Assessments of Research Competencies for Clinical Investigators: A Systematic Review.

Although there is extensive research literature on clinical skill competencies and the use of competency-based frameworks for clinical research, the appropriate methods to assess these competencies are not as well understood. Our goal in this systematic literature review is to identify, compare, and critique assessments of clinical research competencies. Articles were included in this review if they examined clinical investigators or clinical investigators in training, focused on research-based skills, and included some form of assessment of research-based competencies. A total of 76 articles were identified as part of the initial search; 16 met the criteria for inclusion. Two types of assessments of clinical research competence were identified: subjective self-assessments (n = 13) and objective tests (n = 6). These assessments covered a wide range of competencies, but there were no competency domains common to all. Most assessments had limited validation. Training was consistently associated with self-assessed competence but had little relationship to objective measures of competence. In contrast, experience was consistently associated with objectively assessed competence but not with self-assessed competence. These findings have important implications for those interested in assessing medical education programs. We describe a recommended standard for validity for assessments used for the purposes of summative program assessment.