Instructions for phs 398 and sf 424(R&R) Form Approved Through 08/31/2015




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1.12 PHS Metric Program


Consistent with Government-wide implementing regulations, 15 CFR part 19, Subpart B and/or any other Government-wide requirements, PHS policy is to support Federal transition to the metric system and to use the metric system of measurement in all grants, cooperative agreements, and all other financial assistance awards. Likewise, measurement values in reports, publications, and other communications regarding grants will be in metric.

1.13 Transition to the SF424 (R&R) Application and Electronic Submission through Grants.gov


As first announced in August 2005 (NOT-OD-05-067), NIH is transitioning from the PHS 398 application to the SF424 (R&R) application and electronic submission through Grants.gov. This transition is being done by activity code. Applicants should refer to the Timeline to determine when a particular activity code has transitioned to the new form and electronic submission. Information on Transition Strategy and Timeline can be found at: http://grants.nih.gov/grants/ElectronicReceipt/files/timeline_NIH_transitions.pdf.

For more information on NIH’s transition plans, see the Web site for Electronic Submission of Grant Applications: http://grants.nih.gov/grants/ElectronicReceipt/.


1.14 Multiple Program Director/Principal Investigator Policy


Multiple Program Director/Principal Investigator (multiple PD/PI) awards are an opportunity for multidisciplinary efforts and collaboration through a team of scientists under a single grant award. The applicant organization may designate multiple individuals as PD/PIs who share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the applicant organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program including the submission of all required reports. The presence of more than one identified PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI.

Applications designating multiple PD/PIs must include a Multiple PD/PI Leadership Plan describing the rationale for choosing the multiple PD/PI approach, and the governance and organizational structure of the leadership team. Do not submit a leadership plan if you are not submitting a Multiple PD/PI application.

Applications submitted electronically through Grants.gov for most award activity codes permit multiple PD/PIs, with the exception of awards for which multiple PD/PIs would not be appropriate (e.g., CDA and individual fellowship awards, R36, S10, and DP1). Applications submitted on the paper PHS 398 Grant Application may only include multiple PD/PIs if the option is clearly specified in the FOA.

See http://grants.nih.gov/grants/multi_pi/index.htm and NOT-OD-07-017 for additional information.


1.15 New, Including Early Stage, Investigators


NIH encourages all New Investigators to apply for R01 awards. The involvement of New Investigators is considered essential to the vitality of health-related research and has been addressed by several important NIH programs and studies which are detailed on the New Investigator Web site at http://grants.nih.gov/grants/new_investigators/resources.htm. A New Investigator is one who has not previously competed successfully as a PD/PI for a significant NIH independent research award (see complete definition at http://grants.nih.gov/grants/new_investigators/resources.htm#definition).

To encourage earlier application for NIH R01grant support, NIH identifies Early Stage Investigators (ESI). An ESI is a New Investigator who is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent). Applications from New Investigators and ESIs are identified and their career stage is considered at the time of review and award. The procedures for requesting as extension of the ESI period and the conditions under which extensions will be considered are in NOT-OD-09-034.

See NOT-OD-08-121, NOT-OD-09-013, and NOT-OD-09-021 for additional information.

1.16 Policy on Instruction in the Responsible Conduct of Research


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. These mechanisms include: D43, D71, F05, F30, F31, F32, F33, F34, F37, F38, K01, K02, K05, K07, K08, K12, K18, K22, K23, K24, K25, K26, K30, K99/R00, KL1, KL2, R25, R36, T15, T32, T34, T35, T36, T37, T90/R90, TL1, TU2, and U2R. This policy also applies to any other NIH-funded programs supporting research training, career development, or research education that require instruction in responsible conduct of research as stated in the relevant FOA.

A. Instructional Components


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 and describes the accumulated experiences and the best practices of the scientific community over the past two decades.

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. While on-line courses can be a valuable supplement to 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 (see below), 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 collaborations 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. the scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific 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.

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. This instruction can be documented as described below.


B. Special Considerations by Type of Award


Institutional training and institutional career development programs (for example, T15, T32, T34, T90/R90, TL1, K12, or K30 programs): Institutional programs are encouraged to provide instruction in responsible conduct of research for all individuals associated with the program of training regardless of their source of support.

Short-term training and research education programs (for example, T35 and R25 programs lasting six or fewer months, short-term trainees supported on T15, T32 and T34 programs, and short-term participants in R25 programs): The duration of RCR instruction within short-term institutional programs should be appropriate for the total duration of the program and should be justified in the application and is an instance where on-line instruction could be appropriate. Such programs may also use innovative strategies to incorporate instruction in responsible conduct of research and to relate instruction in responsible conduct of research to the scientific focus of the short-term program.

Individual awards: In keeping with the individual nature of these programs, fellows and scholars, along with their institutions and sponsors/mentors, are encouraged to tailor instruction in responsible conduct of research to the needs of the individual. Thus, instruction may go beyond formal institutional courses and provide opportunities for the individual to develop their own scholarly understanding of the ethical issues associated with their research activities and their impact on society. An individualized plan would be appropriate in the rare instances where an institution does not have an established formal mechanism for such instruction.

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.

Additional information, including resources on Instruction in Responsible Conduct of Research, can be found in NOT-OD-10-019.

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