Human Research Policies & Regulations
MoPH’s basic policy for conducting Human research
The MoPH's basic policy “Policies, Regulation, and Guidelines for Research Involving Human" adopts the US regulations CFD 45 part 46 for research involving human. The main elements of the policy clarify the regulatory requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping, the regulatory requirements for assuring compliance by research institutions, the regulatory requirements for researchers' obtaining and documenting informed consent. The policy also provides the requirements for additional protections for certain vulnerable research subject such as pregnant women, in vitro fertilization, and fetuses, children, and prisoners.
Additionally, a list of policies have been developed on stem cell research, genetic/genomic research, clinical research, biobanking, etc.