Key issues of research with human participation

Abstract

Research seeks to contribute to generalizable knowledge about the human condition; Research has certain risks - physical, social, psychological, financial, juridical. Protection of safety, rights and welfare of human participants is paramount. Protection of human participants and data quality are main standards of Good Clinical Practices.Some aspects
covered in this standard are not applicable to all types of research. The basic ethical principles in research are autonomy,
justice, and beneficence/non maleficence. Core elements of informed consent are: disclosure, comprehension, decision
making, voluntariness, free from coercion, provision of information. It should be in a language understandable by the
participant, clear, unambiguous and non-technical, delivered in the most effective mannerbyinvestigators/designees.
Quality system is a formal system to strengthen organization by raising standards of work and ensuring all activities are
done consistently in order to ensure that processes are reliable; data generated is credible, repeatable/reproducible, auditable, and transferable across international boundaries.