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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Navigating Patient Consent Scenarios in COVID-19 Trials
May 25, 2020
In his April 22 blog, my colleague Eric Delente shared the most frequently asked questions that IQVIA Technologies is being asked during the COVID-19 crisis. Many found the article helpful and had further questions around the topic of remote consent in a hospital setting, particularly when the patient is quite ill and requires a legally acceptable representative (LAR) to consent on his or her behalf. Thus, I’d like to share further insights on this topic as we gain experience through real-life implementations around the world.
What options do we have when the patient is unable to consent?
A pharmaceutical client recently summed up the proper perspective on remote consent: “Getting the patient’s direct consent is still the gold standard and should be the first route; but when they are already intubated, we need to pursue other options and then come back to the patient as soon as possible.” This is where a hybrid onsite/remote eConsent solution can really help. We have worked with our clients to clearly map out the consent process, so sites are able to easily navigate and manage different scenarios.
When a patient in the hospital is still able to consent at least verbally, the study doctor can quickly pull up the consent form on a tablet, review it with the patient in the presence of an impartial witness (IW), and have the IW sign on the tablet once verbal consent is given. This provides a time/date-stamped audit trail of the consent process. When the patient is already ventilated and unable to even give verbal consent, that's a scenario where we can turn to remote consent with a LAR. The study doctor can call the LAR, transmit a URL via email, text, or reading it out, so that the LAR has the ability to read and sign the consent from their own computer or smartphone. This document will then be countersigned by the study doctor and emailed back to the LAR, as well as printed or uploaded to the patient’s medical record.
How do we gain consent once the patient recovers?
Sites and monitors can print reports that identify which consents were signed by a LAR or IW, and then follow up on the status of those patients. As soon as the patient has recovered, he or she can read and sign a new eConsent that can be matched by study subject number to the original consent.
What if the patient or LAR does not have their own device available?
While eConsent can be accessed by any internet-enabled device, making “bring your own device” (BYOD) a great option, we have cases where patients are admitted to the hospital and do not have a smartphone with them. We can certainly deploy iPads or other tablets for use in these cases. The devices are shipped with instructions on proper sanitization methods and can be used with medical gloves or inserted into single-use plastic bags to reduce the risk of infection.
Are electronic signatures and remote consent accepted outside the U.S.?
Global regulatory acceptance is a significant issue right now. COVID-19-related trials and those impacted by interruptions are driving a strong, growing demand for remote consent outside the United States. To date, more than 10,000 patients have consented remotely to trials in the U.S., but this is relatively new to other regions in the world. In just the last few weeks, we have been approached by several pharmaceutical companies that need to run studies in a dozen countries. They share a common concern around how to safely engage patients or LARs in the consent process.
The good news is that many countries that have historically only approved print-to-sign are now very keen to consider new solutions that ensure consent can be obtained safely and with a high level of integrity. Brazil recently released guidance in support of remote consent and digital signatures for clinical trials at least through the pandemic. It appears a number of other Latin American countries are following suit.
This is an ideal time for sponsors and sites to engage in discussions with health authorities and ethics committees to assess their openness to electronic and remote consent, and the eConsent team at IQVIA Technologies stands ready to support these types of conversations to help answer any questions. If you’d like to discuss your specific situation, then please reach out to TDSE_Solutions@IQVIA.com.
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