RESEARCH is essential to create new knowledge to advance the interests of society. Whether it is in health, the life sciences or technology, the zest for new knowledge and improved ways of doing things is a perpetual and vital need.

Yet, the pathway to gaining new knowledge that benefits human beings carries risks, and sometimes very high risks. This fact was driven home two weeks ago with the brain death of one participant in a research trial in France, and three others being in critical condition with possible permanent brain damage.

PHASE ONE RESEARCH FOR SAFETY

The men were among 90 healthy people who volunteered for this phase one clinical trial research of a new drug, an endocannabinoid inhibitor that was intended to reduce pain in patients.

A phase one clinical trial means that this is the first time that the drug is being tested in humans, having been tested previously in animals. In this phase, the drug is evaluated in healthy volunteers to determine its level of safety for use in human beings.

In this research, however, the affected people experienced serious adverse side effects, and now some face permanent handicaps. The clinical trial, which had been running for only one week, was cancelled and all participants called back in for medical examination.

In 2006, a leukaemia drug trial in the United Kingdom likewise resulted in the hospitalisation of six men, some of whom now have permanent disabilities.

These examples illustrate that when we seek new knowledge to benefit society, we can only minimise the risk to research participants but we can never eliminate risks altogether. There will always be an inherent risk in exposing people to any new compound.

Even drugs and other compounds that have been approved for use in the general society can still produce harm that manifests much later, perhaps after years of use. This means that laws should always exist in every country, specifically written to address the matter of research with human participants, with the requisite provision for compensation to people or relatives when harm or death occurs.

LACK OF PROTECTION

Jamaica and other English-speaking Caribbean countries, except Guyana, do not have any laws or regulations that address research within its borders.

Consequently, any local person or researcher from overseas may conduct research on volunteers who may be unduly induced to participate by financial incentives, and such researchers do not have to adhere to the international standards for the conduct of research with human participants.

Law written specifically for the purpose would stipulate all the standards which must be met and the sanctions which would be imposed if the researcher does not follow the standards dictated by the law.

As is often said in international research circles, the nature of clinical research means that, every so often, people will be seriously harmed or killed, and there is no way to avoid this. The issue therefore is to ensure that all international standards are met by the research proposal, and that the research is subsequently carried out in accordance with existing regulations.

Further, since not all risks can be predicted in advance, laws should be written to ensure equitable compensation for any impairment, disability, handicap, or death that result from research.

Unfortunately for us, however, we do not have any such regulations in existence here.

Research ethics committees

Whilst some Caribbean countries have Research Ethics Committees/IRBs to evaluate proposals for research in some institutions or among people in society to protect the potential participants from harm, such committees do not have the backing of specific law to provide the foundation for their work.

Consequently, and very unfortunate too, these committees generally have no legal authority to impose any sanction on researchers who violate the stated conditions of their research or the ethical standards for the conduct of research.

These committees should be required to monitor the implementation of any research that they approve, as well as its progression, and to report to governmental authorities any serious non-compliance with international ethical standards.

Failure to submit a proper proposal for research to the committee or to adhere to the process that has been approved should be considered a clear and serious violation under law, and be subject to an appropriate sanction.

DEVELOPED COUNTRIES PROTECT THEIR INHABITANTS

We should note that most developed countries have such laws to protect their inhabitants in research.

Research within their borders is governed by regulation or legislation that specifies the terms and conditions to be met in carrying out research within their jurisdictions. Hence, the participants who were seriously harmed in the research in France two weeks ago and their families will be entitled to research compensation.

Our Caribbean countries therefore need laws which specify that:

a) All researchers must apply for approval for research from an appropriately designated research ethics committee before embarking on research;

b) An appropriately constituted committee with the requisite legal authority shall review all research proposals involving human participants;

c) All approved research should be monitored for the well-being of the participants in research.

The legislation should also contain appropriate sanctions for non-compliance.

Jamaica and other Caribbean countries therefore need to move with haste to protect all inhabitants through appropriate legislation.

Derrick Aarons MD, PhD is a consultant bioethicist/family physician, a specialist in ethical issues in medicine, the life sciences and research, and is the ethicist at the Caribbean Public Health Agency – CARPHA. (The views expressed here are not written on behalf of CARPHA.)