RFA-HG-04-004: INTELLECTUAL PROPERTY RIGHTS IN GENETICS AND GENOMICS

Department of Health
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INTELLECTUAL PROPERTY RIGHTS IN GENETICS AND GENOMICS RELEASE DATE: June 2, 2004 RFA Number: RFA-HG-04-004 EXPIRATION DATE: November 19, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Human Genome Research Institute (NHGRI) (http://www.nhgri.nih.gov ) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.172 LETTER OF INTENT RECEIPT DATE: October 21, 2004 APPLICATION RECEIPT DATE: November 18, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The purpose of this RFA is to encourage the study of the role of laws and policies regarding intellectual property rights in genetics and genomics research and development, and the effect of such laws and policies on progress in these fields and on commercialization, drug development, health care delivery, and the public health. RESEARCH OBJECTIVES Since its inception, the Human Genome Project has attempted to follow a policy of free and open access to genetic and genomic data (e.g., NHGRI Policy Regarding Intellectual Property of Human Genomic Sequence (April 9, 1996), http://www.genome.gov/10000926; NHGRI Policy on Human Genomic Sequence Data (Dec. 21, 2000), http://www.genome.gov/10000910). NIH policy recognizes the appropriateness of intellectual property protections for discoveries that are associated with useful products, but promotes the free dissemination of research tools whenever possible, especially when the prospect of commercial gain is remote (Report of the National Institutes of Health (NIH) Working Group on Research Tools, http://www.nih.gov/news/researchtools/). Over the past three decades, however, many patents have been granted on gene sequences and other types of basic information derived from genetic sequence. For some, this has generated apprehension that gene patents are being granted too broadly or freely, especially for foundational tools. The concern is that the too-liberal issuance of such patent rights, especially when coupled with exclusive licensing practices, will result in the imposition of reach-through restrictions or excessive fees, and inhibit investigators from conducting additional research with these tools. This, it is feared, will ultimately be to the detriment of advances in medical research and to public health. In January 2001, partly in response to a letter from the NIH urging the implementation of stricter criteria for the issuance of biotechnology patents, the U.S. Patent and Trademark Office revised its guidelines to patent examiners regarding patents on DNA sequence and sequence-derived intellectual property, effectively raising the bar on utility standards in this area (U.S. Patent and Trademark Office, Utility Examination Guidelines, Fed. Reg. Vol. 66, No. 4 (January 5, 2001)). However, questions remain about whether this revision raised the bar high enough to serve the public interest. An example of the potential problem is the recent acquisition and aggressive pursuit by Genetic Technologies Limited (GTG), an Australian company, of exceptionally broad global patent protection covering the use of information to derive risks of disease in all non-coding regions of the genome (see Nature, (2003) 423: 105). While this is perhaps an extreme example (and the validity of GTG’s patents has not yet been tested in the courts), other controversial cases can also be cited (e.g., the Myriad Genetics BRCA1 patent, the University of Miami Canavan disease patent, the CCR5 HIV co-receptor gene patent). Such cases are increasingly leading genetics and genomics researchers, business entities, health care providers, and consumers to question how the balance between providing intellectual property protection and fostering biomedical innovation can best be attained. Issues regarding the appropriate scope of protection for intellectual property rights in genetics and genomics research and development will only increase in complexity as progress in these fields continues. For example, large-scale proteomics efforts (such as protein biomarker discovery projects, the NIGMS Protein Structure Initiative (http://www.nigms.nih.gov/psi/), and initiatives to characterize protein-protein interactions) will generate new types of potentially patentable information, and with this information, new intellectual property challenges. Such challenges will also arise in several areas of research being emphasized under the new NIH Roadmap Initiative (http://nihroadmap.nih.gov/). For example, in the chemical genomics area, questions will arise about whether patents should be filed on the compounds that will be discovered or whether to place such compounds in the public domain, and about how pricing should be determined should a compound discovered through this process end up as a drug. In the bioinformatics and computational biology area, questions will arise about how best to promote the widespread distribution of new software to be developed (e.g., using an open source model of licensing or some other model). Anticipating the growing need to confront questions of this type, the NHGRI has identified addressing intellectual property issues as one of the Grand Challenges for the future of genomics. Specifically, the