National Advisory Council for Human Genome Research - Summary of Meeting

National Advisory Council for Human Genome Research
Summary of Meeting

Chevy Chase, Md.

May 20-21, 1996

The National Advisory Council for Human Genome Research (NACHGR) was convened for its seventeenth meeting at 8:30 a.m. on May 20, 1996, at the Holiday Inn, Chevy Chase, Md. Dr. Francis Collins, Director of the National Center for Human Genome Research, called the meeting to order.

The meeting was open to the public from 9:30 a.m. to 4:30 p.m. on May 20. In accordance with the provisions of Public Law 92-463, the meeting was closed to the public from 4:30 p.m. on May 20 to adjournment on May 21 for the review, discussion and evaluation of grant applications.

Council members present:

Dr. Anita Allen
Dr. Lennette Benjamin
Dr. Leroy Hood
Dr. Ellen Wright Clayton
Dr. David Cox**
Dr. Troy Duster
Dr. Richard Mathies**
Dr. Lloyd Smith
Dr. M. Anne Spence
Dr. Shirley Tilghman
Dr. David Valle
Dr. Robert Waterston*
Dr. Barbara Wold**

Council members absent:

Dr. R. Daniel Camerini-Otero
Dr. David Housman
Dr. Rodney Rothstein
Dr. Diane Smith

* Ad Hoc member
** Appointment pending

Liaisons from Professional Societies:

Dr. Beverly Emanuel, American Society of Human Genetics
Ms. Rosalie Goldberg, National Society of Genetic Counselors
Dr. Kurt Hirschhorn, American College of Medical Genetics

Staff from the National Center for Human Genome Research:

Jane Ades, Committee Management Officer
David Benton, Assistant to the Director for Scientific Data Management
Les Biesecker, DIR
Karina Boehm, Education Coordinator
Joy Boyer, Program Analyst
Erin Burgess, Budget Officer
Jean Cahill, Grants Management Officer
Francis Collins, Director
Linda Engel, Chief, Office of Scientific Review
Elise Feingold, Program Director, Mapping Technology Branch
Leslie Fink, Chief, Office of Communications
Mary Glynn, Personnel Officer
Bettie Graham, Chief, Mapping Technology Branch
Mark Guyer, Assistant Director for Program Coordination
Linda Hall, Grants Management Specialist
Kathy Hudson, Assistant Director for Policy Coordination
Elke Jordan, Deputy Director
Jean McKay, Program Policy Analyst
Tara Mowery, Grants Technical Assistant
Kenji Nakamura, Scientific Review Administrator
Diane Patterson, Grants Management Specialist
Jane Paull, Grants Technical Assistant
Jane Peterson, Chief, Mammalian Genomics Branch
Rudy Pozzatti, Health Scientist Administrator
Charlotte Quinn, Program Assistant
Michael Royal, Budget Analyst
Jeffery Schloss, Program Director, Mammalian Genomics Branch
Megan Sexauer, Legislative Analyst
Mathew Thomas, DIR
Elizabeth Thomson, Acting Chief, Ethical, Legal, and Social Implications Branch
Jeffrey Trent, Scientific Director, DIR
James Vennetti, Executive Officer
Margaret Whittington, Program Assistant

Others present for all or a portion of the meeting:

Robert Boyd, Knight-Ridder
Wylie Burke, University of Washington
Cheryl Corsaro, DRG
Pieter de Jong, Roswell Park Cancer Institute
Dan Drell, Department of Energy
Machi Dilworth, National Science Foundation
Robert Green
Elliot Marshall, Science
Mary Moy, SRI International
Al Nugent, Midwest Research Institute
Kathy O'Donoghue, College of American Pathologists
Katherine O'Keefe, Eugenics Watch
David Page, Whitehead Institute for Biomedical Research
Ari Patrinos, Department of Energy
Liz Pennisi, Science
C. Peterson, SRI
Sara Radcliffe, SmithKline Beecham
Steven Rose, Department of Energy
Hiroaki Shizuya, California Institute of Technology
Jay Snoddy, Department of Energy
Marion Stedolsky, Department of Energy
Susan Wallace, HUGO
Joan Weiss, Alliance of Genetic Support Groups
Lisa White, "The Blue Sheet"

