Federal Register / Vol. 59, No. 29 / Friday, February 11, 1994 / Notices 
6709 
provided that no direct clinical benefit is 
expected as a result of the subject's 
participation in iho study; however, 
knowledge may be gained that could benefit 
others. 
“Part I-D-2-b-(2). Eicseription of tlic 
Procedures 
"The subject will be provided a detailed 
description of the procedures associated with 
the propiosed study, including a description 
of the gene transfer procedures in non- 
technical language. 
“Part l-D-2-b-(3). Possible Risks. 
Discomforts, and Side Effects 
"The subject will be provided with a 
detailed description of the risks, discomforts, 
and side effects, including a warning about 
possible unforeseen risks, that may result 
from their piarticipation In the proposed 
study. 
"Part l-D-2-b-(4). Benefits 
"The subject will be provided with a 
detailed description of the possible benefits 
of the proposes study. 
"Part I— D-2-l>-(5). Contact Persons 
"The subject will be provided with a list 
of piersons who are available to answer any 
questions relating to their participation in the 
proposed study and to contact in the event 
that questions ari^ during the course of the 
study, including the follow-up period. 
"Part I-D-2-b-(6). Alternatives 
"The subject shall be informed about the 
availability of other therapies, including the 
possibility of other investigational therapies. 
"Part I-D-2-b-(7). Voluntary Participation 
"The subject shall be informed that their 
pmrticipation in the study is voluntary and 
that failure to participate in the study, or 
withdrawal of consent, will not incur any 
penalty or loss of benefits to which the 
subject Is otherwise entitled. 
"Part l-D-2-b-(8). Confidentiality 
"Tlie subject shall be informed that the 
institution and investigators will make every 
effort to provide protection from the media 
in an effort to protect the participant's 
privacy. 
"Part l-I>-2-b-(9). Explanation to 
Participants of the Specific Requirements of 
Gene Transfer Research 
"Part l-D-2-b-(9}-(a). Female subjects 
shall be informed that they should not be 
pregnant nor planning to become pregnant 
during the course of their participation in the 
study. Male and female subjects shall be 
informed that barrier contraception is 
required during the active phase of their 
participation in the study. 
"Part I-D-2-b-(9)-(b). The subject shall be 
informed about the extent to which he/sbe 
will be responsible for any costs associated 
with medical treatment required as a direct 
result of research-related injury. 
"Part I-I>-2-t>-(9)— (c). The PI shall request 
that the subject keep the laboratory informed 
of a ctiirent address and telephone number. 
"Part I-D-2-b-(9}-(d). The subject shall be 
informed that In the event of death, as a 
result of accident or illness, an autopsy shall 
be requested because of the importance of the 
knowledge that may be gained from such 
studies. 
"Part I-D-2-b-f9>-(e)- "The subject shall be 
informed that any signiffcant findings 
resulting from the proposed study will be 
made known to them and/or their parent or 
guardian. This would include new 
information about the nature of the 
experimental procedure or the physical 
reactions experienced by other individuals 
involved in the study. 
"Part I-D-2-b-(9>-(fl. The subject shall be 
informed that representatives of applicable 
Federal agencies (e.g., the NIH and FDA) and 
representatives of collaborating institutions 
will have access to the participant's medical 
records." 
OMB's "Mandatory Information 
Requirements for Federal Assistance Program 
Announcements" (45 FR 39592, June 11. 
1980) requires a statement concerning the 
official government programs contained in 
the Catalog of Federd Domestic Assistance. 
Normally, NIH lists in its announcements the 
number and title of affected Individual 
programs for the guidance of the public. 
Because the guidance in this notice covecs 
not only virtually every NIH program but also 
essentially every Federal research program in 
which DNA recombinant molecule 
techniques could be used, it has been 
determined not to be cost effective or In the 
public interest to attempt to list these 
programs. Such a list would likely require 
several additional pages. In addition, NTH 
could not be certain that every Federal 
program would be Included as many Federal 
agencies, as well as private organizations, 
both national and international, have elected 
to follow the NIH Guidelines. In lieu of the 
Individual program listing. NIH Invites 
readers to direct questions to the Information 
address above about whether individual 
programs listed in the Catalog of Federal 
Domestic Assistance are affected. 
Dated: February 7, 1994. 
Daryl A. Chamblee, J.D., 
Acting Deputy Director for Science Policy and 
Technology Transfer. 
(FR Doc. 94-3180 Filed 2-10-94; 8:45 am) 
BILLINO CODE 4140-01-M 
Recombinant DNA Research, Volume 19 
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