The references below discuss ethical and policy aspects of sharing individual-level data from clinical and public health research. The references with an asterix have been reviewed in:

Bull, S., Roberts, N., & Parker, M. (2015). Stakeholder perspectives on sharing de-identified individual-level data from medical and public health research: a scoping review. Journal of Empirical Research on Human Research Ethics, 10(3), 225-238.

We welcome your recommendations about articles on sharing individual-level research data to include in this list - please send them to bioethicsresearchreview@tghn.org or discuss them in this group or our blogs.

  • *Anderson, B. J., & Merry, A. F. (2009). Data sharing for pharmacokinetic studies. Paediatric Anaesthesia, 19(10), 1005-1010.
  • * Antman, E. (2014). Data sharing in research: benefits and risks for clinicians. BMJ, 348, g237.
  • * Brewer, D. D., Potterat, J. J., & Muth, S. Q. (2010). Withholding access to research data. Lancet, 375(9729), 1872; author reply 1873. doi: 10.1016/S0140-6736(10)60870-7
  • Burstein, M. D., Robinson, J. O., Hilsenbeck, S. G., McGuire, A. L., & Lau, C. C. (2014). Pediatric data sharing in genomic research: attitudes and preferences of parents. Pediatrics, 133(4), 690-697.
  • * Castellani, J. (2013). Are clinical trial data shared sufficiently today? Yes. BMJ (Online), 347 (7916)(f1881).
  • * Chan, A.-W., Song, F., Vickers, A., Jefferson, T., Dickersin, K., Gotzsche, P. C., . . . van der Worp, H. B. (2014). Increasing value and reducing waste: addressing inaccessible research. Lancet, 383(9913), 257-266.
  • Colledge, F., Elger, B., & Howard, H. C. (2013). A review of the barriers to sharing in biobanking. Biopreservation and Biobanking, 11(6), 339-346.
  • Cleary, M., Jackson, D., & Walter, G. (2013). Editorial: Research data ownership and dissemination: is it too simple to suggest that 'possession is nine-tenths of the law'? Journal of Clinical Nursing, 22(15-16), 2087-2089.
  • * Coady, S. A., & Wagner, E. (2013). Sharing individual level data from observational studies and clinical trials: a perspective from NHLBI. Trials [Electronic Resource], 14, 201.
  • * Dawson, A., & Verweij, M. (2011). Could do better: Research data sharing and public health. Public Health Ethics, 4(1), 1-3.
  • * de Wolf, V. A., Sieber, J. E., Steel, P. M., & Zarate, A. O. (2005). Part I: What Is the Requirement for Data Sharing? IRB: Ethics and Human Research, 27(6), 12-16. doi: 10.2307/3563537
  • * de Wolf, V. A., Sieber, J. E., Steel, P. M., & Zarate, A. O. (2006a). Part II: HIPAA and Disclosure Risk Issues. IRB: Ethics and Human Research, 28(1), 6-11. doi: 10.2307/30033184
  • * de Wolf, V. A., Sieber, J. E., Steel, P. M., & Zarate, A. O. (2006b). Part III: Meeting the Challenge When Data Sharing Is Required. IRB: Ethics and Human Research, 28(2), 10-15. doi: 10.2307/30033191
  • * Doshi, P. (2013). Transparency interrupted: the curtailment of the European Medicines Agency's Policy on access to documents. JAMA Internal Medicine, 173(21), 2009-2011.
  • * Doshi, P., Goodman, S. N., & Ioannidis, J. P. A. (2013). Raw data from clinical trials: within reach? Trends in Pharmacological Sciences, 34(12), 645-647.
  • Dove, E. S., Zawati, M. H., Levesque, E., Simard, J., & Knoppers, B. M. (2014). Towards an Ethics Safe Harbour for Global Breast Cancer Research. Current Oncology, 21 (2), e375.
  • * Editorial. (2014). Data sharing will pay dividends. Nature, 505(7482), 131.
