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IC Directors' Meeting Highlights

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:

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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