Compliance In Focus

In the healthcare industry, stories of patient harm can sometimes be the impetus for positive change. This was the case with the PIP breast implant scandal, where cost-cutting decisions that resulted in injuries eventually led to major regulatory updates. In 1965, plastic surgeon Henri Arion introduced breast implants to France. Jean-Claude Mas, a former butcher turned medical sales representative, and Henri Arion worked together in this field; following the death of Arion in a plane crash, Mas went on to launch Poly Implant Prothese (PIP) in 1991. It was the beginning of a company that would produce approximately two million sets of silicone breast implants over the course of a 20 year period and in its path, create a global health scare and shape medical device regulations. The silicone-based scandal came about when PIP implants made from a cheaper, industrial-grade silicone (that was not approved for medical use) were rupturing at a rate that was double the industry average. When compromised, the silicone gel was known to cause inflammation and possible scarring, and these implants continue to raise questions over the possibility of other harmful long-term affects. The timeline below summarizes the key points of the complex story:

Traditionally, Data Safety Monitoring Boards (DSMBs/DMCs) and Clinical Events Committees (CECs) have been set up to operate independently from each other. They have distinct functions and as such, membership generally does not overlap. However, since the FDA has no explicit regulatory requirement for the establishment of a DSMB/CEC (except in the case of emergency research conducted under 21 CFR 50.24 (a)(7)(iv)), it raises the question as to whether or not it may be feasible or even advantageous to combine their efforts into one safety monitoring board. To explore this option, consider the following Q&A’s:

Not all studies require a data safety monitoring board (DSMB) or a clinical events committee (CEC). But should they be implemented for your study, it’s important to know they are not all created equal. The Data Safety Monitoring Boards (DSMB) review cumulative information from a study and monitor safety oversight with teams of independent physicians and medical professors. Clinical Events Committees (CEC) adjudicate finite sets of adverse events within a study to determine if those events are related to the study or not. While it is critical to understand the primary purposes of a DSMB/CEC, you should also look beyond meeting basic requirements in order to be the most confident in your efforts for patient protection and study results.

Little discussion can be found around the question of whether or not employees of an institution should be permitted to participate as subjects in human research conducted by the institution they work for. To date, there is no specific guidance (protection/provisions) provided by the federal regulations governing research with human subjects. The Office for Human Research Protections (OHRP) presents consideration around students, employees, and normal volunteers in Chapter VI, “Special Classes of Subjects,” of its IRB Guidebook. Similarly, the Centers for Disease Control and Prevention (CDC) offers guidance for employee participation in research. While the enrollment of employees is allowed, there is a potential for fundamental ethical provisions to be compromised. Both the study sponsor and the Institutional Review Boards (IRB) or Independent Ethics Committees (IEC) have a responsibility to address the management of these issues: