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Vannier, Michael
05-27-2002, 08:51 PM
The AAMC position on data sharing is disappointing.
mv

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Michael W. Vannier, MD
Department of Radiology
University of Iowa
200 Hawkins Drive, 3966 JPP
Iowa City, IA 52242

michael-vannier@uiowa.edu


May 24, 2002- The AAMC has submitted a letter in response to a request for
comments on the March 1 NIH draft statement on the sharing of research data.
The policy described in the NIH statement would require applicants for NIH
funding to propose data sharing plans (or offer an explanation of why data
will not be shared) within grant applications. The adequacy of an
investigator's data sharing plan would be assessed during the scientific
review of grant applications. The AAMC, while endorsing new initiatives to
encourage data-sharing, is concerned that requiring investigators to devise
specific data-sharing plans at the time of grant application is premature.
The AAMC is also concerned that the data-sharing proposal does not fully
acknowledge the constraints that the federal medical privacy rule will place
on the sharing of data from clinical trials. The AAMC encourages NIH to
support the establishment of expert advisory panels to seek consensus on
normative data-sharing practices within the various scientific disciplines.
Comments on the NIH proposal must be submitted by June 1.

Information:

Jennifer Kulynych, Director
AAMC Division of Biomedical and Health Sciences Research jkulynych@aamc.org
(202) 828-0484


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Comment Letter on NIH Data Sharing Proposal

May 10, 2002

Wendy Baldwin, Ph. D.
Deputy Director for Extramural Research
Office of Extramural Research
1 Center Drive, MSC 0152
Building 1, Room 150
Bethesda, MD 20817

Dear Dr. Baldwin:

The Association of American Medical Colleges (AAMC) welcomes this
opportunity to comment on the March 1, 2002 NIH draft federal policy
regarding the sharing of research data. Pursuant to this policy, applicants
for NIH funding would be required to propose data sharing plans (or offer an
explanations for why data will not be shared) within grant applications. The
adequacy of an investigator's data sharing plan (or the rationale for
declining to share data) would be assessed during the scientific review of
grant applications. The AAMC, while fully endorsing the laudable aims of
this initiative, shares the concern expressed by the Federation of American
Societies for Experimental Biology (FASEB) that a policy requiring
investigators to devise data-sharing plans when preparing grant applications
is premature and in some cases, unworkable. We also concur with FASEB that
review of an investigator's data sharing plan should be handled by NIH as an
administrative matter external to the peer review process.

The AAMC represents the nation's 125 accredited medical schools, nearly 400
major teaching hospitals and health care systems, more than 105,000 faculty
in 98 academic and scientific societies, and the nation's 66,000 medical
students and 97,000 residents. As an association of researchers and research
institutions, we strongly support the principles that underlie the proposed
data sharing policy and endorse efforts by the NIH to facilitate and
encourage the sharing of research data created with federal funds. Moreover,
we believe that establishing standards for data sharing will become ever
more important as biomedical research addresses increasingly complex
problems with technologies of unprecedented power and scope. At present,
however, there are numerous cultural, technical, and legal obstacles to a
workable uniform federal policy for data-sharing. Certain of these obstacles
are detailed in the comment letter submitted by FASEB and include the
variability of normative data sharing practices across disciplines,
especially in emerging disciplines, difficulties in defining "final" data at
the outset of an experiment, and the need to protect the intellectual
property rights of investigators and institutions.

AAMC believes that effective policies to promote data sharing will require
creative, discipline-specific solutions to these complicated problems. We
recommend that prior to mandating data-sharing proposals, NIH should convene
advisory panels composed of experts in the various scientific disciplines
and charge them with devising standards and normative practices for data
sharing within their respective fields of research. Once consensus is
achieved, a grant applicant could be asked to describe data-sharing plans
with reference to agreed-upon standards for researchers in the applicant's
field. In making this recommendation we note that NIH describes the proposed
data sharing policy as "an extension of the agency's policy regarding
sharing research resources." Those guidelines and policies were developed by
a distinguished ad hoc working group after lengthy deliberations. The
development of proposals for sharing biomedical research data merits a
similarly thoughtful and deliberative approach.

As the NIH policy statement recognizes, clinical data are sensitive and
require special safeguards to prevent breaches of patient privacy and
confidentiality. Under the new federal regulatory regime for the protection
of medical privacy, the sharing of clinical data for research may only occur
in conformance with detailed new rules. Entities covered by the privacy
rule, including teaching hospitals and healthcare providers, face extensive
liability for infractions of these rules and must make difficult judgements
about when, and with whom, they will share patient data for research
purposes. Researchers who create data in a clinical context may not be in a
position to obligate the responsible covered entity, in advance of the
creation of the data, to a data-sharing scheme that involves unknown
recipients and unspecified research purposes.

The proposed NIH data-sharing policy does anticipate that researchers would
remove patient identifiers before sharing clinical data. Yet the statement
fails to acknowledge the scientific and practical difficulties involved in
creating data sets that are "de-identified" to the exacting standards of the
privacy rule. We are particularly concerned that the draft NIH data-sharing
statement would require researchers sharing clinical data to "ensure" that
individual subjects of the data cannot be identified. This requirement would
be impossible for any researcher - or any covered entity - to satisfy. The
structure of the "de-identification" provisions of the medical privacy rule
reflects the fact that most patient-level data are identifiable to an
estimable degree of probability when combined with other publicly available
information. The privacy rule creates avenues for reducing the probability
of re-identification, but does not - and could not - require covered
entities to ensure that subjects cannot be re-identified.

To address the special concerns that arise with the sharing of clinical
data, we suggest that the NIH should fund demonstration projects to create
data enclaves that the Department of Health and Human Services would certify
as "HIPAA-compliant." Such certification might enable researchers more
easily to obtain needed waivers of authorization under the privacy rule for
disclosure of clinical data to a data enclave. Of course, any NIH
data-sharing policy must recognize that under the privacy rule, the research
use of clinical data disclosed pursuant to a waiver and stored in a data
enclave or repository would require a protocol-specific waiver or patient
authorization. Thus, mere creation of the enclave or repository would not
ensure that the research community has ready access to the stored clinical
data.

The difficulties inherent in the sharing of clinical data under the new
federal medical privacy rule are emblematic of the discipline, or field,
specific problems that standards for biomedical research data sharing raise.
We would imagine that equally challenging problems would arise with respect
to developing sharing protocols for nucleic acid and proteomic arrays, for
example. Accordingly, while endorsing NIH's desire to begin the process of
developing such standards, we urge that the process be undertaken
deliberately and in steps, with adequate input from scientific advisory
committees expert in the particularities of the various research disciplines
and areas. We also remind that efforts to deal with the matter of biomedical
research data sharing began more than a decade ago under the aegis of the
former OSIR. That so little has been accomplished in the interim perhaps
bespeaks the difficulty of the problem and the need to proceed cautiously.

Sincerely,

Jordan J. Cohen, M.D.

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