SUPPORT FOR HUMAN SPECIMEN BANKING IN NCI-SUPPORTED CANCER CLINICAL TRIALS RELEASE DATE: April 29, 2004 RFA Number: RFA-CA-05-017 Update: The following update relating to this announcement has been issued: (Reissued as RFA-CA-09-504) EXPIRATION DATE: July 22, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Cancer Institute (NCI) (http://www.nci.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.394, 93.395 LETTER OF INTENT RECEIPT DATE: June 21, 2004 APPLICATION RECEIPT DATE: July 21, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Cooperative Agreement Terms and Conditions of Award o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The purpose of this initiative is to support the infrastructure needed to ensure the collection of, storage of, and access to high-quality, well- annotated human specimens collected from and representative of the patient populations entered into NCI-funded, phase III clinical treatment trials. The advent of powerful molecular technologies and the emergence of targeted therapeutics have opened the door to developing more effective and, in some cases, individualized treatment of patients with cancer. Access to specimens with associated high-quality clinical, treatment, recurrence, and outcome data will be critical to developing and validating the tests needed for diagnosis, target identification, and prediction of response to therapy. Developing and effectively using cancer interventions based on the comprehensive analysis of critical pathways of cancer initiation and progression will ultimately require access to specimens from patients treated in prospective randomized trials. High quality banks of uniformly collected specimens with validated clinical and outcome data will be essential for development and delivery of the new diagnostic and predictive tools that are critical to eliminating the suffering and death due to cancer by 2015. Groups organizing and carrying out phase III clinical trials are uniquely positioned to provide the high quality specimens and have the informative clinical data and resources needed to meet this challenging goal. RESEARCH OBJECTIVES Background This initiative is intended to expand the quantity, quality, representativeness and accessibility of specimen collections developed from NCI-funded, phase III treatment trials in order to better support cancer research needs. Specimen collections from phase III trials provide important support for research studies while providing quality control and economies- of-scale not available from collections of specimens that are assembled outside the context of clinical trials. These specimen collections are unique because they have detailed treatment histories, recurrence data, and careful follow-ups from patients over long periods of time. Improving the quality and accessibility of specimens from NCI-supported clinical trials will facilitate the development of prognostic and predictive markers, molecular signatures, identification of therapeutic targets and other important translational research studies. Objectives and Scope This initiative is intended to support the activities necessary to operate a well-developed bank. The range of activities that can be covered includes support and training for staff to collect and ship specimens from the collection sites to the central banks; to oversee receipt of specimens, and to process specimens at the central bank, including conducting pathologic review and providing histology services. The initiative can also cover support for equipment and supplies, including shipping materials and shipping costs, storage costs such as liquid nitrogen for freezers, travel to required meetings, informatics to track specimens, and miscellaneous costs such as maintenance contracts and subcontracts to participating institutions. Additional support can be obtained to cover some of the costs associated with review of requests for specimens and data, and retrieval and shipment of specimens to researchers and/or return of blocks to the collecting institution for patient care or legal requirements. The costs of organizing or operating data centers beyond those incremental costs directly associated with transmission of data related to operation of the banks will not be covered. At the time that the application is submitted, eligible groups must have current NCI funding for conducting phase III cancer clinical trials and have one or more operating specimen banks with access to detailed demographic, clinical, treatment, and outcome data for the cases (patients) whose specimens make up the bank. Awardees retain custody and primary rights to specimens and data developed under these awards, subject to legally mandated government policies, e.g., NCI, NIH, or PHS rights of access, consistent with current DHHS, PHS, and NIH policies. A major objective of this initiative is to improve the operation of the banks and to assure that there is coordination of banking activities among groups conducting trials. To the extent possible, common collection and storage practices should be implemented. Applicants will be required to agree to work with the steering committee (hereafter referred to as the ‘Group Banking Committee [GBC]) to develop policies with milestones for implementation. The GBC activities shall include, but are not limited to, the following: a. Coordination of activities; b. Best practices for collection and storage and exchange of specimens; c. Common data structures for banking and data exchange; d. Principles for utilization of banked specimens and data; e. Researcher application and review processes; and f. Meeting the needs of emerging technologies. The GBC will establish a timeline for developing and implementing the policies listed, with specific milestones and dates when they are to be completed. Progress will be evaluated annually by the NCI and substantial progress will be expected at a rate that will lead to appropriate policies and actions by the end of the second year of funding. Failure to make substantial progress will be grounds for discontinuing funding. MECHANISM OF SUPPORT This RFA will use the NIH U24 Cooperative Agreement award mechanism for Resource-Related Research Projects. