ライフサイエンスコーパス: IRB

1 IRB-approved study of adult patients discharged with hig

2 IRBs commonly provide text for informed-consent forms th

3 UDY-16-01215/IRB-16-00971 and STUDY-20-00442/IRB-20-03374) vaccinated with a monovalent XBB.1.5 vacci

4 inai, New York, NY, USA, from STUDY-16-01215/IRB-16-00971 and STUDY-20-00442/IRB-20-03374) vaccinated

5 required by the IRBs ranged from 1 to 4; 15 IRBs (48%) required 2 or more consents, while 10 (32%) d

6 of the same genetic epidemiology study by 31 IRBs ranged from minimal to high, resulting in 7 expedit

7 esting was categorized as minimal risk by 43 IRB chairpersons (23%), a minor increase over minimal ri

8 We surveyed a random sample of 893 IRB members at 100 academic institutions (response rate,

9 udy was reviewed and approved by the Advarra IRB (protocol number: Pro00043100).

10 After IRB approval, bacterial subcultures from 30 pediatric su

11 Although all IRBs face pressure to speed reviews and none are entirel

12 cess of continuous quality improvement among IRBs that govern research programs.

13 An IRB approved retrospective study of 140 patients with el

14 Novices (N = 30) were enrolled in an IRB-approved, blinded, randomized, controlled trial.

15 tutions undergoing SILC were entered into an IRB approved database from November 2008 to March 2010.

16 This is an IRB-approved, retrospective study of all adult SOTR on a

17 human subjects were recruited as part of an IRB approved clinical trial studying functional avoidanc

18 Retrospective analysis of an IRB-approved database identified patients treated with M

19 UC-approved porcine model, we embarked on an IRB-approved protocol to ultimately perform a pure NOTES

20 We sent an IRB approved survey to all 57 U.S. OPOs using REDCap.

21 they always disclosed the relationship to an IRB official, 7.7% said they sometimes did, 11.5% said t

22 a Visante time-domain AS-OCT according to an IRB-approved protocol.

23 Fourteen patients, under an IRB-approved clinical study, underwent exam under anesth

24 Under an IRB-approved protocol, intraoperative human Adipose MSCs

25 h 2002 were prospectively evaluated under an IRB-approved protocol.

26 tion of mRNAs for insulin receptor (IR)A and IRB; insulin receptor substrate (IRS)-1 and IRS-2; phosp

27 copy of all consent forms they generated and IRB correspondence regarding the study.

28 ssociated with decreases in investigator and IRB staff effort and faster protocol reviews, although s

29 our studies suggest that coexisting SRB and IRB populations in river sediments contribute to Hg meth

30 Oncology research staff and IRB staff were surveyed to understand effort and timing.

31 Surveys and IRB-approved consent forms were obtained from all of the

32 ious, makes sense for both investigators and IRBs as the research community thinks through the implic

33 thought that the relationships that another IRB member had with industry affected his or her IRB-rel

34 the clinical trials obtained the appropriate IRB or Ethics Committee approval prior to enrolling any

35 in this article, that address topics such as IRB disaster preparedness activities, informed consent,

36 esistance by stabilizing membrane-associated IRB and potentiating insulin signaling.

37 lated phosphorylation of insulin receptor B (IRB) is impaired in primary Cyp2c44(-/-) hepatocytes and

38 borators from various sub-ethnic groups; (b) IRB protocol submissions; (c) consistencies in translati

39 RB) and one group of iron-reducing bacteria (IRB), potential Hg methylators, were active in SR sedime

40 ction of Fe (III) by iron reducing bacteria (IRB), which significantly enhances sulfate reduction by

41 at some interspecific reproductive barriers (IRBs) are related to SI in the Solanaceae.

42 isclosed history of increased risk behavior (IRB) including intravenous drug use (IVDU), imprisonment

43 Relationships between IRB members and industry are common, and members sometim

44 was approved by Institution Research Board (IRB) of Mansoura Medical College.All patients were subje

45 approved by the institutional review board (IRB) and was HIPAA compliant.

