From the Deputy Director for Intramural Research

Everything You Always Wanted to Know about the Conduct of Research in NIH’s Intramural Program

BY MICHAEL GOTTESMAN, DDIR

We all know that the laws, regulations, and guidelines that govern how we do research have become more complex in the past few years. You might very well be confused…or new to the NIH. So, I would like to highlight a new “must-read” work of nonfiction, the Guidelines and Policies for the Conduct of Research in the Intramural Research Program at the NIH (fifth edition). This booklet, available from the intramural Sourcebook is loaded with good stuff, and you need to know about it.

Thanks to the hard work of the NIH Committee on Scientific Conduct and Ethics, under the leadership of Melissa Colbert in the Office of Intramural Research, we have revised and updated this booklet for your reading pleasure and edification. This new user-friendly edition explains in greater detail (than in previous editions) the expectations for the conduct of research in the Intramural Research Program (IRP) and includes all of the guidelines you have grown to know and love plus the policies that inform them.

Having all our rules, regulations, and guidelines together in one document should be a welcome reference. For me, hearing from an NIH scientist that they were unaware of a specific requirement is distressing. I always feel under these circumstances that communication of these requirements has been inadequate in some way. I wanted a new and better enumeration of the Guidelines and Policies to be readily available to all intramural staff and NIH leadership so that we will have in one place most of the important requirements of our work. Please check it out and refer to it frequently if questions arise about any aspect of scientific behavior.

This new version includes all of the old guidelines covering mentoring, publication, authorship, and research misconduct, and adds guidelines about peer review, team science, conflicts of interest, research reproducibility, dual-use research, and biospecimen storage. The expectations that we all have about the behavior of scientists in the IRP are spelled out in clear language, with appropriate hypertext links to other websites. New sections outlining policy in the areas of human-subjects research, fetal-tissue research, health and safety, materials management including high-consequence pathogens, animal care and use, and IT security should supplement already existing documents and training that cover these areas. In addition to the scientific expertise and diligence of the NIH Committee on Scientific Conduct and Ethics in assembling these materials, we had help from other subject-matter experts in areas of law, regulation, and policy.

I would recommend that everyone in the IRP read over these Guidelines and Policies at least once and keep the website link or a printed version of the document available for frequent reference. When new staff enter our laboratories and clinics, they should be instructed how to find and read this document, too. Encourage them to ask questions and generate a discussion about any issues that are not clear or require further explanation. Needless to say, with respect to the many requirements incumbent upon NIH-supported research, an ounce of prevention (education) is worth a pound of cure!

As far as regulation documents go, this really is a wonderful booklet that underscores why the NIH Intramural Research Program has maintained its level of excellence and integrity, respected internationally, for more than 70 years.

Please remember that, as with many of our most important documents, the Guidelines and Policies for the Conduct of Research in the Intramural Research Program at NIH is a living document. Rules and policies change over time, and new and better ways to explain these requirements are always possible. Please read this booklet over and send Melissa Colbert (colbertmc@od.nih.gov) and me (GottesmM@mail.nih.gov) your thoughts about how we might improve it.