INTRODUCTION OF NEW COUNCIL MEMBERS, AD HOC MEMBERS, LIAISONS, VISITORS, AND NEW STAFF

Dr. Jordan introduced new Council members Dr. David Cox, Dr. Richard Mathies, and Dr. Barbara Wold; ad hoc member Dr. Robert Waterston; Dr. Wylie Burke, who would make the scientific presentation to council; Dr. David Page, a visitor from the Whitehead Institute for Biomedical Research; and the liaisons to the council from the professional societies: Dr. Kurt Hirschhorn, representing the American College of Medical Genetics; Dr. Beverly Emanuel, representing the American Society of Human Genetics; and, Ms. Rosalie Goldberg, representing the National Society of Genetic Counselors. Dr. Jordan also introduced Dr. Eric Meslin, who joins the NCHGR in July as the Chief of the ELSI Branch; Dr. Megan Sexauer, the NCHGR Legislative Officer; and Ms. Margaret Whittington, Program Assistant in the Mammalian Genomics Branch.

APPROVAL OF MINUTES

The minutes from the February 5-6, 1996 NACHGR) meeting were approved as amended by Dr. Clayton: on page 7, last paragraph, delete "... is advocating that oncologists make BRCA1 testing routinely available" and replace with "... believes that oncologists may appropriately offer BRCA1 testing with extensive counseling in the clinical setting."

FUTURE MEETING DATES

September 16-17, 1996, January 27-28, 1997, and May 19-20, 1997 were approved for future council meetings.

DIRECTOR'S REPORT

NIH Reauthorization Hearings

On March 6-7, the Senate Labor and Human Resources Committee held a hearing in preparation for the reauthorization of NIH. The hearing was chaired by Senator Nancy Kassebaum and was well-attended by the members of the Committee. Witnesses included Dr. Varmus and fifteen National Institutes of Health (NIH) institutes, centers, divisions and office directors grouped into panels: cancer, genetics and the environment; neuroscience; infrastructure; chronic disabling diseases; and infectious diseases. During the hearing, Senator Harkin asked whether genetic information was included in the health insurance reform bill, which, at the time of the hearing, it was not. Dr. Collins noted that, as a result of Senator Harkin's question, he was given an opportunity to respond in writing to Senators Harkin and Hatfield on this issue. The insertion of the term "genetic information" was ultimately included in the Kassebaum-Kennedy bill as a technical correction by Senator Kassebaum.

Health Insurance Reform

Dr. Collins recognized the substantial contribution of the joint ELSI Working Group-National Action Plan on Breast Cancer recommendations on genetic information and health insurance discrimination. The recommendations, which were endorsed by Council, have been widely cited and incorporated into several bills dealing with health insurance reform. In response to a question asked by Dr. Lloyd Smith, Dr. Collins noted that the House and Senate health insurance reform bills are sensitive to the potential ramifications that these bills may have on the insurance industry. Both the Senate and the House bills included provisions that allowed insurers to impose a limitation or exclusion of benefits for up to one year for pre-existing conditions. However, the period of limitation must be reduced by one month for every previously covered month. Therefore, insurers may not impose exclusions if an individual has held health insurance for the previous twelve months.

The House insurance reform bill passed in March by a vote of 267-151; the Senate bill passed in April by a vote of 100 - 0. However, there are differences in the bills (but not in the treatment of genetic information) that will be resolved in conference: the House bill contained medical savings accounts and caps on medical liability and malpractice; the Senate bill contained parity for the coverage of mental health.

Dr. Collins also mentioned that The Genome Action Coalition (TGAC) worked hard to ensure that health insurance reform bills include language that prohibit denial or limitation of coverage based on genetic information.

FY 1997 Appropriations Hearings

The House appropriations hearings for NIH were held April 18-26; the NCHGR testified on April 23. Dr. Collins reported that the hearings went well and that Congressman Porter, who chairs the House Appropriations Committee, has proposed a 6.5 percent increase for NIH in FY 1997. The issues discussed with the Committee included ELSI, gene patenting, and BRCA1 testing. The Senate appropriations hearings are scheduled for May 23 [Note: these hearings were rescheduled and held June 18]. A shutdown of the government, like the one that occurred in FY 1996, is not expected in FY 1997, though a continuing resolution is possible; it is hoped that an FY 1997 budget will be passed by October 1, 1996.

