33092 
NOTICES 
f. Signature*. The signatures of the 
principal Investigator, the IBC chair- 
person. and the Institutional offlclal(s) 
are required. 
g. Date of MUA. The date of the 
MU A for future reference will be the 
date of the Institutional official’s sig- 
nature. 
2. MU A '* for Recombinant DNA Re- 
search at Multiple Site*. When re- 
search at multiple sites Is proposed, 
the MUA must specify where each 
part of the project will be carried out. 
When research Is proposed at sites 
governed by other than the applicant 
Institution, signatures of the appropri- 
ate officials at both the applicant In- 
stitution and the instltutlon(s) where 
the recombinant DNA research Is to 
be conducted are required. The signa- 
tures shall Indicate that the IBC’s of 
each of the Institution! a) where the re- 
search is to be performed have given 
the certification and/or assurance re- 
quired In item d of the MUA. 
2. MUA *1 Associated with Individual 
Fellowship Application*, Research 
Career Development Award Candi- 
date* ( RCDA ). Research Career Awar- 
dee* (RCA i. and Institutional Nation- 
al Research Service Fellowship Appli- 
cation*. When projects Involving re- 
combinant DNA technology subject to 
the Guidelines are Involved, fellowship 
applicants, RCDA candidates, RCA’s, 
or Program Directors for Institutional 
National Research Service Fellowship 
Applications should attach to the ap- 
plication either a copy of MUA(s) al- 
ready submitted to the N1H. or submit 
a new MUA(s) as Indicated below. If a 
copy Is submitted, the fellowship ap- 
plicant, RCDA candidate. RCA. or 
Program Director (If other than the 
principal Investigator) must sign the 
MUA copy under the signature of the 
principal Investigator. 
If any recombinant DNA work Is 
proposed other than that Indicated In 
an existing MUA(s), a new or amended 
MUA must be submitted to NIH In ac- 
cordance with procedures In II-B and 
II-E of this Appendix. These proce- 
dures also apply to experiments using 
recombinant DNA technology In 
courses supported by an Institutional 
fellowship. 
B. .Submission of Memorandum of 
Understanding and Agreement (MUA). 
1. Competing Application*. For com- 
peting applications Involving recom- 
binant DNA research subject to the 
Guidelines, an MUA must be submit- 
ted to the Division of Research 
Grants, NIH. with the application. 
X Noncompeting Applications. Each 
noncompeting continuation applica- 
tion Involving recombinant DNA re- 
search subject to the Guidelines must 
be accompanied by an updated MUA 
that Indicates that the IBC has re- 
viewed the project prior to submission 
of the application, and has found It 
still In compliance with NIH Guide- 
lines. 
Important Note If an Investigator 
wishes Immediately to Initiate a proj- 
ect after IBC approval, after submit- 
ting a new competing application to 
NIH. the procedures for registration 
of non-NIH projects, described In sec- 
tion IV of this Appendix, must also be 
followed. If an Investigator wishes Im- 
mediately to Initiate new experiments 
In an ongoing project, an MUA must 
be filed with NIH within 30 days of 
IBC approval, even If the proposed ex- 
periments are described In an MUA 
submitted with a noncompeting or a 
competing renewal application. In the 
latter cases, see procedures In section 
II-E of this Appendix, dealing with 
changes In ongoing projects, which 
must also be followed. 
C. Notation on Application* for Re- 
search and Training Grant*. NIH ap- 
plication forms will be revised to In- 
clude a block to be checked Indicating 
whether recombinant DNA research 
subject to the Guidelines Is Involved. 
