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Research that does not consider participants’ health needs is unethical

BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g1423 (Published 11 February 2014) Cite this as: BMJ 2014;348:g1423
  1. Allen G P Ross, professor, Griffith Health Institute, Griffith University, Gold Coast Campus, Australia
  1. a.ross{at}griffith.edu.au

Research in poor countries must put patients first, writes Allen G P Ross, and ethics committees should insist that this happens

My colleagues and I currently coordinate a five year clinical trial investigating the neglected tropical disease schistosomiasis in the remote Philippines. Twenty two villages and almost 20 000 residents in the municipalities of Laoang and Palapag are taking part.

The Northern Samar province is considered the second poorest in the country, with more than half of its rural inhabitants living below the poverty line. The prevalence of malnutrition is high, with stunting, thinness, and wasting seen in 49%, 28%, and 60% of all children respectively (unpublished data). The burden of infectious disease is also high. The prevalence of schistosomiasis was found to be 27.1% (n=10 436; 95% confidence interval 26.3% to 28.0%) and for infection with any soil transmitted helminth (Ascaris, Trichuris, and hookworm) 77.2% (n=10 434; 76.4% to 78.0%).1

While examining participants I am often asked to help with health problems that are beyond the scope of the research that has been funded by the National Health and Medical Research Council of Australia (figure). This presents an ethical dilemma. Do investigators involved in global health research have a responsibility to examine patients in studies for illnesses not being studied—and to treat patients and refer them to specialty care? If so, who should pay the associated expenses? Should national and international ethical review boards take such matters under consideration when reviewing global health research grants? Should global health funding agencies shoulder some of the costs? What role should national and local government have?

Figure1

Research participants in Northern Samar who presented with health problems beyond the scope of the study funding; from left to right, top to bottom: chin tumour, dermatological disease, neck tumour, neck tumour, abdominal ascites from advanced schistosomiasis, and dermatological disease

In our study, I believe that we have a moral responsibility to treat patients presenting with other illnesses when they ask, despite no request from an ethics committee that we do so. We treat patients for simple ailments, such as acute respiratory infections, rashes, arthritis, and headache and refer them to specialty care when appropriate.

The local government has provided drugs for primary care. The provincial government has helped with the cost of transporting surgical patients to the capital, Manila, and several charitable public hospitals in Manila have helped with poor patients’ costs. The national health insurer, PhilHealth (Philippines Health Insurance Corporation), covers only 20% of medical bills; patients must make up the shortfall, perhaps with the help of national charitable organisations such as the Philippine Charitable Sweepstakes.

To complicate matters further, some patients were referred, transferred, and admitted to hospital but ultimately did not have potentially lifesaving operations. To go from small rural villages to Manila, home to more than 22 million people, can be overwhelming, particularly if patients have no family there. Also, taking time off work and raising living expenses while in hospital is simply beyond many people’s means. If governments cannot take full care of such patients and their families, what can be done for them?

The developing world has large disparities in healthcare provision. Parts of rural Asia and Africa have as few as one or two doctors for every 100 000 inhabitants.2 When a global health study is conducted in such an underserved area, local inhabitants may see it as a great opportunity to get the help they so desperately need.

However, it is unethical to conduct such research without meeting participants’ immediate health needs. If a global health project is not willing or able to accommodate such needs, ethics committees should reject the application.

I suggest that a small fraction—for example, 5%—of all global health grants should be set aside for the immediate primary care needs of participants. Moreover, care should be provided for patients who need specialty care or surgery. Ethics committees should ensure that this forms part of all grant applications and is implemented. District, state, and national government should be asked to cover any additional expense. And, again, ethics review boards should not approve studies if the government is not willing or able to do this.

Once a study has ethical approval, careful monitoring and evaluation of study participants by licensed doctors with supervision by the ethical review board would be needed. All grants would need annual audit to ensure that the 5% of allocated funds have indeed been spent on primary care. Reprehensibly, at present very few global health studies worldwide provide such a service for the rural poor being studied.

Notes

Cite this as: BMJ 2014;348:g1423

Footnotes

  • I thank the UBS-Optimus Foundation and the National Health and Medical Research Council, Australia, for providing financial support for research in the Philippines.

  • Competing interests: I have read and understood the BMJ policy on declaration of interests and have no relevant interests to declare.

  • Provenance and peer review: Not commissioned; not externally peer reviewed.

  • Patient consent obtained.

References

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