Disclosure of medical errors involving gametes and embryos: an Ethics Committee opinion
Ethics Committee of the American Society for Reproductive Medicine
Committee members:Judith Daar, Paula Amato, Jean Benward, Lee Rubin Collins, Joseph B Davis, Leslie Francis, Elena Gates, Sigal Klipstein, Barbara Koenig, Laurence McCullough, Richard Reindollar, Mark Sauer, Rebecca Sokol, Andrea Stein, Sean Tipton, …
Ethics Committee of the American Society for Reproductive Medicine (2016). Disclosure of medical errors involving gametes and embryos: an Ethics Committee opinion. Fertility and sterility. https://doi.org/10.1016/j.fertnstert.2016.03.018
Ethics Committee of the American Society for Reproductive Medicine. Disclosure of medical errors involving gametes and embryos: an Ethics Committee opinion. Fertility and sterility. 2016. doi:10.1016/j.fertnstert.2016.03.018
Ethics Committee of the American Society for Reproductive Medicine. "Disclosure of medical errors involving gametes and embryos: an Ethics Committee opinion." Fertility and sterility, 2016.
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RRM Academy Synopsis
ASRM Ethics Committee holds clinics must disclose gamete mix-ups
A 2016 ASRM Ethics Committee opinion holds that clinics must tell patients about wrong-sperm and switched-embryo errors once they find them. The committee also holds that doctors must tell patients about lost or damaged gametes and embryos, unless the impact is clearly minimal. The opinion is a position statement with no data.
Key Findings
The committee holds that disclosing misdirected gametes or embryos is obligatory "without exception", even if the embryo has not implanted or no child has been born.
For lost or degraded gametes or embryos, the committee holds physicians are obligated to tell patients when the error affects their number or quality, unless it could not affect their interests.
For near misses, the committee says disclosure "should be considered" and "is not obligatory". Clinics should have policies for a root-cause analysis after errors and near misses.
The committee calls the view that disclosure may cause harm, such as pregnancy termination or stress, "misguided". In misdirection cases, disclosure lets the people most affected decide what to do.
The committee recommends written clinic policies on reducing and disclosing errors. It calls it advisable for practitioners to start the disclosure and treat it as a process with more than one discussion.
Interpretation
The document is an ethics opinion. The committee reports no patient data and gives no figure for how often these errors occur. The positions rest on ethical argument and on cited legal and ethics sources. The committee says the document reflects the views of its members and does not dictate one exclusive course of treatment. For minor errors that reached the patient, the committee sets a strong presumption in favor of disclosure. The firmest position covers misdirected gametes and embryos.
RRM Context
The opinion names the source of these errors: handling gametes and embryos outside the body creates chances for loss, degradation and misdirection. Restorative reproductive medicine works to find and treat the cause of infertility, so conception can happen in the body. Conception through intercourse has no gamete handling, laboratory or storage steps where a mix-up can occur. Informed consent already calls for honest disclosure in any care.
Our editorial summary of this paper, not the article's abstract.
Abstract
Medical providers have an ethical duty to disclose clinically significant errors involving gametes and embryos as soon as they are discovered. Clinics also should have written policies in place for reducing and disclosing errors. This document was reviewed and affirmed in 2015 and replaces the earlier document of the same name (Fertil Steril 2011;96:1312-4).
Ethics Committee of the American Society for Reproductive Medicine, 2018
Ethics and Policy › Policy and Regulation › Professional Standards · Clinical Guidelines and Standards › Guidelines by Issuing Body › United States Professional Societies
Judith Daar, Paula Amato, Jean Benward, Lee Rubin Collins, Joseph B Davis, Leslie Francis, Elena Gates, Sigal Klipstein, Barbara Koenig, Laurence McCullough, Richard Reindollar, Mark Sauer, Rebecca Sokol, Andrea Stein, Sean Tipton, 0000-0003-0284-2845
J Daar, P Amato, J Benward, L Collins, Joe Davis, Joey Davis, J Davis, L Francis, E Gates, S Klipstein, Barb Koenig, B Koenig, Larry McCullough, L McCullough, Rick Reindollar, Dick Reindollar, Rich Reindollar, R Reindollar, M Sauer, Becky Sokol, R Sokol, A Stein, S Tipton
PMID 27001379 27001379 DOI 10.1016/j.fertnstert.2016.03.018 10.1016/j.fertnstert.2016.03.018 Ethics Committee of the American Society for Reproductive Medicine et al. 2016, Ethics Committee of the American Society for Reproductive Medicine 2016