NLM SENIOR FELLOWSHIP FOR INFORMATIONIST TRAINING (F38) RELEASE DATE: October 21, 2003 PA NUMBER: PAR-04-014 (This PAR has been suspended, see NOT-LM-05-014) (Scientific review contact change, see NOT-LM-05-013) (Contact change, see NOT-LM-05-007 and Correction to eligibility requirements, see NOT-LM-05-005) EXPIRATION DATE: November 30, 2005 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: 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 o Training Objectives o Mechanism of Support o Eligibility Requirements o Eligible Sponsoring Institutions o Allowable Costs o Stipend Supplementation, Compensation, and Other Income o Tax Liability o Payback Requirements o Leave Policies o Trainee Terms of Appointment o Part-Time Training o Other Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Other Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Library of Medicine (NLM) believes that clinical care, biomedical research and education, and public health administration can be improved by the inclusion of in-context information specialists (informationists) into work and decision settings. Informationists are information specialists who have received graduate training and practical experience that provides them with disciplinary background both in medical or biological sciences and in information sciences/informatics. Their cross training provides informationists with a unique perspective on the acquisition, synthesis and application of information to problem solving and program development in their chosen area. The NLM Senior Fellowship for Informationist Training provides support for experienced librarians, scientists, health professionals and others who wish to become in-context information specialists. Priority areas for informationist training are: o clinical informationist to work in health care delivery and clinical research o research informationist to work in biomedical research, research administration, or scientific curation o public health informationist to work in public health at the national, regional or local level o consumer health informationist to work with the general public on health information issues These fellowships are intended for experienced health sciences librarians, scientists, health professionals and others who wish to broaden their existing scientific background by acquiring the additional disciplinary knowledge to function as an informationist. The senior fellowship awards will enable professionally qualified individuals with at least ten years of post-graduate experience to take time from their regular professional responsibilities for the purpose of receiving specialized training. This award can be used in conjunction with a sabbatical experience. The candidates for this award will have an appropriate graduate degree for professional practice in their field, such as a research or health- professional doctorate for researchers and clinicians. The requirement for a doctoral degree need not apply to candidates in the following professional fields: engineering, computer science, library and information sciences, nursing. However, graduate preparation for professional practice is required in those fields. TRAINING OBJECTIVES New strategies are required to bring the benefits of the rich and complex digital information streams into the settings of clinical care, biomedical research, health administration and health professions education in a way that improves outcomes, reduces errors and fosters innovation. NLM sponsors a variety of informatics training programs for basic and applied research informaticians, but there is a need to expand the supply of information specialists who have cross training. Those who apply for NLM’s Fellowship for Informationist Training should have a work setting identified. There is no widely-accepted curriculum framework for in-context information specialists. Upon completion of the training, fellows should be familiar with the use and potential of modern information technology to support work and decisions in one of the four priority areas: clinical practice, biomedical research, public health and consumer health and should also be conversant with a biomedical domain. Informationist fellows will achieve this goal through an individually tailored program of (1) formal coursework, (2) practicum experience, and (3) research project. The program of coursework should augment the trainee's basic professional education by adding graduate-level domain expertise needed for informationist work. The fellowship may lead to a degree, although it is not a requirement. Whether or not the training is to be used for credit or certification in an educational program is up to the applicant, the fellowship sponsor, and the organization involved. The curriculum for each type of informationist may be different from that needed for basic research or for practice in a field. In all cases, the proposed curriculum should provide sufficient theoretical foundation in the chosen area for in-context application. Working with information issues in-context is fundamental to the informationist concept. The fellowship must include a practicum, i.e., hands-on information management experience in the chosen setting. In addition, the fellow must complete a research project in the chosen setting. An opportunity to carry out supervised research, service and/or applications development in is essential to achieve the primary objective of this fellowship. Projects may be in basic informatics or information sciences research areas or may address an informatics application. An applied informatics project does not require the form or concepts of a research project, and need not be