Series: Ask the IRB & IBC Experts
WCG’s IRB & IBC Review professionals get questions about clinical research all the time: from researchers, clinical team members at biopharma companies, and from members of institutional IRBs. We know that for many of the questions, the person asking is not the only one struggling with that issue. We’ve built this forum as an immediate and less formal way to share information across the clinical research community.
Ethics in Clinical Research
If a Subject’s Care Is Divided Equally Between Two Caregivers, Who Should Sign Caregiver Consent?
Blog Posts
Regulatory Compliance
Can we charge a subject for a diagnostic test not done as part of the IRB approved protocol?
Blog Posts
Regulatory Compliance
How should a site document a missing signature on a HIPAA authorization form?
Blog Posts
Clinical Trial Safety
What are the IRB Reporting Requirements for Adverse Events?
Blog Posts
Clinical Trial Safety
Do we need to submit safety events from another site to our IRB?
Blog Posts
Cell & Gene Therapy
How should we handle financial conflicts of interest in FDA-regulated clinical trials?
Blog Posts
Series: Ask the IRB & IBC Experts
Can participants be reconsented over the phone when an ICF is updated?
Blog Posts
FDA & ICH
What are the IRB submission requirements for observational studies?
Blog Posts
Regulatory Compliance
How to resolve irregularities in the documentation of informed consent?
Blog Posts
Ethics in Clinical Research