Ethical, Legal and Social Implications of Human Genetics and Genomic Research Education Grant Program

Release Date: September 22, 2000

PA NUMBER: PA-00-134

National Human Genome Research Institute
National Institute on Drug Abuse
National Institute of Dental and Craniofacial Research
National Institute for General Medical Sciences
National Institute of Mental Health
National Institute of Neurological Disorders and Stroke

This Program Announcement replaces the Education Grant (R25) component of PA-96-042, The Ethical, Legal and Social Implications of Genetics Research, which was published in the NIH Guide for Grants and Contracts, Vol. 25, No. 13 - April 26, 1996. It is complementary to the ELSI Regular Research Grant (R01) and Small Grant (R03) Program Announcements.

Purpose

The Ethical, Legal and Social Implications of Genetic and Genomic Research (ELSI) Education Grant (R25) is a flexible program aimed at developing innovative educational approaches that will increase knowledge and understanding of genetics and genomics research and its ethical, legal and social implications. This program invites investigator-initiated R25 Grant applications that pursue a wide range of objectives such as: the development and pilot testing of short courses, multi-media continuing education tools, national forums, seminars, and/or hands-on workshops designed to educate scientists, health care professionals and the lay community. Other appropriate objectives include: the design, development and evaluation of new curriculum materials for a variety of audiences in a variety of educational settings. Given the current urgent need for health care providers who are genetically literate and knowledgeable, health professional education projects are of particular interest. Applications to this program should be focused on developing and evaluating new and innovative interventions that are designed to reach a large and diverse audience or that can be successfully exported to other institutions or learning environments.

Applications that examine more conceptual issues, such as what constitutes genetic literacy or how various audiences optimally learn genetic information, and projects that use an experimental design to test the effectiveness of a particular education intervention, will be considered under the ELSI Regular Research Grant (R01) program announcement.

The ELSI Research Program also will accept conference grant (R13) applications. These applications are limited to $50,000 and to conferences that are highly focused and result in a specific product, such as the publication of conference proceedings or policy recommendations in a journal article or book. For specific application guidelines and instructions for each of the participating Institutes and Centers (ICs), applicants should refer to the "Guidelines for Support of Scientific Meetings by NIH." [grants.nih.gov]

Applications to support media (television or radio) programs and documentaries will not be accepted under this program announcement, except in special cases in which there is unusually compelling evidence that the proposed project will have sound and measurable educational value for a broad segment of the population. All applicants are encouraged to speak with ELSI Research Program Staff before submitting an application.

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 Program Announcement (PA), "Ethical, Legal, and Social Implications of Human Genetics and Genomic Research," is related to one or more of the priority areas identified in that report. Potential applicants may obtain a copy of "Healthy People 2010" online [health.gov].

Eligibility Requirements

Applications may be submitted by domestic and foreign for-profit and non-profit organizations either public or private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Participation in the program by investigators at minority institutions is strongly encouraged. Investigators from foreign institutions should be aware that, in the area of ethical, legal and social issues, the standard NIH criteria for funding foreign applications are applied very strictly (see Award Criteria below). Such investigators are strongly encouraged to contact program staff before preparing an application.

To be eligible for this award, the proposed Principal Investigator must be an independent investigator. That is, he or she should be genuinely independent of a mentor. Individuals in the final stages of training may apply, but individuals can not be in a training status at the time the award is made.

Mechanism of Support

This PA will use the National Institutes of Health (NIH) education grants (R25) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant.

In general, we expect most applicants will require three years or fewer; however competitive renewals may be submitted. Facilities and Administrative (F&A) costs are payable at the rate of 8 percent of total modified direct costs. The 8 percent F&A cost rate will also apply to all subcontracts on R25 awards.

Project Objectives

Background and Significance

The NIH, along with several other federal and private national and international organizations, is currently engaged in a research effort known as the Human Genome Project (HGP). This project is designed to characterize the human genome and the genomes of selected model organisms. The HGP currently has several interrelated goals: the determination of the complete nucleotide sequence of human DNA and the DNA of several model organisms; the development of new technologies to make sustained high throughput DNA sequencing efficient, accurate and cost effective; the exploration of human genome sequence variation; the development of technologies for interpreting the function of DNA sequence; the identification and analysis of the ethical, legal, and social implications of this research; and research training.

