Chemical Research

Chemical research has made a significant positive impact on the world around us. However, aspects of this valuable discovery can also be used or have the potential for negative purposes. Under these conditions, research chemists must be able to be advocates of safe and secure application of chemistry to benefit humanity and preserve the environment for future generations, as stated in the "Global Chemists' Code of Ethics" compiled by ACS International Activities in 2016 [1]. Therefore, research in chemistry pays attention to the code of ethics‘ basic principles, namely [2-4]:

1. Beneficence: an ethical obligation to maximize the benefits for humanity and minimize the threat of harm to humans and the environment. Thus, the research design must be clear, and the responsible researcher must have appropriate competence and be able to protect the practitioners and research subjects from unwanted risks;
2. Safety and Security. Research practitioners should encourage the application, usage, and development of science and technology while promoting and maintaining a strong culture of safety, health, and security;
3. Safety for people involved in scientific research. In research involving humans as research subjects, researchers must try to minimize the damage and risk, as well as maximize the benefits. Researchers must respect human dignity, privacy, and autonomy, and be able to protect research subjects/individuals with limitations or vulnerabilities from exploitation and harm;
4. Accountability. Researchers have the responsibility to ensure that chemical materials, equipment, and facilities are protected from theft and misappropriation and are not used for illegal, harmful, or destructive purposes. Research practitioners must be aware of applicable laws and regulations governing the manufacture and use of the chemicals, and take action when there is misuse of chemicals, scientific knowledge, equipment, and facilities.

Particularly in the research area, ethical clearance becomes a tool to measure the ethical acceptability of research series processes to be carried out. The main purpose of obtaining ethical clearance approval in the chemical field is to protect research practitioners, research subjects, and the environment from hazards that may arise as a result of the research being conducted.

Researchers can submit an ethical clearance for chemical research if their research falls within the following scopes:

1. Research related to psychotropics;
2. Research using substances included in Substance List 1, 2, and 3 of the Chemical Weapons Convention;
3. Research related to Hazardous Chemicals (natural or synthetic materials);
4. Research using materials containing non-halal substances in terms of pharmaceutical, food, nutraceutical, and cosmetic research;
5. Research using hazardous additive substances for pharmaceuticals, food, nutraceuticals, and cosmetics;
6. Research using packaging-forming chemicals that are hazardous for test objects;
7. Research that conducts organoleptic tests;
8. Research using bioprocess materials (involving microorganisms) that are harmful to humans and/or the environment;
9. Research that produces new things in the form of substances, synthesis, methods, or processes.

Further information regarding each scope can be found in "Pedoman Klirens Etik Riset Bidang Kimia" which can be downloaded in the "Digital Documents" section.

The Ethics Committee for Chemical Research will classify research proposals into 3 categories:

1. Green: No risk (there is no human involvement/use of secondary data or non-“sensitive” research subjects and/or issues);
2. Yellow: At risk (“sensitive“ subject and/or research issues);
3. Red: High risk (very “sensitive“ subject and/or research issues). Research classified as Red is within the scope of a) Organoleptic tests using prohibited additives and using permitted additives but exceeding the permitted threshold; b) Involves psychotropic Group 1 based on Minister of Health Regulation No. 2 of 2021; c) Materials for chemical weapons Chemicals List 1 Law of the Republic of Indonesia No. 9 of 2008; d) Contaminant microbes that exceed the permissible threshold based on the Regulation of the Food and Drug Supervisory Agency No. 13 of 2019; e) Materials prohibited for use as raw materials in traditional medicine, according to the list issued by the Directorate of Registration of Traditional Medicines, Health Supplements and Cosmetics - Food and Drug Supervisory Agency; f) Food packaging materials containing lead, chromium, nickel, cadmium, and mercury, based on Drug and Food Control Agency Regulation No. 20 of 2019

References:

[1] The Global Chemists' Code of Ethics, https://www.acs.org/content/dam/acsorg/global/international/scifreedom/global-chemists-code-of-ethics-fi-2016.pdf

[2] CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects

[3] The Hague Ethical Guidelines, https://www.opcw.org/hague-ethical-guidelines

[4] Pranas Žukauskas, Jolita Vveinhardt, and Regina Andriukaitienė, Research Ethics, DOI: 10.5772/intechopen.70629.

