RESEARCH ON CLINICAL DECISION MAKING

RELEASE DATE:  June 27, 2002

PA NUMBER: PA-02-118  (This PA has been reissued by PA-06-101 and PA-06-077)

EXPIRATION DATE:  June 14, 2005 

National Institute of Nursing Research (NINR) 
 (http://www.ninr.nih.gov)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanisms of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA
 
The National Institute of Nursing Research invites qualified researchers to 
submit research grant applications on clinical decision-making.  Rapidly 
occurring advancements in science and health care technology are generating 
new decision-making issues for health care professionals, patients and/or 
their families.  Patients can now choose between treatments with varying 
risks and benefits, choose to omit treatment, and participate in advance care 
planning for health care decisions.  The goal of this program announcement is 
to increase the scientific knowledge in the area of clinical decision-making 
and to help patients, families and the health care professionals in the 
decision-making process.  In general, research questions should test the 
effects of clinical decision-making on direct patient outcomes.  This Program 
Announcement excludes research on ethical issues in human subjects research 
which is covered in PA02-103. 

RESEARCH OBJECTIVES

This initiative updates a previous Program Announcement published in 1994 
entitled "Research on Clinical Bioethical Dilemmas."  There is evidence that 
some patients want more knowledge and want to be involved in the clinical 
decision-making process.  Patients are facing more and more options in the 
treatment of medical conditions, including the choice between treatments of 
varying risks and benefits, the choice to undergo elective surgery, and the 
choice of non-treatment.  Patients often overestimate the benefits and 
underestimate the risks of a treatment.

The decisions that health care providers make may be different than those of 
the patients and family, suggesting the need for a mutual decision-making 
process.  More information is needed about the process of making a decision 
and the factors that affect the decision, including the patient"s cultural 
and/or ethnic group, the amount of information that patients can comfortably 
absorb during this process, the optimal amount of time needed to assimilate 
the information and make decisions, the influence of the health 
professional"s view of treatment options, the patient"s past history with 
illness, and the cost of the treatment.  Research is needed on what aspects 
of treatment should be emphasized and the optimal time and ways to educate 
patients about the risks and benefits of treatment choices (i.e., oral, 
written, graphic, video).

While some patients want to be actively involved in clinical decision-making, 
others prefer a passive role.  Research is needed to determine whether these 
roles are static or if the roles change over time, and change with different 
conditions.  The preference of the patient should determine the approach to 
the informed consent process where the focus should be to improve the 
knowledge and understanding of the patient about the decisions that need to 
be made.  Little is known about what patients and their families view as 
important information to help them make a decision, or how best to inform 
them about bad news and how to then proceed to discussion of treatment 
options.  Research is needed to determine what is acceptable to discuss in 
culturally and ethnically diverse populations and whether gender, 
cultural/ethnic identity, religious orientation and /or other 
sociodemographics of the health care provider influences the type of 
information provided and how it is received.

Genetic discoveries are occurring more frequently.  Knowledge of a genetic 
predisposition may allow for earlier intervention and lifestyle alterations.  
However, the decision to undergo genetic testing has not been extensively 
evaluated.  Further research is needed on the variables that influence the 
decision to undergo genetic screening, genetic diagnosis and genetic 
therapies.  In addition, information is needed on the cognitive and emotional 
processes that may delay the decision to undergo genetic testing. The 
benefits, risks and limitations of these decisions need to be identified in 
the context of the decision making process.   

Substitute or proxy decision-making occurs on behalf of people who are 
incapable of making decisions for themselves, including children, the 
severely mentally ill, and other groups with cognitive deficits.  Health care 
professionals and caregivers frequently underestimate the ability of these 
various groups to provide assent for treatment.  Each of these groups can be 
involved to some extent in the decision-making process.  However, the extent 
to which these different groups are and should be involved is unknown, as is 
the best medium for communicating treatment choices (i.e., oral, written, 
video).   Health care providers, patients and their families may differ on 
their preference of treatment choice based on side effects and resulting 
quality of life. 

Some health care providers encourage advance care planning to preserve the 
autonomy and wishes of the patient at the end of life.  Further research is 
needed to examine issues such as whether advance care planning protects the 
patient"s autonomy and if the health care provided to the patient is altered 
by advance care planning.  One of the most difficult decisions to be made at 
the end of life is whether or not to discontinue life-sustaining treatment.  
More research is needed to identify the variables contributing to the 
clinical decision to discontinue treatment, whether these variables differ 
across different age groups, gender and cultural/ethnic groups, and how these 
decisions affect the dying process and the family"s grief afterward.  Despite 
widespread support of advance care planning, less than twenty percent of 
patients complete an advance directive.  Additional research is needed in 
this area, including identification of factors that influence advance care 
planning, and comparing these factors from the perspectives of the patient, 
the family, and the health care professionals.  The decision for the 
discontinuation of treatment can result in conflict between patients, family 
members and/or health care professionals.  Research is needed to determine 
the most effective way to resolve conflicts about discontinuing treatment. 

