The challenges of informed consent and its impact on clinical research in Nigeria

Obtaining informed consent is one of the most important aspects of clinical research. Without getting consent from the trial participant, the study cannot be accepted by regulatory bodies and would be considered unethical.

The Institutional Review Board (IRB) mandates informed consent to protect the autonomy of research participants and ensure they have the information needed to make a voluntary decision to participate.

In Nigeria, the process of obtaining informed consent is far from straightforward. Our socio-cultural realities, religious beliefs, poverty levels, and trust issues all come into play. And if we don’t address these challenges, they can enable or halt a research study.

What is informed consent?

Informed consent is an applied ethics principle in which patients are given important information, including the possible risks and benefits, about a medical procedure or treatment, genetic testing, or a clinical trial. This is to help them decide if they want to receive treatment, undergo testing, or join a study.

Before a volunteer or trial participant decides to participate in a study, they will be asked to review an informational document called an informed consent form. This form will provide key facts about the study so they can decide if participating is right for them.

The document is only a part of the story. The most important aspect is the informed consent process itself, which requires an ongoing conversation between the research team and the participant. The researchers/medical personnel are mandated to use clear, non-technical language tailored to the participant’s educational level to ensure a genuine understanding of what they are agreeing to, free from any pressure or coercion. 

Providing consent does not obligate the trial participant/volunteer to stay in the research until its completion.

What does the ICH E6 R3 say about informed consent?

The ICH E6 R3 is the updated guideline that directs how informed consent should be handled. In summary:

• Every participant must give free and informed consent before joining a clinical trial. This consent should be clearly documented.
  
• If a participant cannot give consent themselves due to different circumstances like age or incapacity, a legally acceptable representative can provide consent, and a minor as a participant can also give their assent where appropriate.
  
• The consent process should be clear and tailored to explain the trial, its risks, benefits, and burden in a way that the participants or their representatives can understand.
  
• In emergencies, if prior consent is not possible, it should be obtained as soon as possible afterwards, following regulatory and ethics committee guidelines.
  

Types of Informed Consent

1. Written Informed Consent: This is the most commonly used form of informed consent in clinical research. A written or signed consent follows a conversation between the doctor and the patient. During this conversation, the doctor records the informed-consent process to serve as formal evidence of the process.
   
2. Verbal Informed Consent: This method requires researchers to explain the study in detail and carefully document the conversation, making sure the participant truly understands. In communities where literacy levels are low and many people cannot read or write, verbal consent becomes extremely important. It allows participants to make informed decisions without being excluded simply because they cannot navigate written documents.
   
3. Electronic Informed Consent (eConsent): This method uses digital systems and multiple electronic media, such as text, video, and interactive websites, to provide information about a clinical trial and obtain a participant’s signature for informed consent. Compared to paper-based consent, electronic consent is linked to key factors such as providing adequate information, ensuring accuracy, improving shared decision-making, and increasing efficiency
   
4. Implied Informed Consent: Implied consent occurs when a patient passively cooperates in the process without any form of discussion or formal consent.

Case study of failed informed consent

In 1998, during a meningitis outbreak in Kano, Pfizer, a pharmaceutical company, tested its drug Trovan. Five children died on Trovan and six on ceftriaxone. Later, it was claimed that Pfizer did not have proper consent from parents to use an experimental drug on their children, and questions were raised over documentation.

This is the most documented and frequently cited case of ethical violation in Nigerian clinical research.

Challenges of informed consent in Nigeria

• Low Educational Background: Nigeria’s illiteracy rate is around 31% of the adult population. This high level of illiteracy also influences the capacity of patients to understand and make informed decisions as it pertains to their health.
  
  
• Lack of Trust: Trust is the total confidence or assurance that the physician will make a decision based on the best interest of the patient. The failure of Pfizer, where participants claimed there was no consent because they trusted the doctor, has now created a lasting trust deficit that still affects patient recruitment and public engagement efforts in that part of Nigeria today. Researchers must now actively work to overcome this pre-existing skepticism. The consequence of a past ethical failure now affects the modern-day consent process.
  
  
• Overwhelming Clinical Workload: Nigeria faces a severe shortage of health professionals, with only about 1.95 health workers per 10,000 people, leaving many providers with limited time to conduct the essential, in-depth consent process. A clinical team with a negative attitude or insufficient training would fail to communicate information clearly, even if the patient is willing to participate. 
  
  For example, in early September 2025, a young doctor at the Rivers State University died after being on a shift for 72 hours. This is a cycle that keeps repeating itself. Doctors are being placed on rotating shifts for months without rest. This shows that the problem of improper consent is a complex systemic failure that requires a multi-faceted solution focused on both capacity building and incentives for clinical staff.
  