  • Editorial. (2012). Respectful re-use. Nat Genet, 44(10), 1073-1073.
  • * Eichler, H.-G., Petavy, F., Pignatti, F., & Rasi, G. (2013). Access to patient-level trial data--a boon to drug developers. New England Journal of Medicine, 369(17), 1577-1579.
  • Erlich, Y., & Narayanan, A. (2014). Routes for breaching and protecting genetic privacy. Nature Reviews Genetics, 15(6), 409-421.
  • Erlich, Y., Williams, J. B., Glazer, D., Yocum, K., Farahany, N., Olson, M., . . . Kain, R. C. (2014). Redefining genomic privacy: trust and empowerment. PLoS Biol, 12(11), e1001983. doi: 10.1371/journal.pbio.1001983
  • * Estabrooks, C. A., & Romyn, D. M. (1995). Data sharing in nursing research: advantages and challenges. Canadian Journal of Nursing Research, 27(1), 77-88.
  • * Geller, N. L., Sorlie, P., Coady, S., Fleg, J., & Friedman, L. (2004). Limited access data sets from studies funded by the National Heart, Lung, and Blood Institute. Clinical Trials, 1(6), 517-524.
  • * Godlee, F., & Groves, T. (2012). The new BMJ policy on sharing data from drug and device trials. BMJ, 345, e7888.
  • * Goldacre, B. (2013). Are clinical trial data shared sufficiently today? No. BMJ, 347, f1880. doi: 10.1136/bmj.f1880
  • * Gotzsche, P. C. (2011a). We need access to all data from all clinical trials. Cochrane Database of Systematic Reviews(12), ED000035.
  • * Gotzsche, P. C. (2011b). Why we need easy access to all data from all clinical trials and how to accomplish it. Trials [Electronic Resource], 12, 249.
  • * Gotzsche, P. C. (2012). Strengthening and opening up health research by sharing our raw data. Circ Cardiovasc Qual Outcomes, 5(2), 236-237. doi: 10.1161/CIRCOUTCOMES.112.965277
  • * Greenhalgh, T. (2009). Sharing medical research data: Whose rights and who's right? BMJ, 338(7700), 903.
  • * Haines, I. E., & Gabor Miklos, G. L. (2011). Time to mandate data release and independent audits for all clinical trials. Medical Journal of Australia, 195(10), 575-577.
  • * Hampton, T. (2011). European drug agency under fire: critics charge that trial data are too inaccessible. JAMA, 306(6), 593-595.
  • * Hawkes, N. (2012). Full access to trial data holds many benefits and a few pitfalls, conference hears. BMJ, 344, e3723.
  • * Harris, D. J. (2011). Sharing of research data. Lancet, 378(9808), 1994-1995.
  • * Hawkes, N. (2013). Drug companies should release data from all trials of licensed drugs, say MPs. BMJ, 346, f321.
  • * Hede, K. (2013). Project data sphere to make cancer clinical trial data publicly available. Journal of the National Cancer Institute, 105(16), 1159-1160.
  • * Hrynaszkiewicz, I., & Altman, D. G. (2009). Towards agreement on best practice for publishing raw clinical trial data. Trials [Electronic Resource], 10, 17.
  • * Hughes, S., Wells, K., McSorley, P., & Freeman, A. (2014). Preparing individual patient data from clinical trials for sharing: The GlaxoSmithKline approach. Pharmaceutical Statistics, 13(3), 179-183.
  • * Kirwan, J. R. (1997). Making original data from clinical studies available for alternative analysis. J Rheumatol, 24(5), 822-825.
  • * Kmietowicz, Z. (2013). Drug firms take legal steps to prevent European regulator releasing data. BMJ, 346, f1636.
  • * Kuntz, R. E. (2013). The changing structure of industry-sponsored clinical research: pioneering data sharing and transparency. Annals of Internal Medicine, 158(12), 914-915.
