Informed consent is a basic rule for doing things the right way in healthcare and research. In Cameroon, like many other countries, it signifies the process of educating a participant about the potential risks, benefits, and alternatives of a medical procedure or research intervention. The participant must be competent to make a voluntary decision without any coercion. Informed consent aligns with international standards such as the Declaration of Helsinki and Good Clinical Practice (GCP).

Informed consent in Cameroon extends across various domains of healthcare and research, including:

1. Treatment: Consent before medical interventions.
2. Dissemination of Patient Information: Permission to share health information.
3. General or Specific Medical Procedures: Consent for routine or specialized procedures.
4. Research Study Enrollment: Understanding and voluntary agreement to partake in a study.

Providers must clearly articulate their recommendations, ensuring that patients understand and voluntarily agree. The process should foster collaboration without coercion, aligning with both the patient’s values and Cameroon’s legal requirements.

The Informed Consent Process

The informed consent process in Cameroon must align with applicable regulations, Good Clinical Practice (GCP), and ethical principles rooted in the Declaration of Helsinki. Here is an overview of the critical steps:

1. Approval by IRB/IEC: Obtain written approval for the informed consent form, including any revisions, from the Institutional Review Board (IRB) or Ethics Committee (IEC) before use.
2. Timely Information Sharing: If relevant new information arises, promptly inform the participant or their legally acceptable representative, as it may affect their willingness to continue participation.
3. Avoiding Coercion: The investigator and research staff must not unduly influence or coerce participants into participating or continuing in the study.
4. Clear and Understandable Information: The participant, or their representative if the participant cannot provide consent, should receive a complete explanation of all pertinent aspects of the study, using non-technical language.
5. Time for Decision Making: Provide ample opportunity for the participant to inquire about details and decide whether to participate, ensuring all questions are fully answered.
6. Documentation: The written informed consent form must be signed and dated by the participant or their legally acceptable representative, and the person who conducted the discussion.
7. Special Considerations for Illiteracy: If the participant or representative cannot read, an impartial witness should oversee the entire discussion, ensuring that the consent form is read, explained, and understood. Both the participant and witness must sign and date the form.

By adhering to these guidelines, the investigator ensures that the informed consent process is conducted ethically, transparently, and in accordance with both international standards and Cameroon’s specific regulatory requirements.

Types of Informed Consent in Cameroon

In Cameroon, the legal age and type of consent required vary according to the participant’s age. Here’s a summary:

Cultural and Legal Considerations in Cameroon

When preparing informed consent in Cameroon, it is vital to consider the country’s unique cultural and legal context:

• Language Diversity: Cameroon is home to over 250 languages. Thus, consent forms might need to be translated into the local language to ensure full understanding.
• Community Engagement: In certain communities, engaging local leaders or community members might be essential to ensure culturally appropriate consent.
• Data Protection Laws: Adherence to Cameroon’s laws regarding personal data protection and privacy is crucial.
• Special Consideration for Vulnerable Populations: Extra care should be taken when dealing with minors, pregnant women, or individuals with disabilities.

Informed consent in Cameroon is not just a legal formality but an ongoing, interactive process that reflects respect for the participant’s autonomy, values, and cultural background. By following these guidelines, medical practitioners and researchers can foster trust and ethical integrity in their professional conduct.

Right of Participants to Information and Consent in Medical Research

These rights to information and informed consent is according to the Law Relating to Medical Research Involving Human Subjects in Cameroon. It states in sections 11 and 12 that;

• Any prospective participant in a medical research project must be informed, in a language he/she understands, about the purpose, benefits, advantages of, and procedures for carrying out the research project, the duration of the research, expected constraints and risks, possible medical alternatives, as well as his/her right to refuse or withdraw from the research project, without any disadvantage.
• Only someone who has been informed, has understood the information, and has freely, without pressure, coercion, or inducement, consented in writing to participate in a research project may be enrolled.
• A participant in a research project must withdraw his/her consent in writing. Such withdrawal shall mark the end of the process.
• However, the said withdrawal shall have no effect on the activities conducted or the use of data obtained based on the informed consent given before withdrawal.

Informed Consent in Special Cases (Vulnerable Persons)

• Minors: The consent of a minor shall be given by his/her legal representative. Such consent shall be valid only if the said minor, based on his/her understanding capacity, has given his/her consent after receiving the requisite information from a pedagogically competent staff member. He is free to refuse to participate or withdraw from the study.
• Incapacitated adults: a research project can include an incapacitated adult only where (1) it is consented to by the person concerned, while in a state of capacity and such consent being attested by a document, (2) informed consent has been given in writing by the legal representative, where no documented consent is available, (3) the person concerned does not in an identifiable manner, express opposition to the research intervention either verbally or by his/her behaviour.
• Pregnant women: same procedure as vulnerable (understand all the risks and benefits, procedure and have the right to refuse/withdraw from the study)
• Emergencies: (1) the necessary steps have been taken to ascertain the wishes of the person concerned as soon as possible, (2) the person concerned does not in an identifiable manner, express opposition to the research intervention either verbally or by his/her behaviour, (3) Once it has become possible for the research subject to express his/her wishes, he/she must be adequately informed about the research project, (4) if the person concerned refuses to give post hoc consent, the biological material and data may no longer be used for the research project

Template from the National Ethics (Important information to be found in an informed consent)

Format of an Informed Consent Form

I, the undersigned, Mr/Mrs/Ms (Surname(s) and Forename(s)) ………………………………………..

Have been invited to participate in the research project entitled “…………………………………….”.

whose principal investigator is (Surname(s) and Forename(s)) + address……………………………

• I have fully understood the information leaflet given to me concerning this study.
• The information leaflet concerning this study has been read to me and explained.
• I have fully understood the purpose and objectives of this study
• I have received all the answers to my questions
• The risks and benefits have been presented and explained to me.
• I understand that I am free to accept or refuse to participate.
• My consent does not relieve the research investigators of their responsibilities. I retain all my rights guaranteed by law.

I freely agree to participate in this study under the conditions specified in the information leaflet, i.e. (For example) :

• To answer survey questions
• To provide medical information
• To donate XXml of my blood (according to some studies)
• Etc.

I give my consent for the rest of the samples taken for this study to be used in future studies.

Signed at ………………………….. On ………………………….

Principal investigator (name and address)                            Participant (name and address)

N.B This form is only a model, you must adapt it to the requirements and contours of your study.

References

• SOPs for a document or protocol to be presentable to the National Ethics Committee dossier_clairance_ethique.pdf (minsante.cm)
• Shah, Parth, Imani Thornton, Danielle Turrin, and John E. Hipskind. “Informed Consent.” In StatPearls. Treasure Island (FL): StatPearls Publishing, 2023. http://www.ncbi.nlm.nih.gov/books/NBK430827/.
• Guideline for good clinical practice E6(R2) 2016 version Informed Consent of Trial Subjects (ichgcp.net)
• Edwards S. Review of a medical illustration department’s data processing system to confirm general data protection regulation (GDPR) compliance. J Vis Commun Med. 2019 Jul;42(3):140-143. doi: 10.1080/17453054.2019.1594724 
• 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)