The knowledge and technologies that will become available as a result of accomplishing these goals will: serve as a resource for studies of gene structure and function; promote research into the genetic aspects of human growth, development, and variability; increase the understanding of genetic contributions to human diseases and disorders; and inform clinical and health policies related to genetics. This understanding will lead to insights into new ways of dealing with health and disease, including new risk identification, risk reduction, diagnostic and therapeutic options. It will also help to elucidate more clearly the interaction between genes and the environment in the development of disease.

As the Human Genome Project draws closer to completion of the final "finished" human DNA sequence, researchers are focusing increasing attention on the discovery of variations found in the DNA sequences among individuals. The identification, classification, quantification and analysis of these genetic sequence variations is expected to constitute one of the most powerful, and direct, approaches to the study of a wide range of important biological questions. It will allow researchers to identify genetic contributions to many common diseases and disorders, such as diabetes, heart disease, depression and other forms of mental illness, deafness and hearing impairment, and some forms of cancer. It will also provide the basis for studying how genetic variation influences gene function in human growth and development.

Knowing the entire sequence of the human genome and understanding more about genetic variation among individuals and groups will, however, raise a number of ethical, legal, and social issues. These include: how to design and conduct genetic and genomic research, not only in a scientifically sound, but also an ethical manner; how to interpret and use this information; whether and how to integrate this information into clinical settings; and what impact this information will have in non-clinical and research settings. Many of these issues may be of special concern to individuals from diverse communities who traditionally have not been involved in genetics and genomics research, or who may have been adversely affected in the past by certain types of research. On the one hand, the exclusion of certain groups from research studies has contributed to disparities in the diagnostic and treatment options available to members of these groups. On the other hand, the inclusion of members of these populations in some early genetic studies may have led to an increase in stigmatization and to the potential for discrimination in employment, health care, insurance, or society more broadly. These issues may become even more pressing if ongoing research reveals data on the interactions among genotype, diseases or traits, and traditional, socially-constructed concepts of race, ethnicity and culture.

Project Scope and Objectives

This program announcement emphasizes the ongoing commitment of the NIH to support educational activities related to these and other ethical, legal, and social implications of human genetics and genomic research. The ultimate mission of the ELSI education program is to support activities that improve public and professional understanding about genetics, genome technology and the ethical, legal and social implications of this information and technology.

In July 1997, the ELSI Research Planning and Evaluation Group (ERPEG) was created to evaluate the portfolio of ELSI research grants and develop goals and recommendations to help guide and strengthen the ELSI research program. In February 2000, ERPEG released its final report, which included five goals to help guide ELSI research over the next few years and a series of programmatic recommendations for enhancing the ELSI research program. The five goals, which were originally published in the October 1998 issue of Science as part of the five year plan for the HGP, were designed to capture some of the emerging topics in genetics and genomics research and to help focus the ELSI research and education agenda through the year 2003. The goals, described below, should be seen as a guide to areas of particular interest to the ELSI Research Program, but should not be interpreted as an exhaustive listing of all possible research and education topics. As genetic research and the interpretation and use of genetic information continue to evolve, applicants are encouraged to identify additional topics and issues.

A few examples of possible education activities that would fall within each goal area are provided. These are meant only to serve as examples of the possible types of projects that could be developed, and are not, in any sense, exhaustive or comprehensive.

