Data sharing in healthcare: ethical considerations for a remote era of research

Remote technology has quickly become a critical element of clinical trials. According to a June 2021 survey from WCG, 94% of research sites expect to use at least one form of remote technology in the future.

Remote technology makes it easy for research sites to transmit their clinical trial data to their sponsors, CROs, or coordinating centers. But technology can also be used by sponsors who want to publicly share data from their Phase IV clinical trials when a treatment proves effective. As exciting as these advances are, they raise many questions about how data should be shared.

Is clinical trial data sharing beneficial to public health, or will it remove incentives for research by allowing organizations to use data others have gathered? How can data be shared ethically, with respect for participants’ privacy and personal security? What regulations guide data sharing, and should there be more?

Data sharing can help clinical trial sponsors determine which interventions are most effective. Ultimately, this will lead to better outcomes for patients. However, to achieve this goal, clinical research institutions need to understand the principles of sharing data ethically, securely, and privately.

Benefits of Data Sharing in Clinical Trials

In the guide to sharing clinical trial data, released in 2015, the National Center for Biotechnology Information states that data sharing can “accelerate scientific progress and ultimately improve public health.” Since 2015, it’s become even easier for research sites to transmit data to their sponsors. It’s also become easier for investigators or sponsors to share their final data publicly.

Published, peer-reviewed data allows physicians to better understand the benefits and risks of a specific treatment so they can make informed decisions about patients’ care. Sponsors can save time and money by not reproducing trials other sponsors or investigators have already carried out, and participants don’t have to engage in trials for interventions that have already been proven ineffective or too risky.

Data sharing may even increase public trust in clinical trials, since participants will know how their data is being used and what kind of impact they can have on healthcare. Sponsors and investigators should consider sharing their data in this era of remote or partially remote trials.

Privacy and Security Risks When Data Sharing

Although data sharing could enhance public health, it comes with challenges for participants, research sites, and sponsors. When embracing digital tools, clinical research staff must apply existing privacy and compliance regulations to a new environment. Some of these regulations have not been updated to reflect the widespread use of technology, so compliance experts have to interpret how to apply them.

Leonard Sacks of the FDA brought up this issue in November 2020 while speaking at a virtual clinical trials workshop hosted by the National Academies of Sciences, Engineering, and Medicine.

For Sacks and others in the U.S., this means following FDA 21 CFR Part 11, but other countries have their own regulatory guidelines that must be followed. As virtual or hybrid trials become more common, sponsors may conduct studies in new countries and therefore may need to follow multiple regulations.

Recent Privacy Regulations

It’s also critically important that digital tools and workflows follow privacy laws and protect participants’ data. Laws like California’s Consumer Privacy Act (CCPA) and the European Union’s Global Data Protection Regulation (GDPR) require explicit consent for data sharing, so sites have the burden of ensuring that their software platforms are compliant with these requirements.

CCPA and GDPR also distinguish between data that contains personal identifiable information (PII) or protected health information (PHI) and “de-identified” data, data where a person’s identity cannot be determined. CCPA and GDPR have strict requirements for when data is considered de-identified.

Both laws acknowledge that medical clinical trials have different regulations than private businesses do. Still, if data is shared, clinical research institutions must think carefully about how to ensure it is de-identified.

Protecting Vulnerable Participants

At the same November 2020 workshop hosted by the National Academies of Sciences, Engineering and Medicine, Deven McGraw of the National Council for Biotechnology Information stressed that privacy protections make people more comfortable with enrolling in clinical trials. He pointed out that 1 in 6 people withhold health information because of worries about confidentiality, and on average participants of color are more likely than white participants to have concerns about privacy.”

The Sharing Clinical Trial Data guide from NCBI backs up the assertion that some clinical trial participants are more vulnerable than others. Clinical trial participants could be more harmed by data leaks if they have conditions that are commonly stigmatized, like mental illness, HIV, or drug addiction.

Participants who are already members of vulnerable groups may need additional privacy or confidentiality protections from research sites and sponsors. Clinical researchers should create comprehensive, accessible informed consent forms and discuss any data-sharing plans for vulnerable groups with research participants, disease advocacy organizations, and community advisory boards.

Ensuring Data Isn’t Stolen or Misinterpreted

While protecting trial participants always comes first, participants aren’t the only ones at risk if shared data is misused or misinterpreted. If another researcher or a public figure analyzes data incorrectly, it could lead to unjustified safety concerns or false beliefs spreading throughout the general public.

Sharing data might also decrease incentives for investigators and sponsors to carry out research. They may worry that their data will be taken and used by other researchers, and therefore their investment of time, money, and intellectual capital won’t be paid back.

Though sponsors don’t—and shouldn’t—share confidential information about their products, they still need control over which data is shared so no one can infer trade secrets from that data. Investigators must also be careful to credit one another when they use each other’s research data.

Remote technology companies should never share sponsors’ or investigators’ data without their permission. While technology can enable data sharing, when and how to share data should always be decided by the sponsors and sites who conduct the research.

Creating Ethical Standards for Data Sharing

Many national laws and international guidelines govern when and how clinical data can be shared. But most clinical research institutions also want internal guidelines and SOPs (standard operating procedures) that specifically regulate data sharing.

Each organization needs to create SOPs that help them advance scientific research while protecting participants’ privacy and product information. Investigators and sponsors should think about how participants and their communities can benefit from the data they’ve gathered without sacrificing their confidentiality.

Takeaways about Data Sharing

The process of determining when and how to share data through remote technology is ongoing. However, research organizations can participate in ethical data sharing today by considering participants’ privacy and security and balancing the need to protect their commercial interests with the need to share enough data to benefit medical research.

Photo: eichinger julien, Getty Images