Information sharing in medical research: Who owns my data?
Data in clinical research studies are helping to improve our lives in many ways
Information is big business in the modern world. Information technology is increasingly used to analyse our habits: where we go, what we buy and who our friends are. Some argue that this is an invasion of privacy, but it also has the potential to improve our lives in many ways. Your medical history represents some of the most sensitive and personal information that exists about you, so healthcare professionals are very careful about protecting it. Your consent is needed before it can be shared with anyone.
People taking part in clinical research studies agree to ‘donate’ their health information to doctors and research organisations to help them better understand the risks and benefits of medicines and other medical treatments being studied. A large amount of personal information is collected within a clinical study, such as blood test results (e.g. blood sugar and cholesterol levels), measurements of weight, heart health and blood pressure, medical images from scans and information about mood and mental health. This information is known as data. Once the study is complete, data collected from each individual are combined to enable scientists to carry out an analysis of all the data and answer specific research questions.
Who owns clinical research study data and how is it used?
For most clinical research studies, data are legally owned by the study sponsor (the organisation(s) that paid for the study to be conducted), which is usually a medicines company or an academic institution like a teaching hospital or school of medicine. Scientific and medical communities agree that the owners of the data have a responsibility to announce the main results from a study (whether these were positive, negative or neutral) as soon as possible after they are known1,2. Study results are usually announced at scientific congresses and in journal articles which present overall summary results (e.g. totals or averages). These do not identify results for individual participants (the very large volume of data collected in a typical clinical research study is one of the reasons why up to half the data tends remain unpublished)3. However, it is increasingly thought that study sponsors should share the full details of individual patients’ results with researchers, on request, as long as every participant’s identity is kept anonymous to protect their privacy3,4. This is because it is believed that ‘raw data’ (data from individual participants which hasn’t yet been processed or analysed) may be valuable to scientists planning future research.
Opening access to data has become normal in most areas of life, sharing all the raw data will help to gain the full benefit from the important contribution made by study participants
In recent years, the idea of data sharing has become more and more prominent and it has become easier to access the full results of research studies and not just the analysis and interpretation that the researchers choose to publish5. One example, the International Stroke Trial (1991-96), was a large study with nearly 20,000 participants. This study collected an enormous amount of raw data, which have since been made anonymous and accessible by other researchers6. Increasing use of crowd-sourced health data (where whole communities of people are asked to provide answers to simple questions about their health) and electronic medical records provide opportunities to study real-life medical situations outside traditional clinical studies7,8. Crowd-sourcing also raises the possibility that research results could ultimately be jointly owned and shared by the people who contribute the data, not just by study sponsors9.
What does data sharing mean for clinical trial participants?
Balancing the scientific importance of using and sharing data with the legal requirement to protect people’s privacy is a priority for research organisations10. When joining a study, participants sign a consent form that explains the various kinds of health information that will be collected during the study, who owns the data, and how it will be stored. You can withdraw your consent to participate at any time, which means that you no longer attend study visits or receive study medication. Usually, data that has been contributed before withdrawing consent will remain part of the study, but no further data will be collected unless you give your permission11. The more data a study can continue to collect, the more valid and useful the results are likely to be11.
Data sharing for the benefit of society
Medical science continually builds on and refines previous knowledge with the help of research findings. In the era of electronic information exchange, when open access to data has become normal in most areas of life, sharing all the raw data collected in clinical studies will help to gain the full benefit from the important contribution made by study participants.
Nick Hartshorne-Evans was diagnosed with Heart Failure in January 2010. His experience as a patient stimulated him into developing the only dedicated patient led Heart Failure charity in the UK – The Pumping Marvellous Foundation. Nick is also President of iHHub, which has attracted significant attention from international partners where it advocates for the global heart failure patient voice and in 6 months has managed to recruit 35 patient groups globally. Nick regularly engages and involves himself in both global, regional, national and local patient advocacy along with delivering patient led collaborative solutions. He is a patient expert with NICE, a mentor within NHS England’s clinical entrepreneur programme, the patient lay voice for the NICE Chronic Guidelines commencing April 2016 and an Honorary Research Fellow at the University of Liverpool’s Management School.
The International Heart Hub (iHHub) is the first global non-profit organisation that brings together and supports the creation of patient groups from every country in the world to raise awareness of heart failure and improve lives. iHHub was founded as an alliance of patient organisations from North America, Latin America, Europe, Middle East and Africa and works from the centre of the global heart failure conversation to amplify the patient voice.
- Institute of Medicine. Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age. Washington, DC: National Academy Press; 2009
- Hrynaszkiewicz I, Norton ML, Vickers AJ, Altman DG. Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers. BMJ 2010;340:c181.
- Ross JS; Lehman R; Gross CP The Importance of Clinical Trial Data Sharing: Toward More Open Science. Circ Cardiovasc Qual Outcomes 2012;5:238-240.
- EFPIA Principles for Responsible Clinical Trial Data Sharing, 2013. Available from: http://transparency.efpia.eu/uploads/Modules/Documents/data-sharing-prin-final.pdf Accessed August 2016.
- US Department of Health and Human Services, National Institutes of Health, National Heart Lung and Blood Institute. Biologic Specimen and Data Repository Information Coordinating Center. 2007. Available at: https://biolincc.nhlbi.nih.gov/home/. Accessed August 2016
- International Stroke Trial Collaborative Group. The International Stroke Trial (IST): a randomised trial of aspirin, subcutaneous heparin, both, or neither among 19435 patients with a cute ischaemic stroke. International Stroke Trial Collaborative Group. Lancet1997;349:1569 –1581.
- Patients Like Me. Website available from: https://www.patientslikeme.com/ Accessed August 2016
- Twenty-three and me. Website available from: https://www.23andme.com/en-gb/research/ Accessed August 2016.
- Terry SF, Terry PF. Power to the People: Participant Ownership of Clinical Trial Data. Sci Transl Med 2011;3(69):1-4.
- National Institutes of Health. Clinical Research and the HIPAA Privacy Rule. Available from: https://privacyruleandresearch.nih.gov/pdf/clin_research.pdf Accessed August 2016
- Gabriel AP, Mercado CP. Data retention after a patient withdraws consent in clinical trials. Open Access J Clin Trials. 2011; 3: 15–19.