RFA-NR-01-004: CLINICAL TRIALS: COLLABORATIONS FOR NURSING RESEARCH II

Department of Health
and Human Services (HHS)

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CLINICAL TRIALS: COLLABORATIONS FOR NURSING RESEARCH II Release Date: January 16, 2001 RFA: RFA-NR-01-004 National Institute of Nursing Research (http://www.ninr.nih.gov/) Letter of Intent Receipt Date: April 20, 2001 Application Receipt Date: May 18, 2001 THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA/PA. PURPOSE The National Institute of Nursing Research (NINR) invites nurse investigators to participate in an initiative that capitalizes on the substantial Public Health Service (PHS) resource of available study populations in clinical trials from the unique perspective of nursing research and special expertise of nurse researchers. The purpose of this Request for Applications (RFA) is to link supplemental studies posed by nurse researchers to currently funded clinical research studies, or to link supplemental studies by non-nurse researchers with ongoing clinical studies where nurse researchers are the Principal Investigators (PI). Collaborations and consortia promoting the cross- fertilization of ideas are encouraged. The rationale for this RFA is that supplemental studies are cost effective ways to stimulate ongoing research while capitalizing on resources expended on a parent clinical trial. 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 Request for Applications (RFA), Clinical Trials: Collaborations for Nursing Research II, 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/. ELIGIBILITY REQUIREMENTS The applicant responding to this RFA should be a registered nurse with doctoral preparation who poses a research question from her/his ongoing program of research which can be answered by accessing a currently funded clinical trial, or, a nonnurse doctorally prepared scientist who seeks to answer a clinical question or solve a nursing problem using the clinical study resources where the PI is a nurse researcher. Nurse researchers are to collaborate with non-nurse PIs and/or the steering committees on currently funded clinical trials where resources can be accessed (i.e., study population for screening, recruitment or follow-up visits, data for secondary analyses, fluid samples, genetic data banks) in order to answer a clinical question or solve a nursing problem. Likewise, non-nurse researchers in various fields are encouraged to collaborate with a PHS funded nurse researcher to access a study population in a scientific field of their choice. The spirit of this announcement is to foster new alliances and collaborations with nursing research and other disciplines. Ongoing collaborations with nurse researchers and non-nurse PIs are acceptable, but new collaborations are preferred. For the purpose of this RFA, collaboration on a clinical research study is required. A clinical research study is defined as a clinical trial where large numbers of subjects are being recruited, hypotheses are being tested, and subjects are randomized to a control and experimental groups. Epidemiological study populations are acceptable, but not preferred, and may only be used when large cohorts of patients are recruited. The PI or the steering committee for the clinical trial identified as the collaborator for the applicant’s RFA R01 must provide written assurances in the application that the proposed study is technically and administratively feasible as a complementary study, is compatible with the parent study protocol, and will not add substantial burden to the participants of the currently funded parent grant. In addition, if a Data Safety and Monitoring Board is established for the parent grant, their approval is necessary prior to grant funding but not necessary prior to submission of the application. If collaborative expertise or research resources (i.e., tissue samples, data sets, or access to cohorts) are required to implement the applicant’s RFA R01 successfully, documentation of the characteristics, quality, and availability of these resources must be fully addressed in the application. Examples of potential PIs for nurse researchers to collaborate with include ethicists, physicians, anthropologists, bioengineers, psychologists and other social scientists, epidemiologists, geneticists, and molecular biologists. The following list will assist nurse researcher applicants in locating the names of PIs currently funded on NIH clinical trials: http://cancertrials.nci.nih.gov/ http://www.nei.nih.gov/neitrials/index.htm http://apps.nhlbi.nih.gov/clinicaltrials/ http://www.niaid.nih.gov/clintrials/ http://www.nih.gov/niams/clinical/ http://www.nichd.nih.gov/ct/ct.htm http://clinicalstudies.info.nih.gov/cgi/protinstitute.cgi?NIDCD.0.html http://www.niddk.nih.gov/patient/patient.htm http://www.nida.nih.gov/ClinicalTrials.html http://www.nimh.nih.gov/studies/index.cfm http://rarediseases.info.nih.gov Applicants will find grant information for NIH Institutes and Centers that do not maintain Clinical Trial databases at these websites: http://www.ninr.nih.gov/1999grants/1999NINRgrants.htm http://www.nhgri.nih.gov/Grant_info/Grant_search/query.cgi http://www.nih.gov/nia/research/ http://silk.nih.gov/silk/niaaa1/grants/ResCtrs1198.htm http://www.ninds.nih.gov/index.htm Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal Government. Foreign organizations that have current NIH-supported grants are eligible to apply, and domestic applications may include international components. The NINR encourages applications that include investigators who are racial/ethnic minority individuals, women, and persons with disabilities. MECHANISM OF SUPPORT Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm The mechanism of support for the RFA will be the traditional research project grant (R01). Responsibility for planning the proposed project will be solely that of the applicant. R01 awards will vary in size and duration reflecting the nature and scope of the research proposed on the currently funded parent grant. R01 applications proposing secondary analyses of existing data, pilot studies, small clinical studies or any projects with budgets up to $250,000 direct costs will follow the modular grant procedure. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be received according to customary peer review. Although multidisciplinary approaches and collaboration are required for successful competition of applications, it is not the intent of the announcement to solicit applications for large clinical trials or large epidemiologic studies. In general, funds will not be provided for the purchase and installation of expensive, new equipment. To evaluate the effectiveness of this RFA initiative, there will be a meeting of funded investigators and NINR staff at the National Institutes of Health during the second and third years of funding. Applicants should include travel funds for this purpose in those fiscal years of their budget request. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. This RFA is a one-time solicitation. The anticipated award date is September 29, 2001. FUNDS AVAILABLE The NINR intends to commit $1.5 million in FY 2001 to fund approximately 5 new grants in response to this RFA, pending the availability of funds. Additional projects will be considered on a case by case basis. Because the nature and scope of the research proposed may vary, it is anticipated that the size of awards will also vary. Although the financial plans of NINR are to provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. At this time, it is not known if this RFA will be reissued. RESEARCH OBJECTIVES Background Critical gaps in knowledge about symptom management of acute and chronic illness, prevention of disease and promotion of healthy lifestyles exist. NINR research has attempted to close these gaps by promoting research in the following science areas: neurofunction and sensory conditions (i.e., Alzheimer’s disease, multiple sclerosis, pain, sleep/biorhythms), reproductive and infant health (i.e., low birthweight, teen pregnancy), immune responses and oncology (i.e., HIV, infectious disease, end-of-life), cardiopulmonary and critical care (i.e., asthma, hypertension, pressure ulcers, transplantation, trauma, genetics), chronic illness (i.e., arthritis, diabetes, urinary incontinence) the aging population and long term care, and health promotion and risk behaviors (i.e., smoking cessation, women’s health, children’s health, nutrition, obesity, drug abuse). Currently, the PHS has a wealth of resources and information in currently funded clinical trials that remains untapped by nurse researchers. Adding nursing studies to these clinical trials will capitalize on current PHS wide investments in research by building upon resources already available (e.g., tissue samples, gene data banks, cohorts of subjects with well- delineated medical and health data, pediatric or adult clinical trials testing drugs or drug combinations). In addition, currently funded nurse investigators have large cohorts of patients where biological and genetic questions could easily be asked by nonnurse researchers as companion studies. This RFA is expected to enrich scientifically and to extend the scope of relevant PHS-funded research grants supporting biological, biomedical, or behavioral clinical trials, or nursing clinical studies, by asking additional clinical questions. Research Objectives and Scope The overall objective of this RFA is to take full advantage of the research process by solving additional health care problems on currently funded clinical trials or studies. The following research topics are provided as examples that would extend research currently funded by PHS. They are not listed in any priority order and are not intended to be inclusive or restrictive. o Examine the role that social behavior plays in potentiating infection with HIV. o Determine the efficacy of dietary and/or exercise protocols to modulate sleep disturbances in patients with AIDS. o Assess physiological/immunological/genetic parameters in ethnically diverse groups with and without chronic conditions, such as diabetes, to characterize unique and common responses to medical treatments or pharmacological regimens. o Assess the occurrence of apolipoprotein subtype alleles found in head injured patients and relate them to other disorders such as hypertension, Alzheimer’s disease or stroke. o Perform secondary data analyses techniques to ask questions that are not part of the original study, i.e., describe ways to prevent contributing factors responsible for health disparities, list ways to improve management of discomfort for persons at the end of life, assess why menopausal women decide to initiate estrogen replacement therapy, identify the influence of maternal diet, exercise habits or micronutrients on body mass, insulin levels, cholesterol levels or blood pressure of their offspring. o Determine the efficacy of home monitoring and other types of telehealth technology to promote self-management skills to prevent hospital readmission of patients with chronic diseases such as congestive heart failure. o Develop tools for parents and care providers to be used in the prevention and treatment of asthma attacks in children and adolescents. o Characterize the roles of socioeconomic status, age, gender, behaviors, or dietary patterns in transplantation patients who are noncompliant with medical regimens. o Qualitatively measure the family decision-making processes for declining or choosing therapies when a child is diagnosed with cancer. o Identify factors associated with a reduction in the burden of caregiving of family members with a chronic illness such as Alzheimer’s disease. o Measure endocrine and psychoneuroimmune levels in subjects recruited in ongoing clinical intervention studies and relate to optimum vaccine inoculation in children and adolescents. o Examine ways to promote quality of life at the end of life for those who have reached the end stages of chronic illness and who are facing premature death. o Develop ways to improve management of discomfort for persons at the end of life. o Identify specific nursing care measures to improve the outcomes of critically ill children diagnosed with traumatic brain injury while in intensive care units. o Test unique interventions utilizing modern technology (i.e., the Internet) in various settings to reach rural populations, the elderly, or children and adolescents to maintain healthy lifestyles. 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 sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NINR staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to the Scientific Review Administrator by April 20, 2001. Dr. Mary Stephens-Frazier Scientific Review Administrator National Institute of Nursing Research Building 45, Room 3AN-12 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5971 FAX: (301) 480-8260 Email: Mary_Frazier@nih.gov APPLICATION PROCEDURES The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, List all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations, o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and four 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) At the time of submission, also send one additional copy of the application to: Dr. Mary Stephens-Frazier Scientific Review Administrator National Institute of Nursing Research Building 45, Room Number 3AN-12 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA 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 substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by NINR. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NINR in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council for Nursing Research. Review Criteria The goals of the supported research are to advance our understanding of biological systems, improve the control of disease, improve health care services, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application 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 the 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 be advanced? 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? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator 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 (if any)? (5) Environment: Does the scientific environment in which the 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application. Schedule Letter of Intent Receipt Date: April 20, 2001 Application Receipt Date: May 18, 2001 Peer Review Date: July 2001 Council Review: September 2001 Earliest Anticipated Start Date: September 29, 2001 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Hilary D. Sigmon Program Director Division of Extramural Activities National Institute of Nursing Research Building 45, Room 3AN-12 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5970 FAX: (301) 480-8260 Email: Hilary_Sigmon@nih.gov Direct inquiries regarding fiscal matters to: Cindy McDermott Grants and Contracts Management Office National Institute of Nursing Research Building 45, Room 3AN-12 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5979 FAX: (301) 480-8260 Email: cindy_mcdermott@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361. 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, 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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