Institute’s document A Vision for the Future of Genomics Research, (Nature (2003) 422: 835-847, also available at: http://www.genome.gov/11006873), called for the development of policy options in the area of intellectual property that will facilitate the widespread use of genetic and genomic information in both research and clinical settings. To be maximally informed and effective, however, the development of such policy options must be based on a solid and broad-based body of theoretic and empiric data. While a number of studies already conducted or now underway provide a good preliminary foundation on which to build, there is a clear need for additional research and scholarship in this area. In 2004, the Board on Science Technology and Economic Policy (STEP Board) and the Science, Technology, and Law Program of the National Academies of Sciences convened a committee on Intellectual Property in Genomic and Protein Research and Innovation (the NAS Committee ). The NAS Committee’s charge is to review the patenting and licensing of human genetic material and proteins and their implications for biomedical research, therapeutic and diagnostic products, and medical practice. The NAS Committee is expected to release its report in the Summer of 2005, but there will clearly be a need for other, more in depth, examinations and analyses of these issues, by investigators from a broad range of disciplines. To assist in addressing this need, the NHGRI proposes a new initiative to encourage the study of the role of laws and policies regarding intellectual property rights in genetics and genomics research and development, and the effect of such laws and policies on progress in these fields and on commercialization, drug development, health care delivery, and public health. The initiative is designed to support rigorous, carefully focused legal, statistical, economic, political science, historical, and other social scientific investigations, both theoretical and empirical. As used in this RFA, the term genetics and genomics includes genomics (broadly defined to include both nucleic acid and protein products of large-scale analyses of the human and other genomes and methods for identifying and analyzing them) and human molecular genetics. The term is not, however, meant to include all of biotechnology, although the line between genomics and biotechnology is frequently hard to define. For example, the term genetics and genomics subject matter includes the following: (1) Both individual elements of data and comprehensive databases or other resources regarding genes and gene fragments; gene regulatory sequences; ESTs; SNPs; haplotypes; proteins and protein structures; protein-protein interactions; cellular pathways; computational models of the cell; gene expression profiling (microarrays); small molecules; and mouse (or other animal) knockouts. (2) The relationships between diseases or traits and genes, SNPs, haplotypes, or proteins; the relationships among genotype, environment, and phenotype (e.g., in large databases); and the use of such information in diagnostics. (3) Fundamental tools or methods for the production or analysis of data or databases of the types listed above, the bioinformatics software to probe the databases, and the algorithms that the software elaborates. The term genetics and genomics subject matter as used in this initiative does not, however, include such subject matter as biomedical devices, engineered tissues, stem cells, large-scale cell culture, whole organism cloning, or individual treatment applications. Some examples of appropriate topic areas, with examples of specific research questions for each area, are listed below. Investigators are welcome to propose research in one or more of these topic areas, or in similar areas. Investigators should not be constrained by the specific research questions included on this list. The focus of the research, however, should remain on intellectual property rights to genetics and genomics-related subject matter, and should not be so broad as to encompass other major areas of biotechnology. 1. TYPES OF INTELLECTUAL PROPERTY RIGHTS AND RELATED POLICY IMPLICATIONS. What types of intellectual property rights to genetics and genomics-related subject matter are being, or should be, sought, obtained, or refused? What types of entities are seeking, obtaining, or being refused, intellectual property rights in this field? What are, or should be, the standards for novelty, non-obviousness, and utility in this field? What is, or should be, the breadth of the claims in this field? Do intellectual property rights to genetics and genomics-related subject matter benefit the public when there is no identifiable product? What has been the effect of intellectual property rights in this field on research in the private sector? What are the mechanisms, existing or proposed as well as legal or business custom, for protecting information contained in databases generally, and what are the policy implications of allowing or refusing protection for genomic and genetic databases, whether through intellectual property or sui generis protection? What is, or should be, the role of patents, copyrights, trade secrets, and sui generis intellectual property rights for various data types? How do the laws governing patents, copyrights, trade secrets, and sui generis intellectual property rights act as an incentive, a disincentive, or a neutral factor in determining the planning, content, and progress of genetics and genomics research and development programs? 