RESEARCH ON CLINICAL BIOETHICAL DILEMMAS NIH GUIDE, Volume 23, Number 12, March 25, 1994 PA NUMBER: PA-94-051 P.T. Keywords: National Institute of Nursing Research PURPOSE The National Institute of Nursing Research (NINR) invites applications for grants to support research that will extend current knowledge about clinical bioethical dilemmas (and possible resolutions) that are faced by individuals and families. The goal of this program announcement is to generate research that will contribute knowledge of the ethical implications and actions arising from diagnostic and treatment strategies, in order to support those making decisions that impact their health and well-being and strengthen the quality and appropriateness of decisions made by family members. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Research on Clinical Bioethical Dilemmas, cross cuts all priority areas and relates directly to the responsibilities shared by individuals, families and practitioners for successfully implementing the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit, public and private, organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Topics studied by foreign applications must have direct relevance to U.S. populations. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) award (R29). Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The mechanisms of support will be the National Institutes of Health individual research grant (R01) and FIRST award (R29). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Though the length of individual studies will vary, support will be provided for a period of up to five years, based on availability of funds and sufficient scientific progress. Applicants must plan for five years of support for the R29 award. Costs of individuals projects will vary. The average direct cost of an R01 award in FY 1993 was $186,000. Direct costs for R29 awards are capped at $100,000 in any one year and $350,000 across all years. RESEARCH OBJECTIVES Rapidly occurring advancements in science and health care technology are generating new ethical issues with increasing frequency. The availability of health and illness related information is outpacing knowledge about the best strategies for assisting those who must use this information. Therefore, there is a growing need for strategies and frameworks that can be used by health care professionals to organize and present clinical information in a way that is usefully supportive of the decision-making process that is required of patients and/or their families. These frameworks, when based on empirical studies of bioethical issues, should enable the determination of the best approaches for organizing information, deciding strategies, and facilitating individuals and their families in making clinical decisions. In the absence of such organizing frameworks, it is possible that when unstructured information is provided, it may actually work against the patient's needs and interests. The NINR sponsored an interdisciplinary clinical bioethics workshop in 1989 as a means of exploring the research opportunities in bioethics and clinical practice. Proceedings from this workshop are available from NINR program staff listed under INQUIRIES. As a result of the recommendations made by workshop participants, NINR funded a small grants program from 1989 to 1991 focused on bioethics and clinical decision making research. The program was designed to support pilot and feasibility studies. This current Program Announcement builds on and expands that earlier research program on clinical bioethical issues. Preserving a patient's individual autonomy has been a goal of national and institutional policies, as exemplified by "The Patient Self Determination Act," which was designed to involve patients actively in determining how much care they desire in order to maintain their life. From a policy perspective, involving patients directly in decisions about their own health and clinical care needs has both quality of life and economic imperatives. Advance directives are the means to formalize individual patients decisions about their future clinical care needs. Whether or not such advanced directives are useful and effective and actually protect an individual's autonomy still needs to be determined. It is commonly assumed that knowledge is good, that knowing a diagnosis is better than not knowing. But if the new diagnostic capabilities only predict risk of developing diseases, will having this knowledge potentially cause more harm than good? Will the quality of life be diminished by having the information when nothing can be done to reduce the risk factors or have an impact on the outcome? A central question concerns the optimum way to support people making decisions about therapeutic options when the long term effects of the treatments are not known. These issues become all the more challenging and complex when there is diminished autonomy due to development, such as with minors, or when understanding may be compromised, such as with some mental illnesses, certain disabilities, or mental retardation. The NINR welcomes applications that propose empirical approaches to these ethical issues and dilemmas. Although it is expected that investigators will propose study designs that are appropriate to the research question being asked, it should be noted that both qualitative, quantitative, or combined approaches could be used. Some examples of specific areas that may be pursued include, but are not limited to, the following: 1. Health-Related Decision Making Involving New Clinical Technologies. This area involves questions on how individuals make choices for their personal health when accepting or rejecting new diagnostic and therapeutic technologies, especially when some are still considered experimental. Factors such as psychological, sociocultural, economic, and quality of life issues that influence these decisions need to be examined. Determining which informational, educational, and counseling strategies are most effective in supporting autonomous decision making needs study. What is the influence of choices or the lack of choices when making these decisions? How do individuals respond and what factors are considered when decisions are being made about diagnostic tests that have greater or lesser degrees of uncertainty, sensitivity, or specificity? How do patients and families make decisions about new treatments such as surgical innovations or gene therapies? Do individuals and families consider costs when making these decisions for themselves; for others? 