Decision Making in Cancer: Single-Event Decisions

PA Number: PA-05-017

Part I - Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Cancer Institute (NCI), (http://www.nci.nih.gov)

Announcement Type
 New

Update: The following update relating to this announcement has been issued:

Catalog of Federal Domestic Assistance Number
93.399

Key Dates

Release Date: November 22, 2004
Letter of Intent Receipt Dates: Not applicable
Application Receipt Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date for R21 Non-AIDS Applications: March 2, 2006
Expiration Date for R21 AIDS and AIDS-Related Applications: May 2, 2006
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007

Due Dates for E.O. 12372
Not Applicable

Executive Summary

The purpose of this initiative is to invite applications for research projects that will enhance understanding of human decision-making processes so that individuals can make more informed and satisfying choices regarding their health. The NCI encourages collaborations between basic judgment and decision-making researchers, and applied cancer control researchers that will elucidate single-event decision-making processes at the level of the individual patient or health care provider that are pertinent to cancer prevention, detection, treatment, survivorship, or end-of-life care. For the purpose of this initiative, a single-event decision is defined as a discrete decision made at a specific point in time. This PA will use the NIH exploratory/developmental (R21) award mechanism and the NIH investigator-initiated research project grants (R01) award mechanism. 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. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received. Application material and instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.

You may submit an application(s) if your institution has any of the following characteristics:

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. Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Merit Review Criteria
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources

Section VI. Award Administration Information
1. Award Notices
2. Administrative Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Award Criteria
4. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement
Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The purpose of this Program Announcement is to invite applications for research projects that will enhance understanding of human decision-making processes so that individuals can make more informed and satisfying choices regarding their health. Specifically, this Program Announcement seeks to elucidate single-event decision-making processes at the level of the individual patient or health care provider that are pertinent to cancer prevention, detection, treatment, survivorship, or end-of-life care. Decisions involving the individual patient, provider, patient-provider dyad, patient-caregiver dyad, patient-partner dyad, or the patient-family system are appropriate for study. For the purpose of this Program Announcement, a single-event decision is defined as a discrete decision made at a specific point in time. Examples of single-event decisions include selecting a particular cancer treatment, choosing to have mammography screening, and deciding to accept hospice care. Discrete, single-event decisions are distinct from decisions that must be made repeatedly, such as adhering to a weight-loss program or maintaining smoking abstinence. These kinds of repeated choice decisions, such as required for long-term behavior maintenance, are not responsive to this initiative. Such studies are appropriate for Program Announcement PA-05-016 (http://grants.nih.gov/grants/guide/pa-files/PA-05-016.html), Decision Making in Health: Behavior Maintenance.

Research Objectives

Advances in cancer prevention, detection, treatment, and end-of-life care, coupled with advances in bioinformatics, have created a staggering array of health care options and sources of medical information. Individuals at risk, patients, family members, and health care providers face a multitude of decisions across the cancer continuum that may profoundly affect outcomes in a number of domains, such as life expectancy and quality of life. In recent years, as options in cancer care have increased, cancer patients and their physicians have been faced with increasingly complex decisions. For example, a patient who is considering surgery, chemotherapy, and/or radiotherapy may need to consider the survival benefit and toxicity profile of each treatment option. Additionally, a patient may wish to weigh the costs and benefits of one treatment compared to another with respect to duration of symptom-free survival, time spent with toxicity due to treatment, time to relapse, and impact on activities of daily living. Other decisions, such as choosing to undergo genetic testing for BRCA1/BRCA2 mutations, or to enroll in a cancer clinical trial, may also require an equally complex cost-benefit analysis.

Having access to and knowledge of clinical and quality of life information is only a part of the decision process. It is equally important to understand the cognitive and affective processes involved in using this information to arrive at a decision. For example, despite strong evidence that Papanicolaou (Pap) smear screening reduces the incidence of and mortality from cervical cancer (U.S. Preventive Services Task Force, 2003), Pap smear screening is underused by large segments of the population, notably ethnic minority women and women living in geographically isolated areas (Benard et al., 2004). While lack of information, health insurance, or access to health care may impact adherence to screening recommendations, emotional factors, such as risk perception, fear of cancer, or embarrassment, may also play significant roles.

Often patients and physicians are faced with having to make prevention, screening, or treatment decisions under conditions of uncertainty, such as when there are no randomized clinical trials that establish the efficacy of a particular treatment. This is the case with prostate cancer, the most common malignancy among men in the U.S., which accounts for more than 220,000 cases annually (American Cancer Society, 2003). Although prostate cancer is the second leading cause of cancer mortality for men, prostate cancer screening and treatment are highly controversial (Ransohoff et al., 2002; Holmberg et al., 2002; Talcott, 2003). Because definitive treatment data for localized prostate cancer are lacking, men must choose one or more options from four possible management strategies: observation (watchful waiting), hormone therapy, surgery, and radiotherapy. Each of these options is associated with potential benefits and risks. The literature suggests that critical factors in the prostate cancer patient's decision are the influence of the physician and the physician's medical specialty. In light of this, a major challenge for physicians is how to communicate effectively about the uncertainties surrounding prostate cancer screening and treatment so that patients can make informed decisions about their care.