2. OWNERSHIP AND ASSIGNMENT OF INTELLECTUAL PROPERTY RIGHTS AND RELATED POLICY IMPLICATIONS. What are, or should be, the mechanisms for exploiting intellectual property rights to genetics and genomics-related subject matter? How frequently are, or should, such rights be assigned (e.g., sold, or licensed exclusively or non-exclusively to third parties)? What are, or should be, the usual mechanisms of such assignments? Who are, or should be, the usual parties to such assignments? To what extent would genetics and genomics subject matter be treated differently if the corresponding intellectual property rights were not assigned? What are, or should be, the practices of biotechnology and pharmaceutical companies regarding the sharing of commercially valuable data? What are, or should be, the practices of universities regarding the sharing of commercially valuable data (government funded and non-government funded)? How have universities interpreted the Bayh-Dole Act, and what has been the impact of Bayh-Dole on genetics and genomics research? Are, or should, assignments in this field under Bayh-Dole typically be pursuant to employment contract or policies, or the result of arms-length negotiations? What is the practical impact of restrictions or limitations on the ownership of intellectual property rights imposed by government funding agencies (such as Declaration of Exceptional Circumstances )? How will the mechanisms of assignment of intellectual property rights, and restrictions on such assignment, likely affect genetics and genomics subject matter in the future? 3. LICENSING PRACTICES AND RELATED POLICY IMPLICATIONS. What are the categories of genetics and genomics subject matter for which intellectual property rights are licensed or may be licensed in the future? What are the relative numbers of intellectual property rights involving genetics and genomics subject matter that are subject to licensing arrangements? What are the terms of such licenses (including exclusivity versus non-exclusivity, royalty rates, fields of use restrictions, etc.), and who are the parties to such agreements? What are the structures for such licensing arrangements (e.g., cross-licensing, block or blanket licenses, compulsory licenses, etc.)? What are the structures and operation of patent pools? How are end user license agreements (EULAs) attached to the sale of research tools being used, and how broad are their reach-through provisions? To what extent might the genetics and genomics subject matter be differently treated if the corresponding intellectual property rights were not licensed or were not disclosed and treated as a trade secret? How are the planning, content, and progress of genetics and genomics research and development programs affected by refusals to license or offers to license on unacceptable terms? How does the way in which genetics and genomics subject matter is licensed affect the prospects for commercialization? What is the effect of being required to obtain multiple licenses to conduct some types of research or clinical tests? Does an open source model of licensing genomic software tools increase the usefulness of the tools and improve their acceptance in the research community? Are intellectual property rights involving genetics and genomics subject matter to which licensing arrangements pertain more or less likely to be involved in infringement litigation? What would be the policy implications of limiting exclusive licenses in the field of genetics and genomics to therapeutics and vaccines (i.e., excluding diagnostics)? 4. ENFORCEMENT AND RELATED POLICY IMPLICATIONS. What are the categories of genetics and genomics subject matter for which the intellectual property rights have been involved in administrative or judicial action? What legal issues have been raised in such lawsuits, and who have been the parties to such lawsuits? What has been the resolution of such cases (e.g., dismissal, settlement, administrative action, trial verdict or judgment, appellate judgment, remedies and relief awarded, etc.)? What are the relative numbers of intellectual property rights involving genetics and genomics subject matter that have been filed in various forums? What are the numbers of intellectual property rights involving genetics and genomics subject matter that have been challenged but that do not actually reach litigation? How frequently are cease and desist letters issued, and how do universities or companies respond to them? How have the planning, content, and progress of genetics and genomics research and development programs been affected by threat, actual or perceived, of infringement litigation? What strategies are employed to allocate the risk of, to prepare for, or to defend against, infringement litigation? What impact has Madey v. Duke, 64 USPQ2d 1737, 307 F.3d 1351 (Fed. Cir. 2002), cert. Denied, 156 L.3d. 656 (2003), interpreting the experimental use (research) exemption to patent infringement in the context, had in the context of academic