In the field of medical research, the protection of patient confidentiality is a key aspect of ethical practice, especially in a diverse socio-cultural setting like Cameroon. This blog post explores the concept of confidentiality, offers strategies to ensure its maintenance, highlights common pitfalls, and discusses the legal consequences of confidentiality breaches in the Cameroonian context.
What is confidentiality?
Confidentiality involves keeping an individual’s information private and undisclosed. This principle is crucial in various fields, particularly in medicine, research, and law.
Confidential information refers to details about a person’s private life that they wish to keep undisclosed, except for the purposes of the study. This is distinct from public information, which is accessible to everyone. The right of research participants to control their personal information is increasingly recognized and protected by extensive legislation. In research ethics, confidentiality is about respecting the dignity and autonomy of the participant and ensuring that the use of their information does not violate their interests. This right is recognized in international and national bioethical guidelines, including the Helsinki Declaration, the General Data Protection Regulation (GDPR), and the law governing biomedical research in Cameroon. Practically, safeguarding confidentiality means:
- Keeping research participants’ data anonymous and de-identified.
- Obtaining private data only when necessary.
- Informing participants about the research’s purpose and who has access to their data.
- Ensuring participants give active consent and retain the right to withdraw at any moment.
- Allowing participants to review and correct their data.
Fictional Case Study to Elucidate the Concept of Confidentiality in Cameroon
Consider a case study involving a medical research project in the North-West region of Cameroon, an area known for its cultural and linguistic diversity. The project aimed to study the prevalence of a certain genetic disorder among different ethnic groups in the region. To ensure confidentiality, the research team faced the challenge of communicating effectively with participants who spoke different local languages and had varying levels of understanding and trust in medical research.
The team employed local translators and cultural mediators who were fluent in the predominant local languages and dialects. They also conducted community engagement sessions to explain the purpose of the research, how data would be collected, and the measures in place to protect participants’ confidentiality. Consent forms were translated into multiple local languages, ensuring that participants fully understood their rights and the confidentiality of their data.
Despite these measures, the team encountered a situation where a participant’s genetic data, which had implications for his extended family, was inadvertently disclosed within his community. This breach not only caused distress to the participant and his family but also raised concerns among other participants and threatened the credibility of the research project.
The incident led to a review of data handling procedures. The research team reinforced their data security protocols and provided additional training to staff on the importance of maintaining strict confidentiality. They also held community meetings to address the incident, reassure participants, and restore trust in the research process.
This case study highlights the complexities of ensuring confidentiality in a diverse setting like Cameroon and underscores the need for continuous vigilance, cultural sensitivity, and community engagement in medical research.
Tips on Ensuring Confidentiality and Pitfalls to Avoid
Ensuring confidentiality in medical research involves a multifaceted approach. Here, we explore several key strategies and the pitfalls to avoid:
Ensuring Confidentiality Aspect | Strategy | Pitfall to Avoid |
De-identification of Data | Ensure that all participant data remain anonymous and de-identified. | Collecting data that can be directly linked to a patient, such as names or specific medical records. |
Electronic and Physical Data Protection | Implement robust security measures for electronic data and secure physical storage for paper records. | Using computers with weak passwords or storing sensitive data in unsecured locations. |
Regular Data Backup | Back up all research data on secure and reliable platforms or devices. | Risk of data loss due to technology glitches or mishandling of data storage devices. |
Training for Data Collectors | Provide comprehensive training to all team members on data confidentiality. | Inadequate training leading to unintentional data breaches. |
Confidentiality Agreements for Research Teams | Have all team members sign confidentiality agreements. | Discussing sensitive information in public or with unauthorized individuals. |
Well-Managed Informed Consent Process | Ensure that participants fully understand their rights and the use of their data. | Obtaining consent without adequately informing participants of their rights and data use. |
Controlled Data Disclosure | Disclose data only with explicit permission and under controlled circumstances. | Unauthorized or accidental disclosures of participant information. |
Data Encryption | Encrypt data, especially during transfer, to protect it from unauthorized access. | Transferring data without adequate security measures. |
Legal Implications of a Confidentiality Breach in Cameroon
In Cameroon, the legal framework provides clear guidelines and penalties for breaches of confidentiality in medical research and practice. Cameroon’s law on medical research outlines specific guidelines for data use and sharing. Key articles mandate informed consent for data reuse and sharing, and the obligation to maintain data confidentiality. Non-compliance can lead to legal action. Section 62 of the law states that “whoever, involved in a medical research project, discloses confidential information without the prior consent of its owner, shall be punished with imprisonment of from 3 (three) months to 3 (three) years and a fine of from 20,000 (twenty thousand) to 100,000 (one hundred thousand) CFA francs”. This provision is important to protect the privacy and confidentiality of participants in medical research. It also helps to ensure that research data is not misused or exploited. Example: A researcher is conducting a medical study on a new drug to treat HIV/AIDS. The researcher collects confidential information from the study participants, such as their medical history, HIV status, and treatment response. If the researcher discloses this confidential information to anyone without the prior consent of the participants, they could be punished with imprisonment and/or a fine.
The law also dictates that medical practitioners adhere to professional secrecy. Breaches, as per the Penal Code, can result in imprisonment, fines, and professional sanctions such as suspension or removal from the medical register.
References
- Confidentiality – Definition, Examples, Cases (legaldictionary.net)
- Bos, Jaap. “Confidentiality,” 149–73, 2020. https://doi.org/10.1007/978-3-030-48415-6_7. (10) (PDF) Confidentiality. Available from: https://www.researchgate.net/publication/ 344372529_Confidentiality [accessed Jun 13 2023].
- Avoiding Preventable Breaches of Confidentiality Mary Alice Fisher https://doi.org/10.1093/med:psych/9780199752201.003.0009 Step 5: Avoiding Preventable Breaches of Confidentiality | The Ethics of Conditional Confidentiality: A Practice Model for Mental Health Professionals | Oxford Academic (oup.com)
- The 7 Most Common Causes of Data Breaches (makeuseof.com)
- Journal Officiel de la République du Cameroun; portant Code de Procédure Pénale N°2005/007 27 Juillet 2005, https://bit.ly/3r07gMG
- Law No. 2022/008 of April 27, 2022, relating to Medical Research Involving Human Subjects in Cameroon, LOI Nº 2022/008 DU 27 AVRIL 2022 RELATIVE A LA RECHERCHE MEDICALE IMPLIQUANT LA PERSONNE HUMAINE AU CAMEROUN | Centre de Documentation Numérique du Secteur Santé (minsante.cm)
- Cameroun: Décret N° 83-166 Du 12 Avril 1983 Portant Code De Déontologie Des Médecins. Cameroun: Décret n° 83-166 du 12 Avril 1983 portant code de déontologie des médecins – Camerlex
- Loi no 92/007 du 14 août 1992, portant Code du Travail au Cameroun https://www.medcamer.org/wp-content/uploads/2014/10/Code-du-Travail-au-Cameroun.pdf
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Thank you for this well adapted article
The different scenarios and possible pitfalls were particularly helpful
Hi Dr Tanlaka.
It’s a pleasure to help with these scenarios so that you can have an idea of what to do in your own context.