3 
process. He said the subworking group might consider whether the points 
to consider document adequately makes this distinction. 
Dr. Murray said currently investigators must describe to the Institutional 
Review Board (IRB) the method of selecting the subject (s) . Investigators 
must also provide information on hew the patient will be informed of the pro- 
cedure. The IRB submits assurances to EHHS on this process. The IRB determines 
whether the information and process are appropriate but does not have a mechanism 
to monitor the consent process. 
Mr. Mitchell said a whole body of law is developing for situations in which an 
individual surrenders fundamental rights. This body of law attempts to ensure 
that the individual fully understands and can make a knowledgeable decision 
concerning these rights. He offered as examples individuals entering a guilty 
plea or placing a child in adoption procedures. A similar body of law may be 
developing for informed consent in clinical trials. 
Dr. Walters noted that the language added to Section III-A permits the working 
group to request the consent form in scire circumstances . He said he would 
have preferred the points to consider indicate the working group would review 
consent form(s) as part of the review process. Dr. Anderson agreed it is 
illogical for the points to consider to contain a whole section on informed 
consent but not to request the form. 
Dr. Walters asked whether NTH study sections routinely receive consent forms 
with grant applications. 
Dr. Anderson said study sections receive consent forms, but they are concerned 
primarily with scientific and technical issues and not with the informed 
consent process. Dr. Murray said submission of the consent form with the 
grant application ensures the grant proposal was reviewed by the IRB before 
submission for NIH review. 
Dr. Gottesman suggested the NIH legal advisor did not wish an NIH advisory group 
to be responsible for reviewing consent forms since such review might involve 
the NIH in liability issues. Dr. Walters suggested some risk liability might, 
nonetheless, exist for NIH in performing the scientific risk/benefit analysis. 
Mr. Mitchell said he could understand the legal advisor's concern since a body 
of law regarding informed consent has not yet been developed. The subworking 
group agreed the points to consider should not at this time contain language 
requiring submission of the consent form. 
Dr. Gartland suggested the working group should discuss informed consent issues 
with individuals such as Dr. Charles McCarthy of the NIH Office for Protection 
frcm Research Risks (OPRR) and Mr. Robert La man, the NIH Legal Counsel. 
Dr. Gottesman suggested a meeting of the working group with these individuals 
be arranged . 
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