hypothesis-driven, but the proposal should provide sufficient detail to permit reviewers to judge importance of the problem, feasibility of the approach, and the relevance of the proposed project to the chosen setting. MECHANISM OF SUPPORT This program announcement for Senior Individual Biomedical Informatics Fellowships uses the F38 funding mechanism. For NLM, these awards are authorized by the Medical Library Assistance Act and are not a part of the National Research Service Awards Program (NRSA) of the Public Health Service. However, the policies and requirements of the NLM program are similar in most respects to NRSA awards. Applicants with fewer than ten years of professional experience are encouraged to investigate their eligibility for the Individual Informationist fellowship (F37). The project period may be for one to two years, and awards are not renewable. ELIGIBLE SPONSORING INSTITUTIONS The sponsoring institution may be any of the following: 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 and labs of the Federal government including NIH intramural labs o Domestic or foreign INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS By the date of appointment, applicants must have at least ten full years of relevant independent professional experience beyond the qualifying degree and any associated postdoctoral or residency training. Relevant post-graduation experience may include research experience (including industrial), teaching, internship, residency, clinical duties, library service, or other time spent full-time in a health-related field following the date of the qualifying professional degree. Exceptions must be approved in advance by the NLM Program Officer. All candidates must be willing to spend a minimum of 50 percent of full-time professional effort in fellowship activities during the entire award period. Candidates for the F38, under some circumstances, may have been principal investigators (PIs) on NIH research or career development awards, provided the research experience proposed in this application is in a fundamentally new field of study or there has been a significant hiatus in their research career because of family or other personal obligations. Current PIs on NIH career awards are not eligible. A candidate for the F38 award may not have pending nor concurrently apply for any other type of NIH career development award. Postdoctoral Trainees Postdoctoral trainees must have received a Ph.D., M.D. or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: D.D.S., D.M.D., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., D. Pharm., D.S.W., and Psy.D. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to appointment is acceptable. Professional degrees The NLM recognizes that some professions do not customarily require a doctoral degree (e.g., library science and nursing) and encourages application on behalf of individuals without doctoral degrees who have significant professional training and experience in closely related cognate fields Nurses, health science librarians, researchers, educators, administrators, and other health professionals are eligible, as are computer scientists and engineers who wish to focus on the health domain. Women, underrepresented minorities (African Americans, Alaskan Native, Hispanic Americans, Native Americans and Pacific Islanders) and persons with disabilities are encouraged to apply as applicants and as mentors. Citizenship By the time of award, individuals must be citizens or non-citizen nationals of the United States, or must have been lawfully admitted to the United States for permanent residence (i.e., possess a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status). Non-citizen nationals are generally persons born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. SPECIAL REQUIREMENTS Before submitting a fellowship application, the applicant must identify a sponsoring institution and an individual(s) who will serve as a sponsor (also called mentor or supervisor) and will supervise the fellow’s studies and research experience. To apply for support, an institution must submit an application on behalf of the individual seeking the fellowship. Applicants proposing training at their doctorate institution or at the institution where they have been working for more than a year must document how the fellowship is designed to broaden their scientific background. Each fellow must have mentorship that provides guidance and oversight for the the selection of appropriate coursework, for the research project and the practicum experience. The mentorship may come from an individual or team of individuals who are expert in the domain area and area of informatics or information science that is pertinent to the proposed program. The mentor(s) may be at the applicant's home institution or at another institution. If the latter, the plan for supervision and interaction must be described. OPTIONAL TRAINING COMPONENT AT NATIONAL CENTER FOR BIOTECHNOLOGY INFORMATION Trainees who are interested in bioinformatics, either for clinical or for basic biological research, are encouraged to consider an elective training period during the fellowship of up to nine weeks at NLM’s National Center for Biotechnology Information (NCBI.) Established in 1988 as a national resource for molecular biology information, NCBI creates public databases, conducts research in computational biology, develops software tools for analyzing genome data, and disseminates biomedical information - all for the better understanding of molecular processes affecting human health and disease. Fellows interested in the NCBI elective should contact: Dr. David Wheeler Tel: 301-435-5950 Email: wheeler@ncbi.nlm.nih.gov ALLOWABLE COSTS Stipends Stipends for NLM Informationist Fellowships are determined individually at the time of award. The amount of the stipend shall be based on the documented salary or remuneration paid to the candidate from the home institution at the time of award, and shall be based on the normal full-time 12-month staff appointment at the home institution. However, in no case shall the NIH contribution to the stipend during the fellowship exceed the current legislated maximum salary; in Fiscal Year 2002, the maximum salary provided by a Federal grant is $166,700. For Fellows on sabbatical, the level of the stipend award will take into account concurrent sabbatical salary support provided by the home institution, and any other supplementation. Training awards provide stipends to fellows to help defray living expenses during the research training experience. The awards are not provided as a condition of employment with either the Federal government or the sponsoring institution. For fellows sponsored by domestic non-federal institutions, the stipend will be paid through the sponsoring institution. For fellows sponsored by Federal institutions, the monthly stipend payment will be deposited in the fellow's U.S. bank account or paid directly to the fellow by U. S. Department of Treasury check. No departure from the established stipend schedule may be negotiated between the institution and the fellow. Tuition and Fees NLM will award 100% of the combined costs of tuition, fees, and health insurance up to $3,000 and 60 percent of the combined costs above $3,000. The tuition formula is used for award calculation purposes only. Actual costs may be higher. Costs associated with tuition and fees are allowable only if they are required for specific courses in support of the research training experience supported by the fellowship. A full description of the tuition policy is contained within the NRSA Policy Guidelines on the NIH website at http://grants.nih.gov/training/nrsa.htm Trainee Travel Travel for attendance at scientific meetings that are important to the individual's training is an allowable trainee expense. The base formula for travel allows up to $1,000 per year per trainee. In their proposed budgets, applicants for NLM fellowships should request additional trainee travel funds for a meeting each year, to be held at the National Library of Medicine in Bethesda or at another site. The purpose of these meetings will be to exchange information among all NLM trainees, including those at NLM institutional training program sites, institutional program directors, NLM program staff, and other selected participants. Support for travel by NLM fellows to a training experience away from the primary institution is also permitted. Such experiences are acceptable as a complement to the course work, expertise, and experiences available at the parent institution. Letters requesting such training may be submitted to the NLM at any time during the award period, and should explain the type of opportunities for training available, how these opportunities differ from those offered at the parent institution, and the relationship of the proposed experience to the trainee's career stage and goals. Awards for training at a foreign site may include a single economy or coach round-trip travel fare. No allowance is provided for dependents. U.S. flag air carriers must be used to the maximum extent possible when commercial air transportation is available for travel between the United States and a foreign country or between foreign countries. Funds are not provided to cover the cost of travel between the fellow's place of residence and a domestic training institution. However, in cases of extreme need or hardship, a one-way travel allowance may be authorized by the sponsoring institution. Such travel must be paid from the Institutional Allowance. Health Insurance In order to adjust policies to facilitate the recruitment of women and individuals from disadvantaged backgrounds as required by Section 487 of the Public Health Service Act (as amended), NLM will allow costs associated with family health insurance for trainees who have families and are eligible for family health insurance coverage at the sponsoring institution. Self-only health insurance will continue to be an allowable cost for trainees without families. Institutions may include the cost of family health insurance for trainees who are eligible for this coverage in the calculation of the combined cost of tuition, fees, and health insurance. Institutional Costs NLM provides an institutional allowance of $6000 per year per trainee to defray the costs of other training expenses, including consultant costs, equipment, and research supplies. This allowance is intended to cover training-related expenses for the individual trainee and is not available until the fellow officially activates the award. NIH will provide an institutional allowance of up to $3,000 for fellows sponsored by Federal laboratories for expenses associated with travel to scientific meetings, health insurance, and books. Funds for fellows at Federal laboratories will be disbursed from the NIH awarding institute. The institution may request additional funds when the training of a fellow involves extraordinary costs for travel to field sites remote from the sponsoring institution or for accommodations for fellows who are disabled, as defined by the Americans With Disabilities Act. The funds requested for costs of this nature must be reasonable in relationship to the total dollars awarded under the fellowship and must be directly related to the approved research training experience. Such additional