|T H E N I H C A T A L Y S T||J U L Y A U G U S T 2006|
|FROM THE DEPUTY DIRECTOR FOR INTRAMURAL RESEARCH|
On June 14, 2006, I testified before the House Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce regarding NIH rules and regulations governing conflict of interest, transfer of materials to private industry, and oversight of samples obtained from human subjects. This testimony was occasioned by a congressional investigation of the activities of one NIH scientist, but the issues raised and lessons learned have value for all NIH staff.
After pointing out the many complex regulations that our scientific staff must internalize to prevent future episodes of the kind under congressional scrutiny, I observed that NIH could facilitate this process in three ways:
By communicating clearly just what the laws, rules, and regulations are and providing appropriate continuing education on the issues and requirements
By providing expert administrative staff to help NIH employees navigate through regulatory language that may contain subtle distinctions related to exceptions, exemptions, waivers, and recusals that might be needed for us to carry out our work
By reviewing the facts and imposing clear penalties in the event that rules are negligently or deliberately violated
Let's consider each of these points in turn.
Communication of Rules and Regulations
The rules covering conflict of interest, human subjects regulations, and technology and materials transfer are the subjects of courses required of all NIH scientists. If you have not taken these courses, or have not taken them for a while, please check out the websites below and take advantage of the concise, but complete, information in the accessible computer-based courses:
The principles underlying the messages contained in these subjects can be summarized as follows:
For conflict of interest: Do not use your government position for real or perceived financial gain for yourself, family members, friends, or significant others.
For human subjects research: All NIH researchers and research staff are responsible for knowing when their research activities involve human subjects. Such research may be conducted only after approval by an NIH IRB or the NIH Office of Human Subjects Research (OHSR).
For technology transfer: Inventions and discoveries made at NIH are the property of the U.S. government, whose intent is to encourage their dissemination to advance the development of research tools and biomedical products for the prevention, treatment, and cure of human diseases.
I recently sent out clarifications on the required IRB oversight of the continuing use of identifiable human tissue samples. See
It is not acceptable to use stored human samples obtained under a research protocol unless there is continuing IRB review and approval. This means that if you or a colleague have samples in a freezer from a protocol closed to further accrual and these samples have not been anonymized, the IRB must decide whether your proposed research use is appropriate. Exceptions for anonymized samples can be obtained from OHSR.
A committee of scientists and administrators has been assembled to clarify rules governing transfer of materials from the NIH. Currently, some kind of transfer document is required (for example, a simple letter agreement, a materials transfer agreement, a letter of collaboration, or a CRADA) for all such transfers, but it is clear that more precise advice is needed about which document is necessary for which transfer. For example, we will require that transfer of human samples be under the direct supervision of senior leadership in an institute. Every effort will be made to make the process as straightforward as possible. Further guidance will be forthcoming.
Where To Go for Administrative Help
NIH currently provides administrative support to NIH scientists to help them navigate the complex rules that govern many different activities.
If you have a question about a potential conflict of interest, see your deputy ethics counselor.
If you have a question about human subjects regulations, check with OHSR.
For advice on reporting possible conflicts of interest, contact the Office of Management Assessment.
Recently, I sent out a list of official duty activities that might require more administrative scrutiny. The NIH Ethics Office prepared the list with the help of various advisory committees to apprise our scientific principal investigators of activities that need review and approval.
For outside activities, supervisory, administrative, and/or DEC review and approval is required.
Consequences of Violating Rules
I am often asked whether the individuals whose names became known to NIH or who self-reported various violations of conflict-of-interest regulations were ever called to task. The answer is yes. There is a strong sense among NIH staff that individuals who willfully break NIH rules and regulations should suffer the consequences. To date, detailed investigations and analyses have been completed for all of the 44 persons in this category, with disciplinary action ranging from letters of reprimand to suspensions to termination of government employment, depending on the severity of the violation.
Although no simple set of principles or documents can fully capture the complexity of the laws, rules, and regulations that govern the work of federal scientists, it s up to each member of the NIH staff to be aware of their responsibilities, the basic principles that govern all of their official duty activities and outside activities, and where to seek help if they have any questions about a proposed course of action. I hope this column assists in achieving that objective.
That said, I believe that the vast majority of intramural scientists make every effort to comply with the myriad rules imposed upon them and that we must craft carefully any additional requirements to minimize additional time and effort.
Michael Gottesman, DDIR
|LETTER TO THE EDITOR|
To the Catalyst,
I was pleased to read the article on the Bench-to-Bedside resiniferatoxin research project in the last issue ("Bench-to-Bedside Journey to Morocco: Novel Strategy to Vanquish Intractable Cancer PainResiniferatoxin at Threshold of Clinical Trial," The NIH Catalyst, May-June 2006).
I was especially pleased to see that the pioneering work in this field by my colleague Peter Blumberg [senior investigator, Laboratory of Cellular Carcinogenesis and Tumor Promotion, NCI] was duly noted in a footnote to the article.
This gives me the opportunity to remark on how the critical discoveries of NIH scientists like Blumberg fuel not only their own continuing research but that of other NIH scientists who may or may not directly collaborate with them but who learn from them and readily express their indebtedness to them.
In the case of the very rewarding Bench-to-Bedside research of [Michael] Iadarola and [Andrew] Mannes and others, which has painstakingly tested and refined a promising approach to the relief of excruciating painculminating in a commercial-grade product on the brink of human trialsthere is a foundation built by Blumberg. Blumberg discovered the resiniferatoxin-capsaicin connection, discovered the ability of resiniferatoxin to downregulate pain, and showed that it had a receptor (which resulted in the cloning of the receptorTRPV1).
Blumberg continues to lead the field in TRP receptors and pain and is developing analogues of resiniferatoxin to use clinically.
Needless to say, the NIH infrastructure promotes not only the freedom to pursue at length tantalizing questions but also the cross-talk among basic and clinical researchers working in different institutes that electrifies the atmosphere around here.
Congratulations all around!
Stuart H. Yuspa, Chief,
Laboratory of Cellular Carcinogenesis and Tumor Promotion, NCI
Speaking of cross-talk, see the Interinstitute Interest Group DirectoryEd.
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