ライフサイエンスコーパス: IRB

1 IRBs commonly provide text for informed-consent forms th

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

59 keratectomy was most accurately predicted by IRB/ORA.

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

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

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

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

64 A single center IRB approved study included 874 patients.

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

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

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

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

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

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

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

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

73 246 eyes (215 first eyes and 31 second eyes) IRB using ORA achieved the greatest predictive accuracy

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

75 Following IRB approval, medical records of 662 consecutive patient

76 5 (69%) for midlevel officials, 62 (81%) for IRB members, and 51 (66%) for governing board members.

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

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

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

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

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

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

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

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

85 without altering the signals emanating from IRB.

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

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

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

89 an expedited process with few requiring full IRB approval.

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

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

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

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

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

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

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

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

98 l accordance with the relevant institutional IRB protocol.

99 hoc adjustments by individual institutional IRBs.

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

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

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

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

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

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

106 Local IRBs were not designed to handle the initial evaluation

107 999 federal regulatory actions against local IRBs increased threefold.

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

109 r changes in the regulations governing local IRBs.

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

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

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

113 Adequacy of IRB background information on human subjects research re

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

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

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

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

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

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

120 ecific problems related to the operations of IRB review.

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

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

123 rse events and the performance assessment of IRBs.

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

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

126 One IRB's concern about incentivizing a particular medicatio

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

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

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

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

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

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

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

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

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

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

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

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

139 This retrospective, IRB-approved study investigated retinoblastoma patients

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

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

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

143 rotein convertase PACE4 selectively supports IRB maturation.

144 We surveyed IRB members about such relationships.

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

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

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

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

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

150 The IRB members requested attendees to voluntarily complete

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

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

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

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

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

156 +/-0.5 D and 94% were within +/-1.0 D of the IRB's predicted outcome.

157 rom ethical responsibilities required of the IRB.

158 h the ethical review responsibilities of the IRB.

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

160 t and the research protocol submitted to the IRB.

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

162 The IRBs that approved the protocol classified it as minimal

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

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

165 Informed consent requirements of the IRBs were followed.

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

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

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

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

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

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

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

173 21 mmHg) or control group (>21 mmHg) in this IRB-approved, prospective, consecutive case series.

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

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

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

177 anagement of primary pseudophakic RRD due to IRBs.

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

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

180 Patients underwent IRB for IOL power estimation.

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

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

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

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

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

186 lization characteristics were collected with IRB approval.

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

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

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

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

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

192 ients of organs from donors with and without IRB.