| The competencies needed to practice, teach, and monitor human subjects research are complex and have a specialized set of rules and ethics. Despite the importance of protecting the rights of participants in research, competencies researchers need to in order to conducting safe human subject research have not been identified. Therefore, the purpose of this study was to identify competencies researchers need in order to conduct safe, knowledgeable, and effective research while protecting the research participant's well being.;This study used a Delphi technique design with a panel of 10 experts. This Delphi study was divided into three rounds to identify and define competencies needed by investigators utilizing humans subjects, to reach a consensus of the competencies among the expert panel members, and to rate the importance of each competency. Four broad categories were identified: Personal Competencies, Knowledge and Abilities Competencies, Grasp of Methodology Competencies, and Situational and Organizational Factor Competencies. Personal Competencies contained the four subcategories of Humility, Respect, Ethics, and Avoiding Biases. Knowledge and Abilities Competencies contained the five subcategories of Leadership and Management, Organizational Skills, Communication and Communication Skills, and Cultural Competency. Grasp of Methodology Competencies had no subcategories. Situational and Organizational Factor Competencies had the subcategories of Compliance, Professional Competence, and Conflict of Interest. Overwhelmingly the panel members rated the competencies high with a grand mean of 2.81 out of a 4-point scale for all of the competencies.;Conclusions were drawn that (1) competencies can be identified for conducting safe human subjects research, (2) these competencies can be divided into four areas, and (3) there is a dedicated core group of leaders in the field of research who are aware of and can articulate these competencies. Recommendations related to the implications for the field of the increased knowledge related to competencies, for content for training, and for a new line of inquiry. |
