An Ethics Framework for a Learning Health Care System

Questions: 1. Is anyone to blame for the loss of documents?2. What precautions, if any, would have prevented this loss?.3. Would you have done the same as Dr. Sears or something different? Explain. Answers: 1. The document that was lost was very important but it is not appropriate to blame anyone. Though Dr. Bernard Sears was terminally ill, he needed the access to the documents for preparing manuscript for the publication. The technicians also acted in good faith by providing the documents to Dr. Bernard and the interim principle investigator was working on the phase I clinical trials. The University was also not suspicious of the events that followed in the course of investigation. 2. The documents could have been saved if the University had supplemented it with proper record keeping techniques such as duplicating and saving it in computer files[1]. Research documents should be stored in secure and accessible manner. As per the guidelines OF NIH, it is necessary to adopt an open data policy and research documents must be maintained for at least three years after the submission of last expenditure report[2]. Therefore, it is the responsibility of the University to keep track of research documents and keep a copy of such documents. If the University has taken appropriate steps and acted diligently the documents could have been saved. 3. Before moving of important data from the University to home office, I would have taken steps to ensure that documents are duplicated and securely preserved, in case the original data is lost. As a principle investigator, I would have taken the required steps to ensure that the research documents are preserved, secured and accessible to the interested parties. In this case, the research was not published and interim principle investigator is appointed therefore I would have shared the research documents with the interim principle investigator. References Faden, Ruth R., et al. "An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics."Hastings Center Report43.s1 (2013): S16-S27. Solomon, Jennifer N., Michael C. Gavin, and Abu Conteh. "Codes of ethics are critical for research on non-compliance with conservation rules and regulations."Biological Conservation(2016).