Responsible Conduct of Research (RCR)
Yale University is committed to the conduct of research and research training activities in a scientifically responsible and ethical manner. In support of this commitment the University subscribes to the Department of Health and Human Services’ Office of Research Integrity (ORI) published guidance on what are considered to be essential elements of an appropriate Responsible Conduct of Research (RCR) Program. Other Federal granting agencies as well as many non-federal sponsors have adopted similar standards.
Provided below is a list of the ORI essential elements and resources to assist investigators in preparing RCR plans for proposals as well as training opportunities for researchers.
- Academic Integrity
- Conflict of Interest and Conflict of Commitment
- Human Subject Protections and Human Embryonic Stem Cell Research
- Use and Care of Animals
- Data Acquisition, Management, Sharing and Ownership
- Publication Practices and Responsible Authorship
- Mentor/Trainee Responsibilities
- Peer Review
- Collaborative Science
- RCR Guidance and Programs at Yale
- External RCR Resources (Including NIH, NSF, and others)
- Professional Societies’ Guidelines and Codes of Ethics by Discipline
- Required RCR Training for NIH Training Grants: Specific Requirements and Tools
- Postdoctoral Researcher Mentoring Plan
RCR Standards and Resources
Yale and the federal government define academic misconduct as the falsification or fabrication of data, plagiarism, or gross negligence in the conduct, proposing or reporting of research. Academic misconduct and research misconduct constitute a serious breach of academic integrity. The Yale community has an obligation to report incidents of alleged academic and research misconduct as well as an obligation to respond to such allegations in accordance with established policies and procedures. When suspected research misconduct involves federal funding, the University must adhere to additional regulations, policies, procedures and reporting requirements.
Each member of the Yale community has an obligation to act in the best interest of the University and in furtherance of the University’s mission, and must not let outside activities or outside financial interests interfere with those obligations. According to the University’s Policy on Conflict of Interest and Conflict of Commitment Policy, faculty with appointments of greater that 50% time; all faculty who hold administrative positions and non-faculty personnel who are responsible for the design, conduct or reporting of research are required to submit an annual external interest disclosure form to the Office of the Provost. The University reviews disclosures for conflicts of interest and commitment with University and sponsored research obligations to establish procedures whereby identified conflicts may be avoided or properly managed. Depending on the nature of the conflict, sponsors including the Public Health Services and the National Science Foundation may be notified of the existence of a conflict (but not the nature) as required by regulations. Click here for National Institutes of Health on-line tutorial addressing the requirements of the PHS regulation.
Human Subject Protections and Human Embryonic Stem Cell Research
Human subject research at Yale must be designed, approved, conducted, reported and supported in adherence to the ethical principles of respect for persons, beneficence and justice, and established federal regulations and University policies and procedures. All individuals involved in the design and/or conduct of research involving human subjects must undertake required training.
To ensure that any Yale human embryonic stem cell research is conducted only after full consideration is given to all relevant scientific, medical, regulatory, and ethical issues, Yale’s Embryonic Stem Cell Research Oversight Committee must review all proposed human embryonic stem cell research. All human embryonic stem cell research, prior to conducting the research must be proposed, approved and conducted in accordance with University policy.
The use of animals in Yale research must be approved and conducted in support of the principles of replacement, reduction and refinement, and in accordance with federal regulations and University policies and procedures. All individuals involved in the design and/or conduct of research involving animals may be subject to required training.
The integrity of research data and the usefulness of the research it supports depends on careful attention to detail from initial planning through final publication. While the scientific disciplines may differ in data management practices, there are generally accepted standards with which the University community should be aware and adhere to regarding data ownership, data collection, data protection and data sharing. Key considerations for data collection include using the appropriate method, providing attention to detail, obtaining the appropriate permissions for use of certain categories of data and the accurate and secure recording of data. Data should be maintained and secured in such a way that permits confirmation of research findings, establishes priority, and can be reanalyzed by other researchers. Data should be stored in such a way that protects confidentiality, is secure from physical and electronic damage and destruction and can be maintained for the appropriate time frame dictated by sponsor and University policy. Conditions imposed by sponsors, the University, and data sources may affect data acquisition, management, sharing and ownership. NIH Policy, for example, includes specific criteria for sharing and publishing research data resulting from NIH-sponsored research.
