IRB Insights

Lean Six Sigma in the Clinical Trial Industry: Two Perspectives

by Dawn Pope     As seen in Applied Clinical Trials  Consistent, effective process improvement can be the key to reducing delays and improving data accuracy.  In clinical trials, turnaround time and data accuracy are critical. The cost of a one-day delay in a drug being brought to market can…READ MORE

Streamlining the IRB submission process through collaboration

By Dawn Pope, Chief Operating Officer Effective collaboration with your institutional review board can help prevent delays in start-up activities that  can cost sponsors and CROs valuable time and negatively impact site enrollment activities. In this quarter’s  newsletter, Copernicus Group IRB’s Director of Client Services, Dawn Pope, explores ways…READ MORE

The role and use of Impartial Witnesses in the informed consent process

By Patience Stevens,  MD, MPH, CIP Board Vice Chair Person Federal regulations for the protection of human subjects assign the principal investigator with the ultimate responsibility for ensuring the safety, rights and welfare of research subjects. Chief among those responsibilities is the obligation to ensure that the regulatory and…READ MORE

Dealing with over-reporting: Understanding the FDA’s new regulations

By Glenn Veit, JD, CIP, Copernicus Group IRB Chairperson The Food and Drug Administration this year published revised regulations pertaining to safety reporting for drug and biologic products under an Investigational New Drug (IND) application. The FDA also made bioavailability (BA) and bioequivalence (BE) studies conducted to support the…READ MORE

Advanced Notice of Proposed Rulemaking (ANPRM): Enhancing Protections for Research Subjects & Reducing Burden, Delay & Ambiguity for Researchers

by Yvonne Higgins, AB, CIP, Director, Quality Management Background On July 22, 2011, the U.S. Department of Health and Human Services (HHS) announced a proposal that may result in significant changes to federal regulations on the protection of human research subjects. In the notice, published in the federal register,…READ MORE

Reducing the Reporting Burden: Guidelines for Improving the Protection of Trial Subjects

by Glenn Veit, JD, CIP, Copernicus Group IRB Chairperson To safeguard the rights, safety and welfare of human subjects, clinical research is a shared responsibility among sponsors, investigators, contract research organizations (CROs) and institutional review boards (IRBs). Central to this shared obligation is the meaningful review and communication of…READ MORE

Protecting Vulnerable Populations During Research: Guidelines for safeguarding the health and welfare of children

by Yvonne Higgins, AB, CIP, Director, Quality Management According to federal regulations regarding human research, the principal investigator holds the ultimate responsibility for protecting the safety, rights and welfare of research subjects. Of particular importance is obtaining informed consent according to strict regulatory and ethical requirements. Complicating the issue,…READ MORE