The Ugandan High Court has set out guidelines for obtaining informed consent from the subjects of human clinical drug trials. In Harriet Mukoda v International AIDS Vaccine Initiative, the petitioner claimed that her consent was unlawfully obtained through misrepresentation of the potential effects and benefits of the drug trial. She further claimed that the consent obtained was ineffective as it was not administered in her native language.
The requirements for informed consent prior to conducting clinical trials are in the National Drug Policy and Authority (Conduct of Clinical Trials) Regulations, 2014, the Guidelines on Good Clinical Practice in the conduct of Clinical Trials involving Human Participants, 2019 as well as the National Guidelines for Research involving Humans as Research Participants, 2014. These regulations and guidelines place an obligation on study sponsors and principal investigators to protect the rights and wellbeing of participants in clinical trials through obtaining informed consent. The guidelines also specify how informed consent should be obtained from a subject prior to their participation in a clinical trial.
The court applied the principles set out in these guidelines and further relied on the Guidelines in the Helsinki Declaration, 1964 and the Belmont Report, 1979 to explain the standard and meaning of informed consent.
The Helsinki Declaration and Belmont Report set out a three-pronged strategy on informed consent, namely information, comprehension and voluntariness.
- First, informed consent is obtained on the basis of the kind of information disclosed. Sufficient information must be provided to the participant including, the research procedure, the purposes, risks and anticipated benefits of the research, alternative procedures, and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research.
- Secondly, the participant must comprehend the information disclosed. Information should be presented in an organised manner, allowing time for consideration and opportunities for questioning.
- Finally, the consent should be given voluntarily. Consent should be sought in circumstances that minimise the possibility of coercion, or undue influence that may include an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance.
The court further stated informed consent should not include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
The court found that the consent of the petitioner to participate in the study was properly obtained under the standard set out above. The petitioner was conversant with the language used to obtain her consent and obtained a perfect score when she was assessed to determine whether she had understood the information provided. The court concluded that the petitioner's rights were not violated and the suit was dismissed.
The High Court decision is a timely ruling as the world continues to grapple with the Coronavirus ("COVID-19") pandemic and scientists push to develop a vaccine. Human clinical trials will be necessary and given the dangers of COVID-19, informed consent will be all the more important.
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