research? What would be the policy implications of formalizing a research exemption in the patent law? 5. INTERNATIONAL ISSUES AND RELATED POLICY IMPLICATIONS. What are the categories of genetics and genomics subject matter for which intellectual property rights have been or may be sought both in the United States and abroad? How does the operation of intellectual property rights involving genetics and genomics subject matter differ in the United States from other countries (e.g., what are the differences in the criteria for patentability applied in the U.S. and by other major patent offices, such as in Europe and Japan)? What mechanisms of procurement, ownership, licensing, and enforcement (or restrictions on these activities) exist only in other countries, and what are the advantages and disadvantages of such? How are international treaty obligations likely to affect the laws and customs in the United States governing intellectual property rights to genetics and genomics related subject matter? How do territorial and jurisdictional limitations on intellectual property rights affect the planning, content, and progress of genetics and genomics research and development programs? 6. OVERARCHING ISSUES. Has the planning, content, and progress of genetics and genomics research and development programs been enhanced, or conversely chilled, by intellectual property rights? Have intellectual property rights positively or negatively affected the quantity and quality of the publication of scientific advances involving genetics and genomics, or the timing of data release and publication? What are the legal and practical implications for unfettered research activities (e.g., the significance of a bona fide research use exemption to patent infringement, a fair use defense to copyright infringement, a reverse engineering exception to trade secret misappropriation, etc.)? Are existing mechanisms of protection of intellectual property rights to genetics and genomics related subject matter adequate or inadequate to the task of striking the proper balance between intellectual property rights and open access to devices, methods, products and data involved in genetics and genomics research and development? How have intellectual property rights to genetics and genomics-related subject matter positively or negatively affected public access to health care (e.g., accelerated or delayed the commercial availability of diagnostics or treatments, increased or decreased their cost, etc.)? A major goal of this initiative is to help expand the research base necessary to inform the future development of policy options regarding intellectual property in the contexts of genetics and genomics research and development. In this sense, the proposed development of policy options by applicants to this initiative is not required, but is encouraged when feasible. Investigators may propose to examine existing databases related to biotechnology and intellectual property rights or to gather new empirical data. However, proposals that are primarily dependent on data mining efforts should identify and incorporate innovative analytical methodologies to interpret the data. Although applications for proposals to examine issues regarding intellectual property, genetics, and genomics in the specific context of differing cultures and belief systems are beyond the scope of this initiative, the NHGRI encourages research on these topics as part of its regular research program in the area of Ethical, Legal, and Social Implications (ELSI). Applicants interested in conducting research on such topics are strongly encouraged to consider submitting R01 or R03 applications under one of the appropriate standing NHGRI Program Announcement for the ELSI Program. See http://grants.nih.gov/grants/guide/pa-files/PA-04-050.html (R01 Program Announcement); http://grants.nih.gov/grants/guide/pa-files/PA-04-051.html (R03 Program Announcement). MECHANISMS OF SUPPORT This RFA will use NIH R01 and R03 award mechanisms. Applicants are solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The earliest anticipated award date is July 15, 2005. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm ). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE NHGRI intends to commit approximately $1 million in FY 2005 to fund about 6-8 new or competitive continuation grants in response to this RFA. An applicant for an R01 award may request a project period of up to three years and a budget for direct costs of up to $250,000 per year; an applicant for an R03 award may request a project period of up to two years and a budget for direct costs of up to $50,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NHGRI provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution to develop an application for support. Investigators who have not previously applied for or received NIH funding and who are unfamiliar with the NIH grants process are welcome to apply. Such investigators are particularly encouraged to contact the individuals designated in this announcement (see WHERE TO SEND INQUIRIES) as the contact points for questions about scientific/research issues, peer review issues, and financial or grants management matters with questions about the NIH grants application process. Investigators from a