Intended for healthcare professionals


Streamlining ethical review of data intensive research

BMJ 2016; 354 doi: (Published 02 August 2016) Cite this as: BMJ 2016;354:i4181
  1. David Townend, professor1,
  2. Edward S Dove, researcher2,
  3. Dianne Nicol, professor3,
  4. Jasper Bovenberg, lawyer4,
  5. Bartha M Knoppers, professor5
  1. 1Department of Health, Ethics and Society, CAPHRI Care and Public Health Research Institute, Maastricht University, Netherlands
  2. 2J Kenyon Mason Institute for Medicine, Life Sciences and the Law, University of Edinburgh, UK
  3. 3Centre for Law and Genetics, University of Tasmania, Australia
  4. 4Legal Pathways, Aerdenhout, Netherlands
  5. 5Centre of Genomics and Policy, McGill University, Montreal, Quebec, Canada
  1. Correspondence to: E S Dove edward.dove{at}

Unfounded concerns about local liability should not delay urgent reform

Research that crosses international borders and analyses large volumes of data from multiple sources is growing. Such data intensive research—for example, precision medicine studies driven by genomic research and DNA sequencing—creates difficult governance challenges, one of which is repetitive and inefficient ethical review. There is no clear evidence that review of the same study by multiple research ethics committees better protects participants, particularly for research analysing large aggregate datasets.

International, data intensive research may require different assessment from research that risks physical harm to participants.1 2 However, concerns about liability mean that local ethics committees—and their administrators and institutional lawyers—tend to insist on reviewing research protocols themselves, rather than “delegating” review to another ethics committee or otherwise recognising outside reviews. These concerns are some of the main barriers to reform of the ethics review system for international research.3 We argue that the concerns are more perception than reality.

The first concern is that mutual …

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