Responses to Initial Review 
Appendix B 
RAC Application 
Kenneth L. Brigham, M.D. 
PRINCIPAL INVTSTIGATOR: Kenneth L. Brigham. M.D. 
TITLE OF PROPOSAL- Expression of an Exogenously Etelivered Human Alpha- 1 Antitrypsin Gene in Na<al Fnithelium 
.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. 
1 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 Adminstration) does have free access to any information obtained in the 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 any "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 udner the conditions oudined 
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 my 
rights and pri>acy will be maintained. I also understand that in the event this study is being funded through the Department 
of Health and Human Senices (DHHS), The National Institutes of Health (NTH). ..the Secretary of the Department of Health 
and Human Senices or his designated representative (such as the Food and Drug Administration) does have free access to any 
information obtained in the 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 bdepeodendy sponsored studies, the FDA also has access to these records should it become necessary. 
I agree to become a participate in this program. 
(Date) 
Signature of Participant 
(Date) 
Signature of Witness(es), when applicable 
Recombinant DNA Research, Volume 19 
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