Recombinant DMA Advisory Committee - 3/3-4/94 
"quality and content of Informed Consent documents into constructive changes in the 
informed consent process," specifically in relation to human gene transfer, during his oral 
presentation to the RAC on December 4, 1993, and in his memorandum dated 
December 23, 1993. Dr. Ellis recommended that the Points to Consider should be 
amended to introduce consistency in the Informed Consent document language. 
Dr. Zallen, Chair of the RAC Working Group on Informed Consent, said that in order 
to reduce the frequent problem of inadequately prepared Informed Consent documents 
and because of the importance of informed consent issues in clinical research, a working 
group has been formed to amend Part I-D, Informed Consent, of the Points to Consider. 
The working group includes: Ms. Buc, Mr. Capron, Ms. Meyers, Drs. Krogstad, 
Motulsky, Secundy, and Straus. 
Dr. Zallen said that frequently investigators do not adequately address informed consent 
questions in their preparation of the Points to Consider. Dr. Zallen provided two 
versions of the revised Part I-D: (1) the version drafted by the worldng group, and (2) a 
modified version incorporating modifications suggested by Mr. Capron. The first version 
attempts to separate the informed consent process from the Informed Consent document. 
Ms. Meyers recommended inclusion of a statement indicating that subject selection 
should be equitable. The second version has been modified according to Mr. Capron's 
suggestions to consolidate the consent process and consent document in a single section 
in the Part I-D. 
Dr. Zallen said that questions on how informed consent is obtained from study subjects 
is very important considering the recent scandal involving radiation research performed 
during the 1940s and 1950s. She would prefer the first version to have the informed 
consent process separated from the document. The second version has incorporated a 
more simplified and polished language suggested by Mr. Capron. 
Dr. Straus expressed his concern that it is difficult for principal investigators to describe 
very intimate personal interactions involved in the consent process. Dr. Parkman added 
that an effective informed consent process may vary depending on a particular disease to 
be treated and the ethnic background of a participating subject. Dr. Secundy stated that 
the informed consent process can be well written. There are trained individuals with 
expertise in this area who can deal with this process effectively, and the qualification of 
these experts can be evaluated from their curriculum vitae. Dr. Parkman disagreed on 
the need for another trained expert to obtain informed consent. Dr. Straus inquired 
what will be the qualification of such individuals. Dr. Secundy said that those are 
persons trained in bioethics, social work, and communication skill. Demonstrating 
sensitivity to these issues is becoming a requirement for submitting grant applications to 
the Ethical, Legal, and Social Implications Program of the National Center for Human 
Genome Research at NIH. Dr. Straus said that a well written Informed Consent 
document would indicate whether an effective informed consent would be obtained. Dr. 
Parkman expressed his reservation about separation of the process from the document in 
two sections. Dr. Secundy said that the informed consent process can be described in a 
short statement. 
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Recombinant DNA Research, Volume 19 
