Ethics and Scientific Misconduct in Regulated Studies

Why Should You Attend:

This presentation discusses the high risks of scientific misconduct in regulated studies. It distinguishes between large and small errors in misjudgment and how QA professionals manage these occurrences. It also describes a plan for ensuring the highest ethical standards in your lab. The webinar begins by giving a brief introduction to terms related to regulatory action, such as “fraud,” “misconduct,” “injunction,”, “disqualification,” etc. It describes the root causes of scientific misconduct. These root causes are discussed with special attention to the various individuals most likely to make these errors in judgment. Thus, the webinar covers ethical behavior with respect to sponsors, testing facility management, study directors, study scientists, regulatory affairs professionals, and quality assurance professionals. The webinar then summarizes the main warning signs of scientific misconduct from the perspective of regulatory agencies and auditors. This discussion covers “red flags” in raw data, reporting, and the sponsor-CRO relationship.

The session next describes a plan for identifying high-risk situations in data collection and reporting. This part of the webinar will be useful to testing facility management instituting a new GXP environment as well as managers and QA professionals dealing with past ethical issues at their facility. The presenter then discusses how to analyze possible cases of scientific misconduct. This analysis can be done by an outside auditor but also can be performed by a manager or QA professional inside the organization. The analysis includes, but is not limited to, interviews, data review, and study audits. The presenter emphasizes the importance of performing this due diligence, even if no misconduct actually occurred. The extra effort devoted to ethical standards in your organization far outweighs the risks of receiving regulatory actions from FDA, EPA, or other agencies. The webinar includes a discussion of the special responsibilities of the QA professional as a liaison between the company (or university) and a regulatory agency. The presenter discusses how this role is distinct from regulatory affairs professionals, who tend to be advocates for their organization. The webinar concludes with a brief history of scientific misconduct in the drug industry and summarizes the current regulatory actions that can and do occur today due to serious transgressions from regulatory compliance.

Areas Covered in the Seminar:

• How to recognize fraud and scientific misconduct
• Why scientific fraud and misconduct happen
• What are the warning signs of scientific misconduct?
• How QA professionals can spot scientific misconduct
• How to develop a plan for identifying high-risk situations
• How to analyze a case of possible scientific misconduct
• What is the role of QA professionals in scientific integrity
• What are the risks of scientific misconduct?

Who Will Benefit:

This webinar is for all facilities and organizations that produce data related to the safety and efficacy of drugs, devices, food, and chemicals.

• Drug, veterinary drug, and medical device companies
• Biotechnology companies
• University labs and CROs that support regulated studies
• Food manufacturers
• Chemical manufacturers
• Management, study directors, and QA professionals

Instructor Profile:

Anne Maczulak, PhD, RQAP-GLP, is an independent consultant at Acorn GLP Consulting. She has more than 20 years experience as sponsor, study director, or participating scientist in preclinical studies. Anne works with established companies, startups, and universities in need of guidance in GLP regulations. She has presented webinars for FDA and training courses for the Society of Quality Assurance. She audits laboratories that conduct nonclinical studies and/or bioanalysis and provides on-site as well as remote training in GLP.

Follow us :