Variation in Institutional Review Board Responses to a Standard, Observational, Pediatric Research Protocol

Mansbach, Jonathan; Acholonu, Uchechi; Clark, Sunday; Camargo, Carlos A.

doi:10.1111/j.1553-2712.2007.tb02027.x

Cited by 43 publications

(49 citation statements)

References 8 publications

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“…This single-center study may not be generalizable to other cancer centers. As has been demonstrated for ethical review boards (ie, IRBs), 16 there may be considerable variation in concerns and decisions across institutions. Furthermore, the proportion of clinical trials that are sponsored by industry versus investigator-initiated may differ between institutions, thereby affecting the relative impact of scientific review committees.…”

Section: Discussionmentioning

confidence: 99%

Impact of NCI-Mandated Scientific Review on Protocol Development and Content

Ning¹,

Yan²,

Xie³

et al. 2015

J Natl Compr Canc Netw

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Purpose The NCI requirement that clinical trials at NCI-designated cancer centers undergo scientific review in addition to Institutional Review Board review is unique among medical specialties. We evaluated the impact of this process on protocol development and content. Methods We analyzed cancer clinical trials that underwent full board review by the Harold C. Simmons Cancer Center Protocol Review and Monitoring Committee (PRMC) from January 1, 2009, through June 30, 2013. We analyzed associations between trial characteristics, PRMC decisions, and protocol modifications using Chi-square testing, Fishers exact testing, and logistic regression. Results A total of 226 trials were analyzed. Of these, 77% were industry-sponsored and 23% were investigator-initiated. Initial PRMC decisions were: approval (40%), provisional approval (52%), deferral (7%), and disapproval (1%). These decisions were associated with study sponsor (P<.001) and phase (P<.001). Ultimately, 97% of industry-sponsored and 90% of investigator-initiated trials were approved (P=.05). Changes were requested for 27% of industry-sponsored trials compared with 54% of investigator-initiated trials (P<.001). Total changes requested (mean, 5.6 vs 2.4; P<.001) and implemented (mean, 4.6 vs 2.1; P=.008) per protocol were significantly greater for investigator-initiated trials. Changes related to study design were more commonly requested (35% vs 13% of trials) and implemented (40% vs 5% of trials) for investigator-initiated trials compared with industry-sponsored trials (P=.03). Conclusions NCI-mandated scientific protocol review seems to have a substantial impact on investigator-initiated trials but less effect on industry-sponsored trials. These findings may provide guidance on development and prioritization of institutional protocol review policies.

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Section: Discussionmentioning

confidence: 99%

Impact of NCI-Mandated Scientific Review on Protocol Development and Content

Ning¹,

Yan²,

Xie³

et al. 2015

J Natl Compr Canc Netw

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“…Although bioethicists debate the appropriateness of pediatric research that does not offer direct benefit to individuals [9], empiric data support the acceptability of nonbeneficial research among different populations of adolescents and parents [10 -12]. In the absence of data, there can be marked variation in how IRBs quantify research risk [13,14], as well as systematic errors in this quantification [15].…”

Section: Respect For Persons Beneficence and Justice: The Devil Is mentioning

confidence: 99%

It Takes Two to Tango: Ethical Issues Raised by the Study of Topical Microbicides with Adolescent Dyads

Ott

2008

Journal of Adolescent Health

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“…13 approved it with no changes, 18 approved it with minor revisions, and 3 deferred the approval, pending substantive revisions. [36] Stark and colleagues examined how 18 IRBs reviewed a study of vitamin A supplementation in low birth-weight infants. Their study found that there was considerable variability in IRB review, due to difficulties with assessing the appropriateness of the study design.…”

Section: Unequal Treatment Of Human Research Subjectsmentioning

confidence: 99%

Unequal treatment of human research subjects

Resnik

2014

Med Health Care and Philos

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Unequal treatment of human research subjects is a significant ethical concern, because justice requires that equals be treated equally. If two research subjects are the same in the relevant respects, they should be treated equally. However, not all human subjects are the same in relevant respects: people differ with respect to age, health, gender, race, mental abilities, socioeconomic status, and other characteristics. Disputes sometimes arise concerning the issue of whether subjects are the same in relevant respects and should therefore be treated equally. Allegedly unequal treatment occurs when subjects are treated differently and there is a serious dispute about whether subjects are the same in relevant respects. Patently unequal treatment occurs when there is no significant dispute about whether subjects are the same in relevant respects and they are treated unequally. Research regulations can help to minimize patently unequal treatment by providing rules for investigators, institutional review boards, institutions, and sponsors to follow. However, patently unequal treatment may still occur because the regulations are subject to interpretation. Additional guidance may be necessary to minimize patently unequal treatment of research subjects.

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Variation in Institutional Review Board Responses to a Standard, Observational, Pediatric Research Protocol

Cited by 43 publications

References 8 publications

Impact of NCI-Mandated Scientific Review on Protocol Development and Content

Impact of NCI-Mandated Scientific Review on Protocol Development and Content

It Takes Two to Tango: Ethical Issues Raised by the Study of Topical Microbicides with Adolescent Dyads

Unequal treatment of human research subjects

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