Restricted accessResearch articleFirst published online 2013-11
An Exploratory Study on the Policies of Health Care Institutions in the New England Region of the United States Regarding Third-Party Access to Medical Records of Research Participants
Source document verification (SDV) is a basic and vital part of monitoring activities in clinical trials. In most cases, SDV involves the examination of medical records by a third party or an individual who is not an employee of the health care institution responsible for medical records storage and maintenance. It is therefore vital for health care institutions to ensure that their third-party access policies are compliant with applicable guidelines, laws, and regulations. A quantitative cross-sectional study design using a confidential online survey was used to examine policies of health care institutions in New England as they pertain to the legal and ethical aspects of third-party access to medical records of clinical research participants. A wide variation in institutional policies was found, and some were non-compliant with applicable laws, regulations, and/or basic ethical principles.
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