Task Force on Genetic Testing

A year ago, the Task Force on Genetic Testing held their first meeting; since then, the group has met three additional times. In mid-March, the Task Force released for public comment their Interim Principles, which will form the basis of their final recommendations. The Interim Principles were mailed to council members in April. The Interim Principles are also available on the World Wide Web. Written comments are being accepted by the Task Force until May 31, 1996. Dr. David Cox, a member of the Task Force, noted that the members of the Task Force, who represent nearly all the stakeholders and bring diverse points of view to the table, have worked extremely well together and have shown a willingness to see other points of view on particular issues. Dr. Cox identified three major issues facing the Task Force: how to implement the recommendations developed from these principles; defining "medical research" and "medical care" with respect to genetic tests; and education about and accessibility of genetic tests. The Task Force will meet again on September 24-25; it is anticipated that their work will be completed by the end of 1996.

Cancer Genetics Network

The Director of the National Cancer Institute (NCI), Dr. Richard Klausner, has created a Cancer Genetics Working Group that has begun to develop a plan for a National Cancer Genetics Network. It is envisioned as a network of health care providers and researchers linked as a cooperative research group to address the many questions about genetic predisposition to cancer. The goals of the network are to:

• Provide a mechanism to learn about outcomes for those who seek and receive testing through longitudinal observational studies.
• Provide a mechanism for dissemination of information and education to providers about genetics and cancer.
• Enable utilization of national IRB-approved protocols for testing.
• Provide for development of confidential registries and other research resources.
• Provide for a mechanism to communicate information confidentially.
• Provide infrastructure to facilitate studies about all aspects of cancer genetics.

The Cancer Genetics Working Group has established three subcommittees:

1. Protocol development (chaired by Ken Offit)
2. Informatics (chaired by Ken Buetow)
3. Information/Education (co-chaired by Judy Garber, Mary Jo Kahn, and Reed Pyeritz)

Council members raised questions and concerns about the Cancer Genetics Network, including restricting provision of cancer genetic testing to IRB-approved protocols (to which some members of industry have expressed objection), and reimbursement for genetic testing and genetic services. Dr. Collins noted that the Cancer Genetics Network has outlined an ambitious agenda.

Dr. Collins also called council's attention to the statement on genetic testing recently published by the American Society of Clinical Oncologists in the Journal of Clinical Oncology (vol. 14, no. 5, May 1996), and the accompanying commentaries from the National Breast Cancer Coalition, the National Action Plan on Breast Cancer, and Myriad Genetics, Inc.

Health Professional Education

Dr. Collins described two efforts that are underway to address the genetics education of health care professionals. The National Action Plan on Breast Cancer (NAPBC) Hereditary Susceptibility Working Group and the American Society of Clinical Oncology co-sponsored a workshop on April 10, entitled "Preparing Health Care Providers for a New Era of Practice: Hereditary Susceptibility to Breast and Ovarian Cancer." The meeting included many health professional organizations, who agreed that primary care organizations need to educate their members about cancer genetics, and a consensus statement has been drafted for endorsement by the meeting participants. The NAPBC developed an outline for a proposed curriculum that identifies the core information that health care providers need to know when working with patients who present for cancer risk assessment. The curriculum is being reviewed by the meeting participants.

The NCHGR is working with the American Medical Association (AMA) and the American Nurses Association (ANA) on a proposal to establish a National Coalition for Health Professional Education in Genetics. The efforts of the proposed coalition will be aimed at physicians, nurses, physician assistants and allied health professionals. There will be a meeting of the Steering Committee in late July to further discuss the formation of the coalition and to identify its priorities. The Steering Committee members will include representatives from consumer organizations, medical professional organizations, nursing professional organizations, and genetics professional organizations. Dr. Clayton noted that the American Academy of Pediatrics is not represented by the AMA. Dr. Benjamin added that thought needs to be given about how to incorporate knowledge into practice. Dr. Wold suggested that information about these efforts be made available on the World Wide Web. Overall, the council was enthusiastic about these efforts.

Completion of Human and Mouse Maps

Dr. Collins noted the publication in Nature of the completion of comprehensive genetic maps of the human (Jean Weissenbach and colleagues) and of the mouse (Eric Lander and colleagues), which effectively achieves the goals of the genetic mapping phase of the Human Genome Project (HGP).

Completion of the Yeast Sequence

Dr. Collins also mentioned the announcement of the completion of the DNA sequence of Saccharomyces cerevisiae, which, for the first time, gives scientists an opportunity to obtain a comprehensive look at how all genes in a eukaryotic cell function as an integrated system. The yeast sequencing initiative involved 92 labs in Europe, as well as several labs in the U.S. Dr. Andre Goffeau in Belgium coordinated the European efforts. U.S. labs at Stanford (Ron Davis) and Washington University in St. Louis (Mark Johnston) collectively sequenced about 21 percent of the yeast genome. Their work was supported by NCHGR.

