IRB Advisor
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Study Shows Research Programs and IRBs Responded Quickly to the Pandemic
Human research protection programs and IRBs nationwide responded quickly and efficiently to changing processes and policies during the early months of the COVID-19 pandemic, according to the results of a recent study.
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FWA Revisited: ‘Checking the Box’ and IO Responsibilities Under the Revised Common Rule
Revisions to the Common Rule took effect in 2018, but questions remain about how these changes have affected the Federalwide Assurance (FWA) and institutional responsibilities under the FWA.
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Chief Ethical Considerations for Continued COVID-19 Vaccine Research
The COVID-19 pandemic has created more uncertainty in human research protections in 2021. One issue IRBs will face is whether the benefits continue to outweigh the risks for people who enroll in COVID-19 vaccine studies.
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Research World Can Help Build Trust Among Minorities
The COVID-19 vaccine rollout has raised issues about trust among many Americans who are hesitant or unwilling to take the vaccine. The issue of trust is especially problematic among minority communities that have been harmed in historic medical and research incidences. People also are skeptical of a vaccine that was developed in record time, considering most vaccines take 10-15 years to make it to market.
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Research Trust Issues Affect Vaccine Rollout
The first month of the COVID-19 vaccine rollout among frontline healthcare workers was a reality check to the human research world after many people said no to the vaccine. There are several reasons for vaccine hesitancy, including distrust in the accelerated vaccine development process.
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DSMBs Have Helped Advance Safe, Effective HIV/AIDS Research
Data safety monitoring boards (DSMBs) have played a big role in helping the most effective and safe HIV therapies advance.
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Data Safety Monitoring Boards Were Quietly Behind the Scenes, but No More
DSMBs have been an essential fabric of clinical trials in recent decades, but until 2020, their work largely was under the public radar.
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OHRP Looks Back at its First 20 Years
IRB Advisor asked OHRP to look back since its launch in June 2000 to see how human research protections has evolved.
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20 Years of Reports on Research Protection
To commemorate the past 20 years of human research protection, as well as two decades of IRB Advisor, we asked editorial advisory board members to comment on how things have changed since 2001.
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COVID-19 Trial Protocol/Consent Issues Discussed on National Stage
Placebo vs. access to the available vaccine