Summary: Informed consent is a central pillar in conducting research involving human participants. It ensures that each volunteer fully understands the objectives, methods, risks, and benefits before authorizing their participation (Grady et al., 2017). In the Brazilian context, regulations such as Resolution CNS 466/12 and the General Data Protection Law (LGPD) make the adoption of clear and ethical consent processes even more urgent. This guide offers an in-depth look at the principles of informed consent, presenting the most common doubts, common mistakes, and best practices to be adopted in qualitative research — including those that use artificial intelligence (AI) and tools such as requalify.ai, Nvivo, Atlas.ti, MaxQDA, Iramuteq and other options software for qualitative data analysis.
Introduction
To what extent should the freedom and protection of participants be at the center of research? This debate has been ongoing throughout much of the history of science, intensifying after notorious cases of rights violations that highlighted the lack of consent or lack of clarity about risks. To protect volunteers and legitimize scientific findings, informed consent has become the cornerstone of research ethics (Xu et al., 2020).
In this text, you will find not only the formal definition of informed consent, but also practical insights on how to apply it correctly in your studies, taking into account cultural, linguistic, legal and technological aspects. We will also address the role of ethics committees, the relevance of secure platforms and how adopting good practices strengthens the quality of the results obtained. By the end, we hope that you will be able to conduct research in a more transparent and respectful manner, regardless of the method or technology used.
Concepts and Definitions
What is Informed Consent?
Informed consent consists of an ethical and legal process in which participants receive, in a clear and accessible manner, information about the objectives, procedures, risks and benefits of a research study (Riden et al., 2012). The fundamental principle is voluntariness: each individual has the right to accept or refuse participation without suffering pressure or retaliation.
The basic elements that make up informed consent include:
- Research objectives: Brief description of what you intend to investigate.
- Methods used: Details of the steps and resources used, such as interviews, questionnaires or content analysis.
- Risks and benefits: Explanation of what may be undesirable and what is expected as a contribution to the participant or to science.
- Rights and guarantees: Security that the participant can withdraw at any time and that their data will be treated confidentially.
Transparency
In qualitative research, the transparency is essential for participants to trust the results and participate consciously. This involves clearly explaining each stage of the research and the final destination of the collected data (Frost et al., 2021). In studies involving qualitative research with AI, for example, it is essential to detail how algorithms, processes codification and analysis tools (such as requalify.ai or Iramuteq) will be applied, ensuring that the use of artificial intelligence does not pose a risk to privacy.
Privacy and Confidentiality
Ensuring data confidentiality means ensuring that personal information is not disclosed inappropriately. In qualitative data analysis, especially those that use software such as Nvivo, Atlas.ti, MaxQDA or requalify.ai, it is necessary to adopt appropriate security protocols. Protections such as encryption, access permissions and secure storage are examples of recommended safeguards, always in line with the LGPD.
Accessible Language
Sometimes researchers use overly technical vocabulary, which makes it difficult for participants to understand. To respect informed consent, it is essential to write terms and forms in simple language, using practical examples and avoiding jargon (Gelinas et al., 2016). In Brazil, a country with great cultural and linguistic diversity, this may mean adapting the language to the regional context or translating documents into local languages, including Libras when necessary.
Important Questions in Informed Consent
What information needs to be included in the consent form?
Mainly, the consent form should include the following sections (Riden et al., 2012):
- Objectives: Make clear the problem or hypothesis that motivated the research.
- Procedures: Describe how data collection and analysis will be carried out, including whether there will be content analysis, qualitative research with AI, etc.
- Risks: Point out any discomfort or negative implications for the participant.
- Benefits: Explain what is expected in terms of scientific advances, improvements in practice or social return.
- Participant rights: Make explicit the freedom to refuse, withdraw and maintain confidentiality of data.
- Contacts: Provide the email or telephone number of the responsible researcher and the ethics committee for further clarification.
How to ensure that participants understand risks and benefits?
