What are the key components of a successful informed consent form?

my focus involved navigating the legal landscape surrounding artificial intelligence within the country. Research aimed to uncover specific legal challenges within AI, employing methodologies such as case analysis and policy review. Participant engagement, often through interviews or surveys, significantly contributed to comprehending the local nuances. The research extended over several months, with participants requiring only a minimal time commitment. Presenting the information in an accessible manner was crucial, ensuring that complex legal terminologies didn’t obscure the study’s objectives for participants in Kenya.

Há riscos previstos ou não previsto na participação da Pesquisa? Quais os benefícios à sociedade ou a parte dela que a pesquisa apresenta?

It should be clear to the subject that the study that this is research. This section should include the rationale for the research that is being conducted and the specific purposes for the research.

In an informed consent form, the second component involves outlining potential risks and benefits for participants and society. It’s crucial to address potential discomforts or harms participants might encounter during or after the research. Simultaneously, outlining realistic expectations regarding the outcomes or benefits for participants and relevant stakeholders is vital. Researchers should clarify how they’ll measure and communicate these benefits without exaggerating or downplaying the potential impact of the research. Being honest and realistic in presenting these aspects ensures transparency and trust among participants

Detalhamento sobre os riscos e benefícios torna-se mais concreto quando apresentamos as aplicações sociais, a grupos ou indivíduos

This includes any risks of being in the study, there may be unforeseeable complications; the subject should be made aware of. Also, if there is no expectation of direct benefit to the subject that should also be stated clearly.

Fundamental enfatizar a possibilidade de desistência ou mesmo solicitação dos dados e informações. Leis sobre Governança e Proteção de Dados oferecem suporte legal aos participantes.

Um principio fundamental de acesso, via e-mail ou telefone aos responsáveis pela pesquisa, agregam credibilidade e promovem os direitos dos usuários.

Em tempos de certificação digital, registro de número de IP ou um simples aceite sobre os termos e condições do estudo permitem uma participação informada e elucidada. Preveni problemas a partir do respeito ao participantes.

I agree and to compliment this suggestion, the information should be in a language that the participant understands. The document should include a verified translated version of the information or at least have the information presented by an interpreter. Another component is the mode of delivery of the information. Presenting a document to be read and signed by person who can neither read nor write would be wrong. All the information must be presented in a format that the participant can understand.

When conducting multi-country research or research across cultures and languages, it is of utmost importance to translate the consent form properly into a language the participant understands. If necessary, have someone explain it to them so the participant can actually consent. Do have a native speaker proofread the translated consent form. It may sound basic, but I have come across people who don’t think it’s necessary. It is unethical to do research without getting real consent due to poorly translated consent forms or being given consent forms they do not understand.

There should also be an option for the right to withdraw from the study at any time without penalty. In any scenario if the subject feels uncomfortable being a part of the study, they should be able to withdraw.

Para mis investigaciones sobre Centennials, que son adolescentes menores de edad, donde aplicamos encuestas e hicimos abordajes con herramientas cualitativas, decidimos pedir ayuda del consultorio juridico de la universidad donde trabajo. En mi experiencia no hay nada mejor que recibir una mano de un experto y que mejor que los abogados. Al final salimos a hacer trabajo de campo con toda la confianza porque el documento de consentimiento informado era seguro y no había posibilidad de error. No dejes de considerar esta opción.