TY - CHAP
T1 - Conflict of interest in medical research
AU - Krejcikova, Helena Van Beersel
PY - 2023
Y1 - 2023
N2 - Conflicts of interest in medical research have been regulated in many countries by various laws, policies or internal regulations, in order to enhance the quality of research and ethical standards of research integrity. Leaving aside the conflicts of interest of public officers (i.e., employees of regulatory bodies or main public research funds, etc.), the focus of this paper lies in mapping the US, EU and Czech legal frameworks, policies and practice designed to identify and further manage conflicts of interest of researchers conducting clinical trials, both from the perspective of regulatory/scientific bodies involved in authorizing the marketing application (namely, FDA, EMA and the Czech State Institute for Drug Control) and main public research funds (namely, National Institutes of Health, European Scientific Council and Czech Science Foundation and Technology Agency of the Czech Republic). As there has only been limited attention paid to conflicts of interest in research in the Czech Republic, the primary aim of this paper is to introduce the concept of conflicts of interest, together with some selected strategies for identifying and managing them, and to evaluate the current Czech approach towards conflicts of interest in medical research.
AB - Conflicts of interest in medical research have been regulated in many countries by various laws, policies or internal regulations, in order to enhance the quality of research and ethical standards of research integrity. Leaving aside the conflicts of interest of public officers (i.e., employees of regulatory bodies or main public research funds, etc.), the focus of this paper lies in mapping the US, EU and Czech legal frameworks, policies and practice designed to identify and further manage conflicts of interest of researchers conducting clinical trials, both from the perspective of regulatory/scientific bodies involved in authorizing the marketing application (namely, FDA, EMA and the Czech State Institute for Drug Control) and main public research funds (namely, National Institutes of Health, European Scientific Council and Czech Science Foundation and Technology Agency of the Czech Republic). As there has only been limited attention paid to conflicts of interest in research in the Czech Republic, the primary aim of this paper is to introduce the concept of conflicts of interest, together with some selected strategies for identifying and managing them, and to evaluate the current Czech approach towards conflicts of interest in medical research.
KW - Conflict of Interest
KW - medical research
KW - research integrity
KW - disclosure and management of conflicts of interest
M3 - Book chapter
SN - 978-80-87488-54-6
VL - 14
T3 - Czech Yearbook of Public & Private International Law
SP - 373
EP - 392
BT - Czech Yearbook of Public & Private International Law
A2 - Sturma, Pavel
ER -