Examine the issues surrounding the completion of the human DNA sequence and the study of human genetic variation.
- Development of effective strategies for educating health professionals, policy makers, the media, students, and the public regarding the interpretation and use of information about genetic variation.
Examine the issues raised by the integration of genetic technologies and information into health care and public health activities.
- Development of curriculum materials that can be used to educate health professional students about the integration of genetic information and technologies in clinical settings and the associated ethical, legal and social issues.
- Development of innovative approaches to provide continuing education to practicing health care providers on the appropriate integration of genetic information and technologies in clinical settings and the associated ethical, legal and social issues.
- Development of effective methods for educating patients and the lay public about the use and interpretation of genetic information in health care settings.
Examine issues raised by the integration of knowledge about genomics and gene-environment interactions into non-clinical settings.
- Development of effective strategies for providing information to the general public on the use of genetic technologies in educational and workplace settings.
- Development of innovative educational approaches for diverse audiences, such as judges, educators and legislators, on the use and interpretation of genetic information and technologies in non-clinical settings.
Explore the ways in which new genetic knowledge may interact with a variety of philosophical, theological, and ethical perspectives.
- Development of innovative approaches that can be used to help a variety of audiences explore the ways in which genetic information and technologies may interact with a variety of philosophical, theological, and ethical perspectives.
Explore how socioeconomic factors, gender, and concepts of race, ethnicity and culture influence the use and interpretation of genetic information, the utilization of genetic services, and the development of policy.
- Development of educational interventions that will teach health care professionals how to provide genetic services in a culturally sensitive and relevant manner.
- Development of culturally appropriate education materials that can be used to convey information on the use and interpretation of genetic information and technologies to culturally and socio-economically diverse audiences.

Projects must integrate a strong scientific foundation with consideration of relevant ethical, legal and social issues. Interdisciplinary teams to develop education projects are encouraged. Of particular interest are projects that explore new, innovative approaches to education. Projects that propose to develop educational interventions should involve the target audience in planning, include an effective evaluation component, and propose a model that is transferable and transportable. Because of the current urgent need for health care providers who are genetically literate and knowledgeable, health professional education is regarded as having a high program priority.

This program announcement is designed to be complementary to several other National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH), and other Interagency Program Announcements. A complete listing of these announcements is available at the end of the "Research Objectives" section of the Regular Research ELSI PA.

Inclusion of Women and Minorities in Projects Involving Human Subjects

It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the project. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).

All investigators proposing projects involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," [grants.nih.gov] published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, and amended October, 2001.

Inclusion of Children As Participants in Projects Involving Human Subjects

It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all projects involving human subjects, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998.

All investigators proposing projects involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" [grants.nih.gov] that was published in the NIH Guide for Grants and Contracts, March 6, 1998. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policies.

URLs In NIH Grant Applications and Appendices

All applications and proposals for NIH funding must be self-contained within specified page limits. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access the Internet site.

Application Procedures

Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research, or online [grants.nih.gov] and may be obtained from:

Division of Extramural Outreach and Information Resources,
National Institutes of Health,
6701 Rockledge Drive, MSC 7910
Bethesda, MD 20892-7910
Phone 301/435-0714
E-mail: GrantsInfo@nih.gov.

Applicants planning to submit an investigator-initiated new, competing continuation, competing supplement, or any amended/revised version of an education grant (R25) application requesting $500,000 or more in direct costs for any year are advised that they must contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts [grants.nih.gov], March 20, 1998, revised in October, 2001.

Submit a signed, typewritten original of the application, including the checklist, and five 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)

Special Requirements

This program announcement requires a special section titled "Evaluation Plan" that clearly denotes how the proposed education program will be evaluated for success or failure based on its purpose and objectives. This plan should include strategies for both formative evaluations (evaluations designed to provide feedback to investigators while the project is in progress, enabling them to modify their strategies if necessary) and summative evaluations (evaluations conducted after the educational intervention has been completed, to determine whether the intervention actually improved the genetic "literacy" of the targeted audience). In addition, one of the evaluation criteria should focus on the degree of portability that the proposed program may have to other institutions or to other settings or broader audiences.

In general, allowable costs must be consistent with NIH policy and recommended by peer reviewers. These costs include but are not limited to the following: supplies, personnel costs, student compensation (when appropriate), consultant costs, equipment, travel, subcontractual costs, other expenses and other student costs (when appropriate). Faculty members participating in the design and implementation of the education program can request, with proper justification, the percent of their time devoted to curriculum design and specialized organization, coordinating, and implementation activities which are essential to achieving the goals of their proposed education plan. R25 grants may not be used to conduct traditional biomedical research or as training grants.