funds shall be provided only in exceptional circumstances that are fully justified and explained by the sponsoring institution. Consultation with NLM program staff in advance of such requests is advised. Facilities and Administrative (F&A, indirect) costs are not allowed on individual fellowship awards. Salary for mentors, secretarial, and administrative assistance, etc., is not allowed. STIPEND SUPPLEMENTATION, COMPENSATION, AND OTHER INCOME An institution is permitted to provide funds to a fellow in addition to the stipend paid by the NIH. Such additional amounts may be in the form of augmented stipends (supplementation) or compensation. The grantee institution may provide supplementation or additional support to offset the cost of living on the condition that such supplementation does not require any additional effort from the trainee. Federal funds may not be used for supplementation unless specifically authorized under the terms of both the program from which such supplemental funds are to be received and the program whose funds are to be supplemented. Under no circumstances may Department of Health and Human Services (DHHS) funds be used for supplementation. An institution may also provide additional compensation to a trainee in the form of compensation (as salary and/or tuition remission) for services such as teaching, research, or clinical care. A trainee may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS research grant. However, compensated services should occur on a limited, part- time basis apart from the normal research training activities. In addition, compensation may not be paid from a research grant supporting research that is part of the research training experience. Under no circumstances may the conditions of stipend supplementation or additional compensation interfere with, detract from, or prolong the trainee's approved training program. Additionally, compensation must be in accordance with institutional policies applied consistently to both federally and non-federally supported activities and supported by acceptable accounting records determined by the employer-employee relationship agreement. Educational Loans or G.I. Bill. An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation. Concurrent Awards. An NLM fellowship may not be held concurrently with another Federally sponsored fellowship or similar award that provides a stipend or otherwise duplicates provisions of the NLM award. TAX LIABILITY Section 117 of the Internal Revenue Code applies to the tax treatment of all scholarships and fellowships. Under that section, non-degree candidates are required to report as gross income any monies paid on their behalf for stipends, or any course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization. The taxability of stipends, however, in no way alters the relationship between NIH trainees and institutions. NLM fellowship stipends are not considered salaries. In addition, trainees supported under these fellowships are not considered to be in an employee-employer relationship with the NIH or the awardee institution. It is therefore, inappropriate and unallowable for institutions to charge costs associated with employment (such as FICA, workman's compensation, or unemployment insurance) to the fellowship award. It must be emphasized that the interpretation and implementation of the tax laws are the domain of the Internal Revenue Service (IRS) and the courts. The NIH takes no position on the status of a particular taxpayer, and it does not have the authority to dispense tax advice. Individuals should consult their local IRS office about the applicability of the law to their situation and for information on their tax obligations. PAYBACK REQUIREMENTS Because the NLM informationist fellowships (F38) are not subject to NRSA policies, there are no service payback requirements. LEAVE POLICIES In general, fellows may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Fellows may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Fellows may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director. A period of terminal leave is not permitted and payment may not be made from fellowship funds for leave not taken. Fellows requiring periods of time away from their research training experience longer than specified here must seek approval from the NLM program staff for an unpaid leave of absence. TRAINEE TERMS OF APPOINTMENT Full-time Fellows Funded training periods may be for one to two years, and customarily require a full-time commitment. That is, trainees are typically required to pursue their informationist training on a full-time basis, devoting at least 40 hours per week to the program. Within the 40 hours per week training period, informationist trainees in clinical areas must devote their time to the proposed training and must confine clinical duties to those that are an integral part of the research training experience. If the fellowship is proposed at less than full time, stipends will be adjusted appropriately. The minimum effort permitted is 50 percent of full-time. Part-time Fellows Fellows are typically expected to make a full-time commitment to their training program. However, under unusual and pressing personal or professional circumstances, part-time training may be appropriate. Part-time training program at a level of 50 to 99 percent effort will be considered on an ad hoc basis with sufficient justification of need. If part-time training is requested, the application clearly justify the level of effort proposed, and clearly demonstrate how the research and program of study will be accomplished with respect to other duties and responsibilities. A fellow will not