Medical Ethical Committee
" The design and performance of each research study involving human subjects must be clearly described in a research protocol. The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest, incentives for subjects and provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study. The protocol should describe arrangements for post-study access by study subjects to interventions identified as beneficial in the study or access to other appropriate care or benefits."
Every research protocol has to be tested on ethical and juridical aspects by a medical ethics comite. Read more
The protocol should also contain a compleet discription about how data is collected and data analysis aspects, to assure the compliance and data integrity.