How COVID-19 is changing consent forms

"Very little is known"/ "no one can be certain"/ "there is limited information"/ "however"/ "risks"/ "complications"/ "uncertainties"/ "even without a positive test"/ "may cancel"/ "no compensation for costs"/ "I understand"/. 

COVID-19 is changing consents.

Organizations like the European Society of Human Reproduction and Embryology (ESHRE) and the Society for Assisted Reproductive Technology (SART) are advising fertility clinics to make sure their patients understand that pregnancy during the pandemic carries significant uncertainties.

"Consent before COVID and consent during COVID need to be different," says Edgar Mocanu, a fertility doctor in Dublin, and a member of ESHRE'S COVID-19 working group. "Remember, it takes nine months to deliver a child from conception, from transfer... We have a duty to tell our patients that we still don't know these long-term impacts."

SART, in the US, is encouraging fertility clinics to document that patients have been fully informed, and the organization provides templates for leaflets, medical notes and consent forms. 

The American Society for Reproductive Medicine (ASRM), to its credit, underscores that "[i]t is important to recognize that patients may interpret a physician’s willingness to treat as an indication that their risk is minimal, and this may well not be the case. The issue of risk/benefit should be highlighted as a starting point for all patients treated in this environment."

The Canadian Fertility and Andrology Society (CFAS) suggests clinics inform patients of risks "as early as possible before treatment," provide them opportunities for questions, and "confirm their understanding of the risks and policies in writing." 

The CFAS doesn't mention anything about a new standard Canada-wide consent form, but Toronto's Trio clinic does: "Please note that every clinic in Canada will be asking patients to sign the exact same consent. You will not be able to begin fertility treatment until you have signed this form." (This document, also described as a "waiver," appears to be it.)

I'm not going to knock clinics for admitting uncertainties; I've criticized them in the past for failing to do just that, especially regarding procedures like egg donation. So I think these revised forms are probably a good thing.

But let's face it, we all know that consent forms are more about liability than permission. And as such, they can be highly informative, because they spell out some of the things fertility clinics are genuinely concerned about. 

Below, drawing from a small collection of consent forms and posts addressing consent, I highlight some of the clauses patients are now being asked to acknowledge or agree to. (The bolding is mine.)

Just sign here

The effect of pregnancy on COVID-19 disease course

"There is very little known regarding a pregnant woman's susceptibility to catching COVID-19 or experiencing severe symptoms or dying. The currently available data on COVID-19 does not indicate that pregnant women are at increased risk. However, pregnant women are more susceptible to and at greater risk of mortality and complications from other respiratory infections such as influenza and SARS."

"There is very little research on a pregnant woman's susceptibility to catching COVID-19. This means that no one can be certain if pregnant women are more likely to contract COVID-19 compared to a non-pregnant adult."

"There is limited information from published scientific reports about the susceptibility of pregnant women to COVID-19 and the severity of infection. In general, pregnant women experience immunologic and physiologic changes that make them more susceptible to viral respiratory infections, as is observed with other coronavirus infections and viral respiratory infections, such as influenza, during pregnancy. However, there is currently no evidence that pregnant women who contract COVID-19 may be at greater risk for severe illness, or even death, compared with the general population."

The effect of COVID-19 on pregnancy

"There is little known regarding the impact of COVID-19 on pregnancy. Prior data suggest that high fever in early pregnancy may be associated with an increased risk of birth defects and miscarriage. Some infections in later pregnancy may result in stillbirth and preterm birth."

"The risks of COVID-19 on pregnancy, if any, are unknown but could include birth defects, miscarriage, stillbirth, preterm birth or other pregnancy complications."

"The impact of COVID-19 on pregnancy are unknown. Some guidance societies have recommended a strategy to minimize pregnancy during this crisis. I understand that the risks could include miscarriage, stillbirth, preterm birth and other unknown impacts on pregnancy."

"High fever from any cause, including COVID-19, in the first trimester of pregnancy may be associated with an increased risk of birth defects. Covid-19 or seasonal influenza in the third trimester of pregnancy may be more likely to lead to pneumonia. Cases of pneumonia in pregnancy may be more severe and require hospitalization and may lead to maternal and fetal compromise."

"There is very limited information on how COVID-19 affects women and unborn children in the first trimester of pregnancy.Further, there may not be any significant data on pregnancy and COVID-19 soon as all information takes time to collect and evaluate. There is no current approved treatment (medication) for COVID-19, and if a pregnant woman gets COVID- 19, the current medication used to provide compassionate care to patients afflicted with COVID-19 is contraindicated for use in pregnancy."

"Delaying pregnancy until the risk of COVID-19 infection is low should be considered for women living in those areas where there is a high risk of infection."

The effect of COVID-19 on offspring

"Currently, it is unclear if COVID-19 can cross the placenta to directly harm the fetus. Although it is unclear what the optimal medical treatments are for this infection, a variety of medications are used to combat the illness. It is possible some of these medications may cause harm to the pregnancy or fetus."

"There is very little information on the transmission of COVID-19 to fetuses. The small amount of data reported out of Wuhan, China and New York does not show any definitive evidence of intrauterine fetal infections with COVID-19; therefore, it is believed that the risk of transmission of COVID-19 to a fetus in utero is low or non-existent."

The effect of COVID-19 on sexual transmission

"There is currently no scientific evidence showing that COVID-19 is transmitted to or carried by oocytes (eggs) or sperm."

"It is currently unknown if COVID-19 can be spread through semen, vaginal secretions, or sexual intercourse."

The risk of catching the disease through the fertility clinic

"I may become exposed to COVID-19 while receiving treatment by other patients or a [PRACTICE NAME] provider."

The economic risks to the patient

"If I am directly exposed, infected or diagnosed with COVID-19, or have symptoms with any febrile illness or have flu like symptoms which could possibly be COVID-19 (even in the absence of a positive COVID-19 test), my/our treatment cycle will be cancelled."

"My/our treatment cycle may be cancelled if PRACTICE NAME is not able to support treatment as a result lack of essential staff or supply shortages."

"...if the cycle is cancelled for any reason... this may affect my insurance benefits and/ or I may be financially responsible for any services performed, including any medication expenses incurred."

"If I am diagnosed with COVID-19, am directly exposed to COVID-19 or am suspected to have COVID-19 based on symptoms (even without a positive test), [PRACTICE NAME] will not continue with my treatment cycle. I understand that the expenses occurring to date will not be reimbursed."

"Individuals with confirmed or suspected COVID-19 infection, or potential exposure to any individual with COVID-19... [m]ay have their treatment postponed, rescheduled, terminated or the manner in which the service is rendered modified depending on the clinical circumstances and there will be no compensation for costs incurred."

"COVID-19 tests are not 100% accurate as diagnostic tests may sometimes give false negative results and positive antibody tests do not guarantee immunity from COVID-19. If I demonstrate symptoms, [PRACTICE NAME] may cancel my treatment, even if I have been tested and had a negative result."

"I understand that a treatment cycle started could be cancelled due to unforeseen

circumstances, such as new government regulations, staff shortages, PPE shortages, personal infection with COVID-19 or a COVID-19 outbreak within the clinic."

"I have the option to review this with my legal representative before signing."

"I/we hereby release and forever discharge [PRACTICE NAME], its predecessors, successors, affiliates, agents, physicians and employees from any and all claims, liabilities and responsibilities which may arise should I become infected with the novel coronavirus and/or develop COVID-19."

"Due to the increased administrative and nursing support that is necessary to operate the clinic as a result of the COVID-19 pandemic, there is a one-time administration fee of $300 per patient."

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Related links

ESHRE

SART

ASRM

CFAS

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