Competence and Clinical Research

A word that is finding increasing use in the clinical research sector is competence. But what does it mean and what is its significance?  Competence can be defined as the ability of an individual to demonstrate knowledge, skills and behaviors. When someone is competent in a particular job role they have mastered all the knowledge skills and behaviors required for that position or function.

Most of us have had some kind of competence assessment during our adult lives. When we learn to drive a car we must prove to the relevant authorities that we have the appropriate knowledge (of road signs, rules of the road, relevant laws), and the skills to manoeuver and control the car. We also need to demonstrate the correct behaviors such as respect for other motorists, keeping to the speed limits, not driving recklessly and driving with “due care and attention”. Once we have proved we are competent we are given a driving license and are allowed to drive unaccompanied on our country’s roads.

One common misconception of competence is that it can be demonstrated by a person passing a multiple-choice test or writing essays in response to hypothetical scenarios. True, these assessments can demonstrate knowledge but they are not reliable measures of skills or behaviors. Another fallacy is that experience equates to competence. Naturally the right experience contributes to the gaining of competence but in no way does it guarantee it.

Why is competence so important to clinical research? Medical research on human subjects is quite rightly highly regulated using legal frameworks and guidelines. This helps to ensure that ethical standards are maintained and that sound scientific principles are adhered to, to protect patients and produce valid and creditable data. Organizations working in clinical research have processes and procedures, including SOPs as part of their quality management systems to enable them to comply with the requirements of the appropriate regulations and guidelines. What is also equally important is that the people who implement these processes and procedures are fully competent in their use as well as having the expertise to fulfil the requirements of their jobs. This is a critical factor in protecting the rights and wellbeing of clinical research subjects and the integrity of the data

Competence can be measured against performance standards known as competencies. Competency frameworks are used to describe the knowledge skills and behaviors required for specific job roles. The difference between a person’s competence and the required competency is known as a performance gap. Regular reviews with a line manager can be used to identify any gaps and then solutions can be implemented to close the gaps using interventions such as coaching, attending a training course or seminar, conducting work place assignments or using self-directed learning.

Competency frameworks are also used for identifying individuals suitable for promotion and can be used for recruitment interviewing.  Theconcept is about using objective criteria to identify the most suitable candidate either for promotion, change of job role or recruiting new staff.