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• W2038631034 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. 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. Before the second half of the 20th century, the performance of scientific research was primarily governed by personal conscience and ethical standards. Over the past 50 years, increased attention and widespread discussion of research ethics have given rise to specifically articulated guidelines for the performance of clinical research, most notably the Declaration of Helsinki in 1964 and the Belmont Report in 1979. These and other related documents have established the defining principles that clinical research studies must undergo review by an independent committee, and that informed consent must be obtained from human subjects participating in clinical trials. The process has evolved as studies have become more complex and the clinical research community has become much larger and more sophisticated. Other factors, including increased attention to medical-legal risk, financial oversight, protection of personal health information, and the widespread reliance on electronic record systems, have all contributed to what seems to be an ever-expanding mountain of regulatory and oversight documentation.The increased burden produced by these many requirements is daunting to many researchers, perhaps most compellingly to those who participate in multicenter trials that are subject to frequently inconsistent and variable reviews by local Institutional Review Boards (IRBs) (1Helfand B.T. Mongiu A.K. Roehrborn C.G. Donnell R.F. Bruskewitz R. Kaplan S.A. et al.Variation in Institutional Review Board responses to a standard protocol for a multicenter randomized, controlled surgical trial.J Urol. 2009; 181: 2674-2679Abstract Full Text Full Text PDF PubMed Scopus (33) Google Scholar, 2Greene S.M. Geiger A.M. A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval.J Clin Epidemiol. 2006; 59: 784-790Abstract Full Text Full Text PDF PubMed Scopus (93) Google Scholar). In such trials, each site must negotiate not only their own institutional review process, but in addition may be required to modify protocols or policies based on determinations of IRBs at other sites. Thus, the challenges at any one site are often multiplied by the requirements of others even though the submitted protocol is identical at all sites. Ultimately, this ungainly and inefficient process can consume significant time and resources from both the investigative teams and the IRB staffs (3Green L.A. Lowery J.C. Kowalski C.P. Wyszewianski L. Impact of Institutional Review Board practice variation on observational health services research.Health Serv Res. 2006; 41: 214-230Crossref PubMed Scopus (115) Google Scholar), introduce mistakes in the protocol and consent forms (4Burman W. Breese P. Weis S. Bock N. Bernardo J. Vernon A. The effects of local review on informed consent documents from a multicenter clinical trials consortium.Control Clin Trials. 2003; 24: 245-255Abstract Full Text Full Text PDF PubMed Scopus (75) Google Scholar), and significantly increase the time required to initiate and conduct a clinical trial.Performing clinical research on “vulnerable populations” necessitates additional review and produces even more burdens (5Stark A.R. Tyson J.E. Hibberd P.L. Variation among Institutional Review Boards in evaluating the design of a multicenter randomized trial.J Perinatol. 2010; 30: 163-169Crossref PubMed Scopus (36) Google Scholar). In the United States, vulnerable populations include pregnant women, fetuses, neonates, prisoners, and children who require “additional safeguards,” which are not specified in the federal code but left to the discretion of local IRBs (6Iltis A.S. Wall A. Lesandrini J. Rangel E.K. Chibnall J.T. Federal interpretation and enforcement of protections for vulnerable participants in human research.J Empir Res Hum Res Ethics. 2009; 4: 37-41Crossref PubMed Scopus (5) Google Scholar). For example, even a simple observational trial in a pediatric population requires additional documentation which is often assessed differently by local IRBs and may ultimately discourage some investigators from participating (7Mansbach J. Acholonu U. Clark S. Camargo Jr., C.A. Variation in institutional review board responses to a standard, observational, pediatric research protocol.Acad Emerg Med. 2007; 14: 377-380Crossref PubMed Google Scholar). Because infertility studies often include two vulnerable populations, i.e., pregnant women and fetuses, researchers in the field of reproductive medicine must typically satisfy these additional requirements, made all the more difficult if they are participants in a multicenter trial.The Reproductive Medicine Network (RMN) was established by the National Institute of Child Health and Human Development (NICHD) in the 1990s to design and conduct multicenter trials which would address critical questions in the field of reproductive medicine. The centers chosen to participate in the RMN have varied over its several iterations; since 2007, the RMN has been comprised of seven clinical sites and one data and coordinating center (DCC). The RMN Steering Committee, consisting of the experienced principal investigator (PI) from each site, the PI of the DCC, and a National Institutes of Health–appointed project officer and committee chair, develop and prioritize all clinical protocols. Approved protocols are then critiqued and refined by an Advisory Board as well as a Data Safety Monitoring Board, both convened by the NICHD, before submission to the local IRBs and ultimate implementation. The goal of the present study was to obtain objective data describing the impact of evolving institutional review requirements on initiating clinical research in RMN-sponsored multicenter trials.Materials and methodsThe RMN Steering Committee collected data from the institutional reviews of two multicenter clinical trials for the treatment of infertility in women with polycystic ovary syndrome, a series of studies now referred to as Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II. PPCOS I (ClinTrials.gov registration no. NCT00068861) was initiated in 2002, and we have since reported our main outcomes (8Legro R.S. Barnhart H.X. Schlaff W.D. Carr B.R. Diamond M.P. Carson S.A. et al.Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome.N Engl J Med. 2007; 356: 551-566Crossref PubMed Scopus (775) Google Scholar). PPCOS II (ClinTrials.gov registration no. NCT00719186) was initiated in 2009 and is now completing its final phase of enrollment. The two studies were extremely similar in design; both compared a new ovulation induction medication (metformin in PPCOS I and letrozole in PPCOS II) to the existing first-line ovulation induction drug (clomiphene citrate) in a double-blind manner. Both were powered to examine live birth as the primary outcome. There were minimal differences between the two studies regarding study design, none of which were associated with a significant difference in the risk/benefit analysis or other major informed consent issues. PPCOS II included consenting of male partners, whereas PPCOS I did not.The formal RMN protocol submitted to the individual IRBs was identical, although there was significant variability of submitted documents at each site owing to differences in local requirements and format. To perform the present study, each of the seven RMN sites retrospectively reviewed the documents submitted to its local IRB for PPCOS II, and the four sites that also participated in PPCOS I provided the same information for that trial. The data were then analyzed to examine both the variation between sites and the changes that have occurred over time. We chose to obtain four specific sets of data which we thought would reflect the challenges each site faced in obtaining IRB approval. These included: 1) the total number of pages required for the submission to the IRB: The total number of pages excluded the formal RMN protocol but did include the locally required protocol in the necessary format, consent forms, attachments, disclosures, administrative documents, and requests for advertisement approval; case report forms prepared by the DCC and any investigator drug brochures were excluded from this page count; 2) the total page length of the final approved informed consent document; 3) the number of attachments required by the IRB to address specific research or administrative questions; and 4) the number of days from submission of the completed IRB package to final approval by the IRB.Because the process of developing the protocols (peer review in the application process, consensus of RMN investigators, review and refinement by the Advisory Board, and approval by the Data Safety Monitoring Board) as well as the protocols themselves were so similar, we hypothesized that additional IRB burdens which evolved between submission of PPCOS I and II would be reflected by increases in the factors described above. Additionally, because four of the seven sites that participated in PPCOS II also participated in PPCOS I, we hypothesized that these established sites might have experienced less delay in obtaining IRB approval. Furthermore, we thought that reviewing the experience of this small subset of four established sites would provide a direct measure of the changes that have occurred over the 7-year period between the two studies.Statistical AnalysesWe performed Student t tests of overall data to compare the experience of the seven present RMN sites in the PPCOS II study with that of the four sites that participated in PPCOS I. We then performed pairwise Student t tests to compare the parameters of the four clinical sites that participated in both PPCOS I and II.ResultsThe total length of the IRB submission and the number of attachments were both significantly greater for the PPCOS II study compared with PPCOS I (Table 1). Most notably, the length of the consent form was dramatically greater for PPCOS II. Interestingly, there was no significant difference in the time from submission to approval between the two studies, although we did note that the mean time required was ∼2 weeks (21.9%) longer for PPCOS II. When we compared the experience from only the four established sites we again observed the same relationships, i.e., longer submissions and consent forms, more attachments, but no statistically significant difference in time from submission to approval (mean increase in time to approval 17.8 days, or 26.6%). Furthermore, we found no significant difference in these parameters when we compared the experience of the four established sites with that of the three new sites in PPCOS II. Total number of pages was 104.5 ± 45.3 versus 85.7 ± 49.9, number of attachments was 13.0 ± 6.6 versus 9.7 ± 7.0, number of consent form pages was 23.5 ± 4.0 versus 25.3 ± 6.5, and submission to approval time was 84.8 ± 67.2 days versus 77.7 ± 29.3 days. We observed a high degree of variability for most of the parameters studied across the sites, which appeared to be much greater for PPCOS II than for PPCOS I.Table 1Parameters reflecting the Institutional Review Board (IRB) submissions of Reproductive Medicine Network (RMN) sites in the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies.PPCOS II (n = 7)PPCOS I (n = 4)P valueat test of