Articles Tagged With: irbs
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Quality Improvement Project Reveals Reasons for Long IRB Approval Process
Researchers analyzed minutes of IRB meetings for 33 protocols that were approved in 2019. All 33 protocols required at least two full board reviews before approval. They also evaluated 244 protocols that were reviewed faster. Most delays were attributed to protocols that did not adequately describe the research. Some consent documents are incomprehensible to people without medical backgrounds. Safety risks, duration, and allocation of cost sometimes are unclear. All this requires feedback from the IRB, to which researchers must respond.
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IRBs Use Inconsistent Processes for Informed Consent with Non-English Speakers
Translations, interpretation services, and other necessary accommodations for non-English speakers need to be built into study budgets
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IRBs Facing Ethically Controversial Questions on Brain Research
The field of brain research sounds a lot like science fiction, but human neural organoids, human neural transplants, and human-animal chimeras all are imminent realities. IRBs are going to be facing some difficult decisions on whether this research can proceed. The authors of a recent report examined these issues.
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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. -
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. -
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. -
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 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. -
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. -
Consistency Is a Chief Goal for Relying IRBs
Juggling the work of an IRB of record and becoming a relying IRB can be challenging. But one underlying goal can keep an IRB on track with both roles: consistency.