DNA Sequencing Grants Patent Policy

In April, the NCHGR made six awards for pilot human sequencing projects. It is expected that these projects will yield 100 megabases over a two-year period, at approximately fifty cents per base pair. As part of the award, each grantee institution proposed a policy to make DNA sequence information generated by their project available as rapidly and as freely as possible. There was some discussion among council members about whether or not such a policy makes sense for human DNA: early release of short stretches of sequence data may be confusing. Dr. Collins noted that it was likely that short stretches of sequence data would be available at the grantee's institution, and that larger blocks of assembled sequence data will be deposited in GenBank. The spirit of the policy is to ensure that sequence information generated by the grantees will flow through the system, and not be held for a long period of time at the originating institution. Dr. Collins stated that the other piece of the policy dealt with patenting. It was thought that the sequence data alone would not likely meet the utility criteria for patenting. NCHGR will continue to monitor and evaluate the outcome of the policy.

Planned Workshop with Howard Hughes Medical Institute

The NCHGR and the Howard Hughes Medical Institute (HHMI) will co-sponsor a workshop, in September 1996, to discuss new scientific opportunities that will be made possible upon the completion of the sequence of the human genome. This workshop will follow-up on some of the topics covered at the December 8, 1995 symposium sponsored by NCHGR, entitled "Visions of Sequenced Based Biology." The NCHGR-HHMI workshop will include about 30 to 40 genome and non-genome scientists. Council members were asked to submit their suggestions for participants to Dr. Elke Jordan.

ELSI PROGRAM REVIEW

Ms. Elizabeth Thomson, the Acting Chief of the NCHGR Ethical, Legal and Social Implications (ELSI) Branch, gave a brief overview of the five-year review of the NCHGR ELSI Research Program, which she has recently completed. She described the ELSI Research Program mission, goals, and high priority areas. Current program priority areas include:

• Fair use of genetic information.
• Clinical integration of genetic technologies.
• Issues surrounding genetics research.
• Public and professional education.

Ms. Thomson noted that 46 percent of the principal investigators (PI) of NCHGR ELSI-funded projects are women; ELSI-funded investigators come from diverse backgrounds and many are first time applicants to the NIH; 45 percent of the projects currently funded have significant minority components; and the ELSI grant success rate in FY94 was 15.8 percent and in FY95 was 16.4 percent.

Dr. Duster, on behalf of the ELSI Working Group, thanked Ms. Thomson for her efforts over the past two years as the Acting Chief of the ELSI Branch. Dr. Collins complimented Ms. Thomson on the five year review of the ELSI Program.

SCIENTIFIC PRESENTATION: DR. WYLIE BURKE

Dr. Burke, a member of the NCHGR-supported Cancer Genetics Studies Consortium (CGSC), reported on a recent activity of the CGSC to develop recommendations for cancer surveillance and prevention for individuals who have mutations in their BRCA1, BRCA2, and HNPCC genes. In order to develop consensus on these recommendations, the CGSC carried out an extensive review of published studies of cancer risk, surveillance and prevention. The recommendations that were published in each study were assessed using the criteria of the U.S. Preventive Services Task Force. The CGSC concluded that, while progress in understanding the molecular basis of cancer has led to the possibility of genetic testing and identification of individuals at increased risk for cancer, the effectiveness of cancer surveillance in these individuals remains unknown. The group recommended that individuals considering cancer genetic testing be thoroughly counseled regarding the uncertainty of the benefits of the available surveillance options and be actively involved in choosing their course of follow up. Recommendations for surveillance are likely to be revised as new evidence emerges. The results of the CGSC deliberations have been summarized in a document, which has been submitted for publication.

ELSI WORKING GROUP MEETING OF MAY 2-3

Dr. Duster, Acting Chair of the ELSI Working Group, reported to the Council on the May 2-3 meeting and other activities of the Working Group: the Task Force on Genetic Testing issued its Interim Principles for public comment; the ELSI Working Group submitted comments on Congressman McDermott's draft bill to protect the confidentiality of health information; the ELSI Working Group's statement on stored tissue specimens will be revised and published in two to three months; and the ELSI Working Group's statement on genetic discrimination in the workplace is being revised. One of the next topics the ELSI Working Group will explore is consumer/family issues, such as how families deal with genetic information and how to involve families in a dialog about clinical genetics.

