As Christina Brennan, MD, MBA, CCRC, FACRP, begins her volunteer duties as the 2025 Chair of the ACRP Board of Trustees, she took time to answer some questions about her experience in the clinical research enterprise, some of the challenges and opportunities facing it, and how ACRP can be of service to its members and stakeholders.
While the U.S. Department of Justice continues to prioritize its investigation of fraud and misconduct within the clinical research space, the Office of Research Integrity (ORI)-Department of Health and Human Services (HHS) recently released its Final Rule on regulations governing Public Health Service Policies on Research Misconduct, which takes effect January 1, 2025. Clearly, the role of compliance in clinical research is a critical area of focus, one with the potential for significant consequences if overlooked or minimized.
ACRP, the trusted global authority for training clinical research professionals, announced that Marian Valia has joined the association as Head of Learning & Development. Ms. Valia is an expert in developing, designing, and implementing learning and career development programs for diverse learners.
Whether it is a case of early-career love at first sight or an arena that a seasoned job seeker enters for a change of pace after time spent in traditional drug studies, there’s little doubt that specializing in clinical trials of medical devices can be an attractive and rewarding, but very different, rodeo for clinical research professionals to play in.
Informed consent, a cornerstone of ethical research involving human subjects, presents a unique challenge in emergency medical cases. However, utilizing exceptions to obtaining informed consent in emergency research offers significant benefits.