NEEDS IMPROVEMENT
Asia-Pacific study says ethics-review mechanisms in medical-research institutions must be strengthened to ensure independence, protect subjects and volunteers
By Grace Roxas, Contributing Writer
Tagged the weakest link among key stakeholders in a clinical trial, research-ethics committees or the so-called institutional review boards (IRBs) should live up to their charge of providing a system of checks and balances to improve public trust in such trials.
"Research sponsors have a profit motive. For investigators, their careers depend on the outcome of the trial. If you're in IRB, what is your motivation? A cup of coffee? So your tendency is to give a cup of coffee's worth of effort," says social scientist Dr. Cristina Torres of the University of the Philippines-National Institutes of Health.
An Asia-Pacific survey of IRB practices that Torres spearheaded showed all 16 ethics bodies reviewed in Taiwan, South Korea, China, Thailand, and the Philippines can use some improvements in certain aspects.
A key concern is ensuring the independence of these committees by looking, for instance, at their structure and composition. Torres notes the need to improve the balance of membership to include more lay persons, women, and young people.
Nonmedical people in particular can provide the critical perspective of a patient. "The main responsibility of IRBs is human-subject protection in research. Sometimes, investigators and sponsors can be very aggressive. They want fast results and sometimes, human rights are violated in the process. Good IRB procedures not only protect human subjects, they also contribute to quality data," she observes.
Even the most respected medical-research institutions in the world fall through the cracks, ethics-wise. Torres cites conflict of interest issues lodged against big-name universities like Johns Hopkins and Harvard by the United States Department of Health and Human Services.
She adds that part of the clinical-trials audit conducted by the US Food and Drug Administration is auditing the auditors by checking if IRB decisions are arrived at without any strings attached. On the local front, her group is negotiating with the Bureau of Food and Drugs to groom the agency as a local regulating arm for IRBs.
Medicolegal expert Rodel Capule reite-rates that independence is the chief issue especially for IRBs affiliated with medical institutions. "If you are a medical- institution-based IRB, it becomes hard, in a way, for its members to act independently if you are put there by the hospital board. So I would strongly recommend that members be nominated by their peers rather than the board."
Capule stresses, however, that laymen participating in the IRB should themselves be free from circumstances that might compromise their judgment, like having relatives who are suffering from the condition that the trial is investigating.
He affirmed the inclusion of more nonmedical specialists like lawyers in research-ethics bodies. "Remember that it is the legal issues that bring you to court and not the ethical ones because ethical issues can still be discussed in private."
Lawyers in the board can also bring their expertise to bear on a number of paralegal questions during IRB deliberations.
Not a "Christmas party" committee
The survey also unearthed the need to look into process improvements among Asia-Pacific IRBs. "IRB operations require resources and continuity. They cannot be like a Christmas- party committee that folds up after Christmas, when the job is done," Torres points out.
She observes that many IRBs don't even have standard operating procedures (SOPs). The study recommends regular member training on relevant issues including national and international regulations, monitoring of these training programs, and developing and improving compliance with SOPs.
IRBs should also work through the complete review process starting with submission requirements such as investigators' curriculum vitae and information on the research team, trial site, advertisements, and patient data.
Torres puts particular stress on assessing the qualifications of investigators. "In many places in Asia, we see that it is usually the hospital or institute director who is the principal investigator even if he doesn't have the relevant training for this kind of protocol," she notes.
Other process improvements proposed are giving adequate attention to important issues during review like subject vulnerability, risk-benefit-ratio assessment, and compensation and injury issues.
Capule points out that in developing countries like the Philippines, subjects are vulnerable by definition. "The reason is financial. You get subjects who get minimum wage so the temptation [to] join a research [arises] from the additional income," he argues.
He also calls for possibly extending the storage of protocol files from the current three years to ten, although this might mean more voluminous files to keep. Under the law, an aggrieved party has up to four years to file a court case for negligence or injuries and up to 10 years for breach of contract.
During the review proper, improvements should be instituted for submission and assessment forms and checklists; the assessment itself of scientific and ethical issues in a protocol; member interaction during board meeting; and reports on serious adverse events, research progress, and final findings.
Postreview, an IRB should be able to specify frequency of continuing review during protocol approval, take action on adverse events (both serious and otherwise), address pretermination issues related to patient enrollment and safety and monitor schedule of progress and end-of-study reports.
"IRBs are always in between the pharma industry and the patients. If the IRB becomes lax, you can be sure that the end result will not be palatable," Capule warns.
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