Dr. Duster outlined the issues that the ELSI Working Group would like the ELSI Working Group Evaluation Committee to consider: the changing role of the ELSI Working Group over the past several years; budget authority; reporting mechanisms; resource allocation; and representing ELSI issues. Dr. Duster noted that after the role of the ELSI Working Group is redefined, then it will be possible to determine how to move forward.

ELSI WORKING GROUP EVALUATION

The ELSI Working Group was established in 1989 as one of several working groups of the Program Advisory Committee on the Human Genome (predecessor to the NACHGR). The activities of the other working groups (e.g., sequencing, mapping) were completed or subsumed into NCHGR Branch functions. The ELSI Working Group, however, remained separate from the ELSI Branch. Over time, the organization of the NCHGR changed to meet the challenges and opportunities presented by the Human Genome Project, a vigorous intramural program, and the ELSI research and policy issues. Therefore, it was thought that an evaluation of the ELSI Working Group in the context of current and future activities would ensure that the most appropriate mechanism was in place to examine this important aspect and outcome of human genome research. Dr. Jordan noted that the evaluation of the role of the ELSI Working Group was under discussion prior to the resignation of Lori Andrews, chair and member of the ELSI Working Group.

Since the ELSI Working Group is a joint effort between the NIH and the DOE and reports to the respective advisory committees, the evaluation committee is co-chaired by representatives of these advisory committees. Dr. M. Anne Spence and Mr. Mark Rothstein agreed to chair the evaluation panel. Dr. Spence is a member of the council and Mr. Rothstein, a lawyer, was chosen by the DOE's Health and Environmental Research Advisory Committee (HERAC) as the DOE co-chair. The co-chairs selected the panel members. The council was provided with a copy of the evaluation panel charter and the roster. The panel plans to conduct several meetings, hearings and in-depth discussions with current and former members of the ELSI Working Group, NCHGR and DOE staff, members of professional societies, and other ELSI stakeholders. It is anticipated that the review panel will have completed their assessment and provided written recommendations to the council and the HERAC by the end of 1996.

In response to questions raised by several members of council regarding the scope of the review, Dr. Spence noted that the panel would assess the interactions among the components of the ELSI programs (e.g., DOE and NCHGR/ELSI research programs, NCHGR Office of Policy Coordination) and other federal advisory committees that may be similar in scope to the ELSI Working Group (e.g., National Bioethics Advisory Commission).

PROPOSAL FOR SPECIAL RECOGNITION AWARDS

The NCHGR would like to honor those who have made significant contributions to human genome research, and has proposed to name fellowships, lectures, conferences and courses after those who have made such contributions. It was proposed that nominations of retired or deceased individuals (scientists and non-scientists) be submitted by council and NCHGR staff. Nominations would be approved by council. Dr. Collins suggested that a three-year NRSA fellowship be named in honor of Dr. John Wasmuth. Dr. Wasmuth was, until his death, the director of the University of California-Irvine Genome Science and Technology Center, and was instrumental in the discovery of the genes for achondroplasia. Council was in favor of the proposal, and recommended not limiting the awards to those who have retired or are deceased. Dr. Spence made a motion to approve the implementation of the "NCHGR Lifetime Achievement Award," Dr. Tilghman seconded the motion, which was passed unanimously.

REPORT ON SEQUENCE VALIDATION WORKSHOP

Dr. Leroy Hood reported on the April 15 NCHGR Workshop on DNA Sequence Validation. The purpose of the workshop was to consider scientific approaches to the assessment of DNA sequence quality for the recently-awarded pilot projects to sequence human DNA (RFA HG-95-005). This workshop was held in response to council's recommendation that monitoring of these projects include an evaluation of the quality (completeness and accuracy) of the DNA sequence product. The major conclusions of the workshop were:

• The pilot DNA sequencing projects should strive for an error rate not to exceed 1:10,000 bases.
• The quality of individual base-calls and of the sequence assembly should each be assessed in a validation study. To the extent possible, methods for validation should be independent from those used in the initial sequence determination.
• It is desirable to check enough data from each grantee to be able to corroborate the grantee's representation of data quality.
• The minimum criterion for demonstrating the fidelity of clones used as sequencing templates should be clear evidence that the genomic region is represented by the same restriction enzyme digest pattern in at least two clones derived from independent transformation events. Greater depth of coverage is highly desirable, and is expected to be achievable in most cases.
• To support validation and for use by the community, the public databases should store quality measures on each base pair, along with map data, including depth of cloned coverage available and identification of map landmarks that are included in the sequence.