46 Institutional review board (IRB) approval was obtained for this retrospective study

47 Institutional review board (IRB) approval was obtained from each site.

48 Institutional review board (IRB) approval was received at the University Medical Cen

49 ve research) and institutional review board (IRB) approval were obtained for the original prospective

50 Following institutional review board (IRB) approval, a retrospective review evaluated the outc

51 s enrolled on an institutional review board (IRB) approved protocol were selected.

52 ch only when the institutional review board (IRB) determines that the risks are minimal or a minor in

53 single, central institutional review board (IRB) for multicenter clinical trials, despite statements

54 ited review by 1 institutional review board (IRB) member, and simplifying reviews of multicenter rese

55 In addition, institutional review board (IRB) members attended these meetings and made a separate

56 een industry and institutional review board (IRB) members in academic institutions.

57 xamining whether institutional review board (IRB) members, granting agencies, and journal reviewers f

58 approved by the Institutional Review Board (IRB) of the American College of Radiology Imaging Networ

59 An Institutional Review Board (IRB) of the Health Services Academy (HSA) approved this

60 example, in the institutional review board (IRB) process, less than one third of the steps add value

61 nterest, lack of institutional review board (IRB) resources, and the volume and complexity of clinica

62 ond conventional institutional review board (IRB) review is needed because of the potential for adver

63 nvolves parallel Institutional Review Board (IRB) reviews based on the premise that local review refl

64 gn, choice of an institutional review board (IRB), and trial outcomes.

65 In this Institutional Review Board (IRB)-approved and Health Insurance Portability and Accou

66 types through an institutional review board (IRB)-approved clinical trial that involved 276 outpatien

67 n enrolled in an institutional review board (IRB)-approved prospective phase 2 trial with TCD velocit

68 An Institutional Review Board (IRB)-approved prospective study was conducted of all pat

69 rticipated in an Institutional Review Board (IRB)-approved randomised double-blind trial comparing ac

70 IPAA)-compliant, Institutional Review Board (IRB)-approved retrospective study of 1,597 subjects unde

71 nducted under an Institutional Review Board (IRB)-approved study.

72 central vs local institutional review board (IRB).

73 We conducted an institutional review board-IRB-approved retrospective review of advanced cancer pat

74 General Brigham Institutional Review Boards (IRB) as part of the RoCI, and all procedures performed w

75 Institutional review boards (IRBs) are charged with safeguarding potential research s

76 Institutional review boards (IRBs) are given discretion to interpret and apply the fe

77 rticle are that Institutional Review Boards (IRBs) are not violating Office of Protection from Resear

78 rsight of local institutional review boards (IRBs) became evident.

79 of research by institutional review boards (IRBs) due to the rush to enter the disaster field.

80 ng concern that institutional review boards (IRBs) impose burdensome delays on research, little is kn

81 is reveals that institutional review boards (IRBs) may approve children's participation as HSC donors

82 While Institutional Review Boards (IRBs) oversee research activities, they do not assess ri

83 tiveness of the institutional review boards (IRBs) responsible for overseeing research involving huma

84 vestigators and institutional review boards (IRBs) until the research community reaches consensus, or

85 ulatory bodies (institutional review boards [IRBs] and data and safety monitoring boards) should cons

86 chments (RRDs) with inferior retinal breaks (IRBs).

87 ted from the greater Washington, DC, area by IRB-approved written and electronic media.

88 keratectomy was most accurately predicted by IRB/ORA.

89 benefit categories for pediatric research by IRB chairpersons is variable and sometimes contradicted

90 r the readability of sample text provided by IRBs exceeded the stated standard by 2.8 grade levels (9

91 We hypothesized that text provided by IRBs in informed-consent forms falls short of the IRBs'

92 erage readability score for text provided by IRBs was 10.6 (95 percent confidence interval, 10.3 to 1

93 A single center IRB approved study included 874 patients.

94 time was shorter among sites using a central IRB (199 days [IQR, 140-292 days]) than those using a lo

95 CTTI recommends that sponsors use a central IRB and discuss trial endpoints with regulators, includi

96 d reforms, such as accreditation and central IRBs, according to how well they address these 15 proble

97 erceptions of barriers to the use of central IRBs and to formulate potential solutions.

