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Some of the latest versions of electronic health records have created logistical dilemmas for research institutions as they find that providing access to information is more difficult for research monitors, researchers browsing for information about potential subject pools, and other activities.
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Research institutions occasionally have studies that involve a population or topic that brings up issues of social injustice, such as studies involving war refugee populations or pediatric HIV foster children.
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Research in environmental sciences, engineering and related fields can raise unique ethical issues that may be unfamiliar to many IRBs, particularly when it comes to community-based research.
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When reviewing cancer clinical trials, IRBs must weigh the risks and benefits to potential participants. But it's not always clear what participants themselves consider to be a risk or a benefit of their enrollment in a study.
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Sometimes an IRB's caseload grows so big and complex that new processes have to be implemented or the workload is unmanageable.
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If an IRB's policy and procedures manual needs updating, it might be time to write or revamp the section on criteria for review.
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Involving a disability community in research from its inception can help shape the research so that it's more successful and addresses the community's needs better.
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Human research protection programs (HRPPs) often must balance the need to handle research complaints with the goal of conducting fair and reasonable investigations into any potential problem. HRPPs also must use staff time efficiently and not get bogged down in disputes that clearly are not pertinent to protecting research subjects, an expert says.
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Whole genome sequencing research raises important informed consent issues for IRBs and investigators, and the recent report by the Presidential Commission for the Study of Bioethical Issues (PCSBI) addresses these in its recommendations.
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More subject diversity is needed in clinical trials to reduce the risk of adverse outcomes, according to the keynote speaker at the Clinical Trials in Georgia conference.
