PRH^.^ 9 fr/^-MA ! Kk? 1<X0GY Jeffrey Holt MD Page 5 “ 
TITLE OF PROPOSAL: Antisense Retrovirus Gene Therapy for Metastatic 
Breast Cancer 
STATEMENT BY PERSON AGREEING TO PARTICIPATE IN THIS RESEARCH 
PROJECT: 
[ ] (a) I have read this Consent Form. All my questions have been answered and I freely 
and voluntarily choose to participate I understand that I may withdraw at any time. I 
understand that my rights and privacy will be maintained. I also understand that in the 
event this study is being funded through the Department of Health and Human Services 
(DHHS), The National Institutes of Health (NIH) ... the Secretary of the Department of 
Health and Human Services or his designated representatives (such as the Food and Drug 
Administration) does have free access to any information obtained in this study should it 
become necessary. I also understand that when a research study involves the use of drugs 
and the study and/or the drugs are sponsored by an "independent organization" (that is, 
not sponsored by the Department of Health and Human Services or any other federal 
agency), the records of that study are accessible to the study/drug sponsors under the 
conditions outlined in the Food and Drug Administration (FDA) Guidelines. I also 
understand that in such independently sponsored studies, the FDA also has access to these 
records should it become necessary. 
I agree to become a participant in this program. 
[ ] (b) The material contained in this Consent Form has been explained to me orally. All 
my questions have been answered and I freely and voluntarily choose to participate. I 
understand that I may withdraw at any time. I understand that I may withdraw at any 
time. I understand that my rights and privacy will be maintained. I also understand that, 
in the event this study is being funded through the Department of Health and Human 
Services (DHHS), The National Institutes of Health (NIH) ... the Secretary of the 
Department of Health and Human Services or his designated representatives (such as the 
Food and Drug Administration) does have free access to any information obtained in this 
study should it become necessary. I also understand that when a research study involves 
the use of drugs and the study and/or the drugs are sponsored by an "independent 
organization" (that is, not sponsored by the Department of Health and Human Services or 
any other federal agency), the records of that study area accessible to the study/drug 
sponsors under the conditions outlined in the Food and Drug Administration (FDA) 
Guidelines. I also understand that in such independently sponsored studies, the FDA also 
has access to these records should it become necessary. 
I agree to become a participant in this program. 
(Date) 
(Signature of Volunteer) 
(Date) (Signature of Witness 
Recombinant DNA Research, Volume~20 
[ 185 ] 
