ASRM PAGES

Denition of experimental
procedures: 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 denition of experimental procedures. This version replaces the document, Def-
inition of Experimental Procedures, that was published most recently in 2009. (Fertil Steril
2013;99:11978. 2013 by American Society for Reproductive Medicine.) Use your smartphone
Key Words: Investigational, evidence-based medicine, routine, informed consent, human to scan this QR code
subjects and connect to the
discussion forum for
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Discuss: You can discuss this article with its authors and with other ASRM members at http://
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P
rocedures (including tests, treat- not be represented or marketed to pa- Acknowledgments: This report was
ments, or other interventions) tients as established or routine medical developed under the direction of the
for the diagnosis or treatment practice. Any educational materials, ad- Practice Committee of the American
of infertility will be considered experi- vertisements, or other documents de- Society for Reproductive Medicine as
mental or investigational until the scribing or relating to the procedure a service to its members and other prac-
published medical evidence regarding should state specically that the proce- ticing clinicians. Although this docu-
their risks, benets, and overall safety dure is not established medical practice ment reects appropriate management
and efcacy is sufcient to regard and is classied by ASRM as experimen- of a problem encountered in the prac-
them as established medical practice. tal or investigational. Patients also tice of reproductive medicine, it is not
Relevant medical evidence can derive should receive counseling that species intended to be the only approved stan-
only from appropriately designed, the experimental nature of the procedure dard of practice or to dictate an exclu-
peer-reviewed, published studies per- and have that counseling documented in sive course of treatment. Other plans
formed by several independent investi- their permanent medical record. of management may be appropriate,
gators, including a description of By denition, procedures classied taking into account the needs of the in-
materials and methods sufcient to by ASRM as experimental or dividual patient, available resources,
assess their scientic validity and to investigational require further re- and institutional or clinical practice
allow independent verication. The search. This research may or may not limitations. The Practice Committee
American Society for Reproductive be required to be conducted under the and the Board of Directors of the Amer-
Medicine (ASRM) will state specically oversight of a properly constituted In- ican Society for Reproductive Medicine
in ofcial publications that a procedure stitutional Review Board (IRB) (1). The have approved this report.
is considered experimental or investi- consent form for the intervention This document was reviewed by
gational, will review relevant new sci- should state clearly that the procedure ASRM members and their input was
entic evidence at regular intervals, is experimental. The decision or considered in the preparation of the
and will remove a procedure from ex- opinion of a local IRB does not affect nal document. The following mem-
perimental or investigational status the status of a procedure or the bers of the ASRM Practice Committee
when evidence warrants. requirements attached to procedures participated in the development of this
Procedures classied by ASRM as classied by ASRM as experimental or document. All Committee members
experimental or investigational should investigational. disclosed commercial and nancial
relationships with manufacturers or
distributors of goods or services used
Received December 20, 2012; accepted December 20, 2012; published online February 1, 2013. to treat patients. Members of the
No reprints will be available. Committee who were found to have
Correspondence: Practice Committee, American Society for Reproductive Medicine, 1209 Montgom-
ery Hwy., Birmingham, Alabama 35216 (E-mail: ASRM@asrm.org). conicts of interest based on the rela-
tionships disclosed did not participate
Fertility and Sterility Vol. 99, No. 5, April 2013 0015-0282/$36.00
Copyright 2013 American Society for Reproductive Medicine, Published by Elsevier Inc.
in the discussion or development of
http://dx.doi.org/10.1016/j.fertnstert.2012.12.036 this document.

VOL. 99 NO. 5 / APRIL 2013 1197

ASRM PAGES
Samantha Pfeifer, M.D.; Jeffrey Goldberg, M.D.; Roger
Lobo, 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.; Mitchell
Rosen, 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.;
1198
Kim Thornton, M.D.; Robert Rebar, M.D.; Andrew La
Barbera, Ph.D.
REFERENCE
1. National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research. Belmont report: ethical principles and guidelines for the
protection of human subjects involved in research. Federal Register 1979;44.
VOL. 99 NO. 5 / APRIL 2013