  • * Langat, P., Pisartchik, D., Silva, D., Bernard, C., Olsen, K., Smith, M., . . . Upshur, R. (2011). Is there a duty to share? Ethics of sharing research data in the context of public health emergencies. Public Health Ethics, 4(1), 4-11.
  • * Lopez, A. D. (2010). Sharing data for public health: where is the vision? Bull World Health Organ, 88(6), 467. doi: 10.2471/BLT.10.078956
  • * Manju, R., & Buckley, B. S. (2012). Systematic archiving and access to health research data: rationale, current status and way forward. Bulletin of the World Health Organization, 90(12), 932-939.
  • * Mello, M. M., Francer, J. K., Wilenzick, M., Teden, P., Bierer, B. E., & Barnes, M. (2013). Preparing for responsible sharing of clinical trial data. New England Journal of Medicine, 369(17), 1651-1658.
  • * Nisen, P., & Rockhold, F. (2013). Access to patient-level data from GlaxoSmithKline clinical trials. New England Journal of Medicine, 369(5), 475-478.
  • Parker, M., Bull, S. J., de Vries, J., Agbenyega, T., Doumbo, O. K., & Kwiatkowski, D. P. (2009). Ethical data release in genome-wide association studies in developing countries. PLoS Medicine, 6(11), e1000143. doi: 10.1371/journal.pmed.1000143
  • * Pearce, N., & Smith, A. H. (2011). Data sharing: not as simple as it seems. Environmental Health: A Global Access Science Source, 10, 107.
  • * Pisani, E., & AbouZahr, C. (2010). Sharing health data: good intentions are not enough. Bulletin of the World Health Organization, 88(6), 462-466.
  • * Pisani, E., Whitworth, J., Zaba, B., & Abou-Zahr, C. (2010). Time for fair trade in research data. Lancet, 375(9716), 703-705.
  • * Pisani, E., Whitworth, J., Zaba, B., & AbouZahr, C. (2010). Withholding access to research data - Authors' reply. The Lancet, 375(9729), 1873.
  • * Piwowar, H. A., Becich, M. J., Bilofsky, H., Crowley, R. S., ca, B. I. G. D. S., & Intellectual Capital, W. (2008). Towards a data sharing culture: recommendations for leadership from academic health centers. PLoS Med, 5(9), e183. doi: 10.1371/journal.pmed.0050183
  • * Rabesandratana, T. (2013). Europe. Drug watchdog ponders how to open clinical trial data vault. Science, 339(6126), 1369-1370.
  • Ramos, E. M., Din-Lovinescu, C., Bookman, E. B., McNeil, L. J., Baker, C. C., Godynskiy, G., . . . Rodriguez, L. L. (2013). A mechanism for controlled access to GWAS data: experience of the GAIN Data Access Committee. American Journal of Human Genetics, 92(4), 479-488.
  • * Rani, M., Bekedam, H., & Buckley, B. S. (2011). Improving health research governance and management in the Western Pacific: A WHO Expert Consultation. Journal of Evidence-Based Medicine, 4(4), 204-213.
  • * Rathi, V., Dzara, K., Gross, C. P., Hrynaszkiewicz, I., Joffe, S., Krumholz, H. M., . . . Ross, J. S. (2012). Sharing of clinical trial data among trialists: a cross sectional survey. BMJ, 345, e7570.
  • * Reidpath, D. D., & Allotey, P. A. (2001). Data sharing in medical research: an empirical investigation. Bioethics, 15(2), 125-134.
  • * Rodwin, M. A., & Abramson, J. D. (2012). Clinical trial data as a public good. JAMA, 308(9), 871-872.
  • * Ross, J. S., Gross, C. P., & Krumholz, H. M. (2012). Promoting transparency in pharmaceutical industry-sponsored research. American Journal of Public Health, 102(1), 72-80.
  • * Ross, J. S., & Krumholz, H. M. (2013). Ushering in a new era of open science through data sharing: the wall must come down. JAMA, 309(13), 1355-1356.
