8/11/2020
Image by Sharon McCutcheon from Pixabay
During the pandemic, it has become evident that we must continue to consent COVID-19 patients into clinical trials as we work to discover treatment options and better understand other aspects of the disease. Because of isolation restrictions, it is more cumbersome for all involved to conduct the informed consent process as we are accustomed. The investigator or delegate is likely not permitted into the isolation room to discuss the aspects of the trial with the potential subject. This leads to barriers to their ability to see important facial features communicated during a conversation. The Food and Drug Administration (FDA) released a Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency with a series of updates to inform clinical researchers on how to adequately consent subjects while respecting their rights. This includes using phone or video conference to communicate with the potential subject to explain the trial. The Office for Civil Rights (OCR) released an Enforcement Discretion allowing telehealth to be used to communicate with the subjects during the trial.
However, there is a concerning aspect related to consenting COVID-19 patients. Many who are sick enough to be hospitalized experience neurocognitive changes. Would the investigator or delegate pick up on their level of understanding through a phone call with the potential subject? With a face-to-face interview, it is easier to assess whether the potential subject has a good understanding of what they are consenting to. There are small clues communicated such as eye contact or a confused stare to indicate understanding or lack of it. They are free to take the consent home and discuss it with loved ones when in a comfortable, low stress environment. This is not so when a COVID-19 patient is in isolation. We need to be cognizant of the stress that may impair their ability to make a decision on whether or not to consent.
Also, since their friends and family are not permitted in the room with them, they may not have adequate opportunity to discuss the intricacies of the clinical trial with them. Add in cognitive changes due to the virus and it is difficult to see that they have the minimum requirements under Good Clinical Practice to consent to a clinical trial. Did they have adequate time to decide and did they truly understand? Was their legal representative included in discussions? Would they have declined if a family member was there?
This in no way should diminish the urgency to consent COVID-19 patients, but it should remind us that there are new and extenuating factors to consider compared to consenting potential subjects in non-COVID-19 clinical trials. We need to be mindful of the stresses the patient in isolation is experiencing and ensure they not only have all the information they need to consent, but also access to others to discuss and ask questions on their behalf if needed. A patient in isolation should be granted the same privileges as a potential subject who is not, just with different accommodations. They should be appreciated, not taken advantage of.
The concern about the rights of patients in isolation is broader than clinical trials. There are reports of people being admitted to the hospital where family members are not permitted to enter the building let alone assist their loved one. There have been cases of admissions where the patient was not cognitively able to agree to hospitalization and family members have not been contacted to make decisions on their loved one’s care. It sounds impossible that ethical protections for people undergoing medical treatment is reverting back to before modern standard of care. It is important to remember that all undergoing medical care are entitled respect and protections from procedures they do not want. Concern over spreading a virus during a pandemic should not be an excuse to hospitalize patients without discussing their care with others. Even in an emergency, the loved ones should be contacted at the earliest convenience to update them on their loved one’s status. Ethical treatment of all involved is the utmost importance.
So, for clinical trials during the pandemic, the risk of significant issues with consent is higher. It is important to be sure that consent is well documented and monitored closely and in a timely manner.
- The Clinical Pathways Team
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