variety of disciplines, including those in law, economics, statistics, health policy, political science, history, and other social science disciplines, are particularly encouraged to apply under this initiative. Investigators are encouraged (but are not required) to form multidisciplinary teams to frame the research questions more effectively and to develop innovative ways of investigating them. Investigators are encouraged to incorporate into their project teams individuals with expertise in genetics, genomics, or other relevant clinical or basic sciences where appropriate. Collaborations between academic investigators and individuals who are actively engaged in the practice of intellectual property law are also encouraged. Investigators from institutions in countries outside the U.S. are eligible to apply under this initiative. However, applications from investigators in institutions in countries outside the U.S. that propose research that will primarily involve analyses of intellectual property rights outside the U.S. must specifically address how the proposed research is relevant to the development of future policy options in the U.S. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Annual meetings of investigators will be held. This will facilitate the sharing of information, encourage collaboration, reduce possible duplication of effort, and promote more rapid dissemination of research findings. The initial meeting will take place shortly after the awards are made. Funds for travel to these meetings for up to two investigators per year should be included in the requested budget. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Applicants are strongly encouraged to consult with the Program Director early in the process of preparing an application. Direct your questions about scientific and research issues to: Jean E. McEwen, J.D., Ph.D. National Human Genome Research Institute Division of Extramural Research Ethical, Legal, and Social Implications Program 5635 Fishers Lane, Suite 4076, MSC 9305 Bethesda, MD 20892-9305 Telephone: Until June 28, 2004: (301) 402-4997 After June 28, 2004: (301) 496-7531 FAX: (301) 402-1950 Email: jm522n@nih.gov o Direct your questions about peer review issues to: Rudy O. Pozzatti, Ph.D. National Human Genome Research Institute Scientific Review Branch 5635 Fishers Lane, Suite 4076, MSC 9306 Bethesda, MD 20892-9306 Telephone: (301) 402-0838 FAX: (301) 435-1580 Email: rp7s@nih.gov o Direct your questions about financial or grants management matters to: Cheryl Chick National Human Genome Research Institute Grants Administration Branch 5635 Fishers Lane, Suite 4076, MSC 9306 Bethesda, MD 20892-9306 Telephone: (301) 435-7858 FAX: (301) 402-1951 Email: ChickC@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NHGRI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Jean E. McEwen, J.D., Ph.D. National Human Genome Research Institute Division of Extramural Research Ethical, Legal, and Social Implications Program 5635 Fishers Lane, Suite 4076, MSC 9305 Bethesda, MD 20892-9305 Telephone: Until June 28, 2004: (301) 402-4997 After June 28, 2004: (301) 496-7531 FAX: (301) 402-1950 Email: jm522n@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Rudy O. Pozzatti, Ph.D. National Human Genome Research Institute Scientific Review Branch 5635 Fishers Lane, Suite 4076, MSC 9306 Bethesda, MD 20892-9306 Telephone: (301) 402-0838 FAX: (301) 435-1580 Email: rp7s@nih.gov APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NHGRI. Incomplete or non-responsive applications will not be reviewed. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NHGRI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Human Genome Research Institute Advisory Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? Are the aims of the application responsive to the goals and objectives of the RFA? If the aims of the application are achieved, how will knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field or on the development of policy? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? It is understood that research methodologies for investigators in law and in certain other disciplines often differ from those used in traditional social science or basic science disciplines. However, an adequate description at least of the conceptual framework and of the analyses is still required by all investigators, regardless of field. INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new approaches to analyzing issues? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the environment in which the work will be done contribute to the probability of success? Does the proposed research take advantage of unique features of the environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). ADDITIONAL CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 21, 2004 Application Receipt Date: November 18, 2004 Peer Review Date: February/March, 2005 Council Review: May 2005 Earliest Anticipated Start Date: July 15, 2005 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities and program balance. The overall balance of the portfolio will be considered when final funding decisions under this initiative are made. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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