NIAID staff recommend the following approach to describe the components that fulfill the requirement for instruction in responsible conduct of research (RCR). Applicants should note that with the exception of the new recommendations for the RCR instructional components described in NOT-OD-22-055, the policy and guidance set forth in NOT-OD-10-019 remain in place.
Check the NIAID Responsible Conduct of Research—Training SOP and learn more about NIAID Training and Career Development Grant Programs.
Table of Contents
The RCR training plan must address the five required instructional components outlined in the NIH Policy on Instruction in the Responsible Conduct of Research (RCR), as more fully described in the NIH Grants Policy Statement, Section 18.104.22.168: Training in the Responsible Conduct of Research.
The section of the application should document prior instruction or participation in RCR training during the applicant’s current career stage, including the date instruction was last completed. This section should also propose plans to either receive instruction or provide instruction (e.g., to participate as a course lecturer) to meet the frequency requirement of RCR training.
1. Format: Describe the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable). Discussion-based instruction should not exclusively employ video conferencing unless there are unusual or well-justified circumstances.
2. Subject Matter: Describe the breadth of subject matter. Applicants will need to respond to the following suggested topics list:
- Conflict of interest – personal, professional, and financial – and conflict of commitment, in allocating time, effort, or other research resources
- Policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices
- Mentor/mentee responsibilities and relationships
- Safe research environments (e.g., those that promote inclusion and are free of sexual, racial, ethnic, disability, and other forms of discriminatory harassment)
- Collaborative research, including collaborations with industry and investigators and institutions in other countries
- Peer review, including the responsibility for maintaining confidentiality and security in peer review
- 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
- Secure and ethical data use; data confidentiality, 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: Describe the role of the mentor(s) and other faculty involvement in the instruction.
4. Duration of Instruction: Describe the number of contact hours of instruction, taking into consideration the duration of the program.
5. Frequency and Timing of Instruction: Instruction must occur during each career stage and at least once every four years.
- Document any prior instruction during the applicant’s current career stage, including the inclusive dates instruction was last completed.
- Institutions are encouraged to provide training that is career stage appropriate—for example, more discipline directed training for advanced graduate students and postdocs.
- Instruction and activities should enhance the applicant’s understanding of ethical issues related to their specific research activities and the societal impact of that research.
- Describe the role of the mentor in RCR instruction.
Renewal Applications: For institutional programs only, describe the RCR instruction activities undertaken during the previous project period as well as future plans for RCR instruction.
NIAID staff offer the following advice:
- NIAID training awards are highly competitive and applicants that neglect the RCR requirements may be disadvantaged.
- Do not underestimate the importance of the RCR section in your grant application. While RCR is not one of the scorable review criteria, an “UNACCEPTABLE” rating for this section will delay the release of funds if your grant application is selected for an award.
- An incomplete or insufficiently detailed RCR section may reflect poorly upon your mentor who, reviewers will assume, provided input on RCR training and read the application before submission.
- Applications lacking a plan for instruction or participation in RCR will be considered incomplete and may be delayed in the review process.
- Online training is not considered sufficient for RCR training though it can serve as a valuable supplement to face-to-face instruction. A plan that employs only online coursework for instruction in RCR will not be considered acceptable, except in special instances of short-term career development programs, or unusual and well-justified circumstances.
NIAID provides the following as one example of how you could approach the RCR page. This is not intended as a template. You should draft your RCR page to fit the nature of training being conducted.
Training in Responsible Conduct of Research (Sample)
XXXXX University provides introductory and ongoing training in Responsible Conduct of Research (RCR) to graduate students and postdoctoral fellows through the Training Office to satisfy NIH RCR requirements. The Training Office maintains a database of all training attendees to ensure compliance of all relevant trainees and personnel.
Format: The RCR training program is comprised primarily of live workshops, presentations, academic coursework, and/or face-to-face discussions led and facilitated by faculty, compliance officers, and mentors. XXXXX University encourages NIH-funded scholars, trainees, and fellows to participate in as much live instruction as possible.
Subject Matter: The RCR training covers a wide array of topics. Below is a sample schedule of the RCR training program.
|Date||RCR Training Topic|
|September 9, 20XX||Introduction to the Responsible Conduct of Research, [Faculty Name]|
|September 30, 20XX||Ethics of Research with Human Subjects and Vertebrate Animals, [Faculty Name]|
|October 14, 20XX||Ethics and Practice of Mentoring, [Faculty Name]|
|October 21, 20XX||Conflict of Interest, [Faculty Name]|
|October 28, 20XX||Data Management, Acquisition, and Ownership, [Faculty Name]|
|November 11, 20XX||Ethics, Integrity, and the Handling of Research Misconduct, [Faculty Name]|
|November 18, 20XX||Ethics of Authorship and Publication, [Faculty Name]|
|February 16, 20XX||Ethics and Practice of Peer Review, [Faculty Name]|
|March 2, 20XX||Ethics of Collaborative Research and Working with Industry, [Faculty Name]|
|March 18, 20XX||Contemporary Ethical Considerations in Biomedical Research, [Faculty Name]|
|April 3, 20XX||Maintaining a Safe and Inclusive Research Environment, [Faculty Name]|
Faculty Participation: In addition to the faculty lecturers named above, my mentor Dr. XXXX will ensure that I maintain current knowledge and practice in RCR in our weekly discussions on the progress of my research. Furthermore, I will discuss RCR topics with my Training Advisory Committee during our bi-annual progress meetings.
Duration of Instruction: The Training Office requires a minimum of nine (9) hours of RCR instruction. No more than 1.5 hours of supplemental online instruction in RCR may count toward fulfilment of the RCR training requirement. Moreover, the Training Office hosts annual one-day mini symposium on Scientific Integrity and Ethics in Research that trainees are expected to attend. Scientific, business, legal, and societal perspectives are presented and explored during the mini symposia.
Frequency of Instruction: In my graduate school training, I completed a ten-week course on biomedical and clinical research ethics at the University of XXXX School of Public Health in Spring 20XX. The course topics included understanding bioethics. I also attended seminars on data sharing and roles and responsibilities of individuals versus institutions during the scientific process. During my post-doctoral fellowship, I participated in multiple group discussions on topics related to ethical research in the clinical pediatric setting. I have also completed the on-line Collaborative IRB Training Initiative (CITI) Program during graduate school and fellowship, and I will continue to keep my CITI training current during this award and my scientific career. The CITI program includes training in all facets of human subjects research, including IRB regulations, informed consent, research with protected populations, and research involving children.