and Human Services (HHS)
EXPIRED
COLORECTAL CANCER SCREENING IN PRIMARY CARE PRACTICE RELEASE DATE: December 12, 2003 PA NUMBER: PAR-04-036 EXPIRATION DATE: June 24, 2005, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Cancer Institute (NCI/NIH) (http://www.nci.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.399, 93.226 LETTER OF INTENT DATES: January 23, 2004; September 22, 2004; January 24, 2005; May 23, 2005 APPLICATION RECEIPT DATES: February 23, 2004; October 22, 2004; February 23, 2005; June 23, 2005 This PAR replaces PAR-02-042, which was published in the NIH Guide on December 20, 2001. THIS PAR CONTAINS THE FOLLOWING INFORMATION o Purpose of the PAR o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PAR Colorectal cancer (CRC) is the second leading cause of cancer death in the United States. A growing body of evidence indicates that the number of individuals dying of colorectal cancer could be greatly reduced through appropriate screening. Although there is now general agreement that average- risk adults aged 50 and older should be screened for colorectal cancer, national survey data show that less than half of eligible adults have ever been screened for this disease. Primary care practice is an important point of entry for colorectal cancer screening. The National Cancer Institute and Agency for Healthcare Research and Quality are interested in promoting research to improve colorectal cancer screening delivery, utilization, and outcomes in primary care practice. The objective of this Program Announcement is to encourage health services, social and behavioral, and outcomes researchers to develop innovative research projects to increase the knowledge base for enhanced translation of effective colorectal cancer screening techniques into community practice. Both R21 and R01 projects will be supported by this program. RESEARCH OBJECTIVES Screening tests in current use for the detection of adenomatous polyps and colorectal carcinomas include the fecal occult blood test (FOBT), flexible sigmoidoscopy, colonoscopy, and double-contrast barium enema (DCBE). These tests differ in their costs, risks, complexity of administration, and in the level of evidence to support their use. Results from three randomized trials demonstrate mortality reductions associated with FOBT screening ranging from 15-33%. Evidence to support screening sigmoidoscopy primarily comes from three case-control studies demonstrating colorectal cancer mortality reductions ranging from 59-80%. The efficacy of DCBE and of colonoscopy in reducing colorectal cancer has been less studied. In general, FOBT is regarded as the least costly, most easily administered CRC screening test and colonoscopy as the most costly and complicated test. Because colonoscopy is the only screening modality that permits direct visualization of the entire colon as well as removal of precancerous and cancerous lesions, there has been debate as to whether colonoscopy should be considered the preferred colorectal cancer screening modality. The high costs, invasiveness, limited data on safety and efficacy, and restricted insurance coverage and provider availability associated with this modality have precluded most major expert groups from issuing screening guidelines that designate colonoscopy as a screening strategy that is preferable to FOBT, sigmoidoscopy, or DCBE. The recent change in Medicare reimbursement policy to extend coverage of screening colonoscopy to average-risk beneficiaries age 50 and older is contributing to increased use of this modality, and underscores the need for data to evaluate its acceptance, delivery, and utilization, especially in community practice. Health services delivery refers to the activities of providers of care and utilization to the extent and kind of health services used by patients. Outcomes assessment involves an examination of the short-term results of and/or long-term impact of health services. Knowledge about delivery, utilization, and outcomes of colorectal cancer screening in primary care practice is limited. In particular, whether screening in community settings approximates outcomes as determined in controlled clinical studies is unknown. Data are needed on the sensitivity, specificity, and predictive value of various colorectal cancer screening approaches in community practice. Similarly, data on the acceptability of and adverse events associated with various screening strategies as delivered in community practice would make an important public health contribution. Although increasing, screening rates for colorectal cancer remain relatively low in the U.S. Data from the 2000 National Health Interview Survey (NHIS) show that only about 43% of adults aged 50 or older reported having FOBT within the preceding year or colorectal endoscopy within the past 10 years. Analysis of NHIS data also indicates that higher income and educational attainment and having health insurance and a usual source of health care are all important factors associated with receipt of colorectal cancer screening. Little is known, though, about specific facilitators of or barriers to colorectal cancer screening delivery and utilization in primary care practice. What characteristics of the primary care setting influence providers to recommend colorectal cancer screening to their patients, and what factors influence patient decisions to comply? What factors facilitate the adoption of colorectal cancer screening guidelines by clinicians and how does this affect screening prevalence? What methods help physicians and their patients to make informed and shared decisions about the benefits and risks of colorectal cancer screening? Further research is needed to assess and inform interventions that will have the greatest potential for increasing colorectal cancer screening utilization and integrating colorectal cancer screening delivery into primary care practice. In addition, the extent to which implementation of organized approaches to colorectal cancer screening delivery influences colorectal cancer screening utilization has not been systematically documented. Moreover, whether diverse types of primary care practices, such as clinics, single or multi-specialty group practices, community health centers, or networks of primary care practices, are able to gather and systematically assess data on colorectal cancer screening delivery, utilization, and short-term outcomes in community practice remains to be demonstrated. For the majority of the U.S. population, primary care is the main point of entry into the health care system. Provision of prevention and health promotion services, including cancer screening, is an important component of primary care practice. Even when the primary care physician does not him or herself deliver a health care service such as screening endoscopy or DCBE for the early detection of colorectal cancer, he or she may be responsible for recommending and facilitating referrals for this preventive service for eligible patients. For these reasons, this Program Announcement is directed toward enhancing understanding of colorectal cancer screening delivery, utilization, and outcomes in primary care practice. A variety of community- based primary care organizations and networks are eligible to participate in research supported by this Program Announcement. Because of their multi- practice organization and focus on conducting research in community-based