Supplemental Guidelines for the Ruth L. Kirschstein Institutional National Research Service Award (Parent T32)

1. Multidisciplinary training

a. At all stages of education and training, Program Directors should foster broad, multidisciplinary approaches to research, including encouragement of interaction and collaboration among trainees in related disciplines. This could include travel by trainees to other laboratories outside the applicant institution to receive training in specialized disciplines, methodologies, or technologies. In addition, throughout each stage of the training program, Program Directors are expected to include instruction on consideration of sex and other relevant biological variables as factors in research strategies for the trainees.

b. Program Directors should encourage new trainees to widen the scope of their interests and capabilities, to avoid too narrow a focus too early in their careers and to develop the flexibility needed for pursuing rapidly evolving scientific advances.

c. NHLBI encourages development of novel programs of research training, to emphasize multidisciplinary team approaches, networking, and collaboration, emphasizing the competencies needed for the future of biomedical research. As an example, teams of the future might include individuals such as behavioral and social scientists, physical scientists, computational biologists, engineers, molecular biologists, geneticists, and clinicians.

d. NHLBI encourages development of “virtual” research training centers, to link (electronically or through other means) multiple institutions with unique or specific expertise to address a common problem. Program Directors are encouraged to broaden training experiences beyond a single institution (in academia and industry) using both long and short-term training experiences. Such experiences might include online resources and exchanges of faculty and students. Plans should be described for how interactions among participants will take place.

2. Useful competencies

a. Applicants are encouraged to identify scientific disciplines and evolving areas of scientific need which are currently under-represented and to design and implement training programs in such disciplines. Documentation of available opportunities in such fields and of the lack of qualified scientists to realize these opportunities should be included to justify emphasis on these evolving areas.

b. Examples of research areas/competencies that may be important areas of training include (but not limited to):

• behavioral, epidemiologic, and population and prevention research
• bioengineering
• bioinformatics
• biotechnology
• comparative effectiveness research
• computational biology and quantitative sciences
• genomics
• global health
• health disparities research
• imaging
• nanotechnology
• other "-omics"
• personalized medicine
• regenerative and reparative medicine
• translation research, including bench to clinical trials (T1), clinical trials to wide-spread evidence-based practice (T2), implementation of guidelines or policy to general practice (T3), and/or research translation to real-world settings (T4).
• Research on the health of women and/or sex differences research

These are examples and are not meant to imply that training programs must include any or all of these topics.

c. Applications can propose coursework appropriate to the objective of the training program. Examples could include Bioinformatics, Systems Biology, Analysis of Biological Networks, Foundations of Algorithms, Computational Techniques in Systems Biology, Linear Algebra, and Fundamentals in the Translation of Basic Research to Clinical Practice.

d. Programs in disciplines related to clinical research should also include training in bioethics, clinical trials and behavioral science. When possible and appropriate, training programs should include training in state-of-the-art technologies, integrative approaches, and such mathematically-based areas as bioinformatics, computational biology, and statistics. Consideration should be given to inclusion of women in clinical research, and the recognition of symptoms and therapies that exhibit sexual dimorphism.

e. Training at the pre- and postdoctoral levels should include “survival skills” such as grant and manuscript writing, public speaking, obtaining funding, mentorship (that is, providing skills that will enable current trainees to train subsequent “generations” of scientists), and establishing research collaborations in a multidisciplinary setting.

f. Training is encouraged to include topics related to the health of women and/or the influence of sex and gender on outcomes relevant to HLBS disorders.

3. Mentorship

a. NHLBI encourages “group mentorship,” where multiple senior partners in team-based research lend their individual expertise to the trainee, as appropriate to the trainee's level of development and under the overall guidance of the Program Director.

b. Applications should have a detailed mentoring plan for the "typical" trainee and should describe the process by which such plans will be developed for future trainees. Items to be discussed in a mentoring plan may include: 1) a description of approaches to be used in mentoring; 2) experience and expertise of mentors and proposed time commitment; 3) training in oral and written communication and personal interactions; 4) career planning; and 5) methods for evaluating and reporting effectiveness of mentoring program in annual progress reports. Formal evaluation by trainees is encouraged. Formal evaluation of trainees by their mentors or advisory committees is also encouraged.

c. Applicant institutions should demonstrate their support of mentoring, in terms of institutional administrative support, protected time for mentoring, and departmental support for student activities. They should detail the steps taken to ensure that trainees are aware of what they may expect from their mentors and institutions and what in turn is expected of them.