98 ese findings suggest that the use of central IRBs has the potential to improve RCT efficiency.

99 isseminated to facilitate the use of central IRBs in multicenter trials.

100 A, OHRP, and NIH in support of using central IRBs to improve the efficiency of conducting trials.

101 EACs complement IRBs by focusing on potential harms to participants and

102 orms were obtained from all of the contacted IRBs (n = 16).

103 ess the validity of concerns about different IRB models.

104 IRB approval of studies, 37 (77%) documented IRB approval with a statement in the manuscript, 7 (15%)

105 the underuse of these mechanisms and exhort IRBs and researchers to take advantage of these importan

106 t audit and as such did not require external IRB review.

107 246 eyes (215 first eyes and 31 second eyes) IRB using ORA achieved the greatest predictive accuracy

108 d the requirement for informed consent, five IRBs permitted telephone consent, and three IRBs allowed

109 Following IRB approval, medical records of 662 consecutive patient

110 5 (69%) for midlevel officials, 62 (81%) for IRB members, and 51 (66%) for governing board members.

111 parative effectiveness analysis was done for IRB predictive accuracy of IOL power determination again

112 An important ethical principle for IRB members and other regulators to consider is that sui

113 little is known about the time required for IRB review across different types of research.

114 cal centers, 6 did not meet requirements for IRB review and 2 declined to participate.

115 ted methylation rates, suggesting a role for IRB in CH(3)Hg synthesis.

116 protocols, additional financial support for IRB functions, and a standardized system for collecting

117 es of U.S. medical schools were surveyed for IRB readability standards and informed-consent-form temp

118 Contrary to expectations, the time for IRB review and approval (median, 47 days) is the fastest

119 o test competency and a range of options for IRBs to ensure that vulnerable subjects are protected fr

120 ts during COVID and as a result did a formal IRB approved retrospective review to see if corneal inju

121 without altering the signals emanating from IRB.

122 Board noted that this study was exempt from IRB approval.

123 Simultaneously, the produced Fe (II) from IRB can alleviate the inhibition of undissociated H2S on

124 the number requiring revision (25%) and full IRB approval (16%) increased significantly (P < 0.0001 a

125 Of the 31 requiring full IRB approval, 7 were pursued while 24 (77%) were abandon

126 an expedited process with few requiring full IRB approval.

127 number considered nonexempt (requiring full IRB review) were determined.

128 Of 17 262 potential donors, 659 (3.8%) had IRB for BBV and 285 (1.7%) were seropositive for BBV, of

129 This retrospective study had IRB approval, as well, and was HIPAA-compliant.

130 member had with industry affected his or her IRB-related decisions in an inappropriate way, 11.9% sai

131 this reliance on IRBs, no data exist on how IRBs apply the risk and benefit categories for pediatric

132 Of the extreme delays in IRB review, 80.0% were due to investigators' slow respon

133 However, S-RNase-independent IRBs also clearly contribute to rejecting pollen from th

134 Initial IRB review took 2 to 4 months, with expedited and exempt

135 l accordance with the relevant institutional IRB protocol.

136 With institutional IRB approval, we examined a subset of our mechanically v

137 hoc adjustments by individual institutional IRBs.

138 lian cells, IR is expressed as two isoforms (IRB and IRA) that are responsible for insulin action.

139 ersonal files and all issues of the journals IRB and Controlled Clinical Trials.

140 IQR, 140-292 days]) than those using a local IRB (287 days [IQR, 205-390 days]; P < .001).

141 Furthermore, local IRB review of the thousands of safety reports from multi

142 We examined the costs and effects of local IRB review of the consent and protocol in a multicenter

143 nt safety, the responsibilities of the local IRB in the oversight of multicenter clinical trials must

144 to unaffiliated sites that used their local IRB for review.

145 Local IRBs were not designed to handle the initial evaluation

146 999 federal regulatory actions against local IRBs increased threefold.

147 ticenter genetic epidemiology study by local IRBs was highly variable.

148 r changes in the regulations governing local IRBs.

149 the current crisis in the function of local IRBs is the ascendance of multicenter clinical trials as

150 COVER) study is a single-site, multisurgeon, IRB-approved investigational device prospective study.

151 higher GT gain after 6 months (NCT05916716; IRB:46852621.0.0000.0077).