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing- continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The NCI may, at its discretion, reissue this RFA for additional future competitions. The anticipated award date is April 2005. The NIH U24 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator (PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the PI, as described under the section "Cooperative Agreement Terms and Conditions of Award". FUNDS AVAILABLE NCI intends to commit approximately $9 million in FY 05 to fund approximately nine new awards in response to this RFA. An applicant may request a project period of up to 5 years and a budget for total direct costs (including sub- contractual party, Facilities and Administrative costs) of up to $1.5 million per year. Because the nature and scope of the proposed research resource 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 NCI 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 meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your organization has all of the following characteristics: o Public or private institutions, such as universities, colleges, hospitals, non-profit organizations and laboratories o Domestic institution/organization o Foreign institutions are not eligible to apply. Organizations responding to this announcement should also: o Have one or more existing banks of human specimens from Phase III treatment trial cases o Organize and coordinate large phase III cancer treatment trials o Have current NCI funding for phase III clinical trials. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to oversee the resource development is invited to work with their institution to develop an application for support. Individuals from under-represented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Applicants are required to agree that if funded they will name three people from their group to participate as members of the GBC as described in the following section, ‘Cooperative Agreement Terms and Conditions of Award.’ They must also agree to abide by the decisions of the GBC and to meet milestones developed by the GBC within the established time-lines subject to the Arbitration clause in the ‘Cooperative Agreement Terms and Conditions of Award’ section. Applicants must include funding in their applications for the three members from their group to attend the GBC meetings. They should anticipate that there will be three meetings in the first year and two in each subsequent year. Applicants should assume that the first meeting will be in Bethesda/Rockville, Maryland and that subsequent meetings will alternate among the various participants’ repository sites. For planning purposes, you may assume that the meetings in the first year will be Bethesda/Rockville, Maryland, one on the west coast and one on the east coast. You may plan on one west coast and one east coast meeting for each subsequent year. Applicants must agree to provide information about their specimen and data collections to the NCI Tissue Expediter after receipt of this award and on a regular basis thereafter. This information will be required at least once annually. (This information can be sent electronically to email@example.com. ) The information will be used to facilitate possible collaborations with appropriate researchers. Applicants must establish policies to make appropriate patient demographic, clinical, outcome and treatment data available to users of the specimen bank. Data policies can and in most cases should be, in collaboration with group statisticians and other participants in the clinical trial(s) in which the specimens were collected. Awardees must also collect and report as part of their non-competing application: the information listed in section 3 of the ‘Cooperative Agreement Terms and Conditions of Award’ section. COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. (Part 92 applies when state and local governments are eligible to apply as a "domestic organization.") The administrative and funding instrument used for this program is a U24 Resource-Related Research Project Cooperative Agreement, an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role, and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the funded activities will be shared among the awardees and the NCI Project Coordinators. 1. Awardee Rights and Responsibilities The PI is responsible for implementing bank operating policies developed by the GBC. The PI is also responsible for overseeing the activities of the group’s representatives to the GBC. This responsibility includes implementing policies, objectives, and approaches developed by the Group Banking Committee in areas such as defined best practices or operating policies, marketing the banks, access procedures, fiscal arrangements such as setting charges for the use of bank specimens, and quality assurance measures for all aspects of the operation of the banks. The PI must also assure that designated banked tissues remain available and that the relevant clinical data are obtainable in accordance with the policies developed by the Group Banking Committee. 