primary care practice settings, primary care practice-based research networks or similar organizational structures for delivering and evaluating primary care may be well-suited to undertaking the type of research outlined in this Program Announcement. Health care organizations such as HMOs, community health centers, large clinics or networks of community-based practices, and Community Clinical Oncology Programs (CCOPs) also are encouraged to submit applications in response to this Program Announcement. Research Goals and Scope This Program Announcement supports research to improve the delivery and uptake, and evaluate the short-term outcomes of colorectal cancer screening in primary care practice. It addresses the priorities for social and behavioral and health services research identified in the NCI Colorectal Cancer Progress Review Group report issued in April 2000 (http://prg.nci.nih.gov/colorectal/finalreport.html). It is intended to support efforts in primary care practice to develop the capability for obtaining and evaluating patient, provider, practice, and clinical data and/or conducting interventions to assess and enhance colorectal cancer screening delivery, utilization, and outcomes. Such capability may entail establishing interfaces with specialty practices, particularly gastroenterologists, so that data on screening and follow-up procedures such as colonoscopy that are typically conducted by specialists are obtained. In addition, linkage to pathology laboratories to obtain data on colorectal lesions, particularly benign pathology, and/or to a high-quality cancer registry to obtain data on cancer outcomes may be required. Furthermore, development of the capacity to collect and evaluate longitudinal data on the entire process of screening (i.e., ever, repeat, follow-up) is encouraged. Priority will be given to applications involving 10 or more physician practices; that have access to large, diverse, or underserved population groups; in which there are established referral linkages to specialty practices (i.e., gastroenterologists, surgeons, or diagnostic radiologists); and in which clinical sites have the ability to obtain data electronically. Moreover, because of the paucity of data on use of colonoscopy in community practice, sites that have the ability to obtain and evaluate data on colonoscopy as a screening and/or follow-up modality are encouraged to incorporate this modality in their applications. This Program Announcement is jointly sponsored by the Applied Research and Behavioral Research Programs, Division of Cancer Control and Population Sciences, National Cancer Institute (NCI), and the Center for Primary Care, Prevention, and Clinical Partnerships, Agency for Healthcare Research and Quality (AHRQ). NCI and AHRQ will work collaboratively and, contingent upon the availability of funds, anticipate sponsoring a meeting of grantees funded under this Program Announcement to facilitate future planning and program direction. Research topics to be supported are those falling within areas of clear importance to assessing the delivery, utilization, and short-term outcomes of colorectal cancer screening in primary care practice. These topics include, but are not limited to, those described below. If applying for funding under the R21 mechanism, investigators should specify research objectives and plans that can be realistically achieved within the budget and time limits associated with this mechanism. Preliminary data are not required for R21 applications. Investigators intending to use administrative claims as their primary data source should direct their applications to PA-04-012: Cancer Surveillance Using Health Claims-Based Data System. 1. Develop appropriate interventions, mechanisms, or systems to monitor the completion of and improve compliance with colorectal cancer screening and follow-up. This includes tracking procedures such as sigmoidoscopy, colonoscopy, or DCBE for which patients may be referred to specialty providers. Development of interventions, mechanisms, or systems that utilize information technologies or computerized patient records to facilitate monitoring and to improve compliance with colorectal cancer screening is especially encouraged. 2. Pilot or refine theories that could inform future interventions to enhance colorectal cancer screening utilization that consider diverse populations and primary care settings. 3. Evaluate how the risk for colorectal cancer is assessed in the primary care setting and propose strategies to improve physician and patient informed and shared decision-making regarding colorectal cancer screening options. 4. Develop innovative data collection approaches to enable evaluation of colorectal cancer screening delivery, utilization, and short-term outcomes in busy practice settings. Development of information technologies to facilitate the acquisition of complete, accurate data while minimizing disruption to busy practices is especially encouraged. Data elements of particular relevance could include patient sociodemographics; colorectal cancer risk factors; screening tests recommended and performed; follow-up tests recommended and performed; test results; adverse events associated with screening or follow-up tests; characteristics of tests performed; characteristics of performing providers; patient and provider knowledge, attitudes, and practices; characteristics of lesions identified, including cancer; and characteristics of the primary care practice setting, including use of office reminder systems. 5. Develop and/or validate open source data collection instruments to assess patient and provider screening-related knowledge, attitudes, preferences, and practices that account for differences among population groups as well as among primary care practice settings. 6. Develop measures, scales, and/or instruments to assess the utilization of and adherence to colorectal cancer screening over time that take into account the multiple available screening modalities and recommended screening intervals that vary by modality. 7. Assess the feasibility and acceptability of conventional and emerging screening technologies from the patient and/or provider perspectives, in community practice. 8. Determine the extent to which data collection procedures in community- based practices for established screening modalities such as conventional FOBT and sigmoidoscopy can be readily adapted for new and emerging screening technologies such as colonoscopy, CT colonography, immunochemical FOBT, stool-based DNA marker testing, etc. 9. Evaluate screening utilization and the efficiency and effectiveness of screening delivery in community practice, including screening and compliance rates by provider type, modality, and population group; time to completion of recommended screening and follow-up procedures; quality of procedures; or adverse events by provider type, modality, and population group. 10. Determine the performance characteristics (i.e., sensitivity, specificity, and predictive value) in terms of ability to detect precancerous lesions and early-stage colorectal cancer, for various colorectal cancer screening modalities, as implemented in community practice. 