Recombinant DMA Advisory Committee - 6/9-10/94 
descriptors are used to convey quantitative information, such terms should be thoroughly 
explained to the patients. 
Committee Motion 2 
The RAC approved a motion made by Dr. Chase and seconded by Dr. Motulsky to 
amend Part I-D-2-a-(5) (Possible Risks, Discomforts and Side Effects) by a vote of 13 in 
favor, 0 opposed, and no abstentions. The following sentence will be added to the 
current language: 
"If verbal descriptors (e.g., rare, uncommon, or frequent) are used to express 
quantitative information regarding risk, these terms should be explained." 
Further discussion ensued regarding proposed language for Part I-D-2-b-(l) regarding 
contraception. Dr. Parkman summarized the conclusions as follows: (1) the subject will 
be informed concerning the possible risks of the experiment to the fetus, (2) the subject 
will be informed concerning the necessity for barrier contraception during the active 
phase of the experiment, (3) the investigator will define the duration of the active phase 
of the experiment, and (4) the inclusion/exclusion of pregnant women in the experiment 
should be addressed. The working group will make minor editorial changes as necessary. 
Committee Motion 3 
The RAC approved a motion made by Dr. Parkman and seconded by Ms. Buc to amend 
the title of Part I-D-2-b-(l) by a vote of 13 in favor, 0 opposed, and no abstentions. Part 
I-D-2-b-(l) will be entitled Reproductive Considerations. 
XII. DELETION OF APPENDIX L, RELEASE INTO THE ENVIRONMENT OF CERTAIN 
PLANTS, OF THE NIH GUIDELINES /HR. WTVEL 
In a letter dated April 29, 1994, Dr. Nelson A Wivel, Executive Secretary, RAC, 
requested that Appendix L, Release into the Environment of Certain Plants, be deleted 
from the NIH Guidelines. Dr. Wivel stated that Appendix L should be deleted based on 
the following: (1) Section I of the NIH Guidelines allows experiments to proceed that 
are reviewed and approved by another Federal agency that has jurisdiction for review 
and approval without the necessity for NIH review or approval (except for experiments 
involving human subjects) (52 FR 31849); (2) the RAC has not reviewed any deliberate 
release experiments involving recombinant DNA since 1984; (3) at its May 30-31, 1991, 
meeting, the RAC recommended deletion of Section III-A-2 of the NIH Guidelines 
regarding environmental release; and (4) experiments involving deliberate release into 
the environment are currently reviewed within the framework of existing Federal 
regulations, i.e., the Environmental Protection Agency and the United States Department 
of Agriculture. 
The RAC approved a motion made by Ms. Buc and seconded by Dr. Chase to delete 
Appendbc L from the NIH Guidelines by a vote of 13 in favor, 0 opposed, and no 
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Recombinant DNA Research, Volume 19 
