The impact of privacy and confidentiality laws on the conduct of clinical trials

Abstract

Justifiable concerns about the use of personal data in many aspects of daily life have led to the recent introduction in many countries of laws intended to regulate data use. Although participation in randomized clinical trials is generally with informed consent, recruitment procedures, complete follow-up, and the efficient conduct of trials may be substantially affected by such national or local privacy legislation. The relevant laws often have exceptions that allow the use of patient information in the public interest - including the use of data collected to improve or monitor public health or as part of medical research. However, regulatory bodies often give conflicting interpretations of the law, and this affects the conduct of large-scale trials. In particular, unnecessarily restrictive interpretation of the law may be a serious impediment to identification of potential participants for a trial, access to records to confirm events, continued follow-up of patients after the trial has been concluded, and secondary use of the trial data for purposes not directly related to the original purpose of the study. These obstacles could be overcome by better informing patients of the uses of records for medical research purposes, by using informed consent procedures that explain the nature of the research and the uses of the data, and by the use of identifiers, such as social security numbers that allow central follow-up. The clinical trial research community needs to ensure that the substantial benefits of large-scale randomized trials are explained both to the public and to those responsible for introducing legislation. The negative impact of privacy legislation on the use of personal health information and on conducting large studies needs to be understood and minimized.

A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage

“…When health organisations provide upfront declarations and opt-out clauses to patients about the use of personal information for electronic health records,32 clinical registries,2 29 health research,20 and the possibility they may be invited to take part in clinical trials,33 it can circumvent the need to obtain opt-in ‘consent for consent’, an approach that impedes participation and equitable access to research 20. Participation in RCTs is generally with opt-in consent; although there are exceptions (research involving incompetent, unconscious or incapacitated patients and cluster RCTs) 30 34.…”

Impediments to Clinical Research in the United States

“…Clinical research often involves protected health information as defined by the US Health Insurance Portability and Accountability Act (HIPAA; http://www.hhs.gov/ocr/privacy), which requires patient's authorization to use such information for research unless the IRB grants a waiver—itself a complex process 14 . Because penalties for violating HIPAA are severe, IRBs have developed a system of procedures and oversight to ensure compliance 15 …”

“…One unintended consequence of HIPAA has been an increase in the number of patients who drop out of protocols and are not followed for major outcomes (e.g., survival and nonfatal myocardial infarction) 15 , 16 . Experience from conducting large cardiovascular outcomes trials coordinated by our own institution (Duke Clinical Research Institute) suggests that privacy laws, including HIPAA, have contributed substantially to the reluctance of site investigators to contact patients or to access their medical records to obtain follow‐up information on critical study end points (C. Granger and J. Alexander, personal communication, 2011).…”

Assessing Subject Privacy and Data Confidentiality in an Emerging Region for Clinical Trials: United Arab Emirates

“…Justifiable concerns about personal data access and usage have led to newer laws in several countries intended to regulate data access (Armitage et al, 2008). Subject participation in clinical trials is generally guided by informed consent.…”