The best way to check understanding of risks and benefits is to provide an open space for questions and clarifications. In virtual environments, you can use explanatory videos, interactive forms or lives quick answers to questions (Hake et al., 2017). If there are changes to the protocol — for example, introduction of a new method of codification or adoption of another software for qualitative data analysis —, the researcher must promptly update the participants, and may even issue a new consent form.
What are the main rights of participants?
Among the rights guaranteed to participants, the following stand out (Grady et al., 2017):
- Right to information: Receive detailed explanations about the study.
- Right to autonomy: Choose whether or not to participate, without coercion.
- Right to privacy: Guarantee that sensitive data will not be exposed.
- Right to revocation: Possibility to withdraw at any time, without justification.
How to deal with cultural and linguistic specificities?
In the Brazilian context, there are regions with minority languages, distinct cultural expressions and different levels of education. Therefore, for an inclusive approach, we recommend the participation of community leaders and translators in the preparation of documents, ensuring that the content is truly understood (Gelinas et al., 2016). In turn, this care extends to the strategies of qualitative data analysis, as the way of interpreting codes and categories can vary depending on the culture.
What is the best practice for updating participants?
In general, when substantial changes occur in the research design, such as the inclusion of new data sources or methods of analysis (e.g., adoption of requalify.ai for transcription and codification), the researcher must immediately notify the volunteers (Gelinas et al., 2016). On the other hand, if the change impacts the risks or procedures, it is prudent to request new consent, reinforcing the autonomy of those involved.
Frequent Questions and Errors in the Informed Consent Process
Ambiguity in Communication
Some researchers fail to explain specific terms, leading to confusion about objectives or risks. Because of this, it is important to avoid ambiguity, which involves carefully reviewing the form, reducing technical jargon (Gelinas et al., 2016). If the research involves AI and content analysis, for example, detailing how algorithms identify patterns can be crucial to participant understanding.
Lack of Transparency
Omitting details about potential risks or reuse of data violates the principle of autonomy. Full transparency, even when pointing out uncomfortable scenarios, is preferable to omission, which compromises the integrity of the study (Grady et al., 2017).
Standardized Processes without Adaptation
“Blanket” consent forms may ignore cultural, regional, or specific sampling needs. Researchers should be willing to customize the documents and the explanation process to ensure effective participation (Frost et al., 2021).
Exaggerated Formalism
Even though a form is signed, it does not mean that the participant truly understood it. Focusing too much on the bureaucratic aspect without establishing an open dialogue reduces the effectiveness of consent and can generate distrust among participants (Dickert et al., 2017).
Inadequate Ethical Review
Failure to submit research to an ethics committee, or seeking only initial approval without periodic reviews, can lead to serious failures in terms of participant safety and rights (Xu et al., 2020). If questions or changes arise during the study, it is essential to resume dialogue with the ethics committee.
Key Topics for Developing Informed Consent
Ethical Approach
Ethical research is based on respect for human dignity, privacy and autonomy (Xu et al., 2020). Therefore, these values should guide all stages, from defining the research problem to archiving the data. Furthermore, if there is an application of qualitative research with AI, for example, the researcher needs to ensure that algorithms used in software for qualitative data analysis respect privacy and do not discriminate against vulnerable groups.
International Standards and Guidelines vs. Brazilian Context
Although international guidelines (e.g. Declaration of Helsinki) are broad references, Brazil has its own regulations, such as Resolution CNS 466/12, which guides research involving human beings. At the same time, LGPD reinforces data protection, requiring explicit consent for the collection and use of personal information (Gelinas et al., 2016). Thus, the researcher must reconcile both dimensions to ensure the legality of the project.
Consent in Online Environments
With increasing digitalization, informed consent extends to virtual platforms. Research that applies online questionnaires, video interviews or the use of requalify.ai for transcriptions, require adjustments. Explaining how the data will be stored, for how long and who will have access are essential steps to maintain transparency (Frost et al., 2021).
