The Participant Consent Form is a crucial legal document required for any research study, clinical trial, or medical procedure involving human subjects in Nigeria. It serves as a formal agreement between the research institution or healthcare provider and the participant, ensuring informed consent is properly obtained in compliance with Nigerian regulations, including the NDPR 2019 and National Health Act 2014. This document must be used before commencing any research activity or medical procedure involving human subjects, providing comprehensive information about the study's purpose, procedures, risks, benefits, and participant rights. The form includes specific provisions for data protection, confidentiality, and the participant's right to withdraw, while accommodating special circumstances such as vulnerable populations, translation requirements, and witness provisions where necessary.
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1. Title and Document Identification: Clear identification of the document as a Participant Consent Form, including study/research title and reference numbers
2. Parties: Identification of the research institution/organization and the participant
3. Background: Brief overview of the research study or medical procedure
4. Definitions: Clear explanations of technical terms and important concepts used in the document
5. Purpose of the Study: Detailed explanation of what the research or procedure aims to achieve
6. Participation Requirements: What will be required from the participant, including time commitment and procedures
7. Risks and Discomforts: Clear outline of potential risks, side effects, or discomforts
8. Benefits: Description of potential benefits to the participant and/or society
9. Costs and Compensation: Information about any costs or compensation related to participation
10. Data Protection and Confidentiality: Details of how personal information will be collected, used, stored, and protected
11. Voluntary Participation and Withdrawal: Statement clarifying the voluntary nature of participation and right to withdraw
12. Contact Information: Details of researchers, medical staff, and ethics committee contacts
13. Declaration and Signatures: Formal declaration of consent and signature blocks for all parties
1. Translation Statement: Required when the participant's primary language is not English, confirming that the form has been accurately translated
2. Witness Statement: Required when the participant is illiterate or unable to read, confirming that the form was read and explained to the participant
3. Guardian Consent: Required for minors or participants who lack capacity to consent, including legal guardian's details and signature
4. Photography/Video Consent: Required when the study involves taking photographs or videos of participants
5. Future Research Use: Optional section for consent to use data or samples in future research
6. Commercial Development: Required when there's potential for commercial development from the research
7. Cultural and Religious Considerations: Required when the research involves culturally or religiously sensitive matters
1. Detailed Study Protocol: Comprehensive description of the research procedures and methodology
2. Participant Information Sheet: Detailed information about the study in plain language
3. Data Protection Notice: Detailed information about data protection rights and procedures under NDPR 2019
4. Medical Procedures Description: Detailed description of any medical procedures involved
5. Risk Assessment: Detailed assessment of potential risks and mitigation measures
6. Emergency Contact Form: Form for participant's emergency contact information
7. Withdrawal Form: Template form for participants to use if they wish to withdraw from the study
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Clinical Operations
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Ethics & Compliance
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