Chemical Research Ethical Clearance Guidelines

Nuclear Research

Considering the importance of carrying out nuclear energy research that applies aspects of safety, security, and peaceful purposes, as well as being able to respect, protect, and act justly towards research practitioners/research subjects under the norms prevailing in society, thus ethical clearance in accordance with appropriate research ethics is required.

The Research Ethical Clearance for Nuclear Research aims to protect researchers, society, and the environment from radiation hazards and legal consequences (getting sued) as a result of carrying out activities or participating in nuclear energy research. All research involving nuclear must pay attention to the basic philosophy of research ethics and the 3 (three) S principles (Safety, Security, Safeguards), namely:

1. Nuclear Safety: in nuclear technology, it is necessary to prevent nuclear hazards against workers, society, and the environment by enforcing radiation protection requirements, namely: justification, limitation, and optimization. In its practice, institutions that utilize nuclear technology are required to have: a) certified safety officer; b) risk assessment, radiation protection, and safety program, as well as established procedures; c) tools/facility operators, supervisors, and support officers who are qualified or certified; d) availability of APD/PPE (Personal Protective Equipment) and other safety equipment.
2. Nuclear security, by preventing attempts of unauthorized possession, domination, sabotage, misuse, and terror against nuclear materials and radioactive substances, including nuclear installations, by fulfilling the following requirements: a) obtaining permission from the authority to access nuclear materials, radioactive substances, and nuclear facilities; b) willing to comply with applicable nuclear area procedures.
3. Safeguards, by complying with safeguards protocol and other additions to the safeguards agreement which guarantee that nuclear materials are used for peaceful purposes, by fulfilling the following requirements: a) informing the nuclear materials, dual-used equipment, and procedures used; b) complying with safeguards provisions.
4. Respect for persons, beneficence, and distributive justice; by fulfilling the following requirements: a) respecting autonomy; b) protecting the research subject; c) providing benefits to society.

In carrying out research in the field of nuclear energy, to ensure the application of research ethics and the 3 (three) S principles (Safety, Security, Safeguards), applicants may apply for ethical clearance to the Ethics Commission for Nuclear Energy. Incoming proposals will be classified into three groups, namely:

1. Green: low risk (low hazard potential);
2. Yellow: moderate risk (moderate hazard potential);
3. Red: high risk (high hazard potential).

The Ethics Committee will decide on approving/rejecting the Ethical Clearance after discussing the ethical feasibility of the submitted proposal. A more detailed explanation regarding the Research Ethical Clearance in Nuclear Research can be seen in the "Buku Saku Klirens Etik Riset Bidang Tenaga Nuklir" which can be found in "Digital Documents"

Nuclear Research Ethical Clearance Guidelines (in Bahasa Indonesia)

Health Research

Health research protocols must cover aspects of humans protections as subjects and animals related to human health research. This includes the risks and benefits for the subject, procedures, and methods for collecting specimens, experimental trials, documents, and informed consent, as well as additional protection when including vulnerable subjects. Vulnerable subjects, for example, are the elderly, children, convicts, people with cognitive disabilities, pregnant women, fetuses, or people who are economically or educationally disadvantaged.

The Health Ethics Committee for the National Research and Innovation Agency (HEC-NRIA) is an Ethics Commission that has independence in making decisions. HEC-NRIA has the following main duties and functions:

1. Conducting assessments on ethical and scientific aspects of health research protocols that include humans as subjects and utilize experimental animals that are submitted through NRIA;
2. Providing ethical clearance (ethical clearance/ethical approval);
3. Monitoring and evaluating the implementation of research that has obtained ethical clearance;
4. Conducting dissemination of Health Research Ethics guidelines both within BRIN and in other institutions;
5. Organizing training on Health Research Ethics both within BRIN and at other institutions;
6. Implementation of the points mentioned above refers to international guidelines from The Research Ethics Review Committee (ERC) World Health Organization (WHO), Declaration of Helsinki, “Standards and operational guidance for ethics review of health-related research with human participants (WHO, 2011), “International Ethical Guidelines for Health-Related Research Involving Human” (CIOMS, 2016), ICH GCP Guideline E6, and Guidelines for Good Clinical Trials in Indonesia (CUKB, 2016) also the National Health Research and Development Ethics Committee, Ministry of Health (KEPPKN, 2021).

