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Last updated on 2024年9月9日

What are some best practices for obtaining informed consent from vulnerable populations?

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Informed consent is a key principle of biomedical ethics that respects the autonomy and dignity of patients or participants in research. However, some groups may face challenges or barriers in understanding, communicating, or exercising their consent, such as children, people with disabilities, refugees, or indigenous communities. These are considered vulnerable populations, and they require special attention and protection from potential harm or exploitation. In this article, you will learn some best practices for obtaining informed consent from vulnerable populations, based on ethical guidelines and standards.

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1 Know the context

Before approaching a vulnerable population for consent, you need to know the context and culture of the group, their values and beliefs, their history and experiences, and their expectations and needs. This will help you tailor your consent process to their language, literacy, and comprehension level, as well as to their social and emotional factors. You should also be aware of any power dynamics, conflicts, or risks that may influence or coerce their consent, and avoid any manipulation or deception.

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Katherine Burnam, MBA

Global Education Advisor
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One thing I have found helpful is to hold space and listen to someone as they share what they know, believe and have experienced personally in their own lives in regard to the medical community and medical research. It gives so much context and helps you figure out where to start!

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David Vogel

Solar Energy Mentor I Streamlining Federal Grant Approvals & Material Distribution for Commercial Solar Projects I Retired CEO Project SunRize I Pastor Church of Unity Society
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Consider how Jesus approached the Samaritan woman at the well, understanding her context and engaging with her respectfully. Similarly, when seeking informed consent from vulnerable populations, immerse yourself in their culture, values, and history to tailor your communication to their comprehension levels and emotional needs. Be mindful of power dynamics and ensure that your consent process is free from manipulation or coercion, reflecting a Godly commitment to ethical integrity and respect. #divineintervention #gabenfreude #MentalHealthAwarenessMonth

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2 Involve the community

One way to ensure that your consent process is respectful and relevant to the vulnerable population is to involve them in the design and implementation of your project or intervention. You can consult with community leaders, representatives, or advocates, and seek their input and feedback on your goals, methods, and outcomes. You can also collaborate with local organizations, institutions, or networks that have established trust and rapport with the group, and use their expertise and resources to facilitate your consent process.

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David Vogel

Solar Energy Mentor I Streamlining Federal Grant Approvals & Material Distribution for Commercial Solar Projects I Retired CEO Project SunRize I Pastor Church of Unity Society
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Imagine Nehemiah rebuilding Jerusalem's walls by rallying the community to participate and support the project. Involving the community in your consent process means consulting with local leaders, representatives, and advocates to gather input and feedback on your goals and methods. Collaborate with trusted local organizations to leverage their expertise and resources, ensuring your approach is respectful, relevant, and rooted in Divine partnership and unity. #divineintervention #gabenfreude #MentalHealthAwarenessMonth

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3 Provide information

A crucial aspect of informed consent is providing clear, accurate, and comprehensive information about your project or intervention, its purpose, benefits, risks, alternatives, and procedures. You should use plain and simple language, avoid technical jargon, and use visual aids, examples, or stories to illustrate your points. You should also explain the rights and responsibilities of the participants, such as their right to withdraw, to confidentiality, to access the results, and to compensation. You should give them enough time and opportunity to ask questions, express concerns, or seek clarification.

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David Vogel

Solar Energy Mentor I Streamlining Federal Grant Approvals & Material Distribution for Commercial Solar Projects I Retired CEO Project SunRize I Pastor Church of Unity Society
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Think of how Jesus taught in parables, using simple and relatable stories to convey profound truths. Similarly, when seeking informed consent, provide clear and comprehensive information using plain language and visual aids to illustrate your points. Explain participants' rights and responsibilities, ensure they have ample time to ask questions, and address concerns, demonstrating a Godly commitment to transparency and respect. #divineintervention #gabenfreude #MentalHealthAwarenessMonth

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4 Obtain consent

After providing information, you need to obtain consent from the participants or their authorized representatives, such as parents, guardians, or proxies. You should use a consent form that reflects the information you have given, and that is appropriate for the literacy and language level of the group. You should also use a consent method that is culturally and legally acceptable, such as verbal, written, or symbolic consent. You should document the consent process and keep records of the consent forms or evidence.

