About Ethical Clearance
Law Number 11 of 2019 on the National System of Science and Technology, Article 39, mandates that all research activities must be carried out in accordance with the code of ethics in certain discipline or field of science. To enforce the code of ethics, an Ethics Committee has been established to review and determine ethical compliance of a research project.
Research Ethics Clearance is an instrument to measure the ethical fulfilment of a research process. Approval from the Ethics Committee must be obtained before research begins. Research Clearance Ethics is a reference for researchers in upholding the values of integrity, honesty, and fairness in conducting research. A good understanding of Research Clearance Ethics is necessary to avoid any problem in conducting research and publishing research results.
The National Research and Innovation Agency (BRIN) provides mechanism to ethically assess research proposal submitted by BRIN researchers and non-BRIN researchers, including foreign researchers who will conduct research in Indonesia.
Foreign researchers who will carry out research activities in Indonesia must obtain a research permit. To obtain a Research Permit, foreign researchers must apply for Research Ethics Clearance that can be accessed through the Research Ethics Clearance information system.
Social Sciences and Humanities
It is stated in International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS, 2002) that all research involving humans must not violate universally accepted ethical standards and also must pay attention to various socio-cultural aspects of the community being studied. Therefore, all research involving humans must go through a process of ethical research clearance.
The main purpose of obtaining ethical clearance in the fields of social sciences and humanities is to protect research subjects/respondents from physical harm (threats), psychological harm (stressful, regret), social harm (stigma, ostracized from society) and legal consequences (sued) as result of participating in a research. Therefore, all research involving humans must pay attention to the three basic principles of the code of ethics (CIOMS, 2002), namely:
1. Respect for persons. There are at least two basic ethics that need to be considered:
a. Respect for autonomy: respecting one’s freedom of choice.
b. Protection of persons: protect research subjects who have vulnerabilities from exploitation and harm.
2. Beneficence: an ethical obligation to maximize benefits and minimize harm. This principle emphasizes that all research should benefit society. Therefore, research design must be clear and the researcher must have the appropriate competence and can protect research subjects from unwanted risks.
3. Distributive justice: A balance of burdens and benefits when participating in research. This principle emphasizes that each individual who participates in research must be treated according to their respective backgrounds and conditions. The difference in treatment between one individual/group and another can be justified if it is morally justifiable and acceptable to society.
Researchers can apply for an ethical clearance in the area of social sciences and humanities if their research meets the following criteria:
1. All research involving humans must go through a process of ethical clearance. Excluded from this is research that uses secondary data, literature reviews or published data, such as:
a. Newspapers, websites, magazines, public reports, public statements, films, television programs, public performances, public exhibitions, public speeches.
b. Published works, systematic reviews, literature reviews, and others.
c. Old materials (such as manuscripts, archives) that are stored and may be used by the public.
2. Research that uses a review of confidential materials (medical records from hospital/health clinic) must go through an ethical clearance process (although it still requires permission from the issuing institution). Likewise, research that uses information from closed/non-public media, such as statistical reviews from an institution (employees, clients, patients, users, service providers, service records, financial records, company records) must go through ethical clearance.
3. Studies that use additional methods, which deals directly with humans such as interviews, Focus Group Discussions (FGD) and others, still require an ethical clearance process, although the main method used is a review of publicly available material.
For research involving humans, whether the research status requires an ethical clearance process or not is determined by the Ethics Commission of Social Sciences and Humanities, not by other researchers or institutions.
The Ethics Committee will classify research proposals into the following three categories:
1. Green: No risk (no human involvement/using secondary data)
2. Yellow: Low risk (subjects and research issues are not “sensitive”)
3. Red: High risk (very “sensitive” research subject and/or issue)
Research included in the Red classification is research involving vulnerable groups, namely children, elderly, pregnant women, mentally and intellectually weak people, disabilities, LGBT groups, people who have experienced trauma, people with HIV, people with drug dependence, people with communication difficulties, convicts, recidivists, and terrorists.
For more information, click this link: https://klirensetik.brin.go.id/