What do ethics have to do with research?
The Important Role of Research Ethics Boards in Research
Effective research data management requires a good understanding of the role of Research Ethics Boards (REBs) in ensuring research data's ethical and responsible management. REBs review research proposals to ensure that they comply with the ethical and legal standards of the institution and society at large. In this capacity, they have a few important responsibilities:
Protecting participants' rights and data privacy
REBs must ensure that the rights and privacy of research participants are protected. Researchers must work submit their research data management plans for review by REBs to ensure that their proposed practices comply with ethical standards for informed consent and that the participant’s data is handled securely to maintain confidentiality, and privacy. They must also ensure that risks to participants are acceptable and within research norms.
Ensuring compliance with legal and/or regulatory requirements
To ensure that research is conducted in compliance with legal and ethical standards, they review data management plans to ensure that they comply with various local, national and international regulations, such as Health Insurance Portability and Accountability Act (HIPAA) in the US, the Personal Health Insurance Protection Act (PHIPA) in Canada, or the General Data Protection Regulation (GDPR) in Europe, as well as many others.
Reviewing data management plans
In submitting their Data Management Plans (DMPs) to REBs, researchers need to demonstrate that their data collection, storage, and sharing practices are done in a manner that protects the confidentiality and privacy of participants. REBs must be satisfied that data is securely stored and that access to the data is restricted to only authorized users.
Monitoring ongoing research
Researchers must also engage with REBs during ongoing research to allow them to monitor research activities and progress to ensure that researchers and their teams are complying with ethical and legal standards. Researchers must facilitate audits or site visits to satisfy REBs that research activities are consistent with the approved data management plans.
Establishing standards, providing guidance, and education
Lastly, REBs provide guidance and education to researchers on ethical and legal standards for research data management and often provide the standards for DMPs with which researchers must comply.
Challenges faced by researchers and REBs
The effective management of research data is challenged by many factors including:
Limited resources to support or adequately address ongoing research volume
Complex research ecosystems and the number of stakeholders involved in any given research initiative.
Complexity of research data-sharing agreements, consent forms, NDAs, and intellectual property concerns (including publishing, copyright, data access, and commercialization) that are part of most sensitive research and require legal services support.
Researchers and REBs must work together to address their collective data management responsibilities. Their roles impose a certain degree of operational inefficiencies in the planning and execution of research regardless of discipline. They must seek out methods and tools that address these operational needs to ensure that these important functions are conducted in a manner that reduces operational inefficiencies, while securing research data as well as the privacy of participants, research team members, and external collaborators.