you can. If you are interested in hearing more about how we recruit reviewers listen to our latest podcast.

Both reviewers and NIH staff follow the policies and procedures that are in place to ensure that every application receives a fair, equitable, timely and unbiased review. We have reviewer conflict of interest policies that prevent an individual from reviewing a friend’s grant, one from a collaborator, or from another investigator at their institution, for example. And while we assign at least three reviewers per application, the entire study section can view the application, and everyone participates in the discussion and scores the application (excluding those who are in conflict). We also have an appeals process in place that allows you to contest the review outcome if you feel that the process used to review your application was flawed.

Our peer review process is rigorous and time-tested, but no process involving humans will ever be perfect. As you know, we went through many changes in the process over the past couple years, based on an evaluation done by the Advisory Committee to the Director and continue to tweak the system. We are committed to continuous review of our peer review system because we know the system should evolve as the science evolves, and there are always ways to make it better. The last thing we want to do is to wait another 20 years to examine peer review again, so we are collecting data and information that will give us adequate metrics and baselines to inform us on how peer review is working and how it could possibly be re-engineered for the better.

However good and fair the peer review process is, the reality is that we receive far more high quality applications than we could ever support. It is vital that we at NIH continue our efforts to look for the best ways to approach funding that will sustain scientific progress and provide the most benefit to the health of the nation.

My boss, Dr. Francis Collins, has just published an article in Science Translational Medicine describing why the time is right to establish the National Center for Advancing Translational Sciences (NCATS) at NIH. In this article, Francis lays out the goals, functions, and structure of the proposed NCATS. A major thrust of his article is to describe the bottlenecks in the therapeutic pipeline that are ripe for reengineering and how NCATS can contribute to overcoming these bottlenecks, all the way from target identification to first-in-human application.

I know that some in the community are concerned that this emphasis on the therapeutic pipeline may shift the balance of the NIH portfolio away from basic research. Francis has recognized these concerns and has spoken to the “virtuous cycle” whereby a strong translational effort will stimulate even more critical basic research. In fact, a clear goal of NCATS is to provide the fertile ground for scientists from academia, government, and the private sector to work together, particularly in the precompetitive space, in ways not seen before that will overcome many of the challenges of moving basic science into application.  He challenges us to move forward now on what can have “profound benefits for humankind.” I share the excitement of what NCATS will become and what the new center will offer to the extramural community. I am looking forward to the next year as we further shape the new center and will keep you updated on events as they unfold. I encourage you to visit the NIH Feedback website to share with us your thoughts on the proposed new center.

If you would like to hear Dr. Collins speak about NCATS in his own voice, listen to his podcast on this topic.