IRB Advisor
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IRB Websites Are a Helpful Resource for Undergraduate Research Ethics
The way IRBs communicate about research ethics varies widely depending on the institution. This article will explore what this means for researchers.
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Does Current IRB System Ensure Ethical Research?
A consensus is needed for how to measure IRB quality or effectiveness, and more inspections are needed to ensure instances of IRB noncompliance are identified, according to the authors of a recent report.
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To Pay or Not to Pay: Researchers Grapple with Implications of Reimbursing Study Participants
Pushback on paying participants comes from both researchers and IRBs. From the researcher’s perspective, concerns revolve around budgetary limitations and how much they can afford to pay. IRBs generally are more concerned about payment amounts causing undue influence on participation.
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Some IRBs Expand Their Purview to Consider Scientific Merit
The most common ethics-related reasons for protocol deferral were inadequate informed consent, insufficient protection of participants’ safety, inadequate detail of risk assessment, and inadequate minimization of risks. Some study protocols were not approved due to issues of scientific merit, such as adequate adverse event reporting or the importance of the knowledge to be gained. Read on to learn how to prevent these problems and avoid delays.
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Ethical Precision Medicine Requires Relying on Scientific Evidence, Safeguarding Information
American College of Physicians offers guidance as genome sequencing technology progresses quickly.
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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.