For PHI, privacy refers to control of how the information is used (Presidential Commission for the Study of Bioethical Issues 2012) and whether others can access the information or make reasonable inferences about a person using the information (Nissenbaum 2010). In research, participants generally provide their consent, either specific or broad, to the use of their data for research. However, some research, including some embedded pragmatic clinical trials, may be conducted with a waiver of consent approved by the IRB when the research activities are deemed to pose minimal risk and could not practicably be carried out without such a waiver.

While much research has explored how research participants feel about privacy, less is known about whether and how these attitudes vary for pragmatic clinical trials, including for research involving waivers or alterations of consent. In a survey of English-speaking adults in the United States, respondents were asked about participation in various hypothetical pragmatic trials. The most frequently cited reason to not participate was fear that privacy and confidentiality of medical records could be compromised (Weinfurt et al 2017).

Reaping the benefits from [pragmatic clinical trials] will require balancing—and not trading off—the need to protect the privacy of individuals while still allowing health data to be leveraged for the common good. Individuals’ privacy interests are rooted in the ethical principles of non-maleficence, respect for persons, and justice, and honoring those principles is at the heart of the social compact between individual data subjects and researchers. (McGraw et al 2015)

Modified approaches to consent and engagement can support justifiable uses of PHI. Alternative mechanisms include an opt-out option, broad or individual notification, and the use of patient advisory councils and community consultation. People’s preferences regarding notification and authorization are discussed in greater detail in the Findings on Approaches to Consent section of the Consent, Disclosure, and Non-Disclosure chapter of the Living Textbook.

Managing Behavioral and Mental Health Data

Special consideration is warranted when potentially stigmatizing mental or behavioral health information might be collected specifically for a pragmatic trial and recorded in the EHR where a range of clinicians and others might have access to it (Ali et al 2022). This issue is also salient when the information collected could signal acute distress (such as suicidal ideation). Prospective planning, adequate communication with all stakeholders, and alignment of expectations regarding appropriate responses are all critical in these cases (Ali et al 2022).