Conducting Human Research in public and private settings

One of the primary ethical justifications for conducting human research is to benefit society. Because human research seeks to understand something not yet known, participation in human research is not without risks. Given the fundamental importance of human research, society must ensure that research is conducted ethically, scientifically, safely, and in a manner that safeguards the rights and welfare of research participants. The necessity for a national standard for the conduct of human research is of paramount importance given the narrow focus of the current Canadian regulations. Canada’s Food and Drugs Act and applicable Regulations incorporate an internationally-accepted good clinical practice guideline. The guideline describes best practices for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials. There are two main deficiencies with this guideline: (i) it only applies to interventional (clinical) research, and (ii) its main focus is on the production of credible and accurate research data, and does not fully describe practices for the protection of human research participants. Verifying the quality of the research conducted at an investigative site requires harmonized procedures derived from a well-developed standard. Adherence to this standard will ensure that the investigative site has the requirements necessary to safeguard the rights and welfare of research participants, safely conduct the research, measure the investigative site’s efficiency and performance, and produce reliable, verifiable and credible data in an efficient and low-risk environment.