Privacy and confidentiality in pragmatic clinical trials

Abstract

With pragmatic clinical trials (PCTs) an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice. Traditional privacy protections for research uses of identifiable information rely disproportionately on informed consent or authorizations, based on a presumption that this is necessary to fulfill ethical principles of respect for persons. But frequently the ideal of informed consent is not realized in its implementation. Moreover, the principle of respect for persons,—which encompasses their interests in health information privacy,—can be honored through other mechanisms. Data anonymization also plays a role in protecting privacy but is not suitable for all research, particularly PCTs. In this paper we explore both the ethical foundation and regulatory framework intended to protect privacy in PCTs. We then review examples of novel approaches to respecting persons in research that may have the added benefit of honoring patient privacy considerations.

Efficacy of a mindful-eating programme to reduce emotional eating in patients suffering from overweight or obesity in primary care settings: a cluster-randomised trial protocol

“…The limits to fully guarantee confidentiality and privacy of the participants included in the study will rely on Fair Information Practice Principles (FIPPS)160—that is, openness and transparency, purpose specification, collection limitation and data minimisation, use limitation, individual participation and control, data quality and integrity, security safeguards and controls, accountability and oversight—and will be in accordance with the ethical standards laid out in the EU General Data Protection Regulation regime as well as the Spanish Organic Law on Protection of Personal Data and Guarantee of Digital Rights, ensuring that the responsibility for protecting data privacy rests primarily on the data holders. If the necessity of fulfilling the objectives of the CRT creates a scenario that could lead to a break in the total compliance with confidentiality, the FIPPS principles in accordance with the ethical standards referred above will ensure a framework of privacy, autonomy and respect for the participants that will minimise the breach of the confidence and in turn the possibility of error due to low quality of data 161. In cases of adverse events or unintended effects, the DMC will be responsible for ensuring anonymity.…”

‘They need to tell you and not just do it’: Veteran and physician perspectives on point-of-care research in VA

“…Another important consideration with respect to research participation is privacy, which entitles a person to regulate how one's personal information is used (McGraw et al, 2015). When a physician is transparent with his or her patients, provides them with a choice, and appreciates their privacy, he or she is acting in accordance with the ethical principle of respect for persons, which underlies the informed consent process (National Commission, 1979).…”

Untitled

“…The information collected during the research should be ethically preserved in privacy and in secret, when a patient takes part in a clinical research, such participation will have a diagnosis and a registration, this also is considered as a private information of the patient which should be kept confidential and all the pharmacists and the trial crew should be highly ethical when practicing their profession [17]. The main ethical behavior of the research staff is to maintain and protect personal and confidential information, they should be highly ethical and do the reciprocity.…”