Language and Culture
Respecting linguistic and cultural differences means not only translating terms, but also adapting examples and illustrations. In this way, one can use mind maps, infographics or short videos to elucidate complex concepts, such as qualitative research with AI. The participation of cultural mediators improves understanding and strengthens the legitimacy of the study (Hake et al., 2017).
Role of Ethics Committees
Ethics committees play a watchdog and advisory role, reviewing the research protocol to prevent abuse or ethical failures (Xu et al., 2020). In addition to reviewing the consent form, they can propose adjustments to ensure that all communication is appropriate for the intended audience, including information about AI use and aspects of codification or content analysis.
Historical Context and Current Relevance of Informed Consent
Historical Evolution
The foundations of informed consent were laid after traumatic events, such as the medical practices condemned at the Nuremberg Trials (1947) (Grady et al., 2017). Subsequently, documents such as the Declaration of Helsinki highlighted the need to respect participants' autonomy as a fundamental condition for scientific legitimacy. In Brazil, several cases and debates reinforced the importance of national regulations.
Current Relevance
Undeniably, in an era where data collection is massive — especially with the advancement of qualitative research with AI and big data —, informed consent becomes even more essential (Dickert et al., 2017). Researchers must be aware that any failure to protect data or provide clarity of information can result in ethical, legal and scientific harm.
Future Implications of Informed Consent
Evolution of Ethical Standards
The rapid pace of technological innovations demands constant updating of consent guidelines. Thus, software such as requalify.ai, Nvivo, Atlas.ti, MaxQDA and Iramuteq allow qualitative data analysis on a large scale, but also raise questions about privacy and secondary use of data (Gelinas et al., 2016). A continuous evolution of ethical standards is expected, contemplating solutions AI and big data.
Impact on Research Credibility
Well-conducted research, with clear and ethical consents, enhances the reputation not only of the researcher, but also of the institution. Therefore, transparency generates trust and can facilitate access to more diverse populations, adding scientific value (Hake et al., 2017). In short, this process of strengthening credibility especially benefits studies of content analysis and qualitative research, in which data quality depends on reliable interaction between researcher and participant.
Technological Challenges
In general, AI tools can automate coding and identify complex patterns in testimonies, but understanding and consent regarding the use of these algorithms must be very clear (Frost et al., 2021). Thus, emerging technologies such as speech recognition and sentiment analysis can collect sensitive data, making it essential that participants understand who will have access, for how long, and how this data will be protected.
Practical Tips for Implementing Informed Consent
Clear and Accessible Forms
First, avoid long, jargon-heavy sentences. Organize the text into sections with subheadings and, if possible, use visuals to illustrate key points. This practice facilitates understanding, reduces confusion and makes consent more participatory.
Clarification Sessions
Second, hold meetings, either virtual or in person, to explain objectives, risks, and benefits. A workshop brief before the start of data collection can be decisive in building a relationship of trust (Dickert et al., 2017). In research that uses software for qualitative data analysis, you can present screenshots or quick recordings to illustrate how the material will be processed.
Adaptation for Online Contexts
In particular, online data collection tools (questionnaires, video conference interviews, etc.) require clarity on data protection and information handling. When using AI platforms or software such as requalify.ai, it is essential to inform how the content is encrypted and who receives access permissions (Frost et al., 2021). The possibility for the participant to withdraw their consent is a right, for which it must be presented with clear contact instructions.
Consultation with Ethics Committees
Review by ethics committees (e.g., CEP/CONEP) must accompany the research process, not being limited to initial approval. Thus, reporting any change in the protocol that modifies the risks, methods or use of data ensures legality and respect for participants (Xu et al., 2020).
Periodic Reviews of Consent
Long-term studies may undergo changes in scope, schedule or methods. If this involves impact on privacy or new risks, it is essential to revalidate consent. Participants must be aware of their role and how their data will be used (Frost et al., 2021).
Conclusion
Informed consent is not just a form; it is an ethical commitment that reflects respect, autonomy and transparency. In Brazil, there are specific regulations, such as Resolution CNS 466/12 and the LGPD, which require a high level of responsibility when handling personal data. Whether the research is conducted in a traditional manner or through qualitative research with AI — using tools such as requalify.ai, Nvivo, Atlas.ti, MaxQDA or Iramuteq —, the duty to protect privacy and communicate risks remains unshakable.