  
• Religion: Religion influences ethics and healthcare in Nigeria, for instance during COVID-19, you’d hear things like “taking the vaccine is the mark of the beast.” Religious perspectives affect the understanding and reception of consent information and may be used by patients to mask the reality of some information they would rather not know.
  
  
• Poverty: Studies have shown that people with poor economic status are likely to accept and obey instructions without questioning them.

The Consequences of Inadequate Informed Consent

Failure to get informed consent is regarded as an ethical violation.

• Operational and Regulatory Failures: A participant who does not understand the study they have joined is more likely to drop out, leading to high attrition rates that can compromise the trial’s efficiency and success.
  
  Inadequate comprehension can lead to non-adherence to study protocols and the provision of inconsistent or inaccurate data, eroding the entire dataset’s integrity. Beyond the operational level, failure to adhere to NAFDAC’s strict GCP guidelines can result in audit failures, protocol rejection, and the suspension of a study, which would pose a significant business and reputational risk for CROs and sponsors.
  
  
• Legal: Trial participants have the fundamental right to be protected from undergoing medical interventions without their agreement, and failing to obtain proper informed consent can have serious legal consequences for healthcare providers, including the risk of malpractice lawsuits and penalties from regulatory bodies.
  
  
• Credibility: When a country’s clinical trial ecosystem is perceived as ethically questionable, international sponsors are deterred, leading to a loss of vital investment and a slower pace of medical innovation. This undermines Nigeria’s vision of becoming a hub for medical research in West Africa. Moreover, data from trials with documented ethical failures may be rejected by global regulatory bodies, such as the Food and Drug Administration (FDA). This means that the time, money, and effort invested are rendered useless. 

How do we solve the issue of informed consent in Nigeria?

Investment:

We can’t fix the problem of consent properly with a broken healthcare system. We need more investment in Nigeria, especially in three critical places: Hospitals and Clinics (so consent doesn’t happen in a packed hallway), Professionals (hire more nurses and doctors, train clinicians properly, and ensure they have the time to carry out their duties effectively), and Programs (fund consent-specific roles like consent educators).

Right now, our health worker density is low, so clinicians are stretched. We need to invest in public–private partnerships, donor grants for rural trial sites, and budget lines that pay for community engagement and consent materials. When our sites are not scrambling for basic equipment or staff salaries, they would actually have the time to talk, listen, and check understanding.

Advocacy:

People don’t know their rights, and we can solve the issues by running clear, repeated messages like: “You can ask questions. You can say no. You can stop anytime.” Use radio, market announcements, church/mosque platforms, local influencers, and short skits in local languages. Push for patient-rights campaigns that show examples (real stories) where proper consent protects people, which builds trust. Push regulators and lawmakers to require plain-language one-page summaries for every trial so communities can read and share the basics before recruiters get to them.

Restructure Medical Education:

Medical and nursing schools need to go beyond teaching clinical facts; they should also be teaching communication. Future doctors and nurses should have mandatory training on GCP, but more importantly, practical classes on using plain language, practising cultural sensitivity, and running real consent conversations.

Role-play with actors from local communities can make this training real, and assessments shouldn’t stop at “was the form signed?” but “did the patient truly understand?” When we train this way, consent stops being a box to tick and becomes a real skill.

Audit Trials (and enforce consequences):

Audits should not just stop at checking the paperwork. They need to go deeper, watching how consent conversations actually happen, reviewing whether participants really understood, and confirming that translations and witness processes were done properly. Regulators (NHREC and NAFDAC) should publish audit results openly and apply sanctions when consent falls short.

Consent quality should be a trial-level KPI, like how many participants passed a short comprehension check, whether re-consent was documented on time, and if the community was properly engaged. When teams know they’ll be assessed on substance, the practice naturally improves.

Technology :

Electronic Consent tools, especially those with videos or audio in local languages, would go a long way in helping people truly understand what they’re signing up for.

Imagine someone in a rural area who struggles with English, you can’t just hand them a paper and expect it to make sense. But if they watch a short video or listen in their own language, the message lands better.

Of course, it shouldn’t stop there. After the digital module, there should always be time for a one-on-one conversation, because people will still have personal questions. When we store those consent records digitally with clear audit trails of who signed, when, and which version, it keeps the whole process transparent and easy to track.

The way forward

This is where UCTSS comes in. As a CRO, we provide the expertise and systems that make ethical, high-quality research possible in Nigeria. 

We train investigators and researchers to clearly communicate the importance of the trials and build transparent relationships with communities.  

We built a clinical trial management system, UCTMS, that simplifies and strengthens the trial process. By doing this, we ensure that trials are not just scientifically rigorous but also ethically sound and when sponsors see that level of integrity and quality, they are more willing to invest in Nigeria’s research ecosystem.

In the end, solving the issue of informed consent is about respect and trust in  Nigeria’s place in global clinical research. If we get it right, we’ll not only protect participants but also prove that Nigeria can set the standard for ethical, world-class trials.