  • * Ross, J. S., Lehman, R., & Gross, C. P. (2012). The importance of clinical trial data sharing: toward more open science. Circ Cardiovasc Qual Outcomes, 5(2), 238-240. doi: 10.1161/CIRCOUTCOMES.112.965798
  • * Sandercock, P. A., Niewada, M., Czlonkowska, A., & International Stroke Trial Collaborative, G. (2011). The International Stroke Trial database. Trials, 12, 101. doi: 10.1186/1745-6215-12-101
  • * Sankoh, O., & Ijsselmuiden, C. (2011). Sharing research data to improve public health: a perspective from the global south. Lancet, 378(9789), 401-402.
  • * Savage, C. J., & Vickers, A. J. (2009). Empirical study of data sharing by authors publishing in PLoS journals. PLoS ONE [Electronic Resource], 4(9), e7078.
  • Shin, S.-Y., Kim, W. S., & Lee, J.-H. (2014). Characteristics desired in clinical data warehouse for biomedical research. Healthcare Informatics Research, 20(2), 109-116.
  • * Sieber, J. E. (2006). Introduction: data sharing and disclosure limitation techniques. J Empir Res Hum Res Ethics, 1(3), 47-50. doi: 10.1525/jer.2006.1.3.47
  • * Smith, C. T., Dwan, K., Altman, D. G., Clarke, M., Riley, R., & Williamson, P. R. (2014). Sharing individual participant data from clinical trials: An opinion survey regarding the establishment of a central repository. PLoS ONE, 9(5).
  • * Smith, G. D. (1994). Increasing the accessibility of data. BMJ, 308(6943), 1519-1520.
  • * So, D., Joly, Y., & Knoppers, B. M. (2013). Clinical trial transparency and orphan drug development: recent trends in data sharing by the pharmaceutical industry. Public Health Genomics, 16(6), 322-335.
  • * Sommer, J. (2010). The delay in sharing research data is costing lives. Nature Medicine, 16(7), 744.
  • * Spertus, J. A. (2012). The double-edged sword of open access to research data. Circ Cardiovasc Qual Outcomes, 5(2), 143-144. doi: 10.1161/CIRCOUTCOMES.112.965814
  • * Strech, D., & Littmann, J. (2012). Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical data. Trials [Electronic Resource], 13, 100.
  • * Tangcharoensathien, V., Boonperm, J., & Jongudomsuk, P. (2010). Sharing health data: developing country perspectives. Bulletin of the World Health Organization, 88(6), 468-469.
  • * Toronto International Data Release Workshop, A., Birney, E., Hudson, T. J., Green, E. D., Gunter, C., Eddy, S., . . . Yu, J. (2009). Prepublication data sharing. Nature, 461(7261), 168-170.
  • * Vallance, P., & Chalmers, I. (2013). Secure use of individual patient data from clinical trials. Lancet, 382(9898), 1073-1074.
  • van Panhuis, W. G., Paul, P., Emerson, C., Grefenstette, J., Wilder, R., Herbst, A. J., . . . Burke, D. S. (2014). A systematic review of barriers to data sharing in public health. BMC Public Health, 14, 1144.
  • * Vickers, A. J. (2006). Whose data set is it anyway? Sharing raw data from randomized trials. Trials [Electronic Resource], 7, 15.
  • * Walport, M., & Brest, P. (2011). Sharing research data to improve public health. Lancet, 377(9765), 537-539.
  • * White, P. D. (2013). Sharing data from clinical trials: Is sharing data from clinical trials always a good idea? BMJ (Online), 346 (7910)(f3379).
  • * Whitworth, J. (2010). Data sharing: reaching consensus. Bulletin of the World Health Organization, 88(6), 467-468.
  • * Wieseler, B., McGauran, N., Kerekes, M. F., & Kaiser, T. (2012). Access to regulatory data from the European Medicines Agency: the times they are a-changing. Systems Review, 1, 50.
  • * Zarin, D. A. (2013). Participant-level data and the new frontier in trial transparency. New England Journal of Medicine, 369(5), 468-469.