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130430P - DATA MANAGEMENT: ETHICO-LEGAL CONSIDERATIONS

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Presentation at the Workshop on Data Management held at King Saud University Riyad Saudi Arabia on April 30th  2013 by Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Chairman Institutional Review Board and Department of Bioethics King Fahad Medical City Riyadh EM: omarkasule@yahoo.com


Abstract
Data includes words, numbers, images, and voice most often in an electronic form. Modern information technology handling large and multiple datasets has spawned new ethical issues that researchers dealing with a single research data base in one institution did not face. These issues are: data costs, data ownership, data confidentiality, and patient safety based on data validity. These ethical issues arise at the stages of data sourcing / collection, data editing, and data storage and retrieval. They also arise in the processes of data sharing and data integration. Data editing and validation can lead to biases that will eventually impact on patient safety through wrong research data and conclusions.

Operational data generated by hospitals, health insurance companies, and administrative units is not collected with due care to ensure research-quality accuracy (accuracy, coverage) and lies unused in data banks while researchers apply for and get grants to collect new data for their research purposes. The defects of these data bases can be overcome by instituting quality control programs and using multiple sources for cross validation. The data can be used for research by permission of the legal owner; laws and regulations are not yet clear on this issue because potential owners include the patients, the physicians, and the institutions. The issue of ownership leads to another question whether routinely collected data can be sold to researchers. A corollary to this is whether researchers can engage in selling or buying data with other researchers or commercial marketing and advertising agencies.

Data integration and data sharing, facilitated by modern information technology, enable access to more data in other institutions for analysis and standard setting. Information technology provides the algorithms for fast integration. Data sharing involves allowing other researchers to access data. Both integration and sharing are an ethical imperative to advance knowledge that benefits patients. Integration and sharing have been used mostly in genomic sequencing, nuclear mapping, imaging, clinical trials, and organ transplantation research. Integration and sharing enable researchers, present and future, to draw upon a larger data base but are associated with ethical issues of intellectual property, informed consent, privacy, and confidentiality are followed. Codes, standards, policies and mapping at local and international levels are being developed to address these issues. Owners of data collected at great expense are reluctant to share or integrate it with others without proper acknowledgement of intellectual property. Informed consent from patients is needed for data sharing unless fully anonymised. Data privacy and confidentiality are assured by use of secure data portals and cryptography.

Data processing within one research project has its own ethical issues. The data manager could introduce biases, random or non-random, in the processes of adjusting for missing data, data transformation, and creation of derived variables. Data processing mistakes underlie several types of bias: misclassification, selection bias, and sampling bias. Any mistakes introduced at this stage will impact the final research results and eventually affect patient safety due to clinical interventions based on false research. The usual procedures for data privacy and data confidentiality must be respected. As far as possible personal identifiers should not be accessible except to a few selected members of the research team. The data should be kept locked up or in password protected computers. If the computers are connected online the institution should have policies and software to assure data security.