Clinical Research & Healthcare Regulatory Compliance

clinical research organization

clinical research organizationBy: Jeff Cohen

Doctors often consider the idea of clinical research to be an easy “add on” to their practices.  The usual idea is “I already have the patients.  This’ll be easy.”  But that’s not the case when you start to look at the healthcare regulatory compliance issues!

Pharmaceutical companies (“Sponsors”) are often looking for resources for clinical research.  They usually turn to clinical research organizations (CROs) to find research centers (Sites) and to manage some of the healthcare regulatory compliance issues in a way that creates enough distance between the Sponsor and the Site in hopes that the metrics from the patients enrolled in the study will provide clarity re the efficacy of a tested drug.

Medical practices that think it’ll be easy to become a Site will be very surprised by some of the key challenges, which include–Continue reading

Final Privacy Rule Affects Clinical Research Organizations

The final HITECH Act rule was published on January 25th, and it includes revisions to HIPAA.  The two things affected by the new rule are (1) compound authorizations, and (2) authorizations for future research.

Compound authorizations are basically authorizations for two separate uses of protected health information (PHI).  The new rule allows combining an authorization for a research study with any other written permission for the same study, such as authorization to participate in the research.  The core elements of a valid authorization remain in place.  The intent is just to provide some flexibility in clinical research settings.

Traditionally, authorizations had to be study specific.  The new rule allows authorizations not to be study specific, but they have to describe future uses or disclosures in a way that patients will understand that their PHI could be used in future research.

Final Privacy Rule Affects Clinical Research Organizations

The final HITECH Act rule was published on January 25th, and it includes revisions to HIPAA.  The two things affected by the new rule are (1) compound authorizations, and (2) authorizations for future research.

Compound authorizations are basically authorizations for two separate uses of protected health information (PHI).  The new rule allows combining an authorization for a research study with any other written permission for the same study, such as authorization to participate in the research.  The core elements of a valid authorization remain in place.  The intent is just to provide some flexibility in clinical research settings.

Traditionally, authorizations had to be study specific.  The new rule allows authorizations not to be study specific, but they have to describe future uses or disclosures in a way that patients will understand that their PHI could be used in future research.