As science evolves, methods and technologies are renewed, demanding constant adaptations of consent practices. Researchers who invest in clarity, accessibility and continuous dialogue with participants and ethics committees certainly conduct more legitimate, reliable and socially responsible studies. In this way, the informed consent It is consolidated as one of the most powerful tools for protection and credibility in academic research.
FAQ: Frequently Asked Questions
What is informed consent in practice?
Namely, informed consent is the process in which the researcher explains the objectives, risks, benefits and procedures of a research study, ensuring that the participant can freely decide about their participation.
How to ensure data privacy in qualitative research?
In order to guarantee privacy, security protocols are adopted (encryption, secure storage) and selected software for qualitative data analysis reliable, such as requalify.ai, which offer protection and access control.
When do I need to update informed consent?
Whenever substantial changes occur in the study, such as new risks, methods or schedule changes. In these situations, it is necessary to notify the participants and assess whether a new consent form is necessary.
What precautions should I take in different cultural contexts?
Adapt language, examples and collection methods to local circumstances. Including cultural mediators can be crucial to ensuring understanding of consent in regions with minority languages or specific customs.
Is it enough to hand over a document for participants to sign?
No. The ideal is to promote dialogue and clarification. The signature formalizes the process, but true understanding comes through the transparent and accessible exchange of information.
Can I reuse data from a survey for another study?
In general, this will depend on what was agreed in the initial consent. If reuse involves new objectives or methods, it is recommended to renew the consent, ensuring transparency and respect for the autonomy of the participants.
Bibliographic References
- Dickert, N. W., Eyal, N., Goldkind, S. F., Grady, C., Joffe, S., Lo, B., Miller, F. G., Pentz, R. D., Silbergleit, R., Weinfurt, K. P., Wendler, D., & Kim, SYH (2017). Reframing Consent for Clinical Research: A Function-Based Approach. The American journal of bioethics: AJOB, 17(12), 3–11. https://doi.org/10.1080/15265161.2017.1388448
- Frost, C.J., Johnson, E.P., Witte, B., Stark, L., Botkin, J., & Rothwell, E. (2021). Electronic informed consent information for residual newborn specimen research: findings from focus groups with diverse populations. Journal of community genetics, 12(1), 199–203. https://doi.org/10.1007/s12687-020-00496-y
- Gelinas, L., Wertheimer, A., & Miller, F. G. (2016). When and Why Is Research without Consent Permissible?. The Hastings Center report, 46(2), 35–43. https://doi.org/10.1002/hast.548
- Grady, C., Cummings, S. R., Rowbotham, M. C., McConnell, M. V., Ashley, E. A., & Kang, G. (2017). Informed Consent. The New England Journal of Medicine, 376(9), 856-867. http://DOI: 10.1056/NEJMra1603773
- Hake, AM, Dacks, PA, Arnerić, SP, & CAMD ICF working group (2017). Concise informed consent to increase data and biospecimen access may accelerate innovative Alzheimer's disease treatments. Alzheimer's & dementia (New York, NY), 3(4), 536–541. https://doi.org/10.1016/j.trci.2017.08.003
- Riden, HE, Grooms, KN, Clark, CR, Cohen, LR, Gagne, J., Tovar, DA, Ommerborn, MJ, Orton, PS, & Johnson, PA (2012). Lessons learned obtaining informed consent in research with vulnerable populations in community health center settings. BMC research notes, 5, 624. https://doi.org/10.1186/1756-0500-5-624
- Xu, A., Baysari, M.T., Stocker, S.L., Leow, L.J., Day, R.O., & Carland, J.E. (2020). Researchers' views on, and experiences with, the requirement to obtain informed consent in research involving human participants: a qualitative study. BMC medical ethics, 21(1), 93. https://doi.org/10.1186/s12910-020-00538-7