overall data between all sites that participated in PPCOS I and PPCOS II (regardless of participation in the other).PPCOS II (n = 4)bData only from sites that also participated in PPCOS I.P valuecPaired t test for comparison of data from sites that participated in both PPCOS II and PPCOS I.Submission to approval (d)81.7 ± 50.6 (42–185)67.0 ± 9.9 (53–75).5184.8 ± 67.2 (42–185).60IRB submission (total pages)dExcluding the formal RMN study protocol, case report forms, and any investigational drug brochures.96.4 ± 44.2 (42–166)40.8 ± 22.4 (18–65).03104.5 ± 45.3 (64–166).03Consent form (pages)24.3 ± 4.5 (18–32)11.3 ± 7.4 (6–22).00623.5 ± 4.0 (18–27).03No. of attachments11.6 ± 6.4 (3–21)3.5 ± 4.4 (0–9).0513.0 ± 6.6 (5–21).04Note: Values are mean ± SD (range).a t test of overall data between all sites that participated in PPCOS I and PPCOS II (regardless of participation in the other).b Data only from sites that also participated in PPCOS I.c Paired t test for comparison of data from sites that participated in both PPCOS II and PPCOS I.d Excluding the formal RMN study protocol, case report forms, and any investigational drug brochures. Open table in a new tab DiscussionWe found that the administrative burden experienced by the RMN, as measured by the length and requirements of the IRB submission, has increased significantly over the past 7 years. Furthermore, we observed that there was significant variability in the performance of individual IRBs, though none ultimately demanded significant changes in the clinical protocols. Although there is a widespread sense that the administrative and regulatory burdens are increasing in infertility research, we are not aware of any previous data that demonstrate these trends in a quantitative manner. We acknowledge that our study is based on data from a small number of sites. Further, we appreciate that it is difficult to be completely certain that all sites included and excluded exactly the same material in determining their total page counts despite clear definitions and our best efforts. We have much greater confidence in the uniformity and accuracy of the other three parameters studied. Finally, we acknowledge that time from submission to approval could have been prolonged if investigators were not efficient in providing the necessary responses and clarifications to their IRB in a timely way. However, we confirmed that the turnaround by investigators corresponding with IRBs was efficient at all sites; delays did not appear to be unduly long. In practice, such delays are part of the review and approval process and, as such, should be considered in a comprehensive analysis of the present system. We accept that these are all potential weaknesses of our study, but nevertheless feel that these findings, being among the first hard data on this subject, can provide important observations to aid in our analysis of the present state of research review in multicenter infertility trials.Several important observations are clear. First, the amount of information required by IRBs is increasing significantly. There can be no question that amassing all of the required information and completing the increasingly numerous attachments in the necessary format takes more time and effort by investigators and their teams. Interestingly, we noted that the new RMN sites did not take any longer from the time of submission to approval than did the established sites, suggesting that more experience did not translate to more rapid or efficient completion of the review process. It is possible that new sites required more time to compile their materials before actual submission to their IRB compared with established sites, but we did not have a way to ascertain these data.A somewhat hidden but critically important question is whether the IRBs themselves are reviewing the submitted material as carefully as they have in the past. If the total pages submitted and the length of the consent form have more than doubled, and the number of required attachments has tripled, we wonder how IRBs can review all this additional material in roughly the same amount of time as they have in the past. We must speculate that either IRB members are more efficient at reviewing material now than they were 7 years ago, or that some or even much of the submitted material is not being scrutinized as closely as it was previously. We hope that it is the former, but fear that it is the latter. If the review of research protocols is more superficial than it has been in the past, the entire research community must ask if this increasingly bureaucratic process is likely to be more or less effective at achieving the most basic goal of the IRB process, i.e., protecting the interests and safety of research participants.A second important observation is the dramatically increasing length of consent forms, a problem which some RMN members have attributed to IRB “mission creep.” Our data show that our informed consent documents are more than twice as long as they were 7 years ago. Although a small portion of this can be explained by the additional pages required for consent of the male partners of our female participants (another important and controversial question to consider), we are struck by the increasing and often numbing detail required by IRBs in designing consent forms. Many elements of consent forms as presently required by numerous IRBs appear to be aimed more at legal indemnification than explaining the nature of the proposed research with an emphasis on the point of the research and a description of potential risks and possible benefits. Furthermore, many have suggested that the level of detail used to explain each and every minute detail of numerous research interactions as is now required by many IRBs is not only unnecessary but may well adversely affect the ability of potential participants to fully understand the research study in which they are enrolling (9Sharp S.M. Consent documents for oncology trials: does anybody read these things?.Am J Clin Oncol. 