152 ra/Northwell under the auspices of Northwell IRB: 17-0140-FIMR Feinstein Institution for Medical Rese

153 After obtaining IRB approval, subjects with ultrasound-proven pyloric st

154 After obtaining IRB permission, expression of ecto-5'-nucleotidase (NT5E

155 We found that 36% of IRB members had had at least one relationship with indus

156 Adequacy of IRB background information on human subjects research re

157 enters to obtain information on frequency of IRB meetings, dates for submission and approval, use/non

158 tematic review of the roles and functions of IRB rather than ad hoc adjustments by individual institu

159 itive for BBV, of whom half had a history of IRB (mostly IVDU [78.5%]).

160 Donors with a history of IRB provide a valuable source of organs for transplantat

161 urin activity, the proteolytic maturation of IRB is greater than that of IRA, and accordingly, the am

162 the selective PACE4-dependent maturation of IRB occurs when furin activity is reduced; accordingly,

163 improvement may be to pursue a new model of IRB oversight: independent nonprofit boards that stand a

164 ecific problems related to the operations of IRB review.

165 dicated that EET-A enhances the retention of IRB in membrane rich fractions, thus potentiating its ac

166 lment) as compared by trial year and type of IRB used.

167 Most respondents reported that the views of IRB members who had experience working with industry wer

168 The most common concern (52%) of IRBs pertained to the genetic aspects of the study.

169 rse events and the performance assessment of IRBs.

170 s that could undercut the ethical mission of IRBs to protect and promote the rights and welfare of re

171 Analysis of survey information on IRBs' approved research practices.

172 Despite this reliance on IRBs, no data exist on how IRBs apply the risk and benef

173 One IRB's concern about incentivizing a particular medicatio

174 among several of the research practices; one IRB waived the requirement for informed consent, five IR

175 mation security officer, privacy officer, or IRB chair.

176 hod described here could be applied to other IRBs to begin identifying and improving inefficiencies.

177 Our IRB-approved diuretic-induced dehydration study demonstr

178 Our IRB-approved study included 1367 serial CXRs from 405 ad

179 nd accordingly, the amount of phosphorylated IRB is also greater than that of IRA.

180 endations that are instrumental in preparing IRBs to review protocols related to public health emerge

181 tions about the increasing use of for-profit IRBs to review research proposals (as opposed to boards

182 ty ownership and consolidation of for-profit IRBs.

183 rals for VM, were recruited in a prospective IRB-approved, HIPAA-compliant study.

184 Policy regarding IRB approval of studies that involve human subjects.

185 l partners that reflects both health-related IRB and natural-resource-related IPR considerations.

186 the 102 journals surveyed, 48 (47%) require IRB approval of studies involving human subjects as a pr

187 In the 48 journals that clearly required IRB approval of studies, 37 (77%) documented IRB approva

188 e risks while allowing appropriate research, IRB chairpersons need guidance on applying the federal r

189 and informed consent forms by the respective IRBs at the University of Florida and West Virginia Univ

190 This retrospective, IRB-approved study investigated retinoblastoma patients

191 ollaborators; (b) checking the institution's IRB policies related to the use of multiple languages; (

192 ase and HT protein function in a pistil-side IRB that causes rejection of pollen from self-compatible

193 is not solved by the transition to a single-IRB model and researchers cannot simply choose one state

194 EHS Best Practices Working Group for Special IRB Considerations in the Review of Disaster Related Res

195 rotein convertase PACE4 selectively supports IRB maturation.

196 We surveyed IRB members about such relationships.

197 ffectiveness compared to standard CBC tests (IRB #4051).

198 and Elliott call attention to the fact that IRB review rarely probes how researchers propose to deal

199 us do not publish guidelines indicating that IRB approval of studies involving human research subject

200 His proposal that IRBs should be encouraged to be more vigilant and throug

201 The risks that IRBs should consider are those that result specifically

202 The IRB approved the study and it was HIPAA-compliant.

203 The IRB members requested attendees to voluntarily complete

204 s and made a separate presentation about the IRB approval of research and the exception to informed c

205 CRIN) and each participating site and by the IRB and the Cancer Therapy Evaluation Program at the Nat

206 time, and number of changes requested by the IRB at each center.