Until such time as revised forms are 
available, applicants should specify In 
capital letters at the bottom of the 
first page of the application the fol- 
lowing statement: 
APPLICATION INVOLVES EXPERIMENTS 
SUBJECT TO GUIDELINES FOR RECOMBIN- 
ANT DNA RESEARCH 
D. Award Procedure*. Prior to 
award. MUA's will be reviewed by 
ORDA for compliance with the re- 
quirements of the Guidelines. Notifi- 
cation of the status of NIH review of 
the MUA will be accomplished by one 
of the following 3 footnotes on the 
Notice of Grant Award: 
Footnote 1. "Protocols In MUA dated 
I— conform to standards of NTH 
Guidelines.’' 
Footnote 2. "Protocols In MUA dated 
—/—/—, as modified, conform to 
standards of NIH Guidelines.’* 
Footnote 3. “Protocols In MUA dated 
—I— I— do not conform to standards 
of NIH Guidelines.” 
Footnote 1 will be used to Indicate 
that the MUA has been reviewed by 
ORDA. and the protocols have been 
found to conform to the standards set 
forth In the Guidelines. 
Footnote 2 will be used to Indicate 
that the MUA has been reviewed by 
ORDA and that certain aspects of the 
MUA do not conform to standards set 
forth In the Guidelines. Use of this 
footnote Indicates that NIH has noti- 
fied the Institution that appropriate 
action must be taken to bring the pro- 
tocols In question Into compliance 
with NIH standards, or that the proto- 
cols In question must not be carried 
out. 
Footnote 3 will be used to Indicate 
that the MUA has been reviewed by 
ORDA and the protocols have been 
found not to conform to standards set 
forth In the Guidelines. This footnote 
Indicates that the proposed experi- 
ments are not to be carried out until 
they have been brought Into compli- 
ance with NIH standards, and a re- 
vised MUA has been submitted to the 
NIH. 
E. Changes in Ongoing Projects. 
Changes In a project subject to the 
Guidelines must be reported to the 
IBC by the principal Investigator. 
1. Protocols for Which Containment 
Level* are Explicitly Specified by 
Guideline*. The procedures described 
In this section apply only to research 
projects for which containment levels 
are explicitly stated In the Guidelines 
or In announcements from ORDA, 
except for projects requiring P4 physi- 
cal containment, which require NIH 
approval prior to Initiation of the re- 
search. 
Depending upon the Judgment of 
the IBC as to whether the proposed 
changes are major or minor, the proce- 
dures described In a and b below are to 
be followed. 
a. Major Changes. A new or revised 
MUA Is required for Introduction of 
recombinant DNA research subject to 
the guidelines Into an ongoing project, 
or for significant changes In the re- 
combinant DNA aspects of an ongoing 
project. Examples of changes In an on- 
going recombinant DNA project which 
would require the filing of a new or 
amended MUA would Include (I) sig- 
nificant changes in hosts or vectors. 
(11) significant changes In the donor 
species or the nature of the DNA seg- 
ment being selected. (Ill) major 
changes In the physical location of the 
experiments, or (iv) a change of the In- 
vestigator responsible for the conduct 
of the experiments. 
For such changes In an ongoing proj- 
ect, a new or revised MUA must be 
submitted to the IBC. Once IBC ap- 
proval has been obtained for other 
than projects requiring P4 contain- 
ment. the experiments may be Initiat- 
ed. The Institution must then forward 
the MUA directly to the program ad- 
ministrator of the awarding NIH 
Bureau. Institute, or Division within 
30 days of approval by the IBC. The 
MUA must Identify the project by 
grant number. The principal Investiga- 
tor will be notified by letter regarding 
the NIH review of the new or revised 
MUA. If review by ORDA finds that 
an MUA. or certain aspects of an 
MUA. do not conform to standards set 
forth In the guidelines, the principal 
Investigator and the IBC will be noti- 
fied. In such cases. Immediate action 
must be undertaken to bring the pro- 
tocols Into compliance with NIH 
standards or the experiments In ques- 
tion must be suspended. 
b. Minor Change*. Principal investi- 
gators should submit Information or 
FEOfRAi IHMSTR, VOL 43, MO. 144— TODAY, JULY 2S, 1*71 
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