Definitions, Guidelines, & Regulations

Accepted practices for acquiring and maintaining research data. Proper methods for record-keeping and electronic data collection and storage in scientific research. Includes defining what constitutes data; keeping data notebooks or electronic files; data privacy and confidentiality; data selection, retention, ownership, and analysis; data as legal documents and intellectual property, including copyright laws.

The definition of conflicts of interest and how to handle conflicts of interest. Types of conflicts encountered by researchers and institutions. Includes topics such as conflicts associated with collaborators, publication, financial conflicts, obligations to other constituencies, and other types of conflicts.

Issues important in conducting research involving human participants. Includes topics such as the definition of human participant research, ethical principles for conducting human participant research, informed consent, confidentiality and privacy of data and patient records, risks and benefits, preparation of a research protocol, institutional review boards, adherence to study protocol, proper conduct of the study, and special protections for targeted populations, e.g., children, minorities, and the elderly.

Issues important to conducting research involving animals. Includes topics such as the definition of research involving animals, ethical principles for conducting research on animals, Federal regulations governing animal research, institutional animal care and use committees, and treatment of animals.

The meaning of research misconduct and the regulations, policies, and guidelines that govern research misconduct. Includes topics such as fabrication, falsification, and plagiarism; error vs. intentional misconduct; institutional misconduct policies; identifying misconduct; procedures for reporting misconduct; protection of whistleblowers; and outcomes of investigations, including institutional and Federal actions.

The purpose and importance of scientific publication, and the responsibilities of authors. Includes topics such as collaborative work and assigning appropriate credit, acknowledgments, appropriate citations, repetitive publications, fragmentary publication, sufficient description of methods, corrections and retractions, conventions for deciding upon authors, author responsibilities, and the pressure to publish.

The responsibilities of mentors and trainees in predoctoral and postdoctoral research programs. Includes the role of a mentor, responsibilities of a mentor, conflicts between mentor and trainee, collaboration and competition, selection of a mentor, and abusing the mentor/trainee relationship.

The purpose of peer review in determining the merit of research funding and publications. Includes topics such as the definition of peer review, impartiality, how peer review works, editorial boards and ad hoc reviewers, responsibilities of the reviewers, privileged information, and confidentiality.

Research collaborations and issues that may arise from such collaborations. Includes topics such as setting ground rules early in the collaboration, avoiding authorship disputes, and the sharing of materials and information with internal and external collaborating researchers.