Review Considerations

Applications will be assigned to specific ICs on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board.

Review Criteria

In the written comments reviewers will be asked to discuss the following aspects of the application. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major 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 education project address an important ELSI or genetics educational need? If the aims of the application are achieved, to what extent will the project further the goals of improving education and understanding of genetic and genomic research and its ethical, legal and social implications?
Approach: Are the conceptual framework, design and methods adequately developed, well-integrated, and appropriate to the aims of the project?

Specifically, to what extent does the project:
- Provide a needs assessment and impact statement.
- Involve the target audience in planning, development and implementation.
- Define and demonstrate the receptivity of the target audience.
- Demonstrate awareness of relevant literature and existing professional and public education standards and resources.
- The transferability/transportability of the model.
- Involve genome scientists, genetics specialists, education specialists, bioethicists, and other individuals as necessary from a wide array of disciplines and provides criteria for their selection.
- Include plans for publicizing the availability of the program to the appropriate community(s).
- Include plans for recruiting potential participants, including women and under represented minorities, as appropriate.
- Include plans for dissemination; and for independent support of the education project if long term support will be needed?
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 methodologies or technologies?
Project Leader (Principal Investigator): Are the project leader and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to their experience level?
Environment: Does the environment in which the work will be done contribute to the probability of success? Does the proposed project take advantage of unique features of the scientific or educational environment or employ useful collaborative arrangements? Is there evidence of institutional support?
Evaluation Plan: Will the evaluation plan adequately assess the effectiveness of the project in achieving its objectives, and the degree to which the proposed project can be used in other educational institutions or settings.

In accordance with NIH policy, the applications will also be reviewed with respect to the following:

The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the goals of the project. Plans for the recruitment and retention of subjects will also be evaluated, as appropriate.
The reasonableness of the proposed budget and duration in relation to the proposed project.
The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application.

Award Criteria

Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: scientific merit of the proposed project as determined by peer review, availability of funds, and program priority.

Grant funds may be used for expenses clearly related and necessary to conduct the proposed project, including both direct costs and allowable facilities and administration (indirect) costs.

In order for the NIH to fund applications from foreign institutions, the application must meet the following three criteria: (1) The proposed project must have special relevance to the mission and objectives of the awarding organization and have the potential to advance knowledge that will benefit the United States; (2) The project must present special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries which are not readily available in the United States or which provide augmentation of existing U.S. resources; and (3) The foreign grant application must be in the upper half of the research grant priority scores.

Inquiries

Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome.

Direct general inquiries regarding programmatic issues to:

The ELSI Research Program
National Human Genome Research Institute
Building 31, Room B2B07
31 Center Drive, MSC 2033
National Institutes of Health
Bethesda, MD 20892-2033
Phone: (301) 402-4997
Fax: (301) 402-1950
E-mail: elsi@nhgri.nih.gov

Direct general inquiries regarding fiscal matters to:

Grants Administration Branch
Division of Extramural Research National Human Genome Research Institute Building 31, Room B2B34 31 Center Drive, MSC 2031
Bethesda, MD 20892-2031
Phone: (301) 435-7858
Fax: (301) 402-1951
E-mail: jc166o@nih.gov

Authority and Regulations

This program is described in the Catalog of Federal Domestic Assistance No. 93.172, Human Genome Research; No. 93.279, National Institute on Drug Abuse; No. 93.121, National Institute of Dental and Craniofacial Research; Genetics Program 93.862, National Institute of General Medical Sciences; No. 93.242, National Institute of Mental Health; and No. 93.361. Awards are made under authorization of sections 301 and 405 of the Public Health Service Act, Title IV, part A (public Law 78-410, as amended by Public Law 99-158, 43 USC 241 and 285)and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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, and 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.

Last Reviewed: may 22, 2012

Last updated: May 22, 2012