RESPONSIBLE CONDUCT OF RESEARCH

It is the expectation of Mass General Brigham and its affiliated hospitals that all members of the Mass General Brigham research community will perform their research in accordance with the highest ethical and professional standards. Principal Investigators, as leaders of scientific projects, are responsible for the scientific integrity of work undertaken in their laboratories and for mentoring the investigators, postdoctoral fellows, and students who work on these projects. Educating staff, fellows, and students in research best practices is the foundation for discouraging scientific misconduct and promoting research integrity.

NIH RCR REQUIREMENTS

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.  Applicable programs 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. 

The following principles are based on several key concepts about responsible conduct of research and best practices that have evolved over the past two decadesʼ experiences:
  1. Responsible conduct of research is an essential component of research training. Therefore, instruction in responsible conduct of research is an integral part of all research training programs, and its evaluation will impact funding decisions.
  2. Active involvement in the issues of responsible conduct of research should occur throughout a scientistʼs career. Instruction in responsible conduct of research should therefore be appropriate to the career stage of the individuals receiving training.
  3. Individuals supported by individual funding opportunities such as fellowships and career development awards are encouraged to assume individual and personal responsibility for their instruction in responsible conduct of research.
  4. Research faculty of the institution should participate in instruction in responsible conduct of research in ways that allow them to serve as effective role models for their trainees, fellows, and scholars.
  5. Instruction should include face-to-face discussions by course participants and faculty; i.e., on-line instruction may be a component of instruction in responsible conduct of research but is not sufficient to meet the NIH requirement for such instruction, except in special or unusual circumstances.
  6. Instruction in responsible conduct of research must be carefully evaluated in all NIH grant applications for which it is a required component.
The following principles are based on several key concepts about responsible conduct of research and best practices that have evolved over the past two decadesʼ experiences:
  1. Responsible conduct of research is an essential component of research training. Therefore, instruction in responsible conduct of research is an integral part of all research training programs, and its evaluation will impact funding decisions.
  2. Active involvement in the issues of responsible conduct of research should occur throughout a scientistʼs career. Instruction in responsible conduct of research should therefore be appropriate to the career stage of the individuals receiving training.
  3. Individuals supported by individual funding opportunities such as fellowships and career development awards are encouraged to assume individual and personal responsibility for their instruction in responsible conduct of research.
  4. Research faculty of the institution should participate in instruction in responsible conduct of research in ways that allow them to serve as effective role models for their trainees, fellows, and scholars.
  5. Instruction should include face-to-face discussions by course participants and faculty; i.e., on-line instruction may be a component of instruction in responsible conduct of research but is not sufficient to meet the NIH requirement for such instruction, except in special or unusual circumstances.
  6. Instruction in responsible conduct of research must be carefully evaluated in all NIH grant applications for which it is a required component.

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.

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:

  1. conflict of interest — personal, professional, and financial — and conflict of commitment, in allocating time, effort, or other research resources
  2. policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices
  3. mentor/mentee responsibilities and relationships
  4. collaborative research including collaborations with industry and investigators and institutions in other countries
  5. peer review, including the responsibility for maintaining confidentiality and security in peer review
  6. data acquisition and analysis; laboratory tools (e.g., tools for analyzing data and creating or working with digital images); recordkeeping practices, including methods such as electronic laboratory notebooks
  7. secure and ethical data use; data confidentiality, management, sharing, and ownership
  8. research misconduct and policies for handling misconduct
  9. responsible authorship and publication
  10. the scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research
  11. safe research environments (e.g., those that promote inclusion and are free of sexual, racial, ethnic, disability and other forms of discriminatory harassment)

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.

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.

Reflection on responsible conduct of research should recur throughout a scientistʼs 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 (as an undergraduate student, graduate student, postdoctoral fellow or faculty), 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.

NSF RCR REQUIREMENTS

The National Science Foundation (NSF) requirement for RCR stems from Section 7009 of the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Act (42 USC 1862o–1). The requirement was amended in 2023 to include faculty and other senior personnel who receive NSF funds. This section, as amended, requires that each institution that applies for financial assistance from the Foundation for science and engineering research or education describe in its grant proposal a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, postdoctoral researchers, faculty, and other senior personnel supported by the proposed research project. Such training must include mentor training and mentorship. 

  1. An institution must have a plan in place to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, postdoctoral researchers, faculty, and other senior personnel who will be supported by NSF to conduct research. As noted in Chapter II.D.1.d(iv), an institutional certification to this effect is required for each proposal.

  2. NSF’s RECR requirement applies to the breadth of research disciplines that the Foundation funds. The training provided should be effective and must be appropriately tailored to the specific needs and circumstances at each institution. Accordingly, it is the responsibility of each institution to determine the content, focus and the delivery method for the RECR training.[69]Such content, however, must include mentor training and mentorship as noted in Section B.1 above. While training plans are not required to be included in proposals submitted to NSF, institutions are advised that they are subject to review, upon request.

  3. An institution must designate one or more persons to oversee compliance with the RECR training requirement.

  4. Institutions are responsible for verifying that undergraduate students, graduate students, postdoctoral researchers, faculty, and other senior personnel supported by NSF to conduct research have received training in the responsible and ethical conduct of research.

  1. An institution must have a plan in place to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, postdoctoral researchers, faculty, and other senior personnel who will be supported by NSF to conduct research. As noted in Chapter II.D.1.d(iv), an institutional certification to this effect is required for each proposal.

  2. NSF’s RECR requirement applies to the breadth of research disciplines that the Foundation funds. The training provided should be effective and must be appropriately tailored to the specific needs and circumstances at each institution. Accordingly, it is the responsibility of each institution to determine the content, focus and the delivery method for the RECR training.[69]Such content, however, must include mentor training and mentorship as noted in Section B.1 above. While training plans are not required to be included in proposals submitted to NSF, institutions are advised that they are subject to review, upon request.

  3. An institution must designate one or more persons to oversee compliance with the RECR training requirement.

  4. Institutions are responsible for verifying that undergraduate students, graduate students, postdoctoral researchers, faculty, and other senior personnel supported by NSF to conduct research have received training in the responsible and ethical conduct of research.

NSF will not tolerate research misconduct in proposing or performing research funded by NSF, in reviewing research proposals submitted to NSF, or in reporting research results funded by NSF. Allegations of research misconduct are taken seriously and are investigated by NSF’s Office of Inspector General (OIG). OIG refers completed investigations of research misconduct to NSF for action. Upon findings of research misconduct, NSF will take appropriate action against individuals or organizations.

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