Ethical consent

Obtaining informed consent is a crucial ethical requirement in biomedical research. This guide outlines the key steps and considerations for ensuring proper informed consent when collecting data or biospecimens for sharing on the ADBEx platform:

1. Prepare Clear and Comprehensive Information:
2. • Develop an information sheet explaining the study's purpose, procedures, and potential risks and benefits.
   • Use simple, jargon-free language accessible to participants with varying levels of education.
   • Translate materials into local languages as necessary.
3. Explain Data and Biospecimen Sharing:
4. • Clearly state that data or samples may be shared on the ADBEx platform.
   • Describe how shared information will be used and who may access it.
   • Explain measures taken to protect privacy and confidentiality.
5. Outline Participant Rights:
6. • Emphasize that participation is voluntary.
   • Explain the right to withdraw consent at any time.
   • Describe what happens to data/samples if a participant withdraws.
7. Detail the Consent Process:
8. • Allow sufficient time for participants to read and understand the information.
   • Encourage questions and provide thorough answers.
   • Use visual aids or multimedia tools if appropriate to enhance understanding.
9. Address Cultural Sensitivities:
10. • Consult with local community leaders or ethics committees about culturally appropriate consent processes.
    • Consider community-level consent in addition to individual consent where culturally relevant.
11. Obtain Consent for Future Use:
12. • Explain that data/samples might be used for future research.
    • Provide options for participants to consent to or refuse different types of future use.
13. Explain Data Protection Measures:
14. • Describe how personal information will be protected on the ADBEx platform.
    • Explain anonymization or pseudonymization processes.
15. Discuss Benefits and Compensation:
16. • Clearly state any direct benefits or lack thereof to the participant.
    • Explain any compensation or reimbursement for participation.
    • Describe potential broader benefits to the community or scientific knowledge.
17. Provide Contact Information:
18. • Give clear instructions on how participants can ask questions or raise concerns.
    • Include contact details for the research team and the relevant ethics committee.
19. Document the Consent:
20. • Use a written consent form for literate participants.
    • For non-literate participants, consider audio recording verbal consent or using a thumbprint.
    • Ensure a witness is present for verbal consent procedures.
21. Verify Understanding:
22. • Ask participants to explain key aspects of the study in their own words.
    • Address any misunderstandings before proceeding.
23. Offer a Copy of the Consent Form:
24. • Provide participants with a copy of their signed consent form.
    • For verbal consent, offer a written summary of the information provided.
25. Plan for Ongoing Consent:
26. • For long-term studies, consider implementing a process for re-confirming consent periodically.
    • Inform participants of any significant new findings that might affect their willingness to continue.
27. Train Your Team:
28. • Ensure all team members involved in obtaining consent are properly trained.
    • Regularly review and update the consent process based on feedback and experiences.
29. Document the Process:
30. • Keep detailed records of the consent process for each participant.
    • Store consent documents securely and separately from research data.

Remember, informed consent is an ongoing process, not just a one-time event. It's crucial to maintain open communication with participants throughout the study. By following these guidelines, researchers can ensure that participants' rights and welfare are protected, fostering trust in the research process and in the ADBEx platform's commitment to ethical data and biospecimen sharing.