Based on these recommendations, Dr. Jeffery Schloss outlined a plan to assess the quality of the DNA sequence data produced by the pilot project grants. This assessment will likely involve a round-robin approach in which clones sequenced by each of the grantees will be validated by other pilot project grantees, and may include some complete resequencing and some restriction fragment analysis. Details of the plan will be developed in conjunction with members of a panel of advisors whose charge will be to assist the NCHGR staff in evaluating the overall progress made under these awards.

REPORT ON ACTIVITIES OF ADVISORY COMMITTEE TO THE NIH DIRECTOR

Dr. Valle reported on the March 14 meeting of advisory board members with Dr. Varmus, which was held separately from the Advisory Committee to the Director. The purpose of this meeting was to discuss the commonalities and differences in the functions of advisory councils and boards across the NIH. As a result of the group's discussions, four subcommittees were formed to address a set of issues: Intramural Research; Grant Review; Strategic Planning (Dr. Valle is a member of this subcommittee); and Advocacy. Subcommittees will report on their activities at the next meeting of the Advisory Committee to the Director.

DISCUSSION OF NIAID AND NIDDK COUNCIL RESOLUTIONS

Dr. Samuel Silverstein, a member of the National Institute of Allergy and Infectious Diseases (NIAID) advisory council, sent a letter to Dr. Collins, encouraging the NACHGR to adopt a similar resolution to that of the NIAID and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) advisory councils. This resolution states that advisory council members will speak to various public groups about the value of NIH and the benefits of biomedical research, and that the NIH director should request all NIH councils to adopt a similar resolution.

The members of the NACHGR supported the resolution, and noted that most already make presentations that describe the benefits of biomedical research and the activities of the NIH. It was also noted that a standard slide set would be useful in making these more effective presentations.

REPORT FROM THE DEPARTMENT OF ENERGY

Dr. Ari Patrinos reported on the appropriations for the Department of Energy (DOE). It is expected that the DOE will receive a decrease in funding for FY 1997. Dr. Patrinos reiterated his support for the DOE genome project, stating that even though the budgets of some DOE research programs may be decreased, the genome research efforts would not be cut. He noted that the programs supported by his office will be reorganized, and that the DOE Health and Environmental Research Advisory Committee is providing guidance to this process. The DOE genome research activities include large-scale sequencing, BAC end sequencing, and quality assessment and quality control of these activities.

ANNOUNCEMENTS

Dr. Jordan noted several items of interest, including: a recruitment announcement for the protocol to study familial cancer in the Jewish community of greater Washington, D.C.; the new NCHGR Fact Sheets describing the NCHGR, the ELSI program, positional cloning, physical mapping, genetic mapping, and DNA sequencing; information about the National Institute of Standards and Technology Advanced Technology Program; the RFA for large-scale functional analysis of the yeast genome; a list of the grants funded since the February NACHGR meeting; and a complete list of grants by goal.

Council also was provided with copies of the NCI booklet "Understanding Gene Testing." Many council members made positive comments about the booklet and requested information about how to obtain additional copies. Dr. Jordan will provide council with this information.

COUNCIL DISCUSSION

Members expressed an interest in having a presentation from the NLM National Center for Biotechnology Information. Dr. Spence reported that she attended a meeting of the GDB Advisory Committee, of which she is a member. Among the issues discussed were international participation and interaction between GDB, the NCBI and other U.S. databases, including OMIM.

CONFLICT OF INTEREST

Dr. Jordan read the Conflict of Interest statement and reminded the council members that all review materials furnished to council members are privileged information. Conflicts involving institutional affiliations already had been identified. Members were asked to absent themselves also during discussions of any applications in which there was a personal or professional conflict not identified by staff.

REVIEW OF APPLICATIONS

Council reviewed 70 applications, totaling $12,181,620. The applications included 22 regular research grants, five pilot projects, 21 ethics grants, one in response to requests for applications, one center grant, seven conference grants, 10 small business innovative research (phase I) grants, two small business innovative research (phase II) grants, and one fellowship grant. A total of 60 applications requesting $10,518,316 were recommended for approval.

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