TEMPORARY NIA POLICY ON FUNDING HUMAN TESTOSTERONE INTERVENTION STUDIES

RELEASE DATE:  April 21, 2003

NOTICE:  NOT-AG-03-001

National Institute on Aging (NIA)

This notice is to inform you of the National Institute on Aging (NIA) 
policy decision that will temporarily affect the funding status of 
applications for clinical intervention studies involving the use of 
testosterone.   As of this date, the NIA has decided to defer funding 
decisions on these applications.  The reasons for this decision are 
described below.

The NIA has held a long interest in hormone therapies for both men and 
women, as well as the pharmacologic and physiologic effects of such 
therapies on aging and aged populations of the United States.  
Testosterone has been the topic of scientific studies supported for 
some years by this Institute, with regard to risks and benefits of 
testosterone therapy.  Recently, at NIA's request, the Institute of 
Medicine (IOM) of the National Academy of Sciences convened a panel of 
experts to make recommendations and assessments on the need for 
clinical trials of testosterone therapy and related issues.  This IOM 
study was inaugurated in November 2002.  The panel's final report is 
expected in November of this year.

One of the issues that the IOM study will address is the assessment of 
the ethical appropriateness of testosterone intervention studies, 
taking into account known and potential risks and benefits to 
participants.  In view of this, NIA has decided to defer funding 
decisions on applications for testosterone intervention studies until 
after receipt of the IOM report.  

This notice is not intended to request or suggest that investigators 
recall or withdraw grant applications involving testosterone that have 
been submitted to the NIH for consideration, nor to withhold future 
submissions.  All applications submitted will receive serious and 
thoughtful review by both the NIH Study Sections and the NIA National 
Advisory Council.  However, funding decisions on such applications will 
be deferred until the IOM Panel presents its recommendations to the 
Institute.  Individuals who have questions concerning either pending or 
planned applications are advised to contact the NIA Program Official 
with whom they have worked in the past, or contact Dr. Miriam Kelty at 
the phone number or e-mail listed below.

INQUIRIES

Interested investigators may direct their inquiries to:

Dr. Miriam Kelty
Associate Director for Extramural Activities
Office of Extramural Activities
National Institute on Aging
Gateway Building, Room 2C218, MSC 9205
7201 Wisconsin Avenue
Bethesda, MD  20892-9205
Phone:  301-496-9322
FAX:  301-402-2945
E-mail:  mk46u@nih.gov

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