Responsible Conduct of Research (RCR)
Federal sponsors supporting research trainees require a program for the responsible conduct of research. For example, the National Institutes of Health’s National Research Services Award requires grantees to establish specific responsible conduct of research curricula. Areas strongly recommended for an appropriate training program include: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Within the context of training in research integrity, it also is beneficial to discuss the mutual responsibilities of the institution and the trainees participating in the program.
In order to support the guidance of the U.S. Department of Health and Human Services’ Office of Research Integrity, Yale's Office of Research Administration provides below a description of each of the fundamental elements of responsible conduct of research program with supplemental resources and links.
RCR Standards and Resources
RCR Guidance and Programs at Yale
External RCR Resources
Professional Societies' Guidelines and Codes of Ethics by Discipline
Required RCR Training for NIH Training Grants: Specific Requirements and Tools
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RCR Standards and Resources
Academic Fraud and Research Misconduct
Conflict of Interest and Conflict of Committment
Human Subject Protections and Human Embryonic Stem Cell Research
Use and Care of Animals
Data Aquisition, Management, Sharing and Ownership
Publication Practices and Responsible Authorship
Mentor/Trainee Responsibilities
Peer Review
Collaborative Science |
Academic Fraud and Research Misconduct
Yale defines academic fraud as falsification or fabrication of data, plagiarism, or gross negligence in the conduct, proposing or reporting of research. Academic fraud and research misconduct constitute a serious breach of academic integrity. The Yale community has an obligation to report incidents of alleged academic fraud and research misconduct as well as an obligation to respond to such allegations in accordance with established policy and procedures. When suspected research misconduct involves federal funding, the University must adhere to additional regulations, policies, procedures and reporting requirements.
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Conflict of Interest and Conflict of Committment
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 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 conflict of interest and conflict of commitment disclosure 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 PHSand NSF may be notified of the existence of a conflict (but not the nature) as required by regulations. Click here for NIH's on-line tutorial relative to financial conflict of interest.
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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 as well as complete a protocol-specific conflict of interest disclosure.
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. |
Use and Care of Animals
The use of animals in research at Yale must be designed, approved, conducted, reported and supported in adherence to the principles of replacement, reduction and refinement, and established 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. |
Data Aquisition, Management, Sharing and Ownership
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 different disciplines and types of research may differ in data management practices, there are generally accepted standards that the University community should be aware of and adhere to relative to 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 as allow it to confirm research findings, establish priority, and be reanalyzed by other researchers. Data should be stored in such a way as to protect confidentiality, be secure from physical and electronic damage and destruction and be maintained for the appropriate time frame dictated by sponsor and University policies. Conditions imposed by sponsors, the University, and data sources may affect data aquisition, management, sharing and ownership. NIH Policy, for example, includes specific criteria for sharing and publishing research data resulting from NIH-sponsored research. |
Publication Practices and Responsible Authorship
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 now 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 Responsibilitites
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.
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Peer Review
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:
- Timely;
- Thorough;
- Constructive;
- Free from personal bias or conflict of interest and committment; 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. External sponsors, including NIH and NSF, have their specific policies and guidance relative to the peer review process. |
Collaborative Science
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;
- Authorship;
- Intellectual property;
- Training and supervision; and
- Compliance with all regulatory matters relevant to the project.
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Required RCR Training for NIH Training Grants: Specific Requirements and Tools
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 attendence, 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 for assistance in understanding the requirements and elements of RCR education and developing an RCR education plan.
Documenting Compliance with RCR Education
Progress reports on the type of instruction provided, topics covered, format, participation must be included in future competing and non-competing application. The Department Business Office is responsible for working with the PIs and trainees to document compliance with RCR training requirements for specific awards.
Coming soon: A template for documenting RCR training compliance! |