IRB Advisor
RSSArticles
-
IRB Staff Training Program Improves Consistency and Work Group Efficiency
When an IRB office aimed to improve its staff training and work efficiency, the solution was to create a new program, called the IRB Staff Training and Onboarding Program. The process began with the IRB’s internal staff training and member work group and leaders identifying ways to improve training and onboarding of new IRB staff. -
Pfizer and Moderna Begin COVID-19 Vaccine Trials in Younger Children
Both Pfizer-BioNTech and Moderna announced in March they had begun clinical trials of their COVID-19 vaccines in children younger than age 12 years. Although public reaction was mixed, researchers and bioethicists now say the timetable for a pediatric vaccine and for the United States to possibly reach herd immunity is early 2022. -
Take Steps to Prevent Damaging Security Breaches in Survey Studies
IRBs can help investigators create a plan to prevent survey security breaches that can lead to false data and study slowdowns and shutdowns. IRBs should ensure researchers know that if they detect a breach that changes/corrupts data, leads to someone outside the research team accessing data, causes potential harm to participants, or requires a change in procedures or informed consent, it should be reported to the IRB.
-
IRBs, Researchers Starting to Recognize Security Breaches of Online Survey Data
Researchers at the University of Houston discovered a survey study had been breached. Large number of surveys poured in, with batches arriving in two-minute intervals. Other signs of a breach included suspicious responses, unusual email addresses and patterns, responses from outside the United States, and missing contact information.
-
United Kingdom Begins First COVID-19 Human Challenge Study
Lawmakers, academics, and the research community have hotly debated the ethics of a human challenge study since the first months of the COVID-19 pandemic. Now that the United Kingdom has started dosing patients in its human challenge study, some bioethicists say this trial can show vaccine efficacy in ways the larger vaccine trials cannot.
-
Study of COVID-19 Vaccine in Pregnant People ‘Too Late’
On Feb. 18, Pfizer and BioNTech announced they would dose about 4,000 healthy pregnant women with the COVID-19 vaccine to evaluate its safety, tolerability, and immunogenicity. Although pregnant people were excluded initially from the COVD-19 trials, research has shown they are at higher risk for more severe disease.
-
Prominent Pastor, Scientists, Researchers Seek to Ease Vaccine Fears in Minority Populations
Minority populations are more likely to participate in clinical research activities when they are encouraged by trusted authority figures, such as family physicians or pastors. One such pastor and author, Bishop T.D. Jakes of The Potter’s House in Dallas, decided to use his popular YouTube channel to broadcast information about the COVID-19 vaccine to dispel myths and to encourage his followers to take the shots.
-
IRB Improves and Simplifies Board Meeting Minutes Process
An IRB revised its board meeting minutes process from a clunky system of writing everything into an electronic document to one in which the minutes are automatically populated through the IRB’s electronic system, saving staff time and work. The old way of creating board meeting minutes sometimes took as long as a month for IRB staff to generate. Since the IRB revised its process, the staff can generate board meeting minutes within a week.
-
IRB Reduces Student Study Review Time from 65 Days to 8 Days
It is possible to shorten IRB review time dramatically, but it requires some resources and time. The IRB of Northcentral University serves a nontraditional population of students, some of whom want to complete a research study as part of their academic plan. The IRB’s streamlining process reduced the submission-to-approval time to eight days, down from an average of 65 days before the new process, according to new, unpublished data.
-
Researchers and IRBs Reconsider Minimal Risk After Trial Results
A clinical trial that involved studying electronic health record alerts for acute kidney injury seemed to be minimal risk to both the researchers and the IRBs that approved it. However, when two hospitals involved in the study reported an increased mortality rate, the researchers and the IRBs reconsidered what is truly minimal risk in these types of studies.