Humans as medical fodder

Using humans for research is not something new. Since the end of World War II humans have been used as test subjects for many new drugs by researchers and pharmaceutical companies. However, as emphasis on ethics of medical research has increased, the ‘ethics’ of conducting clinical trials on humans have been questioned.
 Ragama Medical Faculty Senior Lecturer Dr. Deepthi De Silva and Ragama Medical Faculty Department of Public Health Professor Dr. Pushpa Jayawardana spoke to The Nation about the prospects and challenges of the medical research and clinical drug trials in the country. Both De Silva and Jayawardana were former committee members of the Kelaniya University Medical Faculty Ethics Review Committee.
 Ethics relate to the differentiation between right and wrong. Here it applies to specific guidelines that should be considered when a research team carries out research considering both scientific and humane aspects, said Jayawardana. Good ethical practice secures the rights of participants, researchers as well as research results.
 According to them, there are no programs currently in Sri Lanka to educate patients undergoing these clinical trials. It seems that participation completely depends on doctor’s advice. De Silva and Jayawardana are both of the opinion that it is highly unlikely that doctors in Sri Lanka are bent on misusing patients when it comes to participant’s rights. They said that they weren’t aware of such incidents reported in Sri Lanka. However, what is questionable is that there is no responsible authority to review any of the on-going drug trials other than the Health Ministry and Sri Lanka Medical Association.
 A legal act proving guidelines for these clinical drug trials has been proposed and sources state that this proposal is still in draft form. Some issues have risen since this legal draft has limited access. Sources claim that even medical professionals don’t know who backs this legal act and what revisions have been included in it. The main purpose of this legal act has to focus on the participants’ rights since they are the ones at risk.
 Clinical drug trials are highly supervised and monitored in most countries since human lives are at stake. Every country including Sri Lanka should properly monitor these trials without risking both participants’ and researchers’ rights. An ethics review committee should be able to act independently over a trial. Yet one of the responsible bodies reviewing the clinical drug trials in Sri Lanka, Kelaniya University Medical Faculty Ethics Review Committee was abruptly dissolved in 2010 with some trials in the reviewing process and was reappointed immediately with a new committee.

 Jayawardana emphasized that safety should take precedence since the subjects are human. According to De Silva and Jayawardane, these drugs are tested on humans only after testing those on animals in several stages. Using animals for drug experiments has raised eyebrows of many animal rights organizations as ethical aspects of using animals for experiments are always argumentative. Scientists say that if animal experiments are to be banned it will put an end to testing new drugs or using human beings for all tests. However these phases of experimenting drugs on animals are still not taking place in Sri Lanka.
 When questioned on the ethics of using humans as tests subjects in clinical drug trials, De Silva said that as long as ethics review committees are there to judge and balance the risks of the clinical trials, using humans as test subjects cannot be categorized as an unethical approach.
 First of all any one has a right not to be subject to a clinical trial, said De Silva. He or she must read and thoroughly understand the terms and conditions in the consent form. Moreover a participant also has a right to know the results of a trial. The researcher must reveal and discuss the outcome of the trial with the participants. Most importantly privacy of a research participant should be assured, reiterated Jayawardana.
 A researcher cannot share participant details with any other parties without the participant’s consent. If details are to be given to any other party the researcher must ensure that it is provided under grounds of anonymity. On the other hand, participants must perform their duty as agreed in the agreement. The participants must be completely honest with the research officer and reveal all information, symptoms and complications accurately while undergoing trial as success of a clinical trial depends on the corporation of the both parties.
 “A participant in a clinical trial might receive a payment for participating. Any claimed compensation will only be paid if it is proven to be a cause of the experimented drug,” informed Jayawardana. However, all payments will be made according to the agreement signed in the beginning.
 “A participant should be closely monitored during the process and are subjected to special monitoring even after the trial,” said De Silva. Since these drugs are still in testing phase, there are always risks of adverse or even fatal effects of the new drug. On the other hand, the participant will be able to receive new drugs tested for his illness which may otherwise be unaffordable. Besides, Jayawardana said that their participation is also considered an invaluable service to the society.

Published in The Nation on August 12,2012
Link : http://www.nation.lk/edition/health/item/9152-humans-as-medical-fodder.html