ETHICAL CLEARANCE AS THE ETHICS OF RESEARCHERS AND ITS ROLE IN PHARMACEUTICAL RESEARCH

On Thursday (15/07/2021), a research ethics workshop with the theme “Dissemination of Health and Social Humanities Research Ethics” was held by KEP-UAA. The speakers at the event were Prof.dr. Tri Wibawa, Ph.D., Sp.MK. who is the chairman of the Ethics Commission of FKKMK UGM, and also Prof. Dra. R.A. Yayi Suryo Prabandari, M.Si., Pd.D who is the Head of the Department of Health Behaviour, Environment, and Social Medicine of UGM. On this occasion, the speakers conveyed several concerns about the importance of ethical clearance (EC) in research. The importance of the role of EC in a research is to protect the research subjects and also the researchers themselves. Protection to research subjects is in the form of giving full rights to become research subjects, to be willing to share some data related to themselves as research data, and to know the purpose and benefits of their participation in research. Protection to the researcher is to be able to prove that the research subject is willing to participate in research without coercion.

The principle of applying EC in a research is to respect the participation of research subjects by providing good treatment, protecting the data that has been provided, and providing extra protection for vulnerable subjects. Research subjects who are included in vulnerable subjects include pregnant women, children, the elderly, people with certain conditions (such as having physical disabilities, mental disorders, having a history of certain diseases), prisoners, minorities, and so on. The purpose of protecting research subjects is not to cause ‘harm’ either physically or psychologically. In its application, the first protection to research subjects is to provide an opportunity by considering their capability to choose their participation in research.

Informed consent is a form of consent for someone to participate in research after explaining the research procedures. Informed consent is widely used in behavioural and social science research. Things that need to be considered in writing informed consent are the process of explaining research procedures and consent, the language used in the consent and process is easy to understand, and the need to renew consent if there are procedures or conditions that change.

Pharmaceutical research involving living beings requires ethical eligibility, both for social research and animal studies. Submitting EC is very important to involve a human being and informed consent will be used as a consent form for a person’s decision to become a research subject in social pharmaceutical research. Research in pharmaceutical laboratories involving test animals will require EC for data collection procedures and maintenance of test animals during data collection until after data collection is complete. Research other than the field of social pharmacy, such as the manufacture of a product that will be tested organoleptically by several respondents, requires approval of the respondent’s participation by filling out an informed consent. From here we can know the importance of EC and informed consent to protect us as researchers in conducting research.