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Responsible Conduct of Research: Training

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Standard Operating Procedure Table of Contents

Purpose

To ensure that investigators trained with NIH support receive formal instruction in the responsible conduct of research.

Procedure

NIH mandates that trainees on an NIH institutional research training grant, individual fellowship, career development award (institutional or individual), research education grant, dissertation research grant, or other grant programs that have a significant training component have a minimum of eight hours of formal instruction at least once during each career stage and at least every four years.

This policy affects all new, renewal, and noncompeting applications.

Responsible conduct of research is the practice of scientific investigation with integrity. It involves the awareness and application of established professional norms and ethical principles for all activities related to scientific research.

Applicant Institutions and PIs

Your grant application must include a plan for how you will carry out instruction in responsible conduct of research. This plan will not affect your overall impact score, but if you fail to include a plan, your application will be considered incomplete and will not be reviewed until you provide an acceptable plan of instruction. If you get a fundable score but submit an unacceptable plan, you will need to revise it before you can get an award.

Your plan must address the following five instructional components.

  1. Format
    • Trainees, fellows, scholars, and participants should engage in substantial face-to-face discussions.
    • You should have research training faculty lead instruction, when possible.
    • On-line courses can supplement instruction but cannot be the sole means of instruction except in special instances of short-term training programs or unusual and well-justified circumstances.
  2. Subject Matter—incorporate the following topics for instruction.
    • Conflict of interest—personal, professional, and financial.
    • Policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices.
    • Mentor and mentee responsibilities and relationships.
    • Collaborative research including collaborations with industry.
    • Peer review.
    • Data acquisition and laboratory tools; management, sharing and ownership.
    • Research misconduct and policies for handling misconduct.
    • Responsible authorship and publication.
    • 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 or mentors are highly encouraged to contribute to both formal and informal instruction.
    • In formal instruction, training faculty may serve as discussion leaders, speakers, lecturers, or course directors.
  4. Duration of Instruction
    • Instruction generally involves at least eight contact hours between the trainees, fellows, scholars, or participants and the participating faculty.
    • A semester-long series of seminars or programs may be more effective than a single seminar or one-day workshop.
  5. Frequency of Instruction
    • Instruction must be undertaken at least once during each career stage and no less than once every four years.
    • Initial instruction during predoctoral training should occur as early as possible in graduate school. If you are at an early career investigator level (including mentored K awardees and K12 scholars), you must receive instruction at least once during this career stage.
    • Senior fellows and career award recipients may fulfill the requirement for instruction by participating as lecturers and discussion leaders.

Institutional Applications:  PIs must address the five instructional components and describe how they will monitor participation.

Individual Applications

  • As part of your Research Training Plan or Candidate Information and Career Development Plan, you must include a section on instruction in responsible conduct of research that is appropriate to your career stage (e.g., instruction if you are in the early stage of your career; participation as a course director, lecturer, or discussion leader if you are in the middle or senior stage of your career).
    • Plan must address the five components listed above.
    • Document your participation or instruction in research during your current career stage.
    • Plan may also include career stage-appropriate, individualized instruction or independent scholarly activities that will enhance your understanding of ethical issues related to your specific research activities and the societal impact of your research.
    • Describe the role your sponsor or mentor will play.

 Special Considerations by Type of Award:

  • Institutional training or career development programs: institutional programs are encouraged to provide instruction to everyone associated with the program of training, regardless of their source of support.
  • Short-term training and research education programs:
    • The duration of institutional training or research education should be appropriate for the total duration of the program and should be justified in the application.
    • This is an instance where online instruction could be appropriate. PIs may also use innovative  strategies and may relate instruction to the scientific focus of the program.
  • Individual awards:
    • You may tailor instruction to your needs.

In the rare instance that your institution does not offer any formal instruction, you can also create an individualized plan.

Grantees

Address the five instructional components listed above.

  • PIs in Charge of Institutional Applications
    • Your renewal application must describe changes in formal instruction over the past project period and outline future plans that address any weaknesses in your instruction.
    • All training faculty who served as course directors, speakers, lecturers, or discussion leaders during the past project period must be named in the application.
  • Individual Applications
    • Where applicable, your renewal application must describe instruction undertaken during the past project period as well as future plans in order to meet the frequency requirements outlined in the five instructional components.

Program Staff

  • If a plan is rated unacceptable, advise applicants on how to create an acceptable revised plan by following the five instructional components and other guidelines.
  • Then, document the revised plan's acceptability in the Program Officer Checklist.
  • Review progress reports.
    • Institutional training, education, and institutional career development awards
      • Noncompeting applications should include a description of the proposed type of instruction and how much the trainees and faculty will participate, as required in the PHS 2590.
      • Report must also include a description of any enhancements or modifications to the five instructional components described in the awarded application.
      • Report must name any training faculty who contributed to the formal instruction.
    • Individual fellowships
      • Noncompeting applications must include a description of the fellow's instruction that covers everything in the five components except faculty participation.
      • If instruction took place in an earlier budget period, they must describe that. If it will take place in a future budget period, they must describe that.
      • Fellows should discuss the extent to which they participated.
    • Individual career development awards
      • Noncompeting applications must include a description of instruction in responsible conduct of research, as required in the PHS 2590.
      • Report should describe formal and informal instruction (or participation as a course director, e.g., in the case of senior career awardees) in the past budget period, if applicable.
      • If instruction or participation as a course director occurred in an earlier budget period, the PI should note the date.
      • Report should also discuss what steps have been taken to customize instruction to the PI's career stage.
    • Dissertation research awards
      • Noncompeting applications must report on this instruction under a separate heading.
      • Under this heading, the report should describe both formal and informal participation in instruction in the past budget period, if applicable.
      • If instruction occurred earlier, the PI should note the date when formal instruction was last completed.
      • Report should also discuss what steps have been taken to individualize instruction that is appropriate to the PI's career stage.
      • Report should describe how the PI's mentor participated in these activities.

Scientific Review Officers

  • Instruct peer reviewers on what constitutes an acceptable plan and make sure that the review panel reaches a consensus that the plan is acceptable or unacceptable after the application has been scored.
  • If an application has an unacceptable plan, prepare an administrative note for the summary statement that outlines the deficiencies in the plan.

Grants Staff

  • Confirm that an acceptable plan has been submitted before making an award.

Contacts

Applicants: Contact the AITrainingHelpDesk@niaid.nih.gov.

Grantees: Contact the program officer or grants management specialist listed on your Notice of Award.

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

Links

Update on the Requirement for Instruction in the Responsible Conduct of Research

Training in the Responsible Conduct of Research

NIH Research Training

Bioethics Resources on the Web

On Being a Scientist

NIAID Training and Career portal

Last Updated February 12, 2013

Last Reviewed February 12, 2013