Definition of experimental procedures: a committee opinion
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Definition 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 definition of experimental procedures. This version replaces the document, ‘‘Def- inition of Experimental Procedures,’’ that was published most recently in 2009. (Fertil Steril Ò 2013;99:1197–8. Ó2013 by American Society for Reproductive Medicine.) Key Words: Investigational, evidence-based medicine, routine, informed consent, human subjects Discuss: You can discuss this article with its authors and with other ASRM members at http:// fertstertforum.com/goldsteinj-definition-of-experimental-procedures-committee-opinion/ Use your smartphone to scan this QR code and connect to the discussion forum for this article now.* * Download a free QR code scanner by searching for “QR scanner” in your smartphone’s app store or app marketplace. P rocedures (including tests, treat- ments, or other interventions) for the diagnosis or treatment of infertility will be considered experi- mental or investigational until the published medical evidence regarding their risks, benefits, and overall safety and efficacy is sufficient to regard them as established medical practice. Relevant medical evidence can derive only from appropriately designed, peer-reviewed, published studies per- formed by several independent investi- gators, including a description of materials and methods sufficient to assess their scientific validity and to allow independent verification. The American Society for Reproductive Medicine (ASRM) will state specifically in official publications that a procedure is 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 status when evidence warrants. Procedures classified by ASRM as experimental or investigational should not be represented or marketed to pa- tients as established or routine medical practice. Any educational materials, ad- vertisements, or other documents de- scribing or relating to the procedure should state specifically that the proce- dure is not established medical practice and is classified by ASRM as experimen- tal or investigational. Patients also should receive counseling that specifies the experimental nature of the procedure and have that counseling documented in their permanent medical record. By definition, procedures classified by ASRM as experimental or investigational require further re- search. This research may or may not be required to be conducted under the oversight of a properly constituted In- stitutional Review Board (IRB) (1). The consent form for the intervention should state clearly that the procedure is experimental. The decision or opinion of a local IRB does not affect the status of a procedure or the requirements attached to procedures classified by ASRM as experimental or investigational. Acknowledgments: This report was developed under the direction of the Practice Committee of the American Society for Reproductive Medicine as a service to its members and other prac- ticing clinicians. Although this docu- ment reflects appropriate management of a problem encountered in the prac- tice of reproductive medicine, it is not intended to be the only approved stan- dard of practice or to dictate an exclu- sive course of treatment. Other plans of management may be appropriate, taking into account the needs of the in- dividual patient, available resources, and institutional or clinical practice limitations. The Practice Committee and the Board of Directors of the Amer- ican Society for Reproductive Medicine have approved this report. This document was reviewed by ASRM members and their input was considered in the preparation of the final document. The following mem- bers of the ASRM Practice Committee participated in the development of this document. All Committee members disclosed commercial and financial relationships with manufacturers or distributors of goods or services used to treat patients. Members of the Committee who were found to have conflicts of interest based on the rela- tionships disclosed did not participate in the discussion or development of this document. Received December 20, 2012; accepted December 20, 2012; published online February 1, 2013. No reprints will be available. Correspondence: Practice Committee, American Society for Reproductive Medicine, 1209 Montgom- ery Hwy., Birmingham, Alabama 35216 (E-mail: [email protected]). Fertility and Sterility® Vol. 99, No. 5, April 2013 0015-0282/$36.00 Copyright ©2013 American Society for Reproductive Medicine, Published by Elsevier Inc. http://dx.doi.org/10.1016/j.fertnstert.2012.12.036 VOL. 99 NO. 5 / APRIL 2013 1197 ASRM PAGES
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Transcript of Definition of experimental procedures: a committee opinion
ASRM PAGES
Definition of experimentalprocedures: a committee opinion
Practice Committee of the American Society for Reproductive MedicineAmerican Society for Reproductive Medicine, Birmingham, Alabama
This Practice Committee opinion provides a revised definition of experimental procedures. This version replaces the document, ‘‘Def-
Use your smartphone
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
Discuss: You can discuss this article with its authors and with other ASRM members at http://fertstertforum.com/goldsteinj-definition-of-experimental-procedures-committee-opinion/
to scan this QR codeand connect to thediscussion forum forthis article now.*
* Download a free QR code scanner by searching for “QRscanner” in your smartphone’s app store or app marketplace.
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
VOL. 99 NO. 5 / APRIL 2013
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 [email protected]).
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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ASRM PAGES
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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