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David Vogel

Solar Energy Mentor I Streamlining Federal Grant Approvals & Material Distribution for Commercial Solar Projects I Retired CEO Project SunRize I Pastor Church of Unity Society
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Just as God provided the Israelites with clear commandments, ensuring they understood and agreed to His covenant, so too must you obtain informed consent with clarity and respect. Use a consent form that matches the literacy and language levels of your participants, and choose a consent method that aligns with their cultural and legal standards. Document the entire process meticulously, maintaining records of consent forms or other evidence, demonstrating a Divine commitment to ethical diligence and accountability. #divineintervention #gabenfreude #MentalHealthAwarenessMonth

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5 Monitor and evaluate

The consent process does not end with obtaining consent. You should monitor and evaluate the consent process throughout your project or intervention, and check for any changes in the participants' circumstances, preferences, or understanding. You should also respect their feedback and complaints, and address any issues or problems that may arise. You should also communicate the results and outcomes of your project or intervention to the participants, and acknowledge their contribution and participation.

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David Vogel

Solar Energy Mentor I Streamlining Federal Grant Approvals & Material Distribution for Commercial Solar Projects I Retired CEO Project SunRize I Pastor Church of Unity Society
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Consider how Paul continuously engaged with and supported the early Christian communities, ensuring their needs and concerns were addressed. Similarly, monitor and evaluate the consent process throughout your project, staying attuned to changes in participants' circumstances or understanding. Respect and respond to their feedback, address any issues promptly, and communicate results, acknowledging their invaluable contributions and maintaining a Godly commitment to transparency and gratitude. #divineintervention #gabenfreude #MentalHealthAwarenessMonth

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6 Follow ethical principles

Finally, you should follow the ethical principles and standards that guide your profession, discipline, or field, and that are relevant to your project or intervention. You should adhere to the principles of respect, beneficence, non-maleficence, justice, and accountability, and ensure that your consent process is consistent with these principles. You should also comply with any laws, regulations, or policies that apply to your project or intervention, and seek approval from any ethical committees or boards that oversee your work.

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David Vogel

Solar Energy Mentor I Streamlining Federal Grant Approvals & Material Distribution for Commercial Solar Projects I Retired CEO Project SunRize I Pastor Church of Unity Society
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When Jesus was mocked by soldiers and crucified, He responded with forgiveness and strength, never losing His Divine composure (Luke 23:34). In dealing with online trolls, channel this Godly example—respond with calmness, or choose silence, letting your peace speak louder than their chaos. For obtaining informed consent from vulnerable populations, act with unwavering integrity, ensuring that your process reflects God’s justice and compassion, safeguarding their dignity at every step. #divineintervention #gabenfreude #MentalHealthAwarenessMonth

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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David Vogel

Solar Energy Mentor I Streamlining Federal Grant Approvals & Material Distribution for Commercial Solar Projects I Retired CEO Project SunRize I Pastor Church of Unity Society
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The Rule of Benedict emphasizes listening with the “ear of the heart,” and this is critical when obtaining informed consent from vulnerable populations. These individuals must be given clear, compassionate explanations, ensuring they truly understand what they are agreeing to, so their autonomy remains honored. In these delicate situations, trust in the Divine means walking alongside them, ensuring their safety, dignity, and sacredness are preserved through every step of the process. Seek guidance, review your methods frequently, and always leave room for God's grace to guide the interaction. True consent isn’t just legal—it’s moral, spiritual, and deeply personal. #divineintervention #gabenfreude #MentalHealthAwarenessMonth

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What are some best practices for obtaining informed consent from vulnerable populations?

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1 Know the context

2 Involve the community

3 Provide information

4 Obtain consent

5 Monitor and evaluate

6 Follow ethical principles

7 Here’s what else to consider

Professional Ethics

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