IRB Advisor
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New SACHRP Guidelines on ‘Pay-to-Participate’ Research
The Secretary’s Advisory Committee on Human Research Protections has finalized recommendations to assist IRBs dealing with “pay-for-participation” studies, which raise numerous ethical issues but may produce meaningful data if properly vetted.
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Methods to Improve the IRB/PI Relationship
There are natural conflicts between IRBs and principal investigators, but IRBs can take several steps to improve this crucial relationship. For instance, IRBs should treat everything on a case-by-case basis, depending on the situation, the principal investigator, and the IRB’s policies.
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Protecting Research Data in the Digital Age
The increasing array of devices and systems to access, store, and transfer research data calls for diligence and common sense to prevent breaches. How seriously is the research community taking this threat? The National Institutes of Health has essentially hired hackers to constantly probe and test its database for the All of Us genome research project.
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Is ‘Informed Consent’ an Oxymoron?
A study asking readers to consent to a short form containing only the key information about the research resulted in suboptimal comprehension, suggesting participants only skimmed through it or skipped it outright.
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OHRP Holds Workshop on ‘Pervasive’ Data
The unprecedented level of digital data available across an expanding electronic landscape poses complex challenges for IRBs as they attempt to provide ethical insight and ensure participant privacy. Some of these data are collected in clinical care, but the public also is generating data through health monitoring devices, GPS location systems, social media, and information collected and shared on mobile apps.
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Focus on the Differences Between IRBs and HRPPs
As research institutions move toward a single IRB model and more studies are deemed exempt, there is a greater need for all stakeholders to understand the differences between an IRB and a human research protection program.
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Single IRB Common Rule Changes Arrive in January
Academic institutions are grappling with ensuring their IRBs are prepared for the January 2020 deadline to move multisite research to a single IRB. This deadline looms over all policy and procedural changes.
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Tips for Including Plain Language in Informed Consent Form
Many informed consent forms fail to communicate simply and clearly. They might use language prospective research participants may not process easily. While the new Common Rule provides some suggestions for making informed consent documents more readable, there are additional steps IRBs and researchers could take to improve the forms, including incorporating plain language.
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Sample Models of Post-Approval Monitoring Programs
There are many ways IRBs could conduct post-approval monitoring programs. These can range from simple email questions and answers to full reviews at the research site. These programs often are designed to be educational, as well as adding a layer of accountability in the human research protection process.
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In New Common Rule Era, There Is Role for Post-Approval Monitoring
Post-approval monitoring (PAM) is one method that IRBs could employ when keeping tabs on minimal-risk studies or studies that no longer have to go through the continuing review process. It also can be a way for a small IRB to improve office efficiency and enhance relationships with investigators. IRBs that would like additional information from studies, after continuing review ends, could use PAM to obtain that information.