The Health Ethics Commission will classify research proposals into 3 categories:

1. Green: No risk (does not involve human subjects or utilize experimental animals; uses public information/public domain; uses secondary data/stored biological material that is not related to bioterrorism and/or not linked to the subject);
2. Yellow: Low risk (involving human subjects with "insensitive" issues; involving human subjects or using experimental animals with actions that do not exceed minimal risks);
3. Red: High risk (involving human subjects with "sensitive" issues or involving vulnerable subjects; involving human subjects or using experimental animals with invasive or non-invasive measures that exceed minimal risks).

Social Studies and Humanities

In the book “International Ethical Guidelines for Biomedical Research Involving Human Subjects” (CIOMS, 2002), it is stated that all research involving humans must not violate universal ethical standards, but also must pay attention to various socio-cultural aspects of the community being studied. Therefore, all research involving humans must undergo a research ethical clearance process.

The main purpose of obtaining ethical clearance for human research is to protect research subjects/respondents from physical harm (threats), psychological (stress, regret), social (stigma, exiled from society), and legal consequences (sued) as a result of participating in research. Therefore, all research involving humans must pay attention to the three basic principles of the code of ethics (CIOMS, 2002), that are:

1. Respecting individuals (Respect for persons), there are at least 2 (two) basic ethics that need to be considered (a) respect for autonomy: respect a person's freedom of choice; (b) Protecting research subjects (protection of persons): protect individuals/research subjects who have limitations or vulnerabilities from exploitations and harm.
2. Beneficence: an ethical obligation to maximize benefits and minimize harm. This principle emphasizes that all research should be beneficial for society. Therefore, the research design must be clear, and the responsible researcher must have the appropriate competence and can protect research subjects from unwanted risks.
3. Distributive justice: The balance between 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. Differences in treatment between one individual/group and another can be justified if they can be held accountable morally and can be accepted by society.

Researchers can apply for ethical clearance on social studies and humanities research if their research meets the following criteria:

1. All research involving humans must go through an ethical clearance process. Research that is excluded from the ethics clearance process is the 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, and public speeches; (b) Published works, systematic reviews, literature reviews, and others; (c) Old materials (such as manuscripts, and archives) are stored and may be used by the public.
2. Research that uses a review of confidential materials (hospital/health clinic health records) 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, and company records) must go through ethical clearance.
3. Studies that use additional methods, which are directly related to humans, such as interviews, Focus Group Discussions (FGD), and others, still require an ethical clearance process, although the main method uses a review of publicly available materials.

For research involving humans, the status of the research that requires or does not require an ethical clearance process is decided by the Research Ethics Committee on Social Sciences and Humanities, not by the researcher or other institutions.

The Ethics Committee will classify research proposals into 3 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 (subject and/or research issue is very “sensitive”)

Research classified in Red is research involving vulnerable groups, namely children, the elderly, pregnant women, mentally and intellectually impaired individuals, people with disabilities, LGBT groups, individuals with traumatic experiences, individuals with HIV, drug addicts, individuals with communication difficulties, convicts, recidivists, and terrorists.

Animal Care and Use

All research using animals must go through the Research Ethical Clearance process. This process aims to ensure the implementation of animal welfare concepts, especially in research using animals.

The implementation of animal welfare to the use of animals for research, testing and education purposes will not only give better results due to the low level of stress intervention but also that the scientific community can emphasize the moral awareness of humanity towards animals and can still uphold their obligations to mankind for the advancement of science and technology. The implementation of animal welfare follows the 3R principles, that are:

1. Replacement refers to the method of substituting animals with computer programs, cell culture, or Experimental Animals with a lower sensitivity level;
2. Reduction involves the strategy of using a minimum number of animals without reducing the validity of the data or in the form of reducing treatments that cause pain and stress; and
3. Refinement or improvement relates to the modification of maintenance systems or experimental procedures to improve animal welfare or minimize pain and stress.

