Increasing burden of institutional review in multicenter clinical trials of infertility: The Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies

William D. Schlaff; Heping Zhang; Michael P. Diamond; Christos Coutifaris; Peter R. Casson; Robert G. Brzyski; Gregory M. Christman; Kurt T. Barnhart; J. C. Trussell; Stephen A. Krawetz; Peter J. Snyder; Dana Ohl; Nanette Santoro; Esther Eisenberg; Hao Huang; Richard S. Legro

doi:10.1016/j.fertnstert.2011.05.069

Increasing burden of institutional review in multicenter clinical trials of infertility: The Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies

William D. Schlaff
, Heping Zhang
, Michael P. Diamond
, Christos Coutifaris
, Peter R. Casson
, Robert G. Brzyski
, Gregory M. Christman
, Kurt T. Barnhart
, J. C. Trussell
, Stephen A. Krawetz
, Peter J. Snyder
, Dana Ohl
, Nanette Santoro
, Esther Eisenberg
, Hao Huang
, Richard S. Legro

Research output: Contribution to journal › Article › peer-review

11 Scopus citations

Abstract

Many clinical investigators think that the burden of Institutional Review Board (IRB) requirements has been consistently increasing over recent years, although there are few objective data describing these trends. Over a period of 7 years, the Reproductive Medicine Network observed a significant increase in the size and requirements of IRB submissions and significant variability of IRB performance in reviewing multicenter trials. These additional regulatory and administrative demands represent substantial burdens to researchers and to the IRBs themselves. It is timely to consider whether these changes better protect the interests and safety of human research participants. Clinical trial registration: ClinicalTrials.gov NCT00068861 and NCT00719186.

Original language	English (US)
Pages (from-to)	15-18
Number of pages	4
Journal	Fertility and sterility
Volume	96
Issue number	1
DOIs	https://doi.org/10.1016/j.fertnstert.2011.05.069
State	Published - Jul 2011

All Science Journal Classification (ASJC) codes

Reproductive Medicine
Obstetrics and Gynecology

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10.1016/j.fertnstert.2011.05.069

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Schlaff, W. D., Zhang, H., Diamond, M. P., Coutifaris, C., Casson, P. R., Brzyski, R. G., Christman, G. M., Barnhart, K. T., Trussell, J. C., Krawetz, S. A., Snyder, P. J., Ohl, D., Santoro, N., Eisenberg, E., Huang, H., & Legro, R. S. (2011). Increasing burden of institutional review in multicenter clinical trials of infertility: The Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies. Fertility and sterility, 96(1), 15-18. https://doi.org/10.1016/j.fertnstert.2011.05.069

@article{04048ab628924a6d8b5e3374e64d92dc,

title = "Increasing burden of institutional review in multicenter clinical trials of infertility: The Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies",

abstract = "Many clinical investigators think that the burden of Institutional Review Board (IRB) requirements has been consistently increasing over recent years, although there are few objective data describing these trends. Over a period of 7 years, the Reproductive Medicine Network observed a significant increase in the size and requirements of IRB submissions and significant variability of IRB performance in reviewing multicenter trials. These additional regulatory and administrative demands represent substantial burdens to researchers and to the IRBs themselves. It is timely to consider whether these changes better protect the interests and safety of human research participants. Clinical trial registration: ClinicalTrials.gov NCT00068861 and NCT00719186.",

author = "Schlaff, \{William D.\} and Heping Zhang and Diamond, \{Michael P.\} and Christos Coutifaris and Casson, \{Peter R.\} and Brzyski, \{Robert G.\} and Christman, \{Gregory M.\} and Barnhart, \{Kurt T.\} and Trussell, \{J. C.\} and Krawetz, \{Stephen A.\} and Snyder, \{Peter J.\} and Dana Ohl and Nanette Santoro and Esther Eisenberg and Hao Huang and Legro, \{Richard S.\}",

note = "Funding Information: Supported by National Institutes of Health (NIH)/National Institute of Child Health and Human Development (NICHD) grants U10 HD38998 (W.D.S.), U10HD055925 (H.Z.), U10 HD39005 (M.P.D.), U10 HD27049 (C.C.), H10 HD055944 (P.R.C.), U10 HD055942 (R.G.B.), U10 HD055936 (G.M.C.), U10 HD38992 (R.S. L.), and General Clinical Research Center grant MO1RR10732 and construction grant C06 RR016499 to Pennsylvania State University. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NICHD or NIH. ",