2. NCI Staff Responsibilities One NCI scientist (Project Coordinator) will be assigned to participate as a voting member of the GBC. The Project Coordinator will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for the award. The Associate Director of the Cancer Diagnosis Program or a designee shall appoint the Project Coordinator. The NCI Project Coordinator will have voting membership on the GBC, and on any subcommittees of the Group Banking Committee. The NCI Project Coordinator will have the additional responsibility of coordinating activities of the GBC between meetings. The NCI Project Coordinator will work closely with the Chair of the GBC (who cannot be the NCI representative) to develop agendas and monitor progress toward developing policies and milestones and adhering to the time-lines set by the Committee. The Project Coordinator will also provide technical advice in the development of best practices for collection, processing, storage, retrieval, and shipping of specimens and the development of appropriate processes for assuring access to the banked specimens, legal and ethical issues such as implementation of the DHHS Health Information Portability and Accountability Act (HIPAA) Privacy Rule, the ‘common rule’ (45 CFR 46) and Institutional Review Board (IRB) interactions, as well as other issues for which the GBC will develop policies. Other NCI staff will be asked to attend meetings to ensure that the necessary areas of expertise are represented, but they will not be designated as voting members of the Committee. An NCI program director will be assigned and be responsible for normal program stewardship for the award. The program director may also serve as the Project Coordinator. 3. Collaborative Responsibilities The cooperative agreements (U24) will require cooperation between the NCI representative (the NCI Project Coordinator) and members of the GBC (described below) to assure the success of the project and to ensure smooth interactions among the cooperating organizations. The NCI Project Coordinator participates as a voting member of the GBC and assists in coordinating the activities of the awardees and facilitating communications. Each cooperating organization has one vote on the GBC. The Chair of the GBC is responsible for developing agendas, ensuring progress, facilitating cooperation among participants, and chairing meetings. These responsibilities are described more fully below. Group Banking Committee The GBC, the steering committee for the project, consists of up to three representatives appointed by the principal investigator of each cooperative agreement and the NCI Project Coordinator. While each group may have up to three members, they will have only one vote on the Committee. The GBC as the main governing board of the project will be primarily responsible for developing policies for the participating banks. Policies will be reviewed and implemented by the PI for each award. The Committee will be composed of three representatives from each participating organization (one voting member) and the NCI Project Coordinator. The chairperson, who will be someone other than an NCI staff member, will be selected by the GBC. Subcommittees may be established by the GBC as appropriate and the NCI participants may serve on any subcommittees that they deem appropriate. a). The GBC will develop policies with milestones for implementation. These policies shall include, but are not limited to, the following: i). Coordination of activities; ii). Best practices for collection and storage of specimens; iii). Common data structures for banking; iv). Utilization of banked specimens and data; v). Researcher application and review processes; and vi). Meeting the needs of emerging technologies b). The GBC will determine the format in which information must be reported in the non-competing (Type 5) grant progress report (PHS 2590). Information shall include, but not be limited to the following: i). Marketing of the resource; ii). The number of requests received (report total numbers, and separately list the number of requests from investigators not served previously and those from investigators outside your institution, cooperative group, or cancer center); iii). The number of investigators who received specimens (report total numbers, and separately list the number of investigators not served previously and the number of investigators from outside your group); iv). The number and types of specimens provided to researchers; and v). The study from which the requested specimens were collected. c).Awardees must agree to name three representatives to the GBC and to ensure that at least two representatives are present at each meeting. Representatives are charged with keeping the PI apprised of the policies under discussion and representing any concerns of the PI back to the Committee. d).The NCI will provide one member to the GBC who will be full participants in all deliberations and help coordinate the group between meetings. e).The GBC will meet three times in the first year and at least twice annually thereafter on a date and time agreed upon by the membership. f).Awardees must come to agreement on policies recommended by the GBC and implement those policies. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and the NCI may be brought to arbitration. An arbitration panel will be composed of three members: one selected by the GBC (with the NCI members not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by NCI, and the third member selected by the two previously selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and DHHS regulation at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA 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: Roger L. Aamodt, Ph.D. Resources Development Branch, Cancer Diagnosis Program National Cancer Institute Executive Plaza North, Room 6035A 6130 Executive Boulevard, EPN Room 6035A, MSC 7420 Bethesda MD 20892-7240 Rockville, MD 20850 (for express/courier service) Telephone: (301) 496-7147 FAX: (301) 402-7819 Email: firstname.lastname@example.org 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 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: email@example.com o Direct your questions about financial or grants management matters to: April Winegar Grants Administration Branch National Cancer Institute Fairview Center Building, Suite 300 1003 West 7th Street Frederick, MD 21701-4106 Telephone: (301) 846-6832 FAX: (301) 846-5720 Email: firstname.lastname@example.org 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 RFA. 