NLM Career Development Award in Biomedical Informatics (K01)

NLM Career Development Award in Biomedical Informatics (K01) is sponsored by National Library of Medicine (NLM)/NIH. This award enables scientists with diverse backgrounds to enhance their careers in the NLM Scientific Areas of Interest through mentored research experiences.

Expired PAR-13-284: NLM Career Development Award in Biomedical Informatics (K01) This notice has expired. Check the NIH Guide for active opportunities and notices. of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating National Library of Medicine ( NLM ) Funding Opportunity Title NLM Career Development Award in Biomedical Informatics (K01) K01 Research Scientist Development Award - Research & Training April 19, 2016 - This PAR has been reissued as PAR-16-204 .

NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals NOT-OD-16-012 - Implementing Rigor and Transparency in NIH & AHRQ Career Development Award Applications supersedes instructions in Section III.

3 regarding applications that are essentially the same. November 27, 2013 ( NOT-OD-14-027 ) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after January 25, 2014. Forms-C applications are required for due dates on or after January 25, 2014.

August 21, 2013: Removed reference to ASSIST in section IV. 3, since ASSIST is currently only available for multi-project applications. Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose The purpose of the NLM Career Development Award (K01) in Biomedical Informatics is to provide support and "protected time" (up to three years) for an intensive career development experience in biomedical informatics leading to research independence.

NLM invites K01 applications from junior investigators, who have either a health professional or research doctorate and who are in the first two years of their initial position, at an assistant professor level (or equivalent). Candidates who received their training at one of NLM's university-based biomedical informatics training programs are encouraged to apply.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. AIDS Application Due Date(s) dates apply, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the instructions in (R&R) Application Guide , including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series) , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of the Announcement Section I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The objective of the NIH Mentored Research Scientist Development Award (K01) is to provide salary and research support for a sustained period of protected time (3 years) for intensive research career development under the guidance of an experienced mentor, or sponsor, in the biomedical, behavioral or clinical sciences that leads to research independence.

The expectation is that, through this sustained period of research career development and training, awardees will launch independent research careers and become competitive for new research project grant (e.g., R01) funding.

The National Library of Medicine (NLM) Career Development Award in Biomedical Informatics (K01) is intended to provide support for promising junior investigators as they launch their research careers in biomedical informatics research. NLM supports research career development in clinical/public health informatics, bioinformatics, translational informatics and consumer health informatics.

We define informatics as the intersection of computer, information and behavioral sciences with one or more application domains. Application domains of interest include health care delivery, basic biomedical research, clinical and translational research, public health and others. Regardless of the application domain, the research career focus should be informatics.

The award is intended to promote the career development of informatics researchers who intend to make a long term commitment to biomedical informatics research. K01 awardees are expected to apply for NIH or other independent research grant support (R01 or equivalent) during the final year of the award.

Candidates who received their training at one of NLM's university-based biomedical informatics training programs are encouraged to Applicants must be in the first two years of their initial position, at an assistant professor level (or equivalent) at the time of initial application or resubmission. Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Award budgets are composed of salary and other program-related expenses, as described below. The total project period may not exceed 3 years.

to $85,000 plus fringe benefits per year toward the salary of the career award recipient. The awardee must commit a minimum of 9 person-months (75% full time professional effort) on the K01 award. The total salary requested must be based on a full-time staff appointment.

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. The sponsoring 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. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career award.

Other Program-Related Expenses NIH will contribute $50,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

Salary for mentors, secretarial and administrative assistants, etc. is not Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Black Colleges and Universities (HBCUs) Controlled Colleges and Universities (TCCUs) Native and Native Hawaiian Serving Institutions American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are not allowed. http://grants.

nih. gov/grants/policy/nihgps_2010/nihgps_ch16. htm#_Toc271265275 Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award.

Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam. gov Manage Entity function to manage your entity registrations.

See the Grants Registration User Guide at SAM. gov for additional information. All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

Former PDs/PIs on NIH research project (R01), program project (P01), center grants (P50), sub-projects of program project (P01), sub-projects of center grants (P50), other career development awards (K awards), or the equivalent are not eligible. Former PDs/PIs of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible.

Candidates for this award must have a research or health-professional doctoral degree or equivalent. NLM invites K01 applications from junior investigators, who have either a health professional or research doctorate and who are in the first two years of their initial position, at an assistant professor level (or equivalent).

Candidates who received their training at one of NLM's university-based biomedical informatics training programs are encouraged to This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described Grants Policy Statement ), except for submission: To an RFA of an application that was submitted previously as an investigator-initiated application but not paid; Of an investigator-initiated application that was originally submitted to an RFA but not paid; or Of an application with a changed grant activity code.

Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not duplicate the provisions of the career award application.

K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described At the time of award, the candidate must have a full-time appointment at the academic institution that is the applicant institution.

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.

Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036 . Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience.

The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research. The mentor, or a member of the mentoring team, should have a successful track record of mentoring.

Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the principal mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application.

The mentor should describe the career development plan for the candidate (coordinated with the candidate’s research strategy). The description of the career development plan should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in grant-writing and making effective presentations, is strongly encouraged.

The mentor and any co-mentors are also expected to provide an assessment of the candidate’s qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described.

and Submission Information Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants. gov . 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in (R&R) Application Guide , except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed. Required and Optional Components The forms package associated with this FOA includes all applicable components, required and optional.

Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be Other Project Information All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be SF424(R&R) Senior/Key Person Profile Expanded All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be PHS 398 Career Development Award Supplemental Form All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions: All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Describe prior training and research efforts, and how they relate to the objectives and long-term career plans of the candidate.

Provide evidence of the candidate's potential to develop into a successful independent investigator. Usually this is evident from publications, prior research interests and experience, and letters of reference.

Describe a systematic plan that: (1) shows a logical progression from prior research and training experiences to the research and career development activities that will occur; (2) justifies the need for further career development to become an independent investigator; and (3) utilizes the relevant research and educational resources of the institution.

Development/Training Activities During Award Period The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline is often helpful. The candidate and mentor may propose a mentoring team (or an Advisory Committee).

Provide a description of the career development plan, incorporating consideration of the candidate's goals and prior experience.

Include a plan to obtain the necessary research experience to launch an independent research The career development plan must be tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a Describe the professional responsibilities/activities including other research projects beyond the minimum required effort commitment to the career award.

Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.

in the Responsible Conduct of Research All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions: by Mentor, Co-mentor(s), Consultants, Contributors The candidate must name a primary mentor (sponsor), who, together with the candidate, is responsible for the planning, direction, and execution of the program.

The candidate may also identify co-mentors as appropriate to the goals of the program.

The mentor(s) should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training individuals in postdoctoral positions who have gone on to become independent The mentor(s) should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable Each mentor and co-mentor(s) must provide a statement of his/her areas of expertise and responsibility.

Co-mentors should clearly describe how they will coordinate mentoring of the candidate.

If any of the co-mentors is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of Signed statements must be provided by all consultants/collaborators confirming their participation in the project and describing their specific roles.

Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.

Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent The mentor(s) must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.

Environmental and Institutional Commitment to the Candidate All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions: of Institutional Environment The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.

Describe the sponsoring institution’s scientific environment including the resources and facilities that will be available to the candidate. Commitment to the Candidate’s Research Career Development The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award.

It should be clear that the institutional commitment to the candidate is not contingent upon receipt of Provide assurances that appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions: A sound research project that is consistent with the candidate s level of research development and objectives of his/her career development plan must be provided.

The research description should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the proposed research. The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan.

If more than one mentor is proposed, the respective areas of expertise and responsibility should Do not use the Appendix to circumvent page limits.

Follow all instructions for the Appendix as described in the SF424 (R&R) Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted (letters are due by the application due date as described Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically.

Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants. gov. Part I. Overview Information contains information about Key Dates.

Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. Organizations must submit applications to Grants. gov , the online portal to find and apply for grants across all Federal agencies.

Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review This initiative is not subject to intergovernmental All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement .

Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date.

Section III. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit Applying All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package .

Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM).

Additional information may be found in the SF424 (R&R) Application Guide. tips for avoiding common errors. Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH.

Applications that are incomplete will not be reviewed. Post-Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115 . Section V.

Application Review Information NOT-OD-16-006 for updated review language for applications for due dates on or after January 25, 2016. Only the review criteria described below will be considered in the review process.

As part of the NIH mission , all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer Reviewers should provide their assessment of the likelihood for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact score.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. Does the candidate have the potential to develop as an independent and productive researcher?

Is the candidate’s academic, clinical (if relevant), and research record of high quality? Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator in research?

Do the letters of reference from at least three well-established scientists address the above review criteria, and do they demonstrate evidence that the candidate has a high potential for becoming an independent investigator? Career Development Plan/ Career Goals What is the likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence?

Are the candidate's prior training and research experience appropriate for this award? Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence?

Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress? Are the proposed research question, design, and methodology of significant scientific and technical merit? Is the research plan relevant to the candidate’s research career objectives?

Is the research plan appropriate to the stage of research development and as a vehicle for developing the research skills described in the career development plan? If applicable, are there adequate plans for data and safety monitoring of clinical Consultant(s), Collaborator(s) Are the mentor's research qualifications in the area of the proposed research appropriate?

Do(es) the mentor(s) adequately address the candidate’s potential and his/her strengths and areas needing improvement? Is there adequate description of the quality and extent of the mentor s proposed role in providing guidance and advice to the candidate? Is the mentor’s description of the elements of the research career development activities, including formal course work adequate?

Is there evidence of the mentor s, consultant s, collaborator’s previous experience in fostering the development of independent investigators? Is there evidence of previous research productivity and peer-reviewed support? Is active/pending support for the proposed research project appropriate and adequate?

Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward Environment & Institutional Commitment to the Candidate Is there clear commitment of the sponsoring institution to ensure that the required minimum of the candidate s effort will be devoted directly to the research described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities?

Is the institutional commitment to the career development of the candidate appropriately strong? Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate, adequate and appropriate? Is the environment for scientific and professional development of the candidate of high quality?

Is there assurance that the institution intends the candidate to be an integral part of its Additional Review Criteria As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3) potential benefits to the subjects and others, (4) importance of the knowledge to be gained, and (5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials. For additional information on review of the Human Subjects section, please refer to Subjects Protection and Inclusion Guidelines .

Inclusion of Women, Minorities, and When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines