Common themes in COVID consent documents

Apr 8th, 2020| Jeff Issner By Jeff Issner

Fertility clinics around the world are doing their best to adjust to the rapidly changing atmosphere caused by COVID-19. Balancing industry and government guidelines, patient treatment needs, and business health is not an easy feat. While nobody can claim to be a pandemic-response expert, we feel it’s important for the industry to support each other where we can in order to best weather the storm and prepare for the future.

As the leading platform for fertility patient education and informed consent, we’ve aggregated some of the common themes we see clinics addressing in their COVID-19 consent documents for patients pursuing treatment or preparing for a future cycle. With any informed consent, appropriate communication fosters trust and supports shared decision making, ultimately mitigating your risk. A few key points that we’re consistently seeing in COVID-19 consent documents:

 

  • We don’t know everything: First and foremost, practices are telling patients that information is rapidly evolving. This pandemic has created a situation in flux and patients should review the CDC/WHO/ASRM/ACOG/SMFM websites for the most up-to-date information.

 

  • What we do know: Prior data support that a febrile illness of any kind in pregnancy may pose risks including miscarriage, stillbirth, and preterm birth. Further, medications to treat COVID-19 are not currently tested/approved in pregnancy.

 

  • What we don’t know: The risks are unclear with regard to fetal development and maternal fetal transmission. The potential risk to both the patient and a pregnancy cannot be precisely quantified.

 

  • Risk of transmission: Medical care inherently requires breaking social-distancing guidelines and there is a risk of transmission of COVID-19 during travel to and from the office and at the office visit. Obtaining emergency medical care, if needed, may be challenging during the pandemic due to an overburdened health care system.

 

  • Risk of cancellation: Cancellation of a cycle is possible, especially in the following circumstances:
    • Issuance of new information, governmental restrictions, or governmental mandates
    • Inability for the clinic to support treatment due to staffing shortages, supply shortages, infection risk, or government mandate
    • Patient exposure to or diagnosis of COVID-19, or presentation of symptoms consistent with any illness suspected to be COVID-19 (even in the absence of a positive COVID-19 test)

 

  • Financial terms: It’s important to remember that patients are responsible for all expenses related to treatment, including if treatment is cancelled before its conclusion for any of the above reasons.

 

  • Current society guidelines: Many clinics have opted to clearly state ASRM’s current guidelines for patients to acknowledge. This requires maintenance, but is important for transparency and risk management.

 

  • It’s a two way conversation: Acknowledge that the patient has had the opportunity to discuss the implications of COVID-19 with their clinical team and ask any questions needed to reach an informed decision.

 

“With any informed consent, appropriate communication fosters trust and supports shared decision making, ultimately mitigating your risk.”

 

Our team will continue to monitor how fertility practices are managing informed consent through this pandemic and as treatment resumes. Please reach out to your account manager or through our website if you would like to discuss these trends further.

 

 

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