Behavioral decision theorists recognize that human behavior is not always rational or consistent. The importance of intuition in making medical decisions has been well documented in the medical literature (Redelmeier et al., 1993). Whereas intuitive decision making may be appropriate in certain circumstances, in other situations it may result in suboptimal medical decisions (Ubel & Loewenstin, 1997). Some have argued that if we are to help patients make optimal medical decisions, we need to develop a better understanding of the cognitive and emotional factors that may lead to pitfalls in reasoning. They suggest that we need to understand the role of heuristics and biases in decision making, and how variables such as framing effects, perception of safety and danger, risk aversion, irrational concerns, and worry factor into a decision (Redelmeier et al., 1993).

It is also well recognized that competent patients often make seemingly irrational medical choices, such as delaying treatment that they know is clearly in their best interest (Brock, 1990). This observation, that people act in apparently irrational ways, or ways that appear contrary to their best interests, has been empirically demonstrated repeatedly in the behavioral science and medical decision-making literature (Redelmeier et al., 1993; Tversky & Kahneman, 1981; McNeil et al., 1982). One example of this kind of apparently self-defeating behavior is the lung cancer or head and neck cancer patient who continues to smoke despite evidence that smoking can adversely affect survival, functional status, and second primary tumors (Tucker et al., 1997).

Understanding how patients and physicians gauge health risks may shed light on why competent people sometimes make suboptimal medical decisions. Numeracy, the ability to understand and use basic mathematical concepts, is critical to being able to evaluate health risks. It has been shown that educated laypersons and physicians alike have difficulty comprehending numeric risk estimates, whether risk is expressed in numerical (e.g., percentages) or graphical (e.g., survival curves) format (Weinstein, 1999; Lipkus et al., 2001). Treatment decisions by physicians and patients may be influenced by whether outcomes are expressed in absolute or relative terms. For example, in one study, physicians were more inclined to treat patients when the results of a clinical trial were reported in terms of relative risk reduction (e.g., a 20.3 percent decrease in mortality) than when results were reported in terms of absolute risk reduction (e.g., a decrease in mortality from 7.8 percent to 6.3 percent) (Forrow et al., 1992). Graphic representations of probabilistic information, such as survival and mortality curves, which present information about risk over time, appear to be subject to similar difficulties in interpretation. Investigators have found that the way in which data are framed (e.g., survival vs. mortality) impacts comprehension and treatment preferences (Armstrong et al., 2002).

Innumeracy and framing are among many factors that have been proposed as critical in making health-related decisions. Other important variables include the perceived probability and severity of harm (Weinstein, 2000), affect (Loewenstein et al., 2001), and heuristics and biases (Gilovich et al., 2002).

This Program Announcement encourages research that expands our knowledge of basic cognitive and affective processes underlying single-event decisions related to cancer control. Studies may include, but are not limited to, the following areas of research.

These basic cognitive and affective processes should be explored in the context of cancer prevention, detection, treatment, or survivorship. They may be examined with respect to social or structural factors, or other moderators and mediators of decision making (e.g., sociocultural factors, demographic factors, and health status).

See Section VIII. Other Information Required Federal Citations for policies relation to this announcement.

Section II. Award Information

1. Mechanisms of Support

This funding opportunity will use the NIH investigator-initiated research project grant (R01) and the NIH exploratory/developmental grant (R21) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. For the R21 mechanism, applicants may request a project period of up to 2 years with a combined budget for direct costs of up to $275,000 for the 2-year period. For example, an applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in any single year. The R21 grant is not renewable. (Please note that facilities and administrative [F&A] costs requested by any consortium participants are excluded from the direct cost limit per NIH Guide Notice NOT-OD-05-004 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.)

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget 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 budget format described in the PHS 398 application instructions. Otherwise, follow the instructions for non-modular research grant applications.

2. Funds Available

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 the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Facilities and administrative costs are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

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.

2. Cost Sharing

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part2.htm.

3. Other-Special Eligibility Criteria
Not applicable.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are 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.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001; 9/2004 version after May 10). 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 D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

All instructions for the PHS 398 must be followed. Please see the link for the NIH Exploratory/Developmental Research Grant Award Program at http://grants.nih.gov/grants/funding/r21.htm for specific instructions on submitting R21 applications.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates

Applications must be mailed on or before the receipt date described below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Dates: Not applicable
Application Receipt Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

3.C. Application Processing

Applications must be sent on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

The NIH 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 NIH 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.

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.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Award Criteria).

