scholarly journals Waiver of Consent in a Trial Intervention Occurring at Birth—How Do Parents Feel?

2017 ◽  
Vol 5 ◽  
Author(s):  
Wade D. Rich ◽  
Anup C. Katheria
Author(s):  
Rani Lill Anjum ◽  
Stephen Mumford

One view of what links a cause to an effect is that causes make a difference to whether or not the effect is produced. This assumption is behind comparative studies, such as the method of randomized controlled trials, aimed at showing whether a trial intervention makes a positive difference to outcomes. Comparative studies are regarded as the gold standard in some areas of research but they are also problematic. There can be causes that make no difference and some difference-makers that are not causes. This indicates that difference-making should be taken as a symptom of causation: a feature that accompanies it in some, though not all, cases. Symptoms can be useful in the discovery of causes but they cannot be definitive of causation.


AERA Open ◽  
2021 ◽  
Vol 7 ◽  
pp. 233285842110255
Author(s):  
David Harper ◽  
Anita R. Bowles ◽  
Lauren Amer ◽  
Nick B. Pandža ◽  
Jared A. Linck

English learners (ELs) in K–12 schools must acquire English while simultaneously mastering content knowledge. Educational technology may support students’ learning through the affordance of individualized language practice. The current randomized controlled trial intervention study examined the effects of Rosetta Stone Foundations software on English learning among middle school ELs. The study took place in Grades 6 to 8 of an urban U.S. school district ( N = 221). Predictors of interest included time of testing (pretest vs. posttest) and software usage, and covariates included grade level, sex, and attendance. Additionally, socioeconomic status and home language were accounted for due to sample homogeneity. Multilevel models indicated that treatment group students showed larger gains than control group students on oral/aural outcomes. These results indicate that the software intervention enables individualized practice that can produce proficiency-related gains over and above the typical classroom curriculum.


2004 ◽  
Vol 44 (3) ◽  
pp. 278-279 ◽  
Author(s):  
Andrew D. McRae ◽  
Charles Weijer

2018 ◽  
Vol 45 (1) ◽  
pp. 36-40 ◽  
Author(s):  
Mike King ◽  
Angela Ballantyne

Donor-funded research is research funded by private donors in exchange for research-related benefits, such as trial participation or access to the trial intervention. This has been pejoratively referred to as ‘pay to play’ research, and criticised as unethical. We outline three models of donor-funded research, and argue for their permissibility on the grounds of personal liberty, their capacity to facilitate otherwise unfunded health research and their consistency with current ethical standards for research. We defend this argument against objections that donor-funded research is wrongly exploitative, unfair and undermines the public good of medical research. Our conclusion is that, like all human subjects research, donor-funded research should be regulated via standard health research legislation/guidelines and undergo Research Ethics Committee/Institutional Review Board and scientific peer-review. We expect that, measured against these standards, some donor-funded research would be acceptable.


2006 ◽  
Vol 32 (4) ◽  
pp. 18-25 ◽  
Author(s):  
Christine R. Kovach ◽  
Patricia E. Noonan ◽  
Andrea Matovina Schlidt ◽  
Sheila Reynolds ◽  
Thelma Wells

Author(s):  
Anup C. Katheria ◽  
Phillip Allman ◽  
Jeff M. Szychowski ◽  
Jochen Essers ◽  
Waldemar A. Carlo ◽  
...  

Objective This study aimed to determine whether outcomes differed between infants enrolled in the PREMOD2 trial and those otherwise eligible but not enrolled, and whether the use of waiver effected these differences. Study Design The multicenter PREMOD2 (PREmature infants receiving Milking Or Delayed cord clamping) trial was approved for waiver of antenatal consent by six of the nine sites institutional review boards, while three sites exclusively used antenatal consent. Every randomized subject delivered at a site with a waiver of consent was approached for postnatal consent to allow for data collection. Four of those six sites’ IRBs required the study team to attempt antenatal consent when possible. Three sites exclusively used antenatal consent. Results Enrolled subjects had higher Apgar scores, less use of positive pressure ventilation, a lower rate of bronchopulmonary dysplasia, and a less frequent occurrence of the combined outcome of severe intraventricular hemorrhage or death. A significantly greater number of infants were enrolled at sites with an option of waiver of consent (66 vs. 26%, risk ratio = 2.54, p < 0.001). At sites with an option of either approaching families before delivery or after delivery with a waiver of antenatal consent, those approached prior to delivery refused consent 40% (range 15–74% across six sites) of the time. Conclusion PREMOD2 trial demonstrated analytical validity limitations because of the variable mix of antenatal consent and waiver of consent. A waiver of antenatal consent for minimal risk interventional trials conducted during the intrapartum period will be more successful in enrolling a representative sample of low and high-risk infants if investigators are able to enroll all eligible subjects. Clinical Trial Registration ClinicalTrials.gov identifier: NCT03019367. Key Points


2009 ◽  
Vol 77 (1) ◽  
pp. 90-96 ◽  
Author(s):  
Celette Sugg Skinner ◽  
Kathryn I. Pollak ◽  
David Farrell ◽  
Maren K. Olsen ◽  
Amy S. Jeffreys ◽  
...  

2018 ◽  
Vol 21 (10) ◽  
pp. 1050-1056 ◽  
Author(s):  
Ryan E. Rhodes ◽  
Mark R. Beauchamp ◽  
Chris M. Blanchard ◽  
Shannon S.D. Bredin ◽  
Darren E.R. Warburton ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document