HEALTH AND WELLBEING
Can research ethics survive a pandemic ?
Medical researchers have been under immense political and community pressure to find out more about the coronavirus and develop treatments and vaccines . But what should be done if arguments for ‘ the public good ’ start to push ethical boundaries ?
When looking at whether a trial should go ahead ,
RECs ask :
• Does it need to be done ?
• Is it asking the right question ?
• Is it appropriately designed to elicit a useful answer to that question ?
• How are researchers considering the safety and needs of participants ? This system has worked well in normal times , but the urgency of the COVID-19 pandemic has thrown up major challenges .
One concern caused particularly by the fastmoving nature of the pandemic relates to the rigour that goes into justifying the requirement for new research . In normal times researchers may be expected to spend months conducting extensive literature , or even systematic , reviews prior to proposing an experiment or trial . But the pandemic has not allowed time for such careful preparation . “ We ’ ve been seeing researchers who have been saying , ‘ because of COVID we ’ re going to do this ’,” Dr Kolstoe says . He notes a lack of the usual systematic groundwork that should happen before a proposed study even gets to an ethics committee .
I n 1946 , 20 Nazi doctors stood trial in Nuremberg , Germany , for their part in the torture and murder of prisoners , conducted under the guise of medical experiments . The Doctors ’ Trial , as it was named , laid the foundations for the 1964 Declaration of Helsinki , which addresses issues such as consent , risk , purpose and design when conducting human experimentation .
Central to the Declaration of Helsinki is the clear statement that the pursuit of knowledge should never come at the expense of the rights and interests of the research participants . These principles have guided research ethics committees ever since .
But the context and subject of medical research changes , so ethics committees have to constantly consider how these principles can be applied in new contexts . This has been especially relevant during the COVID-19 pandemic , says Dr Simon Kolstoe , Reader in Bioethics and expert on research ethics at the University of Portsmouth .
“ The historical view of ethics committees is that they are solely about protecting participants from nasty researchers who are trying to harm them ,” says Dr Kolstoe , who chairs research ethics committees ( RECs ) for the National Health Service ( NHS ), the Ministry of Defence and Public Health England . “ But while the protection of participants is clearly still central to a REC ’ s role , our central concern is to support researchers in designing and conducting the best research , because good research will be ethical research .”
Using patient data without consent is contentious and potentially harmful . Our committee makes sure the right questions are asked and right checks are in place .
– Dr Simon Kolstoe
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ISSUE 03 / 2021