11. Identify factors that may influence performance characteristics for colorectal cancer screening procedures in community-based practices. Factors examined could include characteristics of different population groups, provider types, and practice organizations, or technical aspects such as test or equipment type. 12. Develop innovative approaches to promoting colorectal cancer screening utilization in diverse populations that take into account multiple levels of intervention. Projects that address populations with compromised access are of particular interest. 13. Develop innovative approaches that attempt to integrate the delivery of colorectal cancer screening with other preventive health services provided in the primary care setting. MECHANISMS OF SUPPORT This PAR will use the NIH Research Project (R01) and Exploratory/Developmental (R21) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an application submitted in response to this PAR may not exceed 2 years for an R21 application and 5 years for an R01 application. For an R21 application the applicant may request a project period of up to two years with a combined budget for direct costs of up $275,000 for the two year period. For example, the 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. These grants are non-renewable and continuation of projects developed under this PA will be through the traditional unsolicited investigator initiated grant program. There is no dollar limit for R01 applications. This PAR uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting 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. Otherwise follow the instructions for non-modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. 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 institutions/organizations o Faith-based or community-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 PAR 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: o Direct your questions about scientific/research issues to: Carrie N. Klabunde, Ph.D. Applied Research Program Division of Cancer Control and Population Sciences National Cancer Institute EPN 4005; 6130 Executive Boulevard Bethesda, MD 20892-7344 Telephone: (301) 402-3362 FAX: (301) 435-3710 Email: [email protected] Erica S. Breslau, Ph.D. Behavioral Research Program Division of Cancer Control and Population Sciences National Cancer Institute EPN 4098; 6130 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 435-2839 FAX: (301) 480-6637 E-mail: [email protected] David Lanier, M.D., M.P.H. Center for Primary Care, Prevention, and Clinical Partnerships Agency for Healthcare Policy and Research 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1567 FAX: (301) 427-1595 Email: [email protected] o Direct your questions about peer review issues to: Referral Officer National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: [email protected] o Direct your questions about financial or grants management matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute Executive Plaza South - 243 Bethesda, MD 20892 Telephone: (301) 496-8634sa FAX: (301) 496-4801 Email: [email protected] LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this PAR 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 IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Carrie N. Klabunde, Ph.D. Applied Research Program Division of Cancer Control and Population Sciences National Cancer Institute EPN 4005; 6130 Executive Boulevard Bethesda, MD 20892-7344 Rockville, MD 20852 (express/courier service) Telephone: (301) 402-3362 FAX: (301) 435-3710 Email: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). 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 DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document 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]. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box checked. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted by the receipt dates listed on the first page of this program announcement. 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. For the NIH Exploratory/Developmental Grant (R21), applicants may request direct costs in $25,000 modules, up to a total direct cost of $275,000 for the combined two year award period. 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: 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. Identify, in a cover letter sent with the application, the staff member 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 three 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, two additional copies of the application and all copies of the appendix material must be sent to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) Appendices should be comprised of single-sided, unbound materials, with separators between documents. APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e. FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html) This change in practice is effective immediately. This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING: Applications must be received on or before the receipt dates listed on the first page of this program announcement. CSR will not accept any application in response to this PAR 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. 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. PEER REVIEW PROCESS Applications that are complete and responsive to the PAR will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: 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 written critique 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 evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment 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. 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? 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? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 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)? 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be applied to ALL applications 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 criteria included in the section on Federal Citations, below). 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 Inclusion Criteria in the sections on Federal Citations, below). 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 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. 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 PAR 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 RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Dates: January 23, 2004; September 22, 2004; January 24, 2005; May 23, 2005 Application Receipt Dates: February 23, 2004; October 22, 2004; February 23, 2005; June 23, 2005 Peer Review Dates: June 2004; March 2005; June 2005; November 2005 Council Review: September 14, 2004; June 7, 2005; September 20, 2005; February 2006 Earliest Anticipated Start Dates: December 2004, July 2005; December 2005; April 2006 REQUIRED FEDERAL CITATIONS 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), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety 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 "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. A continuing education program in the protection of human participants in research is available online at: http://cme.nci.nih.gov/ 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 PAR 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). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (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 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 PAR 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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