On Television, “participation in the phase one clinical trial” is often introduced as a part-time job that pays well compared to the time and effort spent there. If you were suffering from a headache and were offered to participate in a clinical trial for headache medication, what would you do? What aspect would you check before deciding? I strongly recommend checking whether or not the trial obtained the Institutional Review Board (IRB) approval! But what is IRB?
When we have a headache, we go to the pharmacy and buy pills. We expect the headache to go away, but we do not think the pills would be lethal to our health. Why? It is because we are aware the pills are verified by the authority such as Korea Ministry of Food and Drug Safety. Clinical trial is the process of checking both the effects and the side effects of drugs. In other words, clinical trial is evidently different from “treatment” because this is conducted before being fully aware of the drug’s safety.
Should we let researchers conduct clinical trials as they would like to? No, we cannot. This is because these trials may be risky due to the invasive methods such as collecting blood used to confirm the unknown. And these risks may even lead to some problems regarding the safety of the participants. Therefore, since a few years ago, the government has been enforcing hospitals to install an IRB for the review of clinical trials. The IRB would review the ethical and scientific validity of the so-called research protocol, the adequacy of the informed consent form and explanation provided to the research participants and so on. Only the researches approved by the IRB can be legally conducted.
Then what about the research conducted through an online survey? Would these not be approved by the IRB because they do not use invasive methods? After the enforcement of the wholly amended Bioethics and Safety Act on Feb. 2, 2013, the scope of researches regulated by this law expanded to human research and human material research. Furthermore, if the researchers belong to the educational or research institution such as universities, they have the legal responsibility to establish the IRB for the review of human research and human material research.
Social Behavior Research is one type of human research as well as one of the most frequent researches conducted in universities. They use non-invasive methods such as surveys or interviews so the chances of physical risks are very slim. However, the risks are not just limited to physical aspects but also to psychological, social, economic, and legal aspects. The inconvenience and burden of the participants should be considered as well. For example, if the research requires the participants to give personal information such as name and ask more detailed personal questions, there may be problems maintaininig confidentiality and cause psychological, social damages to the participants.
It is important that the drugs and medical devices be developed for better diagnosis, prevention and treatment of illnesses. It is also crucial that research about social phenomena or people’s minds be conducted for the social development. As the rights of researchers are protected by the law, those of the participants should also be protected as well. This is the mission of the IRB. Before participating in a clinical trial or a Social Behavior Research, remember to ask the researcher: “Is this research approved by the IRB?”
* Professor Kim Eun-ae has a master’s degree and a doctoral degree from Ewha Womans University. She is the member of Ewha IRB and the director of Ewha IRB Office.