be permitted to engage in NLM- supported research training for less than 50 percent effort. Individuals desiring to reduce their commitment to less than 50 percent effort must take a leave-of-absence from NLM fellowship support. The fellowship notice of award will be reissued and the stipend will be pro-rated during the period of any approved part-time training. Stipend levels for part-time trainees will be appropriately pro-rated according to their level of effort. Other Appointment Terms No individual trainee may receive more than 4 years of aggregate NLM support at the predoctoral level or 3 years of support at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Any extension of the total duration of trainee support at either the predoctoral or postdoctoral level requires approval by NIH. Requests for extension must be made in writing by the trainee, endorsed by the sponsor and the appropriate institutional official, and addressed to the NLM Program Officer. The request must include a sound justification for an extension of the limits on the period of support. General information about NIH support of fellowships, including those awarded by the NLM, can be found at http://grants.nih.gov/training/extramural.htm. Please note that the "Service Payback" provisions do not apply: NLM's Fellowships for Informationist Training require no payback. Information about current NIH stipend levels and other support may be found in NATIONAL RESEARCH SERVICE AWARD (NRSA) STIPEND INCREASE AND OTHER BUDGETARY CHANGES EFFECTIVE FOR FISCAL YEAR 2002 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-028.html. OTHER SPECIAL REQUIREMENTS Certification and Reporting Procedures. No application will be accepted without the applicant signing the certification block on the face page of the application. Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award. When support ends, the fellow must submit a Termination Notice (PHS 416-7) to the NIH. Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm. Inventions and Publications. Fellowships made primarily for educational purposes are exempted from the PHS invention requirements. F38 awards will not contain any provision giving PHS rights to inventions made by the awardee. Data Sharing. It is the policy of the DHHS that the results and accomplishments of all funded activities should be made available to the public. This policy also applies to individuals supported by individual NRSA postdoctoral fellowships. The sponsoring institution should place no restrictions on the publication of results in a timely manner. Copyrights. Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes. WHERE TO SEND INQUIRIES Inquiries from potential applicants concerning this PA are encouraged. Inquiries about NLM Fellowships may fall into two areas, programmatic, and financial or grants management issues, and should be directed to the following individuals accordingly. o Direct your questions about scientific/research issues to: (Contact changed, see NOT-LM-05-013) Dr. Charles Friedman
6705 Rockledge Drive, Suite 301 Bethesda , MD 20892-7968 Telephone: (301) 594-4882 FAX: (301) 402-2952 Email: Friedmc1@mail.nih.gov o Direct your questions about financial or grants management matters to: Dwight Mowery Extramural Programs National Library of Medicine Rockledge 1, Suite 301, 6705 Rockledge Drive Bethesda, MD 20892 Telephone: (301) 496-4221 FAX: (301) 402-0421 SUBMITTING AN APPLICATION Individuals must submit the application form PHS Individual National Research Service Award (PHS 416-1, rev. 6/02). APPLICATIONS MUST INCLUDE AT LEAST THREE SEALED LETTERS OF REFERENCE. APPLICATIONS WITHOUT AT LEAST THREE LETTERS OF REFERENCE MAY BE RETURNED OR DELAYED IN REVIEW. Application instructions and forms are available at: http://grants.nih.gov/grants/funding/416/phs416.htm . 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 12 of the face page of the PHS 416-1 form. The PHS 416-1 is available at http://grants.nih.gov/grants/funding/416/phs416.htm in an interactive format. Complete Item 3 on the face page of the application indicating that the application is in response to this announcement and print F38 NLM SENIOR FELLOWSHIP FOR INFORMATIONIST TRAINING. If the applicant has been lawfully admitted to the United States for permanent residence, the appropriate item should be checked on the Face Page of the application. Applicants who have applied for and have not yet been granted admission as a permanent resident should check the Permanent Resident block on the Face Page of the PHS 416-1 application, and also write in the word "pending." A notarized statement documenting legal admission for permanent residence must be submitted prior to the issuance of an award. Submit a signed, typewritten original of the application (including the Checklist, Personal Data form, AT LEAST THREE SEALED REFERENCE LETTERS, and all other required materials) and two (2) exact, clear, single- sided photocopies of the signed application, 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) INCOMPLETE APPLICATIONS WILL NOT BE REVIEWED. Concurrent Applications An individual may not have more than one individual NRSA fellowship or comparable application pending review or award at the NIH or other DHHS agencies at the same time. 