Issues to Consider When Collecting and Using Patient Data

Many leading thinkers in the medical community support the sharing of historically guarded research data. The view that there is an ethical obligation to responsibly share data for the benefit of global research and patients alike, raises questions about each patients’ role in managing that data and the responsibilities of clinical researchers to patients to ensure the privacy of trial participants. There are four key issues to consider in the shifting debate:

Issue #1: Trust is everything

A successful clinical database must be built on trust – i.e., a serious commitment by researchers to the participants and patient advocates that the intended goal of an open database is to generate actionable, life-changing medical insights. Trust is not only an obvious ethical imperative; it’s also essential on a practical level. Advocates suggest that patients will be more willing to participate if they understand the reasons for the study and feel that they are partners in the process, i.e., that they will benefit from the study or have a degree of control over the use of the data they contribute, either by limiting its use or by ensuring that it is available to all researchers (not just a few).

In short, trust must be earned, and acts that generate distrust can be devastating. In the new world of shared clinical research, participation is a form of partnership between patient and researcher.[i]

Issues #2: Patients are the rightful owners of their data

Many patients enrolling in clinical studies or whose medical information resides in a research database believe that confidential medical data taken from them also belongs to them (as does President Obama), and, accordingly, have expectations about the use of those data. Three key questions to consider in this setting:

  • Is the database being used in a manner consistent with the patient’s expectations?
  • Is the database or research project operating in patients’ best interests and/or contributing to the advancement of science?
  • Is anyone profiting from it, and if so, are the profits reinvested in research?

A response of “no” to any of these question can lead to — and has led to — widely publicized accusations of misconduct. Cognizant of the belief that patients “own” their data and are merely letting researchers borrow it, NIH’s Francis Collins and biopharma industry leaders, patient advocates and genomics/bioinformatics experts convened in 2015 to ensure that patients participate in and benefit from the NIH’s Precision Medicine Initiative. Trust, transparency, real-time individualized patient benefit and patient ownership of their data were agreed by many to be the new norms for clinical studies.

Issue #3: Patients’ fully informed consent must be obtained before using their data

Patients must understand and have a say in how their data are used. The intended use of the data must be clear to both patients and curators at the onset of the project. Furthermore, the informed consent process must offer patients a real choice about participation. For example, the patient’s consent to research should not be presented as a condition of obtaining treatment or as one of many documents the patient must sign when they enter a treatment center. Instead, researchers should separate consent from other paperwork and activities and provide simple mechanisms for the patient to opt-out.

Issue #4: Failure to meet patients’ expectations can result in project-jeopardizing backlash

Failure to obtain “true” consent, or any perceived misuse of data, may have significant and long-lasting repercussions. Similar situations where governments have sold the rights to an entire gene pool — without informing the people in that gene pool about the transaction — have taken place in Estonia and in Australia. While some have forgotten these experiences from the late 1990s and early 2000s, similar biomedical data capturing efforts are taking place more frequently than most realize. The extent to which these modern-day efforts learn from the mistakes of others — and the subsequent respect they show in handling consumers’ rights to their data — will determine the degree to which they are embraced by the public and scientific communities.

Guiding Principles and Responsibilities

When dealing with patients’ biomedical data, expectations are high and scrutiny is intense.  Any research endeavor today must respect the rights of patients. The pharmaceutical industry itself has published a set of principles that supports transparency and data sharing, creating a de facto minimal standard for biomedical research projects. Stakeholders have an obligation to create a culture of responsible clinical trial data sharing and mutually reinforcing incentives for sharing. Adherence to the IOM, PhRMA and NIH’s proposals, basic ethical principles and concepts of transparency and data sharing is essential for success and avoiding disastrous reputational damage.

And, on a positive practical note, adherence to these industry principles may lead to rapid patient recruitment, excellent study results and patient benefits.[ii]

Alex Brownstein is a senior vice president for BioScience in New York.


[i] Zatzkin, Whitney (@MsWZ). “The framework for respect by @MightyCasey #BuildingTrust” 28 March 2015. Tweet.

[ii] Wilbanks J, Friend SH. First, design for data sharing. Nat Biotechnol. 2016 Apr 7; 34(4):377-9.