Core Competencies

The Clinical and Translational Research Ethics CORE COMPETENCIES are:

Protection of Human Subjects

Study Design and Analysis

Research in Communities

Dissemination of Research Results

Conflicts of Interest and Misconduct in Research

The Clinical and Translational Research Ethics COMPETENCIES are the ability to:

Protection of Human Subjects

• Understand the fundamental principles of the protection of human subjects, the main authoritative bodies, relevant codes, and scope of enforcement;
• Determine risk-benefit ratio of research protocols, balancing risks against potential outcomes, and critique protocols for risks to human subjects;
• Describe the elements of informed consent, including ensuring voluntariness and decision-making capacity of participants, avoiding undue influence  or coercion, and providing details of the risk-benefit calculation; 
• Apply the main regulatory precepts, rules, guidelines, codes, and professional standards in the conduct of clinical and translational research;
• Ensure fairness in recruiting participants and in distributing the benefits and burdens of research;
• Understand and critique special issues that arise in research with vulnerable participants and the need for additional safeguards;
• Adhere to all institutional review board (IRB) procedures and describe the principles of research documentation, validation, and audit;
• Ensure appropriate levels of privacy protection throughout all phases of a study;

Study Design and Analysis

• Describe the basic principles and practical importance of proper study design and analytical techniques;
• Discuss the importance of data and safety monitoring plans and boards;
• Use bioinformatics ethically in clinical and translational research;

Research in Communities

• Recognize the demographic, geographic, and ethnographic features within communities and populations when designing and critiquing clinical studies
• Sumarize the principles and practices of community-engaged research, including its ethical complexities and cultural sensitivities.
• Describe cultural and social variation in standards of research integrity;

Dissemination of Research Results

• Determine authorship using relevant standards and criteria;
• Describe the role of peer review in funding and publication;
• Avoid irresponsible practices, such as duplicate publication, redundant publication, and copyright violation;

Conflicts of Interest and Misconduct in Research

• Identify and manage conflicts of interest in research, including conflicts in financial affairs, intellectual property, employment, and industry collaboration.
• Identify and manage conflicts of interests associated with research industry collaborations.
• Identify, investigate, and report misconduct in research — fabrication and falsification of data, and plagiarism.