I have extensive experience ensuring compliance with federal regulations, including the Common Rule, FDA guidelines, and HIPAA. My role involved reviewing research protocols, consent forms, and monitoring ongoing studies to ensure adherence to ethical standards and legal requirements. I've also conducted audits and provided training to researchers on compliance matters, ensuring that all human subject research meets the highest ethical and regulatory standards.

In such cases, I would first document the specific ethical concerns and discuss them with the research team to seek clarification or modifications. If unresolved, I would escalate the issue to the Institutional Review Board (IRB) for further review. My approach is always collaborative, aiming to educate researchers on ethical standards while ensuring the protection of human subjects is never compromised.

I once identified a study where the consent process was not adequately informing participants of potential risks. I worked with the research team to revise the consent form, ensuring full transparency. Additionally, I recommended implementing a more robust participant education process. This experience highlighted the importance of vigilance and advocacy in protecting participant rights and ensuring ethical research practices.

I regularly attend professional workshops, webinars, and conferences focused on human subject protection. I also subscribe to regulatory agency newsletters and participate in professional networks to exchange knowledge. This proactive approach ensures I remain informed about the latest regulatory changes and best practices in the field.

Balancing these priorities involves rigorous review of research protocols to ensure they are scientifically valid while minimizing risks to participants. I advocate for ethical research designs that do not compromise participant welfare. By fostering open communication between researchers and the IRB, we can achieve advancements in science that are both innovative and ethically sound.