207 This study was approved by the IRB at Mayo Clinic.

208 I protocol (NCT03480152) was approved by the IRB committee of the NIH and the FDA.FUNDINGCenter for C

209 l EHR and genotype data is restricted by the IRB.

210 is prospective randomized study compared the IRB-approved paper ICF for an actual clinical research s

211 veloping a detailed process flowchart of the IRB review process, 2 analysts abstracted temporal data

212 +/-0.5 D and 94% were within +/-1.0 D of the IRB's predicted outcome.

213 rom ethical responsibilities required of the IRB.

214 h the ethical review responsibilities of the IRB.

215 to all 103 protocols newly submitted to the IRB at a large urban Veterans Affairs medical center fro

216 t and the research protocol submitted to the IRB.

217 reviews of multicenter research by using the IRB of 1 institution.

218 the clinical research in compliance with the IRB approval at the University of Pittsburgh.

219 The IRBs that approved the protocol classified it as minimal

220 ease in regulatory actions taken against the IRBs of academic medical centers (1 in 1997 compared wit

221 The number of consents required by the IRBs ranged from 1 to 4; 15 IRBs (48%) required 2 or mor

222 Informed consent requirements of the IRBs were followed.

223 in informed-consent forms falls short of the IRBs' own readability standards and that readability is

224 that at least one protocol came before their IRB during the previous year that was sponsored either b

225 Gaps exist in institutions informing their IRBs of potential ICOI in research projects under review

226 This IRB-approved study included 17 single-lesion extremity d

227 This IRB-approved study was conducted at one academic childre

228 This IRB-approved, HIPAA-compliant reader study obtained info

229 This IRB-approved, HIPAA-compliant study had waiver of inform

230 This IRB-approved, retrospective study included 154 SOTR with

231 The review times observed at this IRB are substantially longer than the 60-day target reco

232 crog indocyanine green in the breast in this IRB-approved, HIPAA-compliant, dose escalation study to

233 21 mmHg) or control group (>21 mmHg) in this IRB-approved, prospective, consecutive case series.

234 The objective of this IRB approved retrospective study was to apply deep learn

235 Results of this IRB-approved study were robust to the exclusion of opera

236 IRBs permitted telephone consent, and three IRBs allowed prisoners to be enrolled.

237 property rights (IPR) are also applicable to IRB reviews, as are principles of sovereignty and indige

238 We agree to IRBs should be encouraged to rethink their roles.

239 anagement of primary pseudophakic RRD due to IRBs.

240 research response integration and training, IRB roles/responsibilities, community engagement, and di

241 Within a multicenter trial, IRBs reviewing a common protocol varied in several of th

242 ients after obtaining informed consent under IRB protocol.

243 th and without PTSD from a single site under IRB approval.

244 Patients underwent IRB for IOL power estimation.

245 The study was approved by the University IRB.

246 and treatment preferences were collected via IRB-approved, self-administered survey sent to Glick Eye

247 mmittee of the Medical University of Vienna, IRB number 720/2011.

248 s retrospective single-institution study was IRB approved and HIPAA compliant.

249 This study was IRB approved.

250 This HIPAA-compliant study was IRB-approved with written informed consent.

251 This HIPAA-compliant study was IRB-approved; formal consent was obtained.

252 ticipating children, and the extent to which IRBs use the federal definition of minimal risk when cat

253 lization characteristics were collected with IRB approval.

254 Complying with IRB requirements for a minimal-risk study required subst

255 We held discussions with IRB experts, interviewed representatives of research ins

256 Donors with IRB provided 1091 organs for transplantation (624 kidney

257 Of actual donors with IRB, 393 were seronegative for viral markers at time of

258 t mechanism; patient consent was waived with IRB approval.

259 Rhegmatogenous retinal detachments with IRBs are not uncommon; their management is challenging w

260 nefit of adding SB to PPV to treat RRDs with IRBs.

261 ients of organs from donors with and without IRB.