Other factors can influence the patient"s decision-making process.  These 
include the symptoms of pain, fatigue, and depression, and economic and 
social factors, including the perception of burden.  Knowledge is needed 
regarding the influence of these variables on the decision-making process.  
Clinical decision-making is a complex process where little is known about 
which variables are important for which decisions, how decisions are made 
from a cognitive perspective, and how all the variables interact.

Potential Research Areas:

Listed below are examples of areas of clinical decision-making research that 
would be responsive to this program announcement.  They are not listed in any 
priority order and are not intended to be inclusive or restrictive.  These 
examples are only illustrative examples, and applicants are encouraged to 
propose other topics consistent with the goals of this program.  In general, 
research questions should test the effects of clinical decision-making on 
patient outcomes or investigate more basically the cognitive processes used 
in decision making to better understand how decisions are made.

o  Test innovative strategies to help patients of various groups make a 
decision about a clinical issue with varying risks and benefits to the 
treatments
o  Test and evaluate the impact of a multidisciplinary approach to risk 
communication, for example one involving nurses and pharmacists to target 
prescribers or patients
o  Determine the influence of the health care professional in the decision-
making process
o  Explore whether advanced planning of health care influences the type of 
health care provided to a patient 
o  Evaluate different approaches to end of life decision-making besides 
advance care planning
o  Investigate how various factors (burden, cost, pain, fatigue) influence a 
clinical decision to initiate and/or discontinue treatment
o  Identify interventions to assist patients and families in clinical 
decisions at the end-of-life
o  Determine whether and how gender and racial/cultural identity influences 
the clinical decision-making process
o  Identify and test different communication approaches to promote 
understanding by the patient of the clinical decision-making process
o  Investigate how the decision maker(s) processes information individually 
and collaboratively in making decisions
o  Investigate the factors influencing the decision-making process for 
patients and their families using genetic screening, genetic diagnosis, and 
genetic therapies
o  Investigate the factors that influence decision making regarding new or 
experimental diagnostic or therapeutic innovations

MECHANISMS OF SUPPORT 

This PA will use the NIH R01 and R21 award mechanisms.  As an applicant, you 
will be solely responsible for planning, directing, and executing the 
proposed project.  The objective of the exploratory/developmental mechanism 
(R21) is to encourage applications from individuals who are interested in 
testing innovative or conceptually creative ideas that are scientifically 
sound and may advance our understanding of clinical decision making.  
Investigators are encouraged to explore the feasibility of an innovative 
research question or approach that will provide a basis for future research 
project applications.  Exploratory/developmental grants (R21) are limited to 
2 years of support and up to $150,000 per year in direct costs.

This PA uses just-in-time concepts.  It also uses the modular and non-modular  
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, use the non-
modular application instructions.

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) 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
o Faith-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 their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:

o Direct your questions about scientific/research issues to:

Dr. Karin Helmers
Office of Extramural Programs
National Institute of Nursing Research
Building 45, Room 3AN12
Bethesda, MD  20892-6300
Telephone:  (301) 594-2177
FAX: (301) 480-8260
Email: [email protected]

o Direct your questions about financial or grants management matters to:

Ms. Cynthia McDermott
Office of Grants and Contracts Management
National Institute of Nursing Research
Building 45, Room 3AN12
Bethesda, MD  20892-6300
Telephone:  (301) 594-6869
FAX: (301) 480-8260
Email: [email protected]

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 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: [email protected].

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.  Application 
deadlines for the R01 mechanism are February 1, June 1, and October 1.

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.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:
	
Contact the NINR program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study, 

2) Obtain agreement from the NINR staff that the NINR will accept your 
application for consideration for award, and,
  
3) Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

SENDING AN APPLICATION TO THE NIH: 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)

APPLICATION PROCESSING: Applications must be received by or mailed on or  
before the receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR will 
not accept any application in response to this PA that is essentially the 
same as one currently pending initial review unless the applicant withdraws 
the pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude the 
submission of a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous 
critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council 
or board
	
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 your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application"s overall score, weighting them as appropriate 
for each application.  Your 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, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 
tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  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.

INCLUSION:  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 included in the 
section on Federal Citations, below)

DATA SHARING:  The adequacy of the proposed plan to share data. 

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research. This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete
copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. 
The amended policy incorporates: the use of an NIH definition of clinical 
research, updated racial and ethnic categories in compliance with the new OMB 
standards, clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398, and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable, 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

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. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

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.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

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 PA 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.

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 PA 
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 No. 93.361 and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.

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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