d. Consideration should be given to including women as mentors and in leadership positions to serve as role models for rising trainees. Additionally, junior faculty should be considered to serve as mentors or co-mentors. Junior faculty are those who have established active, independent research programs early in their careers. Metrics for evaluating the contribution and mentoring abilities of these dynamic young investigators should be developed and described, since traditional milestones, such as having a long track record of producing seasoned independent investigators may not be appropriate at their career stage. The value of such individuals as role models should be highlighted. Likewise effort should be made to provide mentorship to junior faculty to establish a pipeline of mentors for program mentoring stability.

e. Where possible and practical, the training experience should be broadened by encouraging the active participation of scientists and laboratories in industry settings. This could include industry scientists acting as mentors on training grants or providing short-term experiences in industry settings for trainees. Cost sharing in such partnerships on the part of industry is encouraged.

4. Workforce diversity

a. NHLBI is strongly committed to ensuring diversity in its research training programs. Each application must include plans for active recruitment of individuals from diverse backgrounds such as individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. The definition of diversity recruitment groups and detailed instructions on preparing the diversity recruitment portion of the application can be found in the (T) Application Instructions, Section T.420, 2, C. The diversity recruitment plan must be specific for the program proposed and should not rely on the diversity recruitment efforts of the institution. Applicants should also describe their personal involvement in recruitment efforts for the specific application (visits to minority institutions, personal follow-up of potential applicants and interviewees, etc.). Applications without adequate diversity recruitment plans will not be awarded until an adequate recruitment plan is received and approved. Additional information regarding recruitment strategies for underrepresented individuals from racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds can be found in the document "Recruitment and Retention Plan to Enhance Diversity".

Once all of the awarded predoctoral and/or postdoctoral training positions are filled, including adequate representation of individuals from diverse backgrounds, institutional NHLBI NRSA training grants may request an extra slot to support an additional trainee from an underrepresented racial/ethnic group, a trainee with a disability, and/or an individual from a disadvantaged background. Procedures for requesting these extra slots re available at Instructions for Grantees Requesting an Additional Trainee Position to Enhance Research Training Workforce Diversity.

b. The NRSA program has a program for limited part-time training for trainees beginning families and facing other unique pressures, which is described in the NIH Grants Policy Statement – Institutional Research Training Grants, Section 11.2.7.

c. Literature shows that women face particular challenges at the graduate level and beyond in scientific fields, and based on the NIH Databook, from 1998-2016 women received only 30% or less of all research grant awards, compared to 70% or more among males in the same years. Women are therefore highly encouraged to apply, be included as mentors, and to be recruited as trainees to the training program

5. Clinical research

a. NHLBI encourages development of physician-investigators with necessary skills to translate robust and reproducible findings from the laboratory and clinical research program into clinical practice.

b. Programs of clinical relevance should be established for PhD scientist-trainees, with an emphasis on postdoctoral training and course work in human biology and behavioral science, and population-based research to facilitate their subsequent engagement in human subjects research or clinical trials.

c. Applicants are encouraged to develop innovative approaches to training physicians and non-physicians in clinical research skills in the context of NHLBI clinical networks and multicenter studies. Such training can be facilitated by building on existing study infrastructure and promoting collaboration. Programs that foster translational research skills bridging basic and clinical research, or clinical and population-based research are encouraged.

1. Support may be requested for predoctoral training, postdoctoral training, or a combination of both as defined under the NRSA guidelines. Also, T32 applicants may request support for short-term (8-12 weeks) summer research training positions for students enrolled in a program leading to a clinical doctorate, or doctorate in a physical or quantitative science such as physics, chemistry, mathematics, or engineering. However, the T32 mechanism cannot be solely used for short-term research training. T35 mechanism (PA-20-162) is most appropriate for programs requesting solely short-term research training positions. NHLBI's limits on the number of full-time positions that can be requested are specified below under #5. The T32 PA-20-142 does not support undergraduate training.
2. NHLBI will not award costs through the tuition and fees category for items such as malpractice insurance, computer fees, or radioactive waste disposal.
    
3. Trainee Travel: Up to $1,400 per trainee per year may be requested for trainee travel (for pre- and post-doctoral trainees only).
    
4. Stipend increases are reviewed annually and will be incorporated into future year commitments. Actual funding levels for each budget period will be determined annually following NHLBI staff evaluation of the non-competing renewal application.
    
