A possibly enormous change to health and medical research

Posted by Adrian Barnett on Monday, July 11, 2022

Re-posted from Campus Morning Mail with permission.

The National Statement on Ethical Conduct in Human Research is a vitally important document for researchers and the public, because it determines what research is acceptable and guides how researchers should design studies to adhere to ethical practice. There is a current public consultation on changes to the statement. One proposed change is that this sentence:

  • “Research may lead to harms, discomforts and/or inconveniences for participants and/or others.”

Becomes this sentence:

  • “Research may lead to harm or discomfort for participants and/or others involved in the research or who experience the impact of the research”

Adding “the impact of the research” is a possibly enormous change to health and medical research, greatly increasing the scope of potential harms that researchers and ethics committees will have to consider.

What is research impact

The NHMRC defines research impact as the verifiable outcomes that research makes to knowledge, health, the economy and/or society, and not the prospective or anticipated effects of the research. This definition does not say “positive outcomes” and so negative outcomes are part of research impact.

Thinking optimistically

Being optimistic, perhaps the proposed wording change will make it easier for researchers to get ethical clearance, because the potential downstream benefits of research (as well as the harms) will be more heavily weighted by ethics committees.

Perhaps my study previously rejected study of air pollution might now be allowed. I wanted to use covert pollution monitors on workers in drive-through restaurants because they are potentially exposed to high levels of particulate matter and other pollutants, particularly from diesel vehicles with idling engines. This study was rejected by ethics many years ago and I whenever I see a drive-through I think of the potential ongoing damage to workers’ lungs and brains. Perhaps the long-term benefits of changes to the workplace might have outweighed the risks of a covert study (a necessary design, as no fast-food company was willing to work with me).

Thinking pessimistically

Being pessimistic, extending the scope of potential harms to beyond the immediate study or experiment will very likely increase paperwork and could mean more studies are blocked by ethics.

For example, imagine an early trial of a new drug gave disappointing results which caused the share price of the sponsoring company to fall and some staff contracts to be cancelled. Should the researchers have considered this potential economic loss before conducting the study? It’s a foreseeable and likely impact of this kind of early phase drug trial, and is clearly a harm to those who lost dividends or employment.

As another example, imagine a study by Australian researchers finds that obese men in the USA are twice as likely to die in the next five years as non-obese men. A US insurance company cites this as justification for increasing premiums for obese men. Should the researchers have considered this potential economic impact before conducting their study?

Possibly these are easy examples for ethics committees, and the economic cost is easily outweighed by the knowledge gain. But might a small gain in knowledge be outweighed by a potential million-dollar loss? Will the staff who lost their job or obese men from the USA be able to claim that the study was unethical and sue the researchers? Should the researchers have considered the potential of being sued as another potential long-term impact? Might researchers need to document a wide range of impacts – however unlikely – to protect themselves?

Research impacts often happen many years after the research is completed, which makes them difficult to predict. As an example, a recent analysis from the UK found that the average gap between a paper being published and cited in policy was 10 years. So will researchers need to consider the next ten years and beyond when considering the potential harms of their research?

Including research impact will likely mean a big increase in paperwork for researchers and workload for ethics committees. It could even mean that more researchers abandon studies that they perceive as having little chance of getting through ethics. Our previous survey found that 25% of Australian researchers had abandoned a study due to concerns with getting ethical clearances, and 43% had changed their projects to get through ethics. We might end up with fewer risky studies, but many huge breakthroughs in science would be considered risky by some groups.

Think of the recent RECOVERY trial that found an incredible breakthrough for treating COVID-19 but also showed no benefit for Trump’s favoured treatment of hydroxychloroquine. Some consequences of this finding were that the researchers received hate mail and there was political fall-out for Trump. These are clear social impacts of the research, but it would be a huge mistake to involve politics in research ethics.

Will the additional consideration of research impacts greatly increase safety for patients and the public? I’ve been involved in over 200 studies, and I can recall two incidents where there was an ethical issue. Once when I accidentally emailed confidential information to the wrong person, and once when a participant was bitten by a dog and blamed the trial treatment. From my admittedly narrow perspective, there is not an epidemic of unethical research or bad practice in Australia.

Research ethics and research impact are both hugely important and every Australian researcher should seriously consider both throughout their career. However, formally linking ethics and impact could create an enormous change to what research is conducted in Australia, with flow-on impacts on Australia’s society, economy and health.