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

[Lisa Mazurka]

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

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Article Description:
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.


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Distribution Date and Time: 2009-12-15 14:30:00

Written By: Lisa Mazurka
Copyright: 2009
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Will Training and Education Requirements Become Regulation for Clinical Research Professionals?
Copyright (c) 2009 Lisa Mazurka
Clinical Research Consulting, Inc.
http://www.eclinicalresearchconsulting.com



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




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Lisa Mazurka is Founder and President of Clinical Research
Consulting, Inc. http://www.eclinicalresearchconsulting.com/
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.


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