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. Application Receipt Dates and Review Schedule Fellowship applications undergo a review process that takes between 5 and 8 months. The receipt dates and the three annual review cycles are as follows: Application Receipt Dates: Apr 5 Aug 5 Dec 5 Initial Review Dates: Jun/Jul Oct/Nov Feb/Mar Secondary Review Dates: Aug/Sep Dec/Jan Apr/May Range of Likely Start Dates: Sep 1-Dec 1 Jan 1-Mar 1 May 1-Jul 1 PEER REVIEW PROCESS Applications will be reviewed for scientific and technical merit by the NLM Biomedical Library and Informatics Review Committee (BLIRC) in accordance with standard NIH peer review procedures. In general, the merit review criteria customarily employed by the NIH for fellowship applications will be followed. Additional information may be found at http://grants.nih.gov/training/nrsa.htm. After the initial merit review, the NLM program official will forward to each applicant a written critique and summary of the review of the application prepared by the Scientific Review Administrator. After scientific-technical review, staff within the NLM will provide a second-level review to evaluate relevance to the mission and scope of NLM. Following the second-level review, the NLM program official will notify each applicant of the final disposition of the application. Any questions on BLIRC recommendations and funding possibilities should be directed to the NLM program official, not the Scientific Review Administrator. REVIEW CRITERIA Candidate: An assessment of the candidate's previous academic and career performance and the potential to become an important contributor to the chosen area of in-context information services. Sponsor and Training Environment: An assessment of the quality of the training environment and the qualifications of the chosen mentor(s) for the proposed research training and practicum experience. Research Proposal: The merit of the scientific proposal and its relationship to the candidate's career plans. Training Potential: An assessment of the value of the proposed fellowship experience as it relates to the candidate's needs in preparation for a career as an informationist. Additional Review Criteria In addition to the above criteria, applications will also be reviewed with respect to the following: Protections. The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. Inclusion. 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 included in the section on Federal Citations, below) Budget. The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. Training In The Responsible Conduct Of Research. Applications must include a description of a program to provide instruction in scientific integrity and the responsible conduct of research. (See the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992.) OTHER REVIEW CRITERIA In addition to the general review criteria outlined above, reviewers of Informationist Fellowships will consider the following specific evidence: o The appropriateness of the coursework chosen to provide disciplinary foundations the applicant needs to function as an informationist in the chosen setting o The mentored practicum experience that requires the fellow to apply what is being learned o The quality of the research project that addresses an information problem in the chosen setting o The appropriateness of the mentorship communication plan o The feasibility of the timeline and milestones for accomplishing what is proposed o The adequacy of the proposed plan to share data, if applicable o The fellow’s plan for obtaining employment as an informationist. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to NLM. The following factors will be considered when making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities Activation No funds may be disbursed until the fellow has started training under the award and an Activation Notice (PHS 416-5) has been submitted to the NIH. An awardee has up to 6 months from the issue date on the award notice to activate the award. Under unusual circumstances, an NIH institute may grant an extension of the activation period upon receipt of a specific request from the fellow. Terms And Conditions Of Support Fellowships must be administered in accordance with the current NRSA Policy Guidelines for Individual Awards and Institutional Grants (see the NIH Website at http://grants.nih.gov/training/nrsa.htm), the current NIH Grants Policy Statement (see the NIH Website at http://grants.nih.gov/grants/policy/policy.htm), and any terms and conditions specified on the award notice. Certification and Reporting Procedures No application will be accepted without the applicant signing the certification block on the face page of the application. Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award. When support ends, the fellow must submit a Termination Notice (PHS 416-7) to the NIH. Forms may also be found on the NIH Website at http://grants.nih.gov/grants/forms.htm. Inventions and Publications Fellowships made primarily for educational purposes are exempted from the PHS invention requirements. F38 awards will not contain any provision giving PHS rights to inventions made by the awardee. 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 is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN 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. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). 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 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 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. REFERENCES: 1. National Library of Medicine Long Range Plan 2000-2005/Report of the Board of Regents. National Library of Medicine. [Bethesda, MD]: National Library of Medicine, 2000, pp. 17-18 2. Florance V, Giuse NB, Ketchell, DS. Information in context: integrating information specialists into practice settings. J Med Libr Assoc 2002 Jan; 90(1):49-58. see also Proceedings of the Informationist Conference, http://mlanet.org/research/informationist/conference_0402.html


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