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 NCI 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: Roger L. Aamodt, Ph.D. Resources Development Branch, Cancer Diagnosis Program National Cancer Institute 6130 Executive Boulevard, EPN Room 6035A, MSC 7420 Bethesda MD 20892-7240 Rockville, MD 20850 (for express/courier service) Telephone: (301) 496-7147 FAX: (301) 402-7819 Email: email@example.com 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: GrantsInfo@nih.gov. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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 RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. 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 five copies of the appendix material must be sent to: Referral Officer National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) Appendices should be comprised of 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.) (See http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html). 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 (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.) APPLICATION PROCESSING: 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. 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. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCI. Incomplete and/or non-responsive applications will not be reviewed. 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 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 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 and assigned a priority score o Receive a written critique o Receive a second level review by the National Cancer Advisory Board. REVIEW CRITERIA The goal of NIH-supported human specimen resources is to facilitate research that advances the understanding of biological systems, improves the control of disease, and enhances health. In the written comments reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed resource would 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 an improved 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 the proposed resource address the overall goals and objectives of the RFA? Does the proposed resource address an important scientific need? Is that need adequately justified? Could the need have been easily satisfied in other ways? Will the resource support and facilitate progress in the field? APPROACH: Are the conceptual framework, design, methods and implementation plans for the resource adequately developed, well integrated and appropriate to the aims of the project? Are plans described for appropriate quality control of the resource? Are plans for participation in the Group Banking Committee and for cooperation with the other members of the project adequate? Are plans presented for continued cooperation and coordination among participating awardees and the NCI? INNOVATION: Does this application propose a resource not otherwise available to the researcher users? Has the applicant proposed improved methods, such as more effective means of collection from distributed sites, improved practices for specimen processing and transfer of specimens, specimen tracking and/or encouraging utilization of the resource? INVESTIGATORS: Are the qualifications of the resource leader(s) and key personnel well suited to organize and maintain the resource, maintain quality control and equitable access, and manage record keeping? Is the relationship between the PI and the resource leaders clearly defined? ENVIRONMENT: Does the environment contribute to the probability of success? Are the facilities and equipment for the resource adequate? Does the proposed resource take advantage of unique features of the organizational environment? ADDITIONAL REVIEW CRITERIA In addition to the above criteria, the following items will 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 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below.) ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a data sharing plan in their application. The reviewers will assess the reasonableness of the data sharing plan or the rationale for not sharing research data. 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 21, 2004 Application Receipt Date: July 21, 2004 Peer Review Date: October/November 2004 Council Review: February 2005 Earliest Anticipated Start Date: April 2005 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 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. See 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). Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional review Board (IRB). For details about the Policy for the NCI for Data and Safety Monitoring of Clinical trials, see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. For additional information see NIH Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II Trials" at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available: http://www.cancer.gov/clinical_trials/. SHARING RESEARCH DATA: Investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing (http://grants.nih.gov/grants/policy/data_sharing) or state why this is not possible. Investigators should seek guidance from their institutions, on issues related to institutional policies, 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. 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. 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/. 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 (see 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 RFA 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 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 RFA 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)(cite appropriate authorizations) 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.
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