2004; 27: 570-575Crossref PubMed Scopus (120) Google Scholar, 10LoVerde M.E. Prochazka A.V. Byyny R.L. Research consent forms: continued unreadability and increasing length.J Gen Intern Med. 1989; 4: 410-412Crossref PubMed Scopus (71) Google Scholar). We also fear that increasingly long and detailed consent forms have the potential to erode the important personal relationships between subjects and members of a research team. By making the process excessively bureaucratic, we wonder if there may be an adverse effect on the “team” feeling often shared by subjects and researchers which is so important to participant interaction and retention. In any case, it behooves the research community to thoughtfully consider whether lengthier and more detailed informed consent is better informed consent.The first two points relate to review of any research protocol in any individual institution. Our third key observation relates specifically to the particular challenges in obtaining approval for multicenter trials. As shown in Table 1, there is a huge amount of variability between the various sites. This observation does not appear to be unique to our multicenter trials (11Pogorzelska M. Stone P.W. Cohn E.G. Larson E. Changes in the institutional review board submission process for multicenter research over 6 years.Nurs Outlook. 2010; 58: 181-187Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar). Given that all sites submitted exactly the same protocol to their local IRB, we must question whether they are all consistent in their evaluations and their concerns. Based on discussions at meetings of the RMN Steering Committee, it is our sense that the major barriers to IRB approval were quite different at each site. Furthermore, despite the increased burden to the investigators and the apparent inefficiency of the process, none of the IRBs substantially altered the study protocol. We must conclude that there is significant variability in the information and format required by IRBs, that the issues which provoke greatest concern may well be site-specific, and that the multiple IRB reviews of the same protocol do not seem to have much effect on the final form of the study.There has been increasing recognition of the unbridled growth in regulatory burden and a call for reform by investigators (12Infectious Disease Society of AmericaGrinding to a halt: the effects of the increasing regulatory burden on research and quality improvement efforts.Clin Infect Dis. 2009; 49: 328-335Crossref PubMed Scopus (67) Google Scholar) and, perhaps most importantly, by the federal government (13Menikoff J. The paradoxical problem with multiple-IRB review.N Engl J Med. 2010; 363: 1591-1593Crossref PubMed Scopus (92) Google Scholar, 14Millum J. Menikoff J. Streamlining ethical review.Ann Intern Med. 2010; 153: 655-657Crossref PubMed Scopus (24) Google Scholar). The administrative challenges which individual investigators experience in obtaining IRB approval for a research study may be exponentially increased for those participating in multicenter trials. Therefore, as the research community addresses the issues discussed above, there should be a similar effort toward reducing the regulatory burden for multicenter trials. Effective approaches could include accepting cooperative agreements between local IRBs with one IRB taking on the main review burden (2Greene S.M. Geiger A.M. A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval.J Clin Epidemiol. 2006; 59: 784-790Abstract Full Text Full Text PDF PubMed Scopus (93) Google Scholar) or the creation of independent central IRBs, such as have been instituted by the National Cancer Institute for cancer trials (15Christian M.C. Goldberg J.L. Killen J. Abrams J.S. McCabe M.S. Mauer J.K. et al.A central Institutional Review Board for multi-institutional trials.N Engl J Med. 2002; 346: 1405-1408Crossref PubMed Scopus (116) Google Scholar). Though these remedies can generate their own unique set of problems (16Randal J. Growing pains: central review board project still developing.J Natl Cancer Inst. 2003; 95: 636-637Crossref PubMed Scopus (7) Google Scholar, 17Saginur R. Dent S.F. Schwartz L. Heslegrave R. Stacey S. Manzo J. Ontario Cancer Research Ethics Board: lessons learned from developing a multicenter regional institutional review board.J Clin Oncol. 2008; 26: 1479-1482Crossref PubMed Scopus (12) Google Scholar), they may well represent a significant step forward for both investigators and potential study subjects.Thoughtful investigators have expressed concerns that IRBs have become overly expansive in interpreting regulatory requirements, have increasingly focused on inconsequential details, and have lost sight of their mission as they have become bureaucratically stilted and progressively unresponsive (18Getz K. Frustration with IRB bureaucracy and despotism.Appl Clin Trials Online. 