year = "2011",

month = jul,

doi = "10.1016/j.fertnstert.2011.05.069",

language = "English (US)",

volume = "96",

pages = "15--18",

journal = "Fertility and sterility",

issn = "0015-0282",

publisher = "Elsevier Inc.",

number = "1",

}

Schlaff, WD, Zhang, H, Diamond, MP, Coutifaris, C, Casson, PR, Brzyski, RG, Christman, GM, Barnhart, KT, Trussell, JC, Krawetz, SA, Snyder, PJ, Ohl, D, Santoro, N, Eisenberg, E, Huang, H & Legro, RS 2011, 'Increasing burden of institutional review in multicenter clinical trials of infertility: The Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies', Fertility and sterility, vol. 96, no. 1, pp. 15-18. https://doi.org/10.1016/j.fertnstert.2011.05.069

Increasing burden of institutional review in multicenter clinical trials of infertility: The Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies. / Schlaff, William D.; Zhang, Heping; Diamond, Michael P. et al.
In: Fertility and sterility, Vol. 96, No. 1, 07.2011, p. 15-18.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Increasing burden of institutional review in multicenter clinical trials of infertility

T2 - The Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies

AU - Schlaff, William D.

AU - Zhang, Heping

AU - Diamond, Michael P.

AU - Coutifaris, Christos

AU - Casson, Peter R.

AU - Brzyski, Robert G.

AU - Christman, Gregory M.

AU - Barnhart, Kurt T.

AU - Trussell, J. C.

AU - Krawetz, Stephen A.

AU - Snyder, Peter J.

AU - Ohl, Dana

AU - Santoro, Nanette

AU - Eisenberg, Esther

AU - Huang, Hao

AU - Legro, Richard S.

N1 - Funding Information: Supported by National Institutes of Health (NIH)/National Institute of Child Health and Human Development (NICHD) grants U10 HD38998 (W.D.S.), U10HD055925 (H.Z.), U10 HD39005 (M.P.D.), U10 HD27049 (C.C.), H10 HD055944 (P.R.C.), U10 HD055942 (R.G.B.), U10 HD055936 (G.M.C.), U10 HD38992 (R.S. L.), and General Clinical Research Center grant MO1RR10732 and construction grant C06 RR016499 to Pennsylvania State University. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NICHD or NIH.

PY - 2011/7

Y1 - 2011/7

N2 - Many clinical investigators think that the burden of Institutional Review Board (IRB) requirements has been consistently increasing over recent years, although there are few objective data describing these trends. Over a period of 7 years, the Reproductive Medicine Network observed a significant increase in the size and requirements of IRB submissions and significant variability of IRB performance in reviewing multicenter trials. These additional regulatory and administrative demands represent substantial burdens to researchers and to the IRBs themselves. It is timely to consider whether these changes better protect the interests and safety of human research participants. Clinical trial registration: ClinicalTrials.gov NCT00068861 and NCT00719186.

AB - Many clinical investigators think that the burden of Institutional Review Board (IRB) requirements has been consistently increasing over recent years, although there are few objective data describing these trends. Over a period of 7 years, the Reproductive Medicine Network observed a significant increase in the size and requirements of IRB submissions and significant variability of IRB performance in reviewing multicenter trials. These additional regulatory and administrative demands represent substantial burdens to researchers and to the IRBs themselves. It is timely to consider whether these changes better protect the interests and safety of human research participants. Clinical trial registration: ClinicalTrials.gov NCT00068861 and NCT00719186.

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UR - https://www.scopus.com/pages/publications/79959869555#tab=citedBy

U2 - 10.1016/j.fertnstert.2011.05.069

DO - 10.1016/j.fertnstert.2011.05.069

M3 - Article

C2 - 21645894

AN - SCOPUS:79959869555

SN - 0015-0282

VL - 96

SP - 15

EP - 18

JO - Fertility and sterility

JF - Fertility and sterility

IS - 1

ER -

Increasing burden of institutional review in multicenter clinical trials of infertility: The Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies

Abstract

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