2. Patient Involvement in Clinical Decision Making. This area involves individuals who are receiving ongoing clinical care. The continuing evaluation of the appropriateness, efficacy, efficiency, and effectiveness of treatment and clinical intervention strategies, and the development of clinical practice standards or guidelines, are expected to influence how decisions about clinical care are made and how that care is provided. In addition, it is planned that such information will be made available to patients and their families in a form they can understand to assist them when making decisions about diagnostic, treatment and intervention strategies. Such patient-focused information will include information about clinical effectiveness, potential impact of treatments and intervention strategies on quality of life and cost data. To what extent is this new information available to and used by patients and their families? How patients and their families receive such information and how they respond to it is unknown. How decisions are made in light of this new clinical information needs to be determined. What factors related to psychological, sociocultural, economic and quality of life issues influence these decisions? How best can they be explored? Which informational, educational, or counseling strategies would be most effective in supporting autonomous decision making? Do such clinical factors as symptom intensity influence the outcome of decision making? To what extent? Are patients and their family members now more involved in clinical decision making? Do they make different decisions? To what extent do fiscal issues influence decisions, if at all? 3. Informed Consent in a Pluralistic Society. This area includes examining issues surrounding the informed consent process. Some questions that could be considered include: What factors influence decisions when "informed decisions" are made? Are individuals truly knowledgeable and well informed when they sign consent forms for clinical treatments? What ethnocultural influences play a role in informed decision making? What actually takes place when family members, or non-related members, of an ethnolinguistic group translate information about health status, or obtain consent for procedures or treatments? Who should be involved in obtaining consent when autonomy is diminished? What are the issues and best approaches to informed decision making for the developmentally disabled, children, adolescents, or adults with special needs? 4. Organ and Tissue Donation and Receipt. With increasing availability of transplantation and the ongoing need for organs and tissue, various strategies are used to obtain them. The influence of these strategies on individuals and families have not been fully explored. The aftermath of making a decision to donate either by an individual or a family member needs to be more fully understood. It has been recognized that there are cultural and ethnic differences in responding to organ and tissue donation, this results in some groups having little opportunity for receipt of a donation. These differences need to be examined. In addition, the need for transplantation, for example, of bone marrow, occurs during serious, life threatening illness. What factors influence decisions under these circumstances? Do these factors change over time or in association with complications, such as those occurring after transplantation? What strategies are used to assist patients and families in the decision making process, during treatment, and after treatment? How specific and how much information is provided? 5. Privacy and Confidentiality. This area involves examining such issues as how best to protect the privacy of individuals, who now have access to information about themselves or about other members of their families, that has been previously unavailable. What factors are involved in protecting the confidentiality of information about an individual when it may be important and relevant to other members of the family or community? Increasing amounts of information are available about individuals and their health status in clinical databases and other potentially accessible sources. What strategies are effective in protecting individual privacy under these circumstances? STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH 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 biomedical and behavioral research 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 research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. (NOTE: When the proposed study or studies in the RFA or PA involves a gender specific study or a single or limited number of minority population groups, this should also be stated to inform potential applicants and reviewers.) APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are also found in the PHS 398 (rev. 9/91) instructions. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/435-0714. The title and number of the program announcement must be typed in Section 2a on the face page of the application. Applicants for FIRST awards should note that three letters of reference must be submitted with the application. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892**" REVIEW CONSIDERATIONS Applications received under this program announcement will be assigned to an initial review group on the basis of established Public Health Service referral guidelines. The IRG will review the applications for scientific and technical merit in accordance with the standard NIH peer review procedures. Applications recommended for further consideration will receive a second-level review by the appropriate national advisory council. Only applications recommended by the Council/Board may be considered for funding. AWARD CRITERIA Applications recommended for further consideration will be considered for available funds on the basis of the scientific and technical quality of the proposed project determined by peer review, program needs and balance, policy considerations, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. To receive a copy of "Bioethics and Clinical Practice: Examining Research Outcomes and Methods," direct inquiries to: Office of Information and Legislative Affairs National Institute of Nursing Research Building 31, Room 5B13 Bethesda, MD 20892 Telephone: (301) 496-0207 Direct inquiries regarding scientific programmatic issues to: Dr. Patricia Moritz Nursing Systems Branch National Institute of Nursing Research Westwood Building, Room 738 Bethesda, MD 20892 Telephone: (301) 594-7493 Direct inquiries regarding fiscal matters to: Ms. Sally A. Nichols Grants Management Office National Institute of Nursing Research Westwood Building, Room 748 Bethesda, MD 20892 Telephone: (301) 594-7498 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361, Nursing Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the american people. .
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files. |