2011; 20: 26-28Google Scholar, 19Yusuf S. Randomized clinical trials: slow death by a thousand unnecessary policies?.Can Med Assoc J. 2004; 171: 889-892Crossref Scopus (30) Google Scholar). In a recent commentary in the Journal of the American Medical Association, Christine Grady posed the question “Do IRBs Protect Human Research Participants?” (20Grady C. Do IRBs protect human research participants?.JAMA. 2010; 304: 1122-1123Crossref PubMed Scopus (62) Google Scholar) The research community should strive to develop strategies to answer this most critical question. Unfortunately, in the present study, we do not think that we could point to any outcome data that would allow us to address this issue. We think that the observations described in this study demonstrate the degree to which the burden of research review has increased over a relatively short period of time and how the experience at individual institutions can be extremely different in considering identical well designed multicenter trials. The RMN strongly endorses initiatives intended to streamline research review for multicenter infertility trials as well as efforts to explore whether the increasing regulatory burden experienced by many investigators actually leads to improvement in the protection and safety of participants in clinical research studies. Before the second half of the 20th century, the performance of scientific research was primarily governed by personal conscience and ethical standards. Over the past 50 years, increased attention and widespread discussion of research ethics have given rise to specifically articulated guidelines for the performance of clinical research, most notably the Declaration of Helsinki in 1964 and the Belmont Report in 1979. These and other related documents have established the defining principles that clinical research studies must undergo review by an independent committee, and that informed consent must be obtained from human subjects participating in clinical trials. The process has evolved as studies have become more complex and the clinical research community has become much larger and more sophisticated. Other factors, including increased attention to medical-legal risk, financial oversight, protection of personal health information, and the widespread reliance on electronic record systems, have all contributed to what seems to be an ever-expanding mountain of regulatory and oversight documentation. The increased burden produced by these many requirements is daunting to many researchers, perhaps most compellingly to those who participate in multicenter trials that are subject to frequently inconsistent and variable reviews by local Institutional Review Boards (IRBs) (1Helfand B.T. Mongiu A.K. Roehrborn C.G. Donnell R.F. Bruskewitz R. Kaplan S.A. et al.Variation in Institutional Review Board responses to a standard protocol for a multicenter randomized, controlled surgical trial.J Urol. 2009; 181: 2674-2679Abstract Full Text Full Text PDF PubMed Scopus (33) Google Scholar, 2Greene S.M. Geiger A.M. A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval.J Clin Epidemiol. 2006; 59: 784-790Abstract Full Text Full Text PDF PubMed Scopus (93) Google Scholar). In such trials, each site must negotiate not only their own institutional review process, but in addition may be required to modify protocols or policies based on determinations of IRBs at other sites. Thus, the challenges at any one site are often multiplied by the requirements of others even though the submitted protocol is identical at all sites. Ultimately, this ungainly and inefficient process can consume significant time and resources from both the investigative teams and the IRB staffs (3Green L.A. Lowery J.C. Kowalski C.P. Wyszewianski L. Impact of Institutional Review Board practice variation on observational health services research.Health Serv Res. 2006; 41: 214-230Crossref PubMed Scopus (115) Google Scholar), introduce mistakes in the protocol and consent forms (4Burman W. Breese P. Weis S. Bock N. Bernardo J. Vernon A. The effects of local review on informed consent documents from a multicenter clinical trials consortium.Control Clin Trials. 2003; 24: 245-255Abstract Full Text Full Text PDF PubMed Scopus (75) Google Scholar), and significantly increase the time required to initiate and conduct a clinical trial. Performing clinical research on “vulnerable populations” necessitates additional review and produces even more burdens (5Stark A.R. Tyson J.E. Hibberd P.L. Variation among Institutional Review Boards in evaluating the design of a multicenter randomized trial.J Perinatol. 2010; 30: 163-169Crossref PubMed Scopus (36) Google Scholar). In the United States, vulnerable populations include pregnant women, fetuses, neonates, prisoners, and children who require “additional safeguards,” which are not specified in the federal code but left to the discretion of local IRBs (6Iltis A.S. Wall A. Lesandrini J. Rangel E.K. Chibnall J.T. Federal interpretation and enforcement of protections for vulnerable participants in human research.J Empir Res Hum Res Ethics. 2009; 4: 37-41Crossref PubMed Scopus (5) Google Scholar). For example, even a simple observational trial in a pediatric population requires additional documentation which is often assessed differently by local IRBs and may ultimately discourage some investigators from participating (7Mansbach J. Acholonu U. Clark S. Camargo Jr., C.A. Variation in institutional review board responses to a standard, observational, pediatric research protocol.Acad Emerg Med. 2007; 14: 377-380Crossref PubMed Google Scholar). Because infertility studies often include two vulnerable populations, i.e., pregnant women and fetuses, researchers in the field of reproductive medicine must typically satisfy these additional requirements, made all the more difficult if they are participants in a multicenter trial. The Reproductive Medicine Network (RMN) was established by the" @default.
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• W2038631034 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" @default.
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