IRB Advisor – July 1, 2021
July 1, 2021
View Issues
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Study Results Show Public Support for Alternative Vaccine Design
The results of a recent study indicate potential research participants are open to alternative vaccine trial designs, including challenge trials in which participants are exposed to COVID-19. -
IRB Project Cuts Protocol Modification Time in Half
An IRB process improvement project reduced the protocol modification time by half. The change required the IRB chairs to give up some of their responsibilities and put these new responsibilities on the IRB coordinators. -
Q&A: Data Safety Monitoring Board Experts Explain Role in Clinical Research
Data safety monitoring boards (DSMBs) have played a big role in delivering vaccines and treatments to the public faster in the past 18 months. DSMBs reviewed results and safety data of the various studies involving treatments and vaccines for COVID-19. IRB Advisor asked two scientists about how DSMB work has helped improve research protections during the pandemic. -
IRB Approaches Research Participant Complaints Individually
Like many of its counterparts, the IRB at New York State Psychiatric Institute (NYSPI) evaluates any complaint from a research participant on an individual, case-by-case basis. IRB Advisor spoke with Corinne Rogers, MS, CIP, NYSPI IRB director, to find out more about her research-related dispute procedures. -
Study Author Gives Recommendations to Improve Research Dispute Process
An associate professor at Columbia Law School in New York City wrote about the handling of research grievances from research studies. The processes for resolving research participants’ concerns are a “curiously unregulated space." While the United States court system might recognize claims about physical injuries during a trial or a negligent study design, it usually is left to the IRB to resolve disputes between trial participants and research staff. -
When Complaints Are Not Resolved
IRBs can resolve most research-related complaints, but a policy implemented last year by the National Institutes of Health’s Office of Human Subjects Research Protections offers assistance when the conflict reaches a stalemate.