The Participant Consent Form is a crucial document required for any research involving human subjects in Malaysia. It serves as a formal agreement between researchers and participants, ensuring compliance with Malaysian legislation, including the Personal Data Protection Act 2010, Medical Act 1971, and relevant research guidelines. This document must be used before commencing any research activities involving human participants, whether in clinical trials, academic research, or other studies. The form includes essential information about the study, participant rights, data protection measures, and risk disclosures, while meeting ethical requirements set by Malaysian research authorities. It should be written in clear, accessible language and may need to be provided in multiple languages depending on the participant demographic.
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1. Title and Document Identification: Clear identification of the document as a consent form, including study title, reference numbers, and version date
2. Research Team Information: Names, titles, and contact information of principal investigators and research team
3. Study Description: Clear, non-technical explanation of the research purpose, procedures, and duration
4. Participant Requirements: What will be expected from participants, including time commitments and activities
5. Risks and Discomforts: Clear explanation of potential risks, side effects, or discomforts
6. Benefits: Description of direct and indirect benefits to participants and society
7. Confidentiality Protection: Explanation of how personal data will be collected, used, stored, and protected
8. Voluntary Participation: Statement that participation is voluntary and can be withdrawn at any time
9. Costs and Compensation: Information about any costs or compensation related to participation
10. Contact Information: Who to contact for questions about the research or participants' rights
11. Declaration and Signatures: Formal declaration of consent with spaces for participant and researcher signatures
1. Alternative Procedures: Description of alternative procedures or treatments, used when the research involves medical interventions
2. Future Use of Data: Details about potential future use of collected data, included when data might be used for future research
3. Commercial Applications: Information about potential commercial applications of research findings, included when research might lead to commercial products
4. Genetic Testing: Specific details about genetic testing procedures and implications, included for genetic research
5. Photography/Video Recording: Details about audio/visual recording procedures and usage, included when recordings are part of the research
6. Translator Declaration: Additional section for cases where consent form is explained through a translator
7. Witness Statement: Required when participant is illiterate or unable to provide written consent
8. Parent/Guardian Consent: Additional section for research involving minors or individuals unable to provide consent
1. Detailed Study Protocol: Technical details of the research procedures and methodology
2. Personal Data Processing Statement: Detailed information about personal data handling as required by PDPA 2010
3. Participant Information Sheet: Detailed information about the study in question-and-answer format
4. Risk Assessment Details: Comprehensive list of potential risks and mitigation measures
5. Schedule of Visits/Procedures: Detailed timeline of research activities and participant involvement
6. Compensation Schedule: Detailed breakdown of any compensation or reimbursement
7. Withdrawal Procedures: Detailed procedures for withdrawing from the study and implications for collected data
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Clinical Operations
Regulatory Affairs
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Data Protection
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Relevant Roles
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