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Definition of experimentalprocedures: a committee opinion

Practice Committee of the American Society for Reproductive Medicine

American Society for Reproductive Medicine, Birmingham, Alabama

This Practice Committee opinion provides a revised definition of experimental procedures. This version replaces the document, ‘‘Def-

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inition of Experimental Procedures,’’ that was published most recently in 2009. (Fertil Steril�2013;99:1197–8. �2013 by American Society for Reproductive Medicine.)Key Words: Investigational, evidence-based medicine, routine, informed consent, humansubjects

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to scan this QR codeand connect to thediscussion forum forthis article now.*

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P rocedures (including tests, treat-ments, or other interventions)for the diagnosis or treatment

of infertility will be considered experi-mental or investigational until thepublished medical evidence regardingtheir risks, benefits, and overall safetyand efficacy is sufficient to regardthem as established medical practice.Relevant medical evidence can deriveonly from appropriately designed,peer-reviewed, published studies per-formed by several independent investi-gators, including a description ofmaterials and methods sufficient toassess their scientific validity and toallow independent verification. TheAmerican Society for ReproductiveMedicine (ASRM) will state specificallyin official publications that a procedureis considered experimental or investi-gational, will review relevant new sci-entific evidence at regular intervals,and will remove a procedure from ex-perimental or investigational statuswhen evidence warrants.

Procedures classified by ASRM asexperimental or investigational should

Received December 20, 2012; accepted December 20No reprints will be available.Correspondence: Practice Committee, American Soci

ery Hwy., Birmingham, Alabama 35216 (E-mail:

Fertility and Sterility® Vol. 99, No. 5, April 2013 001Copyright ©2013 American Society for Reproductivehttp://dx.doi.org/10.1016/j.fertnstert.2012.12.036

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not be represented or marketed to pa-tients as established or routine medicalpractice. Any educational materials, ad-vertisements, or other documents de-scribing or relating to the procedureshould state specifically that the proce-dure is not established medical practiceand is classified byASRMas experimen-tal or investigational. Patients alsoshould receive counseling that specifiesthe experimental nature of the procedureand have that counseling documented intheir permanent medical record.

By definition, procedures classifiedby ASRM as experimental orinvestigational require further re-search. This research may or may notbe required to be conducted under theoversight of a properly constituted In-stitutional Review Board (IRB) (1). Theconsent form for the interventionshould state clearly that the procedureis experimental. The decision oropinion of a local IRB does not affectthe status of a procedure or therequirements attached to proceduresclassified by ASRM as experimental orinvestigational.

, 2012; published online February 1, 2013.

ety for Reproductive Medicine, 1209 Montgom-ASRM@asrm.org).

5-0282/$36.00Medicine, Published by Elsevier Inc.

Acknowledgments: This report wasdeveloped under the direction of thePractice Committee of the AmericanSociety for Reproductive Medicine asa service to its members and other prac-ticing clinicians. Although this docu-ment reflects appropriate managementof a problem encountered in the prac-tice of reproductive medicine, it is notintended to be the only approved stan-dard of practice or to dictate an exclu-sive course of treatment. Other plansof management may be appropriate,taking into account the needs of the in-dividual patient, available resources,and institutional or clinical practicelimitations. The Practice Committeeand the Board of Directors of the Amer-ican Society for Reproductive Medicinehave approved this report.

This document was reviewed byASRM members and their input wasconsidered in the preparation of thefinal document. The following mem-bers of the ASRM Practice Committeeparticipated in the development of thisdocument. All Committee membersdisclosed commercial and financialrelationships with manufacturers ordistributors of goods or services usedto treat patients. Members of theCommittee who were found to haveconflicts of interest based on the rela-tionships disclosed did not participatein the discussion or development ofthis document.

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Samantha Pfeifer, M.D.; Jeffrey Goldberg, M.D.; RogerLobo, M.D.; Michael Thomas, M.D.; Margareta Pisarska,M.D.; Eric Widra, M.D.; Mark Licht, M.D.; Jay Sandlow,M.D.; John Collins, M.D.; Marcelle Cedars, M.D.; MitchellRosen, M.D.; Michael Vernon, Ph.D.; Owen Davis, M.D.;Clarisa Gracia, M.D., M.S.C.E.; William Catherino, M.D.,Ph.D.; Daniel Dumesic, M.D.; Randall Odem, M.D.;

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Kim Thornton, M.D.; Robert Rebar, M.D.; Andrew LaBarbera, Ph.D.

REFERENCE1. National Commission for the Protection of Human Subjects of Biomedical and

Behavioral Research. Belmont report: ethical principles and guidelines for theprotection of human subjects involved in research. Federal Register 1979;44.

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