Yale research often involves collaborations among a number of individuals internal and external to the University. Collaborative research brings about inherent difficulties resulting from complex roles and relationships, common, but not necessarily identical, interests, management requirements and cultural and disciplinary differences.
The appropriate reporting of research results entails a full and fair description of the work undertaken, an accurate report of the results, and an honest and open assessment of the findings.
The NIH requires the submission of published articles resulting from NIH-funded research to PubMed Central. The NIH Public Access Policy applies to all peer-reviewed articles that arise, in whole or in part, from direct costs funded by NIH, or from NIH staff, that are accepted for publication on or after April 7, 2008.
Mentor-trainee relationships begin when an experienced and an inexperienced researcher agree to work together. The experienced researcher has knowledge and skills that the inexperienced researcher needs to learn. Under a productive relationship, the two work together to advance knowledge and put ideas to work.
When mentors accept trainees, they assume responsibility for assuring that the persons under their supervision are appropriately and properly trained. The Yale School of Medicine’s Guidelines for the Responsible Conduct of Research sets forth the following expectations for faculty and institutional officials:
- At least one senior faculty member should supervise (with mutual assent) all individuals in a laboratory who are not acknowledged independent investigators.
- Mentors should commit themselves to spend the time required for adequate supervision
- The ratio of trainees to available mentors should be small enough to encourage close and frequent interactions concerning all aspects of research undertaken by a trainee or junior investigator, including the planning and design, data interpretation and preparation of reports.
- Trainees have both the right and responsibility to be certain that they are adequately supervised during their research training and that the research itself is performed in a manner which reflects high standards for the responsible conduct of science.
Peer review—evaluation by colleagues with similar knowledge and experience—is an essential component of academia and research.
The integrity of the peer review process depends on analysis that is:
- Free from personal bias or conflict of interest and commitment; and
- Respectful of the need for confidentiality.
Yale expects that when asked by journals and external sponsors to judge manuscripts and sponsored project applications, faculty and other members of the University community provide opinions which are not only proficient but which are also fair and unbiased.
Researchers increasingly collaborate with colleagues both across the University and external to the University. By nature, collaborations have the potential for dilemmas such as complex roles and relationships, divergent interests, dissimilar management styles and differing disciplinary and cultural interpretations.
Clear communication is key to effective collaborations. Collaborative projects should have effective management plans, agreed upon prior to commencement of a project, that cover:
- Financial issues;
- Intellectual property;
- Training and supervision; and
- Compliance with all regulatory matters relevant to the project.
Various schools, departments and programs at Yale have established guidelines and programs relating to RCR. The following guidelines and programs are available for review and assistance:
- The Office of Academic Integrity
- Template Language for Proposal Submissions
- Graduate School of Arts & Sciences Professional Ethics
- NSF RCR Training Plan for Students and Postdoctoral Researchers
The federal government and sponsoring agencies offer abundant RCR resources and training relative to RCR education requirements:
- AAAS & NAS: Compilation of Resources on Scientific Misconduct and Research Integrity
- Office of Research Integrity: Introduction to the Responsible Conduct of Research
- Office of Research Integrity: RCR Resources
- The Federal Office of Research Integrity: The Lab: Avoiding Research Misconduct (Interactive movie)
- NIH: Training in the Responsible Conduct of Research Resources Page
- NIH: Sharing Biomedical Research Resources
- NSF: Responsible Conduct of Research
The following listing of professional societies has been compiled by Boston College:
Every National Research Service Award (NRSA) and Career Award (K award) trainee must receive instruction in the responsible conduct of research. Each training grant application must include a description of the plan to provide trainees with formal and informal instruction on scientific integrity and ethical principles in research. Plans for instruction in the responsible conduct of research must address the subject matter, format, degree of faculty participation, trainee attendance, and the frequency of instruction. The plans should be developed to meet the specific needs of the trainees. Refer to RCR Guidance and Programs at Yale and External RCR Resources sections above for assistance in understanding the requirements and elements of RCR education and developing an RCR education plan.
Progress reports on competing and non-competing application must include a Postdoctoral Researcher Mentoring Plan. The Department Business Office is responsible for working with the PIs and trainees to document compliance with RCR training requirements for specific awards. The NIH discusses mentoring plans on their website.