The Experiment Consent Form is a crucial document required by Indonesian law and research ethics guidelines before conducting any research involving human subjects. This document is mandatory under various Indonesian regulations, including Law No. 11 of 2019 and Minister of Health Regulation No. 7 of 2019, and must be approved by relevant ethics committees before use. The form serves to protect both researchers and participants by clearly documenting informed consent, outlining research procedures, potential risks and benefits, confidentiality measures, and participant rights. It must be written in clear, accessible language and, when necessary, translated into local languages to ensure full comprehension by participants. The document must comply with Indonesia's Personal Data Protection Law and include specific provisions for data handling and participant privacy.
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1. Study Title and Research Team Information: Clear identification of the study and complete contact information for researchers, institutions, and ethics committee
2. Introduction and Purpose: Brief overview of the research purpose and why the participant has been invited to participate
3. Research Procedures: Detailed description of what participation involves, including procedures, duration, and location
4. Risks and Discomforts: Clear explanation of potential risks, side effects, or discomforts associated with participation
5. Benefits: Description of potential benefits to the participant and/or society
6. Confidentiality and Data Protection: Explanation of how personal information and research data will be protected, stored, and used
7. Voluntary Participation and Withdrawal: Statement that participation is voluntary and can be withdrawn at any time without penalty
8. Costs and Compensation: Information about any costs or compensation associated with participation
9. Declaration of Consent: Formal statement of consent with signature blocks for participant and researcher
1. Future Use of Data: Include when data might be used for future research or shared with other researchers
2. Biological Samples: Include when the study involves collection and storage of biological specimens
3. Audio/Video Recording: Include when the research involves recording of participants
4. Commercial Development: Include when research might lead to commercial products or patents
5. Alternative Treatments: Include for clinical trials where alternative treatment options exist
6. Translator Declaration: Include when consent form needs to be translated for non-Indonesian speaking participants
1. Detailed Study Procedures: Step-by-step description of research procedures, including diagrams or flowcharts if applicable
2. Risk Management Protocol: Detailed procedures for managing potential risks or adverse events
3. Privacy Notice: Detailed information about data protection and privacy practices in compliance with Indonesian law
4. Contact Information Sheet: Complete contact details for all relevant parties including emergency contacts
5. Participant Rights Summary: Summary of participant rights in accessible language, including complaint procedures
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