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.



.


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