Data Governance in Human Research

Human research can provide knowledge that assists society in many ways, including through the production of socially beneficial goods, services, and improved insights into human behaviour. Achieving these benefits in an ethical way requires respect for the dignity and rights of those whose data and participation make these benefits possible. It is incumbent on organizations conducting human research to govern themselves accordingly. Human research incorporates various types of qualitative and quantitative methods, disciplines, and approaches conducted in a variety of domains. Human research may involve the use of existing or prospectively collected data or specimens. Throughout the lifecycle of human research, various types of data are collected, processed, analyzed, shared, re-used, stored, and archived, encompassing a variety of multidisciplinary practices. Data governance in human research serves several purposes. It optimizes research data use to meet the needs of the researcher, it ensures that the use of research data meets ethics, regulatory, and legal obligations, and it applies safeguards to ensure appropriate access and protection against data corruption or other misadventure. When good data governance is demonstrated, it also generates trust among parties – most notably research participants – that research data are being used responsibly and in the public interest. Currently, there is no uniform way to ensure the integrity, quality, and responsible use of human research data that includes all of the various disciplines involved. Adherence to this NSC will ensure that researchers have the requirements necessary to produce reliable, verifiable, and credible data through all stages of the human research lifecycle.