Ethics committees crucial for health research

Ethics committees crucial for health research

Derrick Aarons

Sunday, February 12, 2017

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GOOD health is crucial for the productivity of a society, and so health research has to be conducted perpetually since new diseases are constantly emerging each year.

The response to Ebola and Zika involved rapid research to design effective vaccines, and research into chronic diseases like hypertension and diabetes continue with the search for more effective treatments. Such research, however, depend heavily on human volunteers, without whom new discoveries would not be possible. Consequently, research programmes worldwide are constantly seeking to recruit people who in turn must have confidence in the research process and the safety of its mechanisms.

The Nazi experiments

Ever since the notorious research on unconsenting prisoners of war in concentration camps resulted in the Nuremberg trials and the consequent mandated requirement of informed consent, research with human participants has depended heavily on research ethics committees (RECs/IRBs) to protect the participants in research and ensure the integrity of the research process.

The importance of the work by such committees cannot be overemphasised, as they have been invaluable to the maintenance of public trust in the conduct of research. Without trust in the process, people would not participate in research, and so researchers worldwide depend on the work of RECs/IRBs to reassure the public regarding the standard of their proposed work, as well as the ongoing oversight during the research process.

As a consequence, when people are approached regarding their participation in research, it is incumbent on them to inquire firstly whether the proposed research has been fully evaluated and approved by a competent research ethics committee. Research ethics committees exist at some academic institutions such as The University of the West Indies and the University of Technology Jamaica, with a central committee being found at the Ministry of Health in Kingston. The Ministry of National Security also has a research ethics committee to protect the welfare of prisoners who may be enrolled in research that could benefit them and their health.

Mandate of research ethics committees

A competent REC/IRB will consist of an experienced chairperson and members of varying background expertise to cover the various subject areas of possible research being submitted to the committee for evaluation and possible approval. The committee will also comprise at least one person representing the lay public, a member with legal training, and a member with training in research ethics. These committees should function at the highest international standards, meeting the requirements established by the World Health Organization (International Ethical Guidelines by the Council for International Organizations of Medical Sciences), the World Medical Association’s Declaration of Helsinki, the Belmont Report in the USA, or the standards established by the Tri-Council Policy Statement in Canada.

It is these committees that will provide reassurance to the public that their interests during the research process will be protected, as researchers focus on the scientific research design and reliable outcomes to their research endeavours. Members of the lay public should therefore educate themselves regarding the importance of research, as well as the steps that must be followed in order for researchers to engage them in their research projects.

Enrolment in research

Upon being approached to become a participant in research, whether for a survey in any public space or in hospital, people should be told that they are being invited to participate in research and that they have the right not to participate. People should be aware that a simple survey might actually be research that may involve simple anonymous questionnaires, or a more complex involvement such as measurements and the collection of data and body fluids.

People should be told the purpose of the research, any and all foreseeable risks, and whether they might benefit personally or if any potential benefit might accrue to other people or to generaliseable knowledge for the society. They should be given details on how their particular information will be stored (confidentiality) and how they will be informed about the outcome of the research. They should also be given time to consider their participation and to consult with others if they so wish.

What we

The public should be reassured that they may withdraw from the research project at any time without any loss of the normal health care benefits to which they are entitled, and that they may ask any additional questions or seek advice or reassurance from a person whose contact details will be supplied and who is independent of the research (for example the chair of a research ethics committee).

People will be required to sign an informed consent document only after all the above-mentioned details have been explained to them at a level for their full understanding, and after they have agreed to participate in the research. They should obtain a copy of the informed consent document and be able to refer to it periodically.

Please pass on all these points to your friends, relatives and associates, as we all need to be educated about the importance of health research and research ethics committees, and what should occur when we are invited to participate in the process.

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.)

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