5. New strategies to manage the number of Full-Time Training Positions (FTTPs) will enable the NHLBI to support a greater number of meritorious training programs. During FY 2008 and thereafter, FTTP allocations will be held to the following limits:

• New programs (Type 1) may request no more than 8 FTTPs.
• Renewal Applications (Type 2) that had 12 or fewer FTTPs during the last non-competing award will be capped at 12.
• Renewal Applications (Type 2) that had more than 12 FTTPs during the last non-competing award will be capped at the same number of slots.
• Renewal Applications (Type 2) that entail a change of program director since the prior Competing (Type 1 or Type 2) application will be capped at 8 FTTPs.
• Short-term summer research training positions are not to be included when considering the limit

This policy is applicable to applications submitted for due dates on or after January 25, 2019. Failure to provide the signed letter will result in withdrawal of the application.

Inquiries

Please direct all inquiries to:

Division of Biomedical Research Workforce

Office of Extramural Research

Website: https://researchtraining.nih.gov

Email: NIHTrain@mail.nih.gov

Requirement for Instruction in the Responsible Conduct of Research (NOT-OD-10-019/NOT-OD-16-122)

The NIH requires that all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, and dissertation research grant must receive instruction in responsible conduct of research. The NIH recognizes that instruction in responsible conduct of research occurs formally and informally in educational settings and that informal instruction occurs throughout the research training experience. The guidance provided below is directed at formal instruction in responsible conduct of research. It reflects the accumulated experiences and the best practices of the scientific community over the past two decades. These practices have been incorporated into many of the best regarded programs of instruction in responsible conduct of research.

While courses related to professional ethics, ethical issues in clinical research, or research involving vertebrate animals may form a part of instruction in responsible conduct of research, they generally are not sufficient to cover all of the above topics.

Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process or not reviewed.

New (Type 1) applications must include a plan for instruction in responsible conduct of research. In addition to addressing the five instructional components, the plan must describe how participation in instruction in responsible conduct of research will be monitored.

Renewal (Type 2) applications must, in addition, describe changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current instruction in responsible conduct of research. All training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

1. Format: Substantial face-to-face discussions among the participating trainees/fellows/scholars/participants; a combination of didactic and small-group discussions (e.g., case studies); and participation of research training faculty members in instruction in responsible conduct of research are highly encouraged.

For instruction in responsible conduct of research, online instruction is not considered adequate as the sole means of instruction. A plan that employs only online coursework for instruction in responsible conduct of research will not be considered acceptable, except in special instances of short-term training programs, or unusual and well-justified circumstances.

2. Subject Matter: While there are no specific curricular requirements for instruction in responsible conduct of research, the following topics have been incorporated into most acceptable plans for such instruction:

a) Conflict of interest- personal, professional, and financial;

b) Policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices;

c) Mentor/mentee responsibilities and relationships;

d) Collaborative research, including collaboration with industry;

e) Peer review;

f) Data acquisition and laboratory tools; management, sharing and ownership;

g) Research misconduct and policies for handling misconduct;

h) Responsible authorship and publication;

i) And the scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research

3. Faculty Participation:  Training faculty and sponsors/mentors are highly encouraged to contribute both to formal and informal instruction in responsible conduct of research. Informal instruction occurs in the course of laboratory interactions and in other informal situations throughout the year. Training faculty may contribute to formal instruction in responsible conduct of research as discussion leaders, speakers, lecturers, and/or course directors. Rotation of training faculty as course directors, instructors, and/or discussion leaders may be a useful way to achieve the ideal of full faculty participation in formal responsible conduct of research courses over a period of time.


4. Duration of Instruction: Instruction should involve substantive contact hours between the trainees/fellows/scholars/participants and the participating faculty. Acceptable programs generally involve at least eight contact hours. A semester-long series of seminars/programs may be more effective than a single seminar or one-day workshop because it is expected that topics will then be considered in sufficient depth, learning will be better consolidated, and the subject matter will be synthesized within a broader conceptual framework.


5. Frequency of Instruction: Reflection on responsible conduct of research should recur throughout a scientist's career: at the undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels. Institutional training programs and individual fellows/scholars are strongly encouraged to consider how to optimize instruction in responsible conduct of research for the particular career stage(s) of the individual(s) involved. Instruction must be undertaken at least once during each career stage, and at a frequency of no less than once every four years. It is highly encouraged that initial instruction during predoctoral training occurs as early as possible in graduate school. Individuals at the early career investigator level (including mentored K awardees and K12 scholars) must receive instruction in responsible conduct of research at least once during this career stage. Senior fellows and career award recipients (including F33, K02, K05, and K24 awardees) may fulfill the requirement for instruction in responsible conduct of research by participating as lecturers and discussion leaders. To meet the above requirements, instruction in responsible conduct of research may take place, in appropriate circumstances, in a year when the trainee, fellow or career award recipient is not actually supported by an NIH grant.