Will Training and Education Requirements Become Regulation for Clinical Research Professionals?

By Lisa Mazurka, President and Founder, Clinical Research Consulting, Inc.

Abstract

In July 2008 the Department of Health and Human Services (OHRP) asked the clinical research industry to provide public comment on whether the agency should develop regulations which would mandate education and training requirements for clinical research professionals or whether additional guidance on the topic should be provided (73 Fed. Reg. 37460). This article will review some of the specific questions OHRP requested for public comment, the public response and any action by OHRP to date.

About the Author:

Lisa Mazurka is Founder and President of Clinical Research Consulting, Inc., a full service clinical monitoring, project management, training, and educational service organization committed to raising standards within the pharmaceutical and biotechnology industries. Lisa is an avid clinical educator and has delivered hundreds of educational programs for hospitals, academia and biotech start-ups to leading pharmaceutical companies. She has also taught for the Boston University School of Medicine and The Massachusetts Biotechnology Council.

Will Training and Education Requirements Become Regulation for Clinical Research Professionals?

Training and education within the clinical research industry continues to be an important topic amongst clinical research professionals and regulators. While many industries have standard requirements for training and education within their profession, the clinical research industry does not mandate any requirements or standard baseline training curriculum. Because of this, training for new professionals across our industry varies and for some it may not even exist. This issue has been a hot topic in our industry as issues of research noncompliance continue to be associated with lack of education and training.

Last year, in July 2008, the Department of Health and Human Services (OHRP) asked the clinical research industry to provide public comment on whether the agency should develop regulations which would mandate education and training requirements for clinical research professionals or whether additional guidance on the topic should be provided (73 Fed. Reg. 37460).

OHRP requested industry comment on such topics as: whether institutions/organizations require education and training, if there is no education and training requirements within institutions/organizations, what are the reasons for non-implementation, if an institution/organization does not have an education/training requirement, does this contribute to noncompliance? In addition, the agency requested comment on a variety of other issues relating to training and education such as: the need for regulation on training and education, what industry professionals should be required to complete training and education requirements and how often should training materials be updated?

Public comments were collected through September 29, 2008.
Unfortunately, the request for industry comment did not provide as much feedback and response as OHRP had hoped with only approximately one hundred comments received by the September deadline. In addition, the comments provided seemed dived and vague, giving no clear response to the topic.

Thompson’s Guide to Good Clinical Practice recently covered the OHRP request for public comment on training and education in the September, 2009 issue. As quoted by Elyse Summers, Acting Director of OHRP’s Division of Education and Development when interviewed regarding the responses, she stated: “Taken as a whole, there was not a definitive picture presented by the commentators as to what specific role regulations and/or guidance and/or OHRP should play in achieving the goal of educating people involved in activities relating to human subjects research and protection.”¹

Many clinical research professionals, especially those who provide training and education services, wonder how these comments will be incorporated into the clinical research industry atmosphere and infrastructures. “I think it is unfortunate that the comments were split and there was no definitive sway in either direction”, states Lisa Mazurka, President of Clinical Research Consulting, Inc. Our organization is a CRO which offers clinical research education and training programs and we see a dire need for a stronger foundation for education and training in the industry. Not only do we support a change in industry support for a suggested curriculum of mandated training and education for industry professionals but we would also like to see additional funding for such programs through grants and/or other federal funds. Far too often, individuals do not benefit from baseline training and education upon coming into this industry because their organization does not have such an internal funded program and/or they do not have the funding to outsource training and education services to an outside organization”.

Comments received by OHRP on this topic are public and can be requested through the Division of Education and Development. No decisions or course of action have been made to date from the comments received by the OHRP since the deadline in September, 2008.

References

1. Thompson Guide to Good Clinical Practice. September, 2009; Volume 16, No. 2