Should IRB's Monitor Research More Strictly?

IRBs were established to protect the rights and welfare of human subjects of research. This duty has usually been fulfilled by reviewing the research protocol and the informed consent document to ensure an acceptable level of risk and a complete process of informed consent. Ensuring subject well-being, however, may at times require a contact with the investigator and the project beyond reviewing paperwork. Protection of the subjects of research may occasionally require the IRB to monitor the adherence to its decisions and assess the adequacy of the entire informed consent process.