Responsible Conduct of Research (RCR)

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.

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.

Human Research Protection Program - Education

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 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.

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.

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.

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