August
16, 2001
To: |
IC Directors |
From: |
Director, Executive Secretariat |
Subject: |
IC Directors' Meeting Highlights
— July 26, 2001 |
I. Findings Regarding the Use of Icelandic Biobanks
and Databases by NIH Intramural and Extramural Investigators
Dr. Skirboll reported that US regulations
do not appear to prohibit use of the Icelandic Health Sector Database
or the Icelandic biobanks (both of which are still under development)
by NIH intramural or extramural investigators. However, we have no official
confirmation of this from the Office for Human Research Protections (OHRP).
In response to questions about whether our scientists will be allowed
access to this material, Dr. Skirboll said, first, that the Icelandic
government owns the data. DeCODE Genetics has a 12-year license to operate
the Database for the government, but deCODE is not believed to have the
right to deny access to anyone who meets the access requirements that
will be developed by the Icelandic government. The exact criteria and
process for gaining access are not yet clear. Dr. Skirboll reviewed the
rules for the creation of the Health Sector Database and howresearch will
be conducted using the Database. For more information on the Health Sector
Database, see the following web address: http://www.decode.com/resources/ihd/.
Unlike the Health Sector Database, the biobanks
will not be maintained as one centralized bank. In addition, individual
consent will be required for inclusion of each sample obtained specifically
for a biobank. Dr. Skirboll said the Icelandic Health Delegation indicated
that human biological material maintained in the biobanks will not be
linked to the Health Sector Database. She explained how researchers
will be able to access materials in the biobanks; specifically, consent
will be required and collaboration with an Icelandic scientist may be
required. The rules governing researchers' access to the biobanks are
in an early stage of development.
The Icelandic government has indicated that it welcomes
NIH input. Iceland has invited us to continue the dialogue at a meeting
in Iceland in September. FIC intends to send a representative, and Dr.
Kirschstein will determine whether NIH should send additional representatives.
Dr. Freire said this was a very contentious topic at a recent meeting
of the European Union. She believes we should pursue the dialogue.
To determine if and how researchers are being permitted
access to Icelandic data and biobanks, Dr. Skirboll will identify US
organizations that are beginning to collaborate on research studies
with Iceland. It was noted that NIA has a long-standing collaboration
with Iceland, which does not involve the Health Sector Database. Drs.
Skirboll, Collins, Hodes, and Keusch will also pursue this issue further
to determine the current status of the development of Iceland's data
resources and the rules that will govern researchers' access to these
resources. When more is known about the rules for the development of
and access to Iceland's Health Sector Database and biobanks, Dr. Skirboll
will contact Dr. Koski about OHRP's position on whether Iceland's requirements
are compatible with the DHHS regulation for the protection of human
subjects (45 CFR 46).
II. Information Items
Dr. Collins and Dr. Maddox have been
asked to provide advice about a large-scale genetic epidemiology study
being established by the Marshfield Clinic. Dr. Collins suggested inviting
the Clinic's leadership to address IC Directors in a few months.
Dr. Kirschstein distributed a draft schedule for
the Secretary's visit next month. IC Directors agreed that they would
like to meet with the Secretary early in the week in addition to the
scheduled lunch with him on Friday.
Dr. Kirschstein noted that several organizations
(including groups representing victims of Alzheimer's disease and spinal
cord paralysis) are interested in having a semi-postal stamp similar
to the one for breast cancer. The breast cancer stamp has generated
approximately $12 million since it was issued. Dr. Kirschstein believes
interest in these semi-postal stamps will continue to grow. The postal
regulations require applicants to include a letter from an executive
agency certifying that it is able and willing to process the funds generated
by such a stamp. The group concluded that it would be appropriate for
NIH to draft a neutral letter that certified its capacity to process
revenues from stamps without endorsing any particular proposal. Mr.
Itteilag will investigate setting up funds for no-year money, which
would also be required. Ms. Kvochak noted that OGC must clear anything
that NIH sends to the Postal Service. She will check on their regulations.
Dr. Freire suggested exploring whether and how the NIH Foundation could
be involved.
Dr. Kirschstein reminded the group to review their
research portfolios related to NIBIB as discussed in her memo of July
24. Dr. Spiegel raised questions about the bioengineering partnerships.
Dr. Baldwin said this has been discussed extensively at BECON, and that
group concluded the partnerships have been a useful mechanism. There
is also a question of whether to require ICs to accept further in advance
of the receipt date applications that exceed $500,000. Guidelines are
being drafted to cover this issue. Dr. Kirschstein announced that Drs.
Tabak and Katz will chair the search committee for a NIBIB Director.
Dr. Keusch updated the group on the stigma initiative.
FIC and 10 ICs, plus CDC, SAMHSA, NSF, and other national and international
organizations, will hold an international meeting entitled "Stigma
and Global Health: Developing a Research Agenda," in Bethesda,
September 5-7. Half the participants are expected to be from developing
countries. An RFA for behavioral and social science research on the
determinants of stigma may follow. Dr. Keusch will invite all IC Directors
to the meeting.
Dr. Sieving wants to reposition NEI within the neurosciences
community. He is reviewing the Institute's intramural program and believes
there are major opportunities there. He plans to consult with other
IC Directors.
Dr. Penn reported that Representatives Lane Evans
(D-IL), Jim McDermott (D-WA), Carolyn Maloney (D-NY), and Roscoe Bartlett
(R-MD) and 45 Hill staffers visited NINDS on July 23 to discuss Parkinson's
disease. They heard discussions of the genetics of Parkinson's and of
experimental therapies, including use of stem cells and surgery. The
visit went very well.
Dr. Penn also mentioned the opening of a new brain
exhibit at the Smithsonian, supported by NIDA, NIMH, and NINDS. The
exhibit is very interactive and appeals to children of all ages. It
is located in the Arts and Industries Building and will be on display
for the next six months.
Dr. Collins reported on a recent genomics workshop
on haplotype mapping. It produced a strong endorsement to
generate such a map for Homo sapiens. He also mentioned a meeting that
took place two days ago to discuss future Public-Private Partnerships.
He said it was a very interesting meeting, attended by high-ranking
R&D directors of more than a dozen pharmaceutical companies. One
biotech company was upset at not being included, but ultimately it was
invited. Based on the success of the meeting, the Wellcome Trust plans
to convene the group every four months or so.
Dr. Baldwin discussed a recent legal setback in
which we lost the first round in a court case that will require us to
release the names and addresses of PIs on unfunded applications. Ms.
Kvochak suggested that a legislative change is our best hope. Dr. Kirschstein
will discuss the next steps with Ms. Kvochak and Dr. Baldwin.
The Surgeon General plans to hold a workshop on
health disparities for people with mental retardation, and he has asked
NICHD to take the lead. Dr. Alexander will distribute a list of those
ICs and agencies that are already participating. Other interested IC
Directors should contact him.
Karen Pelham O'Steen
cc: OD Staff
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