Moving innovation to practice: a committee opinion
Ethics Committee of 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 American Society for Reproductive Medicine (2015). Moving innovation to practice: a committee opinion. Fertility and sterility. https://doi.org/10.1016/j.fertnstert.2015.04.003
Ethics Committee of American Society for Reproductive Medicine. Moving innovation to practice: a committee opinion. Fertility and sterility. 2015. doi:10.1016/j.fertnstert.2015.04.003
Ethics Committee of American Society for Reproductive Medicine. "Moving innovation to practice: a committee opinion." Fertility and sterility, 2015.
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RRM Academy Synopsis
ASRM Ethics Committee holds new fertility care needs evidence first
In this 2015 opinion, the ASRM Ethics Committee holds that a new fertility test or treatment needs evidence that it is safe and effective before clinics offer it. The paper also addresses money conflicts and outcome tracking.
Key Findings
The committee holds that safety and effectiveness evidence is "necessary" before a new intervention spreads into practice. Peer review of the study design and conclusions should come before adoption.
The committee lists economic motivation, enhanced reputation and enjoyment of a new skill as possible conflicts of interest. Recognizing them explicitly helps keep patient well-being the top priority.
The committee says infertility providers "should resist offering" treatments not shown effective "just because a patient insists." It adds that patients should be told when a practice recently adopted an intervention.
The committee says published success rates "may not be achieved" where a practice recently adopted a procedure. Research often includes results only from clinicians who have reached competence.
The committee says practices, where possible, should join registries or networks that study new techniques. Ongoing data collection is critical for understanding benefits, harms and best use.
Interpretation
The ASRM Ethics Committee wrote this opinion, and ASRM members reviewed it before its Board approved it. The paper reports no new data and tests no intervention. The committee cites early adoption of preimplantation genetic screening, immunotherapy for recurrent miscarriage, bed rest to prevent preterm birth and fetal heart rate monitoring as cautionary examples. The paper sets no exclusive standard of practice. Clinicians are its audience.
RRM Context
Restorative reproductive medicine is evidence-based care. The committee's call for evidence before adoption and for ongoing outcome tracking fits that principle. The paper also names money conflicts as a concern in fertility care, where patients often pay out of pocket.
Our editorial summary of this paper, not the article's abstract.
Abstract
The introduction of new strategies, tests and procedures into clinical practice raises challenging ethical issues involving evaluation of evidence, balancing benefits and harms, supporting patient autonomy, avoiding conflict of interest, and promoting advances in health care. The purpose of this document is to assist reproductive health practitioners as they introduce new interventions into the clinical care that they provide to patients.
Clinical Guidelines and Standards › Guidelines by Issuing Body › United States Professional Societies · Ethics and Policy › Policy and Regulation › Professional Standards
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 25936239 25936239 DOI 10.1016/j.fertnstert.2015.04.003 10.1016/j.fertnstert.2015.04.003 Ethics Committee of American Society for Reproductive Medicine et al. 2015, Ethics Committee of American Society for Reproductive Medicine 2015
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