Ethics Committee – Overview of the Ethics Committee
The Health Research Ethics Committee (HREC) is an autonomous body authorized by institutional and governmental authorities to conduct ethical reviews of health-related research. The committee evaluates research protocols involving human participants and/or experimental animals in accordance with the three fundamental ethical principles, seven ethical standards, and twenty-five ethical guidelines governing health research ethics.
HREC consists of qualified ethics reviewers from diverse scientific disciplines whose expertise aligns with the research under review, supported by a professional administrative secretariat to ensure efficient operational processes.
The Health Research Ethics Committee is responsible for:
Reviewing the ethical aspects of health research protocols involving human participants and/or experimental animals.
Granting Ethical Clearance (Ethical Approval) for research protocols that comply with ethical standards.
Monitoring and evaluating the implementation of approved research projects.
Disseminating ethical guidelines and standards in accordance with World Health Organization (WHO) recommendations.
Recommending the suspension or termination of research activities that deviate from approved protocols or violate ethical requirements.
Conducting re-evaluations of research protocols involved in disputes between researchers and other institutions.
Participating in accreditation and competency assessment activities for ethics committees in collaboration with the National Health Research and Development Ethics Committee.
Providing education and training in health research ethics for internal and external institutions.
Preparing and submitting committee activity reports to the Faculty of Nursing.
To support its functions, HREC is assisted by a competent secretariat responsible for daily administrative and operational activities.
Informed consent is the voluntary agreement provided by a participant after receiving adequate information regarding all procedures, interventions, risks, and benefits associated with a research study.
In health research, informed consent holds a higher ethical significance than consent obtained in routine healthcare services because research participants may not directly benefit from their participation.
In addition to its ethical importance, informed consent carries legal implications under Indonesian law. Failure to obtain proper informed consent may result in criminal, civil, and administrative sanctions.
Informed consent must be obtained prior to any research involving:
Human participants
Communities or population groups
Medical record data
Biological specimens derived from human tissues or cells
The informed consent document forms an integral part of the Ethical Clearance/Ethical Approval issued by HREC.
Health research requires strict ethical oversight because it involves human participants who may be exposed to discomfort, inconvenience, or potential risks.
Poorly designed research is considered unethical because it may produce inaccurate or unreliable findings, resulting in unnecessary participant burden and misuse of resources. Researchers therefore have a professional responsibility to uphold the highest ethical and scientific standards throughout the research process.
Genetic research
Stem cell research
Research involving stored biological materials
Clinical trials
Epidemiological research
Research involving experimental animals
Pediatric Nursing Research
Maternity Nursing Research
Mental Health Nursing Research
Medical-Surgical Nursing Research
Oncology Nursing Research
Cardiovascular Nursing Research
Critical Care Nursing Research
Family Nursing Research
Community Nursing Research
Gerontological Nursing Research
Nursing Education Research
Nursing Management Research
Researchers are required to uphold the three core ethical principles:
Respect for Persons
Beneficence
Justice
Researchers must also comply with the seven ethical standards established by WHO (2011) and the twenty-five ethical guidelines outlined by WHO (2016).
Principal investigators and research team members share responsibility for ensuring ethical conduct throughout the research process, with particular attention to vulnerable populations, including:
Children
Individuals with physical or mental disabilities
Pregnant women and fetuses
Ethnic minority groups
Older adults
Economically disadvantaged populations
Prisoners
Students
Academic integrity requires researchers to recognize and uphold fundamental values that sustain educational and research institutions. Scientific advancement benefits society and depends upon responsible and ethical scholarly conduct.
Honesty
Trust
Fairness
Respect
Responsibility
The Declaration of Helsinki (Paragraph 10) states:
“It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject.”
Accordingly, researchers must prioritize the protection of participants’ life, health, privacy, safety, and dignity throughout the entire research process. The welfare of participants must always take precedence over scientific interests.
The Declaration of Helsinki emphasizes that:
Health research is ethically justified only when there is a reasonable likelihood that the population participating in the research will benefit from its outcomes.
At the conclusion of a study, participants should have access to the best proven preventive, diagnostic, and therapeutic interventions identified through the research.
At the completion of a research project, all original records and supporting documentation must be appropriately documented, archived, and securely maintained for future verification, clarification, or audit purposes.
Researchers are expected to maintain ethical integrity by avoiding scientific misconduct related to data ownership and intellectual property rights.
According to Thomas D. May, data ownership considerations include:
Who collected the data;
Under whose supervision the data were collected; and
Whether legal or institutional obligations require the transfer of ownership rights.
Intellectual property includes:
Patents
Copyrights
Trademarks
Trade Secrets
These rights belong to individual researchers or research groups and are protected under applicable national laws and regulations.
