IRB Advisor
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The Search for Justice in the Human Genome
With sequencing of the human genome completed at the turn of this century, there was the heady expectation that the summit to great cures was about to be climbed like the iconic spiral staircase of DNA.
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Preparation, Communication Key to Establishing IRB of Record
The first time the Vanderbilt University and Medical Center IRB served as an IRB of record was 15 years ago — a decade before the concept began to catch on with multisite clinical trials and large IRBs.
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Smart Checklists Keep IRB on Track With Study Reviews
As an IRB office prepared for accreditation, staff looked for methods to increase compliance. An answer quickly formed: use the IRB’s electronic system to develop smart checklists.
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Try These Strategies for Improving Review Consistency
One IRB office created simple rules and a process to improve workflow efficiency. Using Toyota lean methodology, the office standardized interpretation of regulations and institutional policies.
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Code of Ethics for IRBs Working With Indigenous Tribes
IRBs and researchers must recognize that “the truth comes from many places” if they want to work in good faith with Native American tribes.
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Respect Tribal Sovereignty in Indigenous Research
In what may help overcome a history of well-earned distrust by indigenous people, a research collaborative has developed a curriculum to teach IRB members and others the distinct cultural issues that arise in studying Native Americans.
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Unique Informed Consent Challenges if Research Participant Is Incarcerated
It is well-established that incarcerated people suffer disproportionately from low literacy and health-related conditions that can affect cognition. Despite this, modified informed consent processes are not required by federal guidelines.
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Ethical Challenges of Social Research in the Digital Age
As we leave the analog age and enter the vast expanse of digital “big data,” the potential benefits and risks for social science research are uncharted. However, this bright future casts a shadow as big data raises the specter of ethical breaches of informed consent and violated privacy.
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Create More Thorough, Efficient New IRB Member Training
Educating and onboarding IRB members should include more than perfunctory online human subjects research training. The goal could be to provide new members with comprehensive information in a well-organized training program.
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Low Health Numeracy Also Is an Informed Consent Problem
Low health numeracy is a problem that could affect how well trials recruit and provide informed consent to potential participants. It’s defined by how well people access, process, interpret, communicate, and act on numerical, biostatistical, and other numbers-related health information.