Internal Review Boards
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Self-Assessing IRB Operations Can Help HRPPs Stay Compliant, on Track
If an IRB sets a goal of greater efficiency, then giving researchers self-assessment tools and using self-auditing tools on IRB operations is a method that can work. These tools can help study coordinators and investigators turn their study protocol submissions from a hot mess into a submission that is mostly compliant and easier to pre-review.
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Government Accountability Office to Study For-Profit IRBs at Senators’ Request
The Government Accountability Office agreed to “investigate the operations” of commercial IRBs at the request of U.S. Sens. Elizabeth Warren, D-MA, Sherrod Brown, D-OH, and Bernie Sanders, I-VT.
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Research Professionals Question Structure, Effectiveness of IRBs
Finding ways to evaluate IRB ethical quality and effectiveness has been an elusive ideal. Two research professionals are advocating for directly measuring quality of board oversight, rather than relying on the structure of the IRB. An upcoming U.S. Government Accountability Office evaluation of commercial IRBs also may promote the conversation.
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Neurotechnology Takes Human Research Ethics to New Frontiers
It is possible that any IRB might someday review a study that involves making healthy people smarter, cognitively faster, and more resilient mentally. Neurotechnology, including research funded by the government, also is designed to help people with Parkinson’s disease, locked-in syndrome, mental illness, and other issues. But it could take things a step further for people with no chronic conditions. This potential raises ethical questions.
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FDA Answers Audit Questions from Researchers, Industry
The Food and Drug Administration issued new guidance on inspections during the COVID-19 pandemic, as the agency began to resume domestic inspections in July.
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COVID-19 Pandemic Changed Informed Consent for Biobanking
Researchers have used the 2018 public health surveillance exception to the Common Rule for the first time during the COVID-19 pandemic. In the early weeks of the pandemic, researchers might have overused this exception. Federal agencies approved some protocols involving lines of genetic materials with explicit research purposes, even if these were secondary to the public health surveillance purpose.
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Tips to Improve IRB-Researcher Productivity and Relationship
Expectations and communication issues are the two biggest challenges between principal investigators and the IRB community. IRBs set expectations through their websites and response letters, but they might not have articulated those expectations to themselves and investigators. From the principal investigator perspective, researchers might not fully appreciate that IRBs can be advocates and not merely a clearing house or impediment to putting research in the field.
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Tips for Reopening or Closing Research Studies
The 2020 landscape for clinical trials looks different than it did five or 10 years ago. Even before the worldwide disruption in research from the COVID-19 pandemic, there were systemic shifts that have squeezed trials in ways that add pressure to investigators and IRBs.
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IRBs Look at How to Get Through Pandemic — and Beyond
As human research protection programs and IRBs enter the next leg of the COVID-19 pandemic, they can draw on experience to find the best balance between safety and efficiency. Each institution and IRB will face its own challenges. But one of the more common challenges as the United States copes with more than eight months of the crisis is pandemic fatigue and burnout.
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Controversy Surrounds Exception from Informed Consent Enrollment
The term “exception from informed consent” for some clinical trials has been around for decades, but most patients know nothing about it. Researchers set out to explore attitudes about enrolling subjects in studies without consent.