Bio-ethics during pandemic: Necessity or ill-timed muscle-flexing?
Recently, a few frontline health care workers were reprimanded and asked to produce written explanation by the Nepal Health Research Council (NHRC) for publishing a research article in an international journal about gene sequencing of the first case of Covid-19 found in Nepal. This has stirred debate amongst researchers in Nepal about norms and ethics that they need to follow, especially during ‘new normal’ days of the global pandemic.
Transporting any specimen from Nepal to other countries without consent from the NHRC is prohibited. But in this case, a specimen was transported to a Hong Kong-based lab at the government level with the help of the WHO, completing all the necessary formalities. This was done to reconfirm the virus by PCR technique. Hence, the specimen was not transferred for anyone’s benefit.
The replicated virus was further mapped for sequencing after verbal consent from Nepal Public Health Laboratory (NPHL) personnel who were the frontline workers to diagnose Covid-19 virus in Nepal. The findings were later published in a short paper in the American Society for Microbiology journal ‘Microbiology Resource Announcements’ in March 2020. This documentation by an internationally renowned journal has laid the foundation for many researches in Nepal but also ignited an untimely controversy between the researchers and the regulatory body.
One of the cornerstones of informed consent in medical ethics is beneficence. A person who is being experimented should know not only benefits but also risks involved with the intervention
It seems the concerned health care workers from the NPHL did not follow all the norms that are normally needed to be fulfilled in normal circumstances to conduct a ‘clinical trial’. They were even accused of bio-piracy for breaching Helsinki protocol. But one should take note that Helsinki protocol, or Nuremberg code on which Helsinki declaration was based, is for human experimentation and was adopted in Nepal to repudiate deadly and debilitating experimentation on the human body without informed consent of the human concerned. This declaration should not apply for the virus which prompted the WHO to declare a global pandemic.
One of the cornerstones of informed consent in medical ethics is beneficence. A person who is being experimented should know not only benefits but also risks involved with the intervention. This applies exclusively in all clinical trials and in human genome studies too. But the current gene sequencing is on a virus that particular person has acquired once upon a time and not part of the person’s gene or part of his body. It is not a clinical trial in which an intervention is tried on a human sample. Gene sequencing on the virus is not going to harm anyone. Hence, this ‘proprietary’ claim over the virus genome is unnecessary.
The NHRC is basically a regulatory body. The recent incident of seeking an explanation from the frontline health workers will discourage health researchers to conduct any research within Nepal. As media reports suggest, the NHRC asking for all the data regarding Covid-19 test conducted at the Nepal Public Health Laboratory (NPHL) is frightening news and against the ethics of any research. This is not the time to fight for the right over the data. All these data are national property and should be used for benefit of all. While the nation is busy preventing the widespread infection, the NHRC should indulge itself in developing research proposals in management of Covid-19 cases.
Focussed, illuminating and result-oriented researches are the need of an hour. For this, institutions like NHRC should adopt a flexible policy towards researchers and practice cross-cutting concepts, putting behind rigid norms.
The NHRC should bring together professional bodies of different medical and public health specialities and come up with locally viable directives to resolve this issue. It should call proposals from interested researchers to study in this field and fast-track ethical approval.
Focussed, illuminating and result-oriented researches are the need of an hour. It is high time that we should contribute to world scientific literature some substantial findings of a solution and our struggle in combating this global pandemic. For this, institutions like NHRC should adopt a flexible policy towards researchers and practice cross-cutting concepts, leaving its rigid norms.
More importantly, gene-sequencing fulfilled just one motive of adding to our knowledge. Any man-made ethics for any research council should never confine knowledge. Knowledge is not anyone’s domain or right of any institution. This statement holds true more in the current global pandemic.
If any ethical clauses retract dissemination of knowledge such restricting law should be corrected at least for the purpose of controlling of the pandemic. This incident will demoralise public health experts and microbiologists who want to contribute to the understanding of this monster virus.
We should take note that Chinese and Australian researchers have generously made Covid-19 viral genome sequencing freely available to speed up the hunt for vaccines. Openness rather than restrictions should be the norm to combat this global pandemic. Hence, the NHRC exercising its power stating it to be a ‘bio-piracy’ is ill-timed and this muscle-flexing attitude will cause a longstanding negative effect in the field of research.
Dr Joshi is a consultant surgeon at B & B Hospital in Gwarko, Lalitpur and editor of the journal of the Nepal Health Research Council.