Chairman Horn, Mr. Turner and other members of the Subcommittee on Government
Management, Information and Technology. I am Harold Varmus, the Director of the National
Institutes of Health. I am pleased to be here today to testify about H.R. 88, a bill
authored by your colleague George Brown, the Ranking Member of the Science Committee, and
a long-time advocate of openness in scientific research.
I too am an advocate for openness in scientific research. Exchanging ideas and sharing
data are absolutely vital to the success of biomedical research. They are the hallmarks of
the success of the NIH research programs. The true understanding of the breakthroughs we
are making in genetics research, medical imaging, clinical research, and all other
scientific investigation funded by NIH could not be accomplished without public access to
methods and data.
Openness has many virtues. It fosters trust in scientific outcomes as well as trust in
the use of federal dollars to conduct biomedical research. It engenders faith that human
subjects and animals participating in research trials are adequately protected. And it
sparks technological innovations that help us find the answers to public health problems.
However, we know that the requirements in different scientific fields vary and that great
care must be taken in crafting such strategies. There are many examples of responsible
data-sharing at NIH. The remarkable strides we are making in our understanding of the
genetic components of various diseases would not be possible without the sharing of data.
Also, NIH's firm stance regarding the patenting of early DNA sequencing data has ensured
that such data are easily available to the scientific community.
And we require that coordinate data developed by x-ray crystallographers be made
available at the time of publication in a peer reviewed journal. In these cases, and many
others, we promote openness.
But a word of caution. I think it would be a mistake to open all underlying scientific
data to public scrutiny simply because of the concept that all openness is good. There are
pitfalls in unrestrained openness, including unwarranted violations of privacy, the
potential harassment of scientific investigators and the chilling effect that
inappropriate public scrutiny could have on the free exchange of ideas and the willingness
to take risks to find answers.
The amendment to OMB circular A-110 contained in Public Law 105-277 could have
unintended, but nonetheless grave consequences. The regulatory requirements embodied in
the law are far more complex than the apparently simple mandate to share data. The kind of
widespread access to data envisioned by the Act could result in unforeseen abuses. Unless
otherwise protected, patient privacy rights could be violated. The willingness of
scientists to speak openly about new ideas and take experimental risks could be fettered
by unrestricted data access. Further, I am concerned that inappropriate sharing of
preliminary data could lead to misinterpretation of results. Finally, the new requirements
could undercut the ability of researchers to build private sector partnerships that now
lead to the eventual marketing of products.
It is because of these concerns that we at NIH have taken the position that, while
expanded access to scientific data should be encouraged, the A-110 amendment may be a poor
vehicle to achieve this goal. I am particularly concerned about the legislation's requirement that the Freedom
of Information Act (FOIA) be the tool of regulatory implementation. FOIA was not designed
to accommodate the confidentiality requirements of the most sensitive scientific data.
Consequently, without additional protections, it would be possible for the privacy of
patients to be compromised or individual scientists to be harassed by selected interests
opposed to their work due to moral or financial concerns. Such intrusions could stop
promising scientific research in its tracks, and the mere threat of such intrusions could
impede the Nation's efforts to recruit its most talented students into publicly-supported research.
For example, imagine what would happen if HIV-infected patients thought their condition
might be revealed by someone using the new requirements to examine raw experimental data.
Patients would not participate in clinical trials if they believed there was an
opportunity for their infected status to be revealed. Progress toward treatment of the
disease would be stymied.
Under this new application of FOIA embodied in the A-110 amendment, a request for
research data would be directed to federal agencies, such as NIH. We would be required to
forward the request to grantee institutions and to the scientists with direct
responsibility for the data. Their data often contains information about individuals who
entered into the research project under a promise of confidentiality. This information
would be forwarded from grantee institutions to federal agencies, who would be responsible
for determining what to release and what to exempt.
It may sound simple to make that determination, but it is not. FOIA would allow the
government agency to remove obvious identifiers such as name, Social Security number,
telephone number, but in a given data set it is quite feasible to identify subjects using
other information. If the requestor knew a few items about an individual's history, such
as place of birth, education, occupation, marital history, or other general information,
an individual could be identified. Such identification would then open up the whole
research record, including personal medical information to the requestor.
While there are many aspects of the A-110 amendment that trouble us, there is a
particular provision that presents a new challenge to those who would make their data
accessible. I am thinking about the multiplicity of partnerships between public sector
researchers and private companies, non-profit organizations, and even foreign governments.
Some of these partnerships make strict requirements on the researcher not to share data
further. Without such agreements, private researchers would not participate in these
In regard to proprietary data, the Bayh-Dole Act specifically provides protections for
the intellectual property of individual researchers. But the A-110 amendment threatens
these protections for our partners. Industry scientists may avoid collaborations with
publicly-funded institutions, including universities, if they believe they can no longer
protect their data from exposure.
The A-110 amendment will lead to increases in administrative burdens and cost for
granting agencies, such as NIH, but also for grantees. Universities and other institutions
that receive Federal grants will need to create formalized procedures to respond to FOIA
requests. Increased administrative costs are not in themselves a reason not to move
forward with policies in the public interest, but we would like to ensure that the
benefits are commensurate with the costs. Increased administrative costs will come at the
expense of research, in both dollars and in investigator time. The paperwork that requests
will generate is enormous and counter to the reduction in paperwork efforts. Entire staffs
will have to be recruited to make the decisions that will have to be made, with consequent
increases in costs of conducting research.
In addition to the administrative burdens, the A-110 amendment is likely to lead to the
filing of lawsuits by individuals or organizations whose requests for data are rejected,
which would be costly to the government and private institutions that perform
I am aware that the Administration is working to implement the A110 amendment in the
least intrusive manner possible. However, it is my view that on balance, you should
support H.R. 88 and repeal the A-110 amendment. Taking such action will not mean the end
of data access. It will signal the beginning of efforts to establish a more responsible
approach to data sharing, one that will protect the rights of individuals, recognize the
proprietary interests of commercial enterprises, and consider the needs of the scientific
community. I pledge to work with you and your colleagues toward those efforts. I would be
pleased to answer any questions you may have.