<p>Clinical trials of new therapies for Covid-19 have stirred heated debate about the scientific validity of research studies. But an important aspect – ethical concerns of participants – are hardly discussed. The voluntary informed consent of clinical trial participant – a vital ethical requirement – is fraught with tremendous challenges during the conduct of Covid-19 clinical trials. </p>.<p>Good Clinical Practice (GCP), which is the international ethical and scientific quality standard for the conduct of clinical trials, describes informed consent as a process by which a clinical trial participant voluntarily confirms his or her willingness to participate. </p>.<p>Valid informed consent process depends on: </p>.<p>Disclosure of all relevant information accurately about the nature, purpose, methods, risks, potential benefits, and alternatives available </p>.<p>Understanding the information provided and its relevance to the personal clinical situation of the participant </p>.<p>Capacity or ability of a participant to make decisions after understanding the information provided and</p>.<p>Voluntary decision to participate in a clinical trial made without coercion.</p>.<p>A person’s competence to consent for a clinical trial is defined by his or her ability 1) to understand relevant information 2) to assess information to make a reasoned decision 3) to decide without undue influence, and 4) to convey consent or refusal. When a patient suffering from a serious infection – Covid-19 is requested to participate in a clinical trial, his or her vulnerability is likely to cloud his ie her voluntariness. </p>.<p>Such patients could be in intensive critical care, receiving high flow oxygen or on a ventilator, and would be worried about complications of disease and death. Such severely ill patients are vulnerable as their decision-making capacity is impaired, affecting their comprehension of the experimental nature of clinical trials, the benefits and risks of the investigational drug, and the concept of randomization--chance of receiving drug or standard care without drug. The patient’s decision may be influenced by high expectations of benefits and/or low understanding of risks of participation in a clinical drug trial and experimental treatment. This situation is made complex by the challenges of language of consent and literacy level, and communication by physicians wearing full personal protective equipment. </p>.<p>Informed consent, as per GCP, requires the signature and date of the participant, and the investigator--clinical research physician. If the patient lacks the capacity to give consent due to the severity of Covid-19, for example, acute respiratory failure or on a ventilator, then consent may be obtained from a family member or relative acting as the patient’s legally acceptable representative over a mobile phone or email. However, consent from family members may not be possible, as they could be quarantined or hospitalized. ICMR 2020 guidelines permit record and documentation of consent orally or by use of electronic methods if written consent is not possible from severe Covid-19 patients or physically isolated patients. </p>.<p>Compliance to GCP standard requires protection of the rights, safety, and well-being of all trial participants. The clinical research physician should educate patients about the research, benefits and risks, and alternatives, take precautions to avoid exploitation, and take informed consent without any coercion or incentive for participation. The informed consent process from the patient or patient’s legally acceptable representative should be well documented by audio-visual recording. The Ethics Committee, which has approved the clinical trial, has the prime responsibility of review and oversight of the clinical trial conduct by visiting the site and monitoring the process. As Ethics Committee would not be able to visit the site during a pandemic and therefore should review the audio-visual recording of the informed consent process. In the rush to discover treatments for a serious medical condition, all individuals, organizations, and sponsors should remember that the rights, safety, and well-being of the trial participants are the most important considerations and should prevail over interests of science and society. </p>.<p><em>(The writer is a Consultant for Clinical Research and Drug Development) </em></p>
<p>Clinical trials of new therapies for Covid-19 have stirred heated debate about the scientific validity of research studies. But an important aspect – ethical concerns of participants – are hardly discussed. The voluntary informed consent of clinical trial participant – a vital ethical requirement – is fraught with tremendous challenges during the conduct of Covid-19 clinical trials. </p>.<p>Good Clinical Practice (GCP), which is the international ethical and scientific quality standard for the conduct of clinical trials, describes informed consent as a process by which a clinical trial participant voluntarily confirms his or her willingness to participate. </p>.<p>Valid informed consent process depends on: </p>.<p>Disclosure of all relevant information accurately about the nature, purpose, methods, risks, potential benefits, and alternatives available </p>.<p>Understanding the information provided and its relevance to the personal clinical situation of the participant </p>.<p>Capacity or ability of a participant to make decisions after understanding the information provided and</p>.<p>Voluntary decision to participate in a clinical trial made without coercion.</p>.<p>A person’s competence to consent for a clinical trial is defined by his or her ability 1) to understand relevant information 2) to assess information to make a reasoned decision 3) to decide without undue influence, and 4) to convey consent or refusal. When a patient suffering from a serious infection – Covid-19 is requested to participate in a clinical trial, his or her vulnerability is likely to cloud his ie her voluntariness. </p>.<p>Such patients could be in intensive critical care, receiving high flow oxygen or on a ventilator, and would be worried about complications of disease and death. Such severely ill patients are vulnerable as their decision-making capacity is impaired, affecting their comprehension of the experimental nature of clinical trials, the benefits and risks of the investigational drug, and the concept of randomization--chance of receiving drug or standard care without drug. The patient’s decision may be influenced by high expectations of benefits and/or low understanding of risks of participation in a clinical drug trial and experimental treatment. This situation is made complex by the challenges of language of consent and literacy level, and communication by physicians wearing full personal protective equipment. </p>.<p>Informed consent, as per GCP, requires the signature and date of the participant, and the investigator--clinical research physician. If the patient lacks the capacity to give consent due to the severity of Covid-19, for example, acute respiratory failure or on a ventilator, then consent may be obtained from a family member or relative acting as the patient’s legally acceptable representative over a mobile phone or email. However, consent from family members may not be possible, as they could be quarantined or hospitalized. ICMR 2020 guidelines permit record and documentation of consent orally or by use of electronic methods if written consent is not possible from severe Covid-19 patients or physically isolated patients. </p>.<p>Compliance to GCP standard requires protection of the rights, safety, and well-being of all trial participants. The clinical research physician should educate patients about the research, benefits and risks, and alternatives, take precautions to avoid exploitation, and take informed consent without any coercion or incentive for participation. The informed consent process from the patient or patient’s legally acceptable representative should be well documented by audio-visual recording. The Ethics Committee, which has approved the clinical trial, has the prime responsibility of review and oversight of the clinical trial conduct by visiting the site and monitoring the process. As Ethics Committee would not be able to visit the site during a pandemic and therefore should review the audio-visual recording of the informed consent process. In the rush to discover treatments for a serious medical condition, all individuals, organizations, and sponsors should remember that the rights, safety, and well-being of the trial participants are the most important considerations and should prevail over interests of science and society. </p>.<p><em>(The writer is a Consultant for Clinical Research and Drug Development) </em></p>