Darshan Kulkarni and Edye Edens discuss the potential and pitfalls of using AI—like ChatGPT—to draft informed consent documents in clinical research. With both legal and regulatory expertise, they explore how AI could save time, whether it fits institutional IRB requirements, and the real-world value (or lack thereof) for different types of organizations.

Key Takeaways:

• Drafting vs. Final Use: AI can be useful as a first-draft tool, especially for high-volume sponsors. But using it for final documents without oversight is risky.
  
  
• IRB Templates Matter: Many IRBs (especially academic or VA-affiliated) require strict templates—limiting AI's value unless those are integrated upfront.
  
  
• Regulatory Landscape: AI-drafted consents must meet not just FDA standards, but also OHRP requirements. Compliance and clarity are non-negotiable.
  
  
• Customization Is Key: Most current AI tools are just wrappers over ChatGPT. Real ROI comes from domain-specific models trained for clinical research.
  
  
• Data & IP Risks: Feeding protocols into AI raises confidentiality concerns. Plus, who owns the output remains unclear due to copyright issues with training data.
  
  
• Why ROI Falls Short: Companies often reassign internal staff instead of building bespoke solutions. Without a clear use case or strategic planning, results disappoint.

AI shouldn’t replace people—it should support them. Darshan and Edye agree: if you're using AI to generate a first draft of informed consent documents, it could help streamline high-volume workflows. But expecting it to generate a compliant final version is unrealistic. Most current tools feel more like flashy "wrappers" around existing models and often lack a strong ROI. And let’s not forget the hidden risks—like IP concerns and exposing proprietary protocols.

Bottom line? AI has potential, but without strategic investment and oversight, it’s just another overhyped shortcut. Use it wisely, or not at all.

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Imagine you're filling a script when a State Board of Pharmacy inspector walks in—no warning, just a clipboard and serious consequences. Most community pharmacists assume, "That won’t happen to me," but audits are no longer rare—they're the norm.

Controlled substances are under intense scrutiny. Inspectors now expect airtight records, ongoing (not one-time) training, and SOPs that reflect current laws—not ones from 2019. If you’re relying on outdated policies, verbal explanations, or friendly smiles to pass inspection, you’re already behind.

Logs must match dispensing. Staff must follow documented protocols. Lock zones must meet state requirements. Every mismatch? A red flag.

At the Kulkarni Law Firm, we help pharmacies:

• Conduct proactive self-audits using real board standards
  
  
• Build strong, defensible SOPs and training systems
  
  
• Respond to audit deficiencies with authority—not panic
  
  

Darshan Kulkarni, a pharmacist and regulatory attorney, brings practical, no-BS insight into what inspectors really expect and how to be prepared. Because waiting for an audit is like waiting for a hurricane to test your roof—too late.

Be ready. Be confident. Be compliant.

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In this video, Edye Edens and Darshan Kulkarni discuss whether sponsors, sites, CROs, or IRBs should self-report compliance issues. Edye, who focuses on sites, explains that whether or not to self-report is highly situation-dependent. Some situations legally require reporting, while in others, organizations might have room to implement corrective actions without immediate reporting—but they must carefully understand applicable regulations and enforcement trends.

Darshan highlights the distinction between “should you report” and “is it reportable.” Not everything unethical is legally reportable, but stakeholders must assess the risks of not reporting, including potential regulatory, investor, or reputational fallout. He also warns that just because an SOP says “do not report,” that might not align with current regulations or enforcement priorities—and could even expose the organization to greater liability.

The conversation also touches on recent Trump administration statements that encourage self-reporting by offering some protection from prosecution—though Edye cautions that administrations often shift their enforcement priorities, so organizations should not rely solely on these statements as a shield. Both agree that any self-reporting should be accompanied by a robust corrective action plan already underway to show good faith. Otherwise, agencies could still decide to prosecute, especially in egregious cases.

Bottom line:
Self-reporting can build trust and potentially reduce penalties, but only if handled thoughtfully. Assess the legal requirements, business risks, and your agency’s enforcement climate before deciding to disclose.

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