GUIDING PRINCIPLES AND ETHICAL PRACTICES
 |
| MICHAEL GOTTESMAN |
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
<http://ethics.od.nih.gov/cbt.htm>
<http://ohsr.od.nih.gov/cbt/cbt.html>
<http://tttraining.od.nih.gov/>
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
<http://ohsr.od.nih.gov/info/DDIR_memo.html> and <http://ohsr.od.nih.gov/info/sheet14.html>.
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 technology transfer questions, check with your
technology development coordinator or the Office
of Technology Transfer.
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