NLM EARLY CAREER DEVELOPMENT AWARD FOR INFORMATICS (K22) RELEASE DATE: March 27, 2003 PA NUMBER: PA-03-090 May 11, 2010 - This PA has been reissued as (PAR-10-195). (Notice of expiration, see NOT-LM-06-002) (Peer Review change, see NOT-LM-05-007) (see change NOT-LM-04-001) EXPIRATION DATE: March 20, 2006, unless reissued. National Library of Medicine (NLM) (http://www.nlm.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.879 NLM Medical Library Assistance THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This K22 award is intended to facilitate the transition of investigators from the mentored to the independent stage of their careers by providing "protected time" for newly independent investigators to develop and receive support for their initial research programs. The award applies to biomedical informaticians who are pursuing research in basic informatics, clinical informatics, or the informatics relevant to biomedical research. RESEARCH OBJECTIVES The NLM Transition Career Development Award has been developed to provide support to promising informatics investigators while they are establishing their first independent research programs. This award is available only to individuals with health professional degrees. To apply, a candidate must have completed TWO YEARS OR MORE of postdoctoral, mentored research or have been in an independent position for LESS THAN TWO YEARS at the time the application is submitted. The unique feature of this award is that individuals may apply without a sponsoring institution while they are still in a "mentored" position. Successful postdoctoral applicants will be given up to 12 months to identify an independent, preferably tenure-track, position at a sponsoring institution before an award can be activated. For postdoctoral applicants, the sponsoring institution for a K22 award can be their current institution or a new institution. Candidates already in their first independent research position may apply for this award in the first or second year of this position. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) K22 award mechanism. The total project period for an application submitted in response to this PA may not exceed 3 years. Planning, direction, and execution of the program will be the responsibility of the candidate. Awards are not renewable. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise 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 https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. The award provides support for three years to individuals who are currently postdoctoral trainees in INFORMATICS research or have just started in an independent position (See ELIGIBILITY REQUIREMENTS). Recipients of this award must devote a minimum of 75 percent effort to the proposed research program. The remaining 25 percent effort can be divided among other clinical and teaching activities only if they are consistent with the program goals, i.e. the candidate's development into an independent clinical investigator. Under unusual and pressing circumstances, an awardee may submit a written request to the awarding component, requesting a reduction in professional effort below 75 percent. Such requests will be considered on a case-by-case basis during the award period. In no case, will it be permissible to work at a rate of less than 50 percent effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate other sources of funding, job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. Further, the awardee must submit assurance of his or her intention to return to full- time professional effort (at least 75 percent) as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly. The sponsoring institution must demonstrate a research environment conducive to the development of the investigator and the progress of his research. Allowable Costs Salary: The Transition Career Development Award (K22) will provide salary up to $75,000 plus fringe benefits. The total salary requested must be based on a full-time, 12 month staff appointment requiring the candidate to devote a minimum of 75 percent effort to conducting informatics research with the remaining effort being devoted to activities related to relevant activities. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. The institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. Because the salary amount provided by this award is based on the full- time institutional salary, no other PHS funds may be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K22. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. Research Development Support: Up to $50,000 per year will be provided for the following types of expenses: (a) research expenses, such as supplies, equipment, and technical personnel; (b) statistical services including personnel and computer time; (c) tuition, fees, and books related to career development; and (d) travel to research meetings or for training. The level of research development support may be negotiated downward with the acquisition of any independent grant support from any source. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc. is NOT allowed. Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. Evaluation In carrying out its stewardship of human resource related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. Other Income Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research- related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: o The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution o The funds may be used for health-related research purposes o The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment o Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, and fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component. Special Leave Leave to another institution, including a foreign laboratory, with award support may be permitted if the proposed experience is directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NIH funding component is required. To obtain prior approval, the award recipient must submit a letter to the NIH funding component describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH funding component and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the grantee institution. Termination of Award When a grantee institution plans to terminate an award, the NIH funding component must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision. Change of Institution Individuals planning a change of institution AFTER AN AWARD HAS BEEN INITIATED (see Award Criteria and Procedures below) must submit to the NLM in advance of the change a written request for transfer, countersigned by the appropriate institutional business official, describing the reasons for the change. The awardee must establish in this request that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer reviewed research program. Staff within the NLM will review this request. Upon approval of this request the new institution must follow all of the procedures outlined in the section on AWARD CRITERIA AND PROCEDURES for submission and NLM approval of a "Statement of Environment and Institutional Commitment." Upon approval of the "Statement" a new career award application must be submitted by the new institution far enough in advance of the requested effective date to permit review. The period of support requested in the new application must be no more than the time remaining within the existing award period. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. ELIGIBLE INSTITUTIONS Only domestic non-Federal organizations, public or private, such as medical, dental or nursing schools or other institutions of higher education, may accept an award on behalf of an applicant. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS To be eligible a candidate must have a doctoral degree (e.g. M.D., Ph.D.) and training in biomedical informatics. Candidates must currently be in a "mentored" informatics research postdoctoral position and have completed TWO YEARS OR MORE of research in this capacity at the time of the application, or be in a suitable independent position for LESS THAN TWO YEARS with continuous previous postdoctoral informatics research training at the time of the application. Postdoctoral informaticians working in informatics research as Federal employees are not eligible for this award. A candidate for a K22 may not simultaneously submit or have pending an application for any other PHS award that duplicates any of the provisions of this award. Former or current principal investigators on any NIH research grants or non-PHS peer reviewed grants that are over $100,000 direct costs per year or project leaders on sub-projects of program project (P01) or center grants (P50) are NOT eligible to apply. Candidates must be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS The information summarized below must be provided in the application: Candidate o (Only for applicants already in an independent position) Describe the current position in terms of its ability to enable the candidate to pursue an INDEPENDENT career in informatics research; o Describe all activities during the "mentored" period of informatics research training. Include all research experiences and mentors, any pertinent didactic experiences and any other experiences designed to acquire critical skills, techniques and scientific perspectives for pursuing an independent career in the chosen area of BIOMEDICAL INFORMATICS RESEARCH. o Describe scientific productivity during the mentored period of career development o Describe factors that support potential to manage an independent research program o Describe opportunities to interact and collaborate with other scientists o Establish the ability to make a commitment of at least 75 percent effort to the career objectives of this award o Three letters of recommendation from established scientists familiar with the candidate's potential and capability to become a successful independent investigator. These letters should be provided in sealed envelopes attached to the front page of the application. Research Plan Describe an original research plan in basic or applied informatics research The research plan must be described as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods; o Describe how the proposed research extends the mentored research training that has been completed into new concepts and ideas o Describe the equipment, specialized facilities and personnel resources that will be needed to conduct the proposed research o Describe the plans for inclusion of women, minorities and children in any clinical or population research activities Budget o Within the limitation of $50,000 direct costs for research development support, provide a description, with justification, for all equipment, supplies and personnel that will be used. Non-Competing renewals o In addition to the information requested in the Application for Continuation Grant form PHS 2590 (Rev. 5/2001), documentation must be provided with the Progress Report for the second year of the award showing that the awardee has submitted an R01-type research grant application to NIH for funding. This documentation should minimally be a copy of the face page of the application with all required institutional signatures. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. Carol Bean Extramural Programs National Library of Medicine 6705 Rockledge Drive, Suite 301 Bethesda, MD 20892 Tel: (301) 594 4882 FAX: (301) 402-2952 Email: email@example.com o Direct your questions about peer review issues to: (Contact changed, see NOT-LM-05-007) Dr. Arthur Petrosian Scientific Review Administrator 6705 Rockledge Drive, Suite 301, MSC 7968 Bethesda, MD 20892-7968 Bethesda, MD 20817 (for courier/express service) Telephone: (301) 594-4933 FAX: (301) 402-2952 Email: firstname.lastname@example.org o Direct your questions about financial or grants management matters to: Mr. Christopher Robey Grants Management Specialist National Library of Medicine 6705 Rockledge Drive, Suite 300 Bethesda, MD 20892 Tel: (301) 496-4221 FAX: (301) 402-0421 Email: email@example.com SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://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. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at https://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Dr. Merlyn Rodrigues Scientific Review Administrator Division of Extramural Programs National Library of Medicine 6705 Rockledge Drive Suite 300 Bethesda, MD 20892 APPLICATION RECEIPT DATES: Applications must be mailed on or before the receipt dates described at https://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. 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 submitted for this PA will be assigned to the National Library of Medicine. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by a peer review group convened by the Division of Extramural Activities of the NLM. Review will be conducted in accordance with standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm). As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the Board of Regents of the National Library of Medicine. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. 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 considered in the determination of scientific merit and the priority score: Candidate o (Only for candidates already in an independent position) Suitability of the position for the candidate to pursue an independent research career; o Quality of the mentored period of Informatics research training in terms of research experience(s), didactic experiences and other experiences (e.g., special skills, perspectives, techniques) that will enhance the candidate's ability to pursue an independent informatics research career in the chosen area of informatics research; o Scientific productivity during the mentored period of career development; o Potential ability to manage an independent research project; o Ability to interact and collaborate with other scientists; o The potential to become a successful independent investigator; o Letters of reference on behalf of the candidate. Research Plan o The originality, innovativeness and scientific merit of the proposed Research Plan relative to the experience level of the applicant; o Extent to which the research plan goes beyond the mentored environment and will test new concepts and ideas o The medical and/or health significance of the Research Plan to informatics; o The adequacy of plans to include women, children and minorities in any clinical or population research activities; o The adequacy of the proposed protection of humans, animals or the environment to the extent they may be adversely affected by activities proposed in the application. Non-Competing Renewals o Adequacy of the progress towards achieving the research and career development objectives of the program o Adequacy of the efforts to obtain R01-type research grant support for the research program. 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 CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities The NLM will notify candidates who have competed successfully for funding with a "Letter of Intent to Commit Funds." Candidates in a postdoctoral position will then have one year from the date of the letter to find an institution that offers a position, preferably tenure- track, suitable for enhancing a research career. For a candidate who already has a position in a sponsoring institution, negotiations with the institution will begin without delay. Negotiations will be initiated by asking the candidate's institution to submit a "Statement of Environment and Institutional Commitment" to the NLM. NLM staff using the following criteria will evaluate this statement: o Documentation of a strong, well-established research program related to the candidate's area of interest, including a high-quality research environment with staff capable of productive collaboration with the candidate; o Agreement of the institution's statement of commitment of equipment, physical and personnel resources with the peer-reviewed recommendation of needs; o Adequacy of the institutional commitment to the required 75 percent effort requirement of this award for the development of an independently funded research program; o Adequacy of the arrangements with the candidate to provide a permanent, preferably tenure-track, position; adequate facilities for conducting a research program, and additional resources conducive to the development of a research project and establishment of a successful research career. For postdoctoral candidates, if the NLM approves the "Statement of Environment and Institutional Commitment" offered by the institution, the institution will be asked to submit a completed PHS Form 398 application. For candidates who already have a position in a sponsoring institution, the NLM only needs to approve the Statement. After NLM approval and subject to the availability of funds, the institution will receive an award. At the time of the award to the grantee institution in support of the K22, any current award held or other support provided for the mentored training of the candidate will be terminated. An award can be terminated prior to the end of the third year by the NLM if the candidate does not submit an R01 type grant application or equivalent for peer review before the end of the second year (See SPECIAL REQUIREMENTS). 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. MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: https://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 (https://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 https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). 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 https://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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance, Medical Library Assistance, 93.879. Awards are made under the authority of the Public Health Service Act, Section 472 (42 USC 286b-3) and administered under PHS grants policies and Federal Regulations, most specifically at 42 CFR Part 61 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 https://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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