According to the American Veterinary Medical Association (AVMA), animal welfare is a prosperous animal life indicated by scientific parameters according to the Five Freedom Animal Welfare. The five concepts include:

1. free from thirst, hunger, and malnutrition;
2. free from discomfort;
3. free from pain, injury, and disease; 
4. free to express normal behavior by providing adequate space, appropriate activities and colonies; and 
5. free from fear and stress by ensuring conditions that avoid mental suffering.

The concept of animal welfare must be applied to animals, especially animals that have lived with human intervention such as pets, farm animals, wild animals, and laboratory animals.

Before conducting animal research, researchers can submit a proposal for a Research Ethical Clearance to the NRIA Animal Care and Use Research Ethics Committee. The submitted proposals will be classified into three groups, that are:

1. Green: no risk (no intervention)
2. Yellow: minimal or low risk (there are interventions but non-invasive)
3. Red: high risk (there are invasive interventions and using the euthanasia method)

The Ethics Committee will decide on granting approval for the Research Ethical Clearance after conducting a meeting to discuss the ethical feasibility of the proposal submitted by the researcher.

Others

For research that is not included in the category of social humanities, experimental animal, health, chemical, and nuclear research but in the research team there are Foreign Citizens (Non-Indonesian Citizens) or in cooperation with Foreign Research Institutes, it is mandatory to apply for a Research Permit through an Ethical Clearance Applications. The application can be made through the Other category. Applications in this category will be charged according to the PNBP rate.

Research Permit Tariff

A. Legal Basis

1. Regulation of the Minister of Finance of the Republic of Indonesia No. 210/PMK.02/2021 concerning Types and Tariffs of Non-Tax State Revenues for Urgent Needs in the National Research and Innovation Agency.
2. Letter of the Minister of Finance No. S-124/MK.2/2022 concerning Approval of the Substances for Regulation of Amounts, Requirements, and Procedures for Tariffs of Up to Rp. 0,00 (Zero Rupiah) or 0% (Zero Percent) on Non-Tax State Revenues in the National Research and Innovation Agency.

B. Research Permit Fee 

C. Requirement for Free Tariff 

The National Research and Innovation Agency (NRIA) provides free tariffs for foreign researchers that collaborate with NRIA's researchers. To apply for free tariffs, researchers must provide the following documents:

1. research proposal;
2. letter of recommendation/ letter of approval from the Guarantor Institutions;
3. Memorandum of Understanding or Letter of Agreement with NRIA working unit; and
4. letter to the Deputy Chairman for Research and Innovation Facilitation NRIA, no later than 7 working days prior to the research implementation.

Documents are uploaded through the website klirensetik.brin.go.id. For further information regarding Research Permit, please contact Foreign Research Permit Secretariat through email: research.permit@brin.go.id; WA: +62 856-9482-1823 (Mr. Bambang Herlambang).

1. FRP Guide Line Book

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 conducted under the code of ethics in the respective field of study. An Ethics Committee has been established to review and determine the ethical feasibility to enforce the code of ethics.

Research Ethical Clearance is an instrument to measure the ethical acceptability of research processes. Ethical clearance from the Ethics Committee must be obtained before the research commences. Ethical clearance is a reference for researchers in upholding the values of integrity, honesty, and fairness in conducting research. An understanding of the research ethical clearance is necessary to avoid problems in conducting research and publishing the findings.

The National Research and Innovation Agency (NRIA), a government institution under and directly responsible to the President for conducting research and innovation, implementation of nuclear energy, and integrated use of outer space, provides services to assess the ethical acceptability of a research project that will be carried out by researchers from inside and outside of NRIA, including foreign parties, referring to foreign science and technology institutions and/or foreigners who will conduct research in Indonesia.

Foreign Parties who will conduct research activities in Indonesia have to obtain a research permit. To obtain a research permit, the Foreign Parties must apply for Research Ethical Clearance. This Research Ethical Clearance application is done through the Research Ethical Clearance information system.

There is no fee for Research Ethics Clearance Application, but for Research Permits a fee is charged according to the PNBP rate. The Research Permit fee can be seen on the "Others" tab.

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Ethical Clearance and Foreign Research Permit : Link

Bagan Alir Klirens Bahan Biologi Berbahaya BRIN

Untuk informasi lebih lanjut dapat menghubungi Sekretariat Manajemen Biorisiko melalui email: ibc@brin.go.id.