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

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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: Mazurka

Copyright: 2009

Contact Email: mailto:lisa.mazurka@...

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Will Training and Education Requirements Become Regulation for Clinical Research

Professionals?

Copyright © 2009 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.

'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 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. Guide to Good Clinical Practice. September, 2009;

Volume 16, No. 2

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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.

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.