6. Other Submission Requirements

Specific Instructions for Modular Grant applications:

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget 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 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the IC 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 IC staff that the IC will accept your application for consideration for award; and

3) Include a cover letter with the application that identifies 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.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal web site, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Award Criteria.

Section V. Application Review Information

1. Criteria

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Appropriate scientific review groups 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:

3. Merit Review Criteria

Applications submitted in response to a funding opportunity will compete for available funds with all other recommended applications.

The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools or technologies that have the potential to significantly advance our knowledge or the status of health related research. Because the research plan is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications.

The goals of NIH-supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an 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.

1. Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

3. Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators: Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

5. Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

3.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to 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 the Research Plan, Section E on Human Subject in the PHS Form 398).

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 will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subject in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

3.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

3.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing .)

3.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and at http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Award Criteria.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

The NGA will be sent via email to the administrative official whose name is listed in Block 12 on the Face Page of the Form PHS 398.

2. Administrative Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award
Not applicable.

3. Award Criteria

The following will be considered in making funding decisions:

4. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity 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:

1. Scientific/Research Contacts:

Wendy Nelson, Ph.D.
Basic Biobehavioral Research Branch
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd. EPN, Room 4064
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-4590
FAX: (301) 435-7547
Email: nelsonw@mail.nih.gov

2. Peer Review Contacts:
Not applicable.

3. Financial or Grants Management Contacts:

Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Blvd., EPS, Room 243
Bethesda, MD 20892
Telephone: (301) 496-8634
FAX: (301) 496-8601
Email: wolfreyc@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm) and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

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).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); and efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (see the NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application (http://grants.nih.gov/grants/policy/data_sharing).seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). At the same time, the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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 "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is 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 Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical 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 (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 applications for research involving human subjects and individuals designated as key personnel. The policy is available 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://stemcells.nih.gov/index.asp 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 (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, 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.

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 web site (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 U.S. 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 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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, see http://www.lrp.nih.gov/.

References

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Benard, V.B., Eheman, C.R., Lawson, H.W., Blackman, D.K., Anderson, C, Helsel, W., Thames, S.F., et al. (2004). Cervical screening in the National Breast and Cervical Cancer Early Detection Program, 1995-2001. Obstetrics & Gynecology, 103, 564-571.

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Gilovich, T., Griffin, D., & Kahneman. (2002). Heuristics and biases: The psychology of intuitive judgment. Cambridge, UK: Cambridge University Press.

Holmberg, L., Bill-Axelson, A., Helgesen, F., Salo, J.O., Folmerz, P., Haggman, M., et al. (2002). A randomized trial comparing radical prostatectomy with watchful waiting in early prostate cancer. New England Journal of Medicine, 347, 781-789.

Lipkus, I.M., Samsa, G., & Rimer, B.K. (2001). General performance on a numeracy scale among highly educated samples. Medical Decision Making, 21, 37-44.

Loewenstein, G.F., Weber, E.U., Hsee, C.K., & Welch, N. (2001). Risk as feelings. Psychological Bulletin, 127, 267-286.

McNeil, B.J., Pauker, S.G., Sox, H.C., & Tversky, A. (1982). On the elicitation of preferences for alternative therapies. New England Journal of Medicine, 306, 1259-1262.

Ransohoff, D.F., Collins, M.M., & Fowler, F.J. (2002). Why is prostate cancer screening so common when the evidence is so uncertain? A system without negative feedback. American Journal of Medicine, 113, 663-337.

Redelmeier, D.A., Rozin, P., & Kahneman, D. (1993). Understanding patients' decisions: Cognitive and emotional perspectives. Journal of the American Medical Association, 270, 72-76.

Talcott, J.A. (2003). What patients should be told before agreeing to a blood test that could change their lives. Urology, 61, 7-9.

Tucker, M.A., Murray, N., Shaw, E.G., Ettinger, D.S., Mabry, M., Huber, M.H., et al. (1997). Second primary cancers related to smoking and treatment of small-cell lung cancer. Journal of the National Cancer Institute, 89, 1782-1788.

Tversky, A., & Kahneman, D. (1981). The framing of decisions and the psychology of choice. Science, 211, 453-458.

Ubel, P.A., & Loewenstein, G. (1997). The role of decision analysis in informed consent: Choosing between intuition and systematicity. Social Science and Medicine, 44, 647-656.

U.S. Preventive Services Task Force. Screening For Cervical Cancer. In: Guide to preventive clinical services, 3 rd ed. Rockville, MD: AHRQ Publications Clearinghouse, 2003. Publication No. APPIPO2-0001.

Weinstein, N.D. (1999). What does it mean to understand a risk? Evaluating risk comprehension. Journal of the National Cancer Institute Monograph, 25, 15-20.

Weinstein, N.D. (2000). Perceived probability, perceived severity, and health-protective behavior. Health Psychology, 19, 65-74.

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