Articles Tagged With: investigators
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Take Steps to Prevent Damaging Security Breaches in Survey Studies
IRBs can help investigators create a plan to prevent survey security breaches that can lead to false data and study slowdowns and shutdowns. IRBs should ensure researchers know that if they detect a breach that changes/corrupts data, leads to someone outside the research team accessing data, causes potential harm to participants, or requires a change in procedures or informed consent, it should be reported to the IRB.
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IRB Websites Can Offer a Wealth of Useful Tools
An important and useful function of an IRB’s website is its ability to give researchers — as well as the public — access to a wide variety of forms, guidance, and tools. When created well, an IRB’s website can be easy to navigate. It also should be updated with new and revised information regularly. Like crowdsourcing websites and with permission, an IRB’s website also can adopt and adapt tools that researchers and other IRBs have found useful.
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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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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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COVERED Project Seeks to Protect ED Personnel from COVID-19
Few questions are of greater concern to emergency health personnel these days than how they can protect themselves from COVID-19. It is an issue loaded with nuance. Much depends on such factors as how someone works in the emergency department, what procedures they perform, what specific practices they use when performing those procedures, and how often they are exposed.
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IRB Highlights Standardized and Effective Metrics Model
As IRBs and research programs increasingly seek IRBs of record and form reliance agreements, they will need to know whom to trust. IRBs also need their own performance data to share with sponsors, researchers, and others. The challenge is developing metrics that work and can be used by other IRBs for benchmarking purposes.
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Researchers Identify Ethical Concerns with Pragmatic Trials
Pragmatic trials raise some new ethical issues that need greater attention, according to the authors of a recent study.
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Study Reveals Preferences for Simpler Research Language
Boilerplate language for informed consent documents is simple, but not always easy for study participants to understand. The goal for IRBs is to help researchers simplify the words and scientific jargon they use to describe studies to participants, but it is unclear how this can be accomplished. One solution is the Consent Language Explicit And Reasonable Initiative.
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IRB’s Re-Engineered Program Makes It More Responsive
The revised Common Rule requires IRBs and research institutions to become more efficient and attentive. It also makes clear that an IRB cannot do all things for all stakeholders. The University of Texas Health San Antonio created a human research protection program office to handle institutional components of research protection work.