NEWS

09/26/1996



<TITLE>HHS REGULATIONS PROVIDE EMERGENCY ACCESS TO PROMISING

THERAPIES</TITLE>

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P96-16                              Food and Drug Administration

FOR IMMEDIATE RELEASE               Don McLearn (301) 827-6242

September 26, 1996



 HHS REGULATIONS PROVIDE EMERGENCY ACCESS TO PROMISING THERAPIES 

     The Food and Drug Administration and the National Institutes

of Health today announced measures designed to protect individuals

who may benefit from emergency research.  

     The FDA issued final rules to make it easier for promising

experimental drugs and medical devices to be studied in persons who

are in life-threatening situations and unable to give informed

consent for their use.  As a companion document, NIH  has published

"Emergency Research Consent Waiver" applicable to all agencies of

the Department of Health and Human Services.  

     These policies establish narrow limits for allowing research 

without informed consent in certain studies of emergency medical

procedures, and harmonize these standards throughout the Department

of Health and Human Services.

     "FDA and NIH have produced a coherent approach to protecting

patients who may be helped by an experimental procedure, but who

cannot give consent on their own," said HHS Secretary Donna E.

Shalala.  "These rules address a difficult ethical situation and

they apply fair, common sense tests for allowing the use of

experimental treatments in life-threatening emergencies."

                             -More-

          Page 2, P96-16, Emergency Access to Promising Therapies

     HHS' new overall approach to emergency research situations may

offer the best hope in cases when critically ill, unconscious,

persons (with no readily available legal representative to give

consent), cannot be successfully treated 

through conventional means, but might benefit from a promising

experimental intervention.  

     FDA addressed this issue last September in a proposal that

defined the main conditions under which patients could be enrolled

in clinical trials without their consent, provided that

an independent physician and an institutional review board (IRB) --

a committee of experts and lay persons established to review

research -- agree that the clinical trial addresses a life-

threatening situation and that other criteria are met.

     The other criteria include:

     -  The individual has to be in a life-threatening situation;



     -  Available treatments are unproven or unsatisfactory;



     -  The research cannot practicably be carried out otherwise

        -- and is necessary to determine the safety and           

        effectiveness of the intervention;



     -  It is not feasible to obtain informed consent from the    

        patient or the patient's legal representative;

 

     -  The risks and benefits of the experimental procedure      

        are reasonable compared to those associated with the      

        patient's medical condition and standard therapy.   



     The proposals also included additional protections such as

consultation with the community, public disclosure of the study

design and attendant risks prior to its commencement, and public       Page 3, P96-16, Emergency Access to Promising Therapies

disclosure of study results when completed.  The FDA will also

review the protocol design and other information on the proposed

therapy before the study is allowed to proceed.

     The "Emergency Research Consent Waiver" authorized by the

Secretary of HHS which was published as a companion document to the

FDA final rules, applies to the basic HHS policy for protection of

human research subjects.  It contains the same criteria as the FDA

rule for permitting this research to proceed.

     These new policies were developed in response to growing

concerns that the current regulations were making high quality

research in emergency circumstances difficult or impossible to

carry out at a time when the need for such research is increasingly

recognized. 

     The FDA proposal, which was broadly supported by 19 leading

medical, patient advocacy, and industrial groups, received more

than 90 comments.  Based on these comments, FDA expanded, in final

regulations, the procedures to be followed by IRBs and

investigators in attempting to obtain informed consent from the

patient's legal representative, or to inform the patient's family

about the research.

     FDA's final rule and the HHS Waiver Notice will be published

in the Federal Register on Oct. 2, 1996.

     The regulations become effective 30 days after the date of

publication.

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