20a NCI Adult CIRB Application

NCI CIRB OMB Nonsubstantive Change Request
OMB #: 0925-0625
Expiry Date: 1/31/2014

ο

Form 5A: NCI Adult CIRB Application for Treatment Studies
Section L. was added to include Amendment-Specific Information. This change is
necessary to clarify necessary information to the public for the CIRB. The additional
time to complete this section is minimal. No additional burden to the public is
foreseen.

“2. State
Text
deleted
the hypothesis for this study”

Text“hypothesis
(i.e.
added
” or study objectives):
“SECTION L: AMENDMENT-SPECIFIC
INFORMATION
This section should be completed only when this
application is being updated as the result of an
amendment to the study
1.0 Briefly describe what prompted this amendment: ___
2.0 Are any of the changes in this amendment significant
enough to impact a study participant’s willingness to
continue participation in the research?
[box] Yes [box] No
2.1 If yes, describe how these findings will be
presented to study participants. ___
2.2 If yes, should the study participants be
reconsented?
[box] Yes [box] No
If yes, indicate how study participants will be
reconsented (letter, addendum, reconsent).
____
Provide drafts of reconsent documents.
Important Note: Please send the completed CIRb
application and the informed consent document(s) to
adultcirb@emmes.com

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Adult CIRB Review Application

NCI ADULT CENTRAL IRB (CIRB) APPLICATION
FOR TREATMENT STUDIES

OMB#: 0925 – 0625 Expiry Date: 1/31/2014
STATEMENT OF CONFIDENTIALITY
Collection of this information is authorized under 42 USC 285a. Your participation is complet ely voluntary. You are subject to no penalty if you
choose not to provide all or any part of the requested information. Data collected as part of the NCI CIRB review is confidential and protected by
law. Under the provisions of Section 301d of the Public Health Service Act, no information that could permit identification of a participating
individual may be released. All such information will be held in confidence and will be presented only in statistical or summary form.
NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for this collection of information is estimated to average 2 hours per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of
information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda,
MD 20892-7974, ATTN: PRA (0925-0625*). Do not return the completed form to this address.

SECTION A: GENERAL INFORMATION
COOPERATIVE GROUP:
GROUP STUDY NUMBER:
STUDY VERSION DATE:
STUDY TITLE:

STUDY CHAIR
Name
Title
Specialty
Site
Address
Phone #
E-mail
FAX #

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STUDY CO-CHAIR (If applicable)
Name
Title
Specialty
Site
Address
Phone #
E-mail
FAX #
CONTACT PERSON
Name
Title
Specialty
Site
Address
Phone #
E-mail
FAX #
WILL THIS BE ON THE CTSU MENU?
PLEASE NOTE: CIRB membership includes individuals who are not part of the oncology
and/or the scientific community. Therefore, you must use lay language (non medical, non
legal terms) and define all terms unique to science when completing this application.

SECTION B: SUMMARY OF STUDY
Please answer each of the following questions in 250 words or less per question.
1. State the question that this study will answer (i.e. hypothesis or study objectives):

2. Describe the background research that has led to your hypothesis/study objectives:

3. Describe the study. (Include schema.)

4. How will the research design answer the hypothesis?

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5. How will the new information gained from this study impact the treatment for this
disease or condition?

6. Will participants be required to discontinue or modify any current medication, or
be denied any standard of care for any condition, in order to be eligible for
participation?

7. Is there an interim safety monitoring plan for this study?
Yes

No

If yes, please explain.

SECTION C: PARTICIPANTS
1. Number of participants to be enrolled in the study:
2. Participant profile (Check all that apply.)
Gender:
Male
Female

Ethnicity
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American (not of Hispanic origin)
White (not of Hispanic origin)
Hispanic or Latino

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Adult CIRB Review Application
3. Specify the age range of eligible participants:
If participants under the age of 18 years old are eligible, an assent form must be submitted.

4. Which of the following vulnerable populations are eligible to be participants (Check
each item yes or no. A “no” indicates that all persons in that category are excluded.):
Incompetent persons (excluding minors):

Yes

No

(Incompetent persons include those who have a legal guardian or those whose mental
status prevents them from giving truly informed consent and making decisions [such
as those with advanced Alzheimer’s disease]).
Physically or Mentally Disabled/Challenged

Yes

No

(Handicapped persons include those with a physical or mental impairment which
substantially limits one or more major life activities [e.g. speaking, breathing, learning,
working, caring for oneself, performing manual tasks, walking, seeing, hearing, etc.], has
a record of such an impairment, or is regarded as having such an impairment)
Women with reproductive potential:

Yes

No

Pregnant women:

Yes

No

Men with reproductive potential:

Yes

No

Minorities:

Yes

No

Prisoners:

Yes

No

4A. Explanation of Exclusion: Federal IRB regulations require equitable selection of
participant s. In addition, NIH policy requires that minorities and women be adequately
represented as research participants. If you checked “no” to any of the categories above,
you must provide a scientific reason for such exclusion.

5. Recruitment
a) Provide the participant recruitment plan.

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Adult CIRB Review Application
b) Provide any recruitment materials (if applicable) that participants will see.

c) Will the participants be paid or receive any other inducements (e.g., free medication, free
medical care) for participating?
Yes
No
If yes, please explain.

6. Will the participants bear any costs which are not a part of standard of care?
Yes

No

If yes,
a) List the relevant tests, procedures, hospitalizations, etc., for which the participants would
be financially responsible.

b) Are there available means of subsidizing these extra costs for participants who cannot
afford them?
Yes

No

If yes, please explain.

SECTION D: DRUGS
1. Please provide the following information for all drugs to be used in this study. (This
includes the study drugs PLUS any othe r medications specified in the study that the
participant will receive while on this study):
Drug/study drug:
Manufacturer:
Supplier:
Is the drug/study drug being used under an IND?

Yes (submit copy of Investigator's Brochure)
IND# :

No

Holder of IND:

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Adult CIRB Review Application

Drug/study drug:
Manufacturer:
Supplier:
Is the drug/study drug being used under an IND?

Yes (submit copy of Investigator's Brochure)
IND# :

No

Holder of IND:

Drug/study drug:
Manufacturer:
Supplier:
Is the drug/study drug being used under an IND?

Yes (submit copy of Investigator's Brochure)
IND# :

No

Holder of IND:

a.) Does this study include an off- label use of an FDA-approved drug?
Yes

No

If yes, please explain. (e.g. Has an IND been applied for? Is this study exempt from an
IND? If exempt, please provide official FDA documentation.)

2. For all study drugs, include the following information:
(Study drugs are all drugs that are investigational or are being studied or compared, alone
or as part of a regimen.)
a) The name of the study drug/regimen:
b) Likely/bothersome effects that are study drug/drug class/regimen specific:
c) Less likely effects that are study drug/drug class/regimen specific:
d) Rare but serious effects that are study drug/drug class/regimen specific:
Risks and side effects related to temozolomide include those that are:
Likely
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Adult CIRB Review Application
•
Less Likely
•
Rare but Serious
•

SECTION E: RADIATION
1. Does this study involve radiation?

Yes

No (If no, skip to Section F.)

2. Specify the type of radiation that the participant will receive:
Diagnostic

Therapeutic

Both

3. Will the participant receive radiation greater than normally received in the course of
standard of care for this disease or condition?
Yes

No

If yes, please explain.

4. Is any radiation modality experimental?
Yes

No

If yes, list the risks associated with the experimental modality.

SECTION F: RISKS, BENEFITS AND ALTERNATIVES
1. List any known or fore seeable risks or discomforts to the participant from procedures
or treatment associated with the study intervention(s). List the frequency and
complications associated with each.

2. List measures planned to minimize risks identified in Question # 1.

3. How do the potential benefits outweigh the risks inherent in participating in the study?

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4. How would you treat this participant in a non-investigational setting? Please describe
the treatment that is considered standard of care, as well as any alternative procedures
or drugs or other courses of therapy that might be used, if such alternatives exist.

SECTION G: GENETIC RESEARCH
Will the research identify genetic characteristics?*

Yes

No

If no, go to Section H.
*It may be useful to think of genetic research as being carried out on a continuum comprising of
four stages: (1) to discover the pattern of inheritance of a disease and to catalog the range of
symptoms involved (pedigree studies); (2) to localize and identify specific genes (positional
cloning studies); (3) to develop techniques for determining the presence of specific DNA
mutations (DNA diagnostic studies); and (4) to develop treatments for genetic disease at the
DNA level (gene therapy research).
If yes:
a) Will results be disclosed to the participants?
Yes

No

If yes, describe in what way:
If yes, how will they be given the option to not receive the results?
b) Will research findings be disclosed to participants’ physicians for clinical use?
Yes

No

If yes, Will this plan be discussed with the participants and their consent
obtained?
c) Will the possible psychological and social risks of genetic research be adequately
considered in the consent process? Will appropriate counseling be provided,
both as part of the consent process and also when communicating test or other
research results to participants? Please explain.

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d) Will the data be protected from disclosure to third parties, such as
employers and insurance companies? Describe confidentiality measures.

e) How are tissue samples secured?

f) What will happen to the tissue samples in the event that a participant
withdraws from the study?

SECTION H: STORAGE OF SPECIMENS FOR FUTURE RESEARCH STUDIES
Does this study involve collection of specimens for future research studies?
Yes

No

(If no, skip to Section I.)

If yes:
a) What are the types and amounts of specimens to be collected? Justify the types and amounts.

b) How will the specimens be linked to the participants?

c) For what types of research do you anticipate using the samples in the future?

d) How will access to the specimens be governed?

e) What procedure will be used if the participant withdraws consent after the specimen has been
collected and stored?

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Adult CIRB Review Application

SECTION I: ANCILLARY STUDIES
Will participants enrolled in this study be asked to register in any ancillary/companion
studies?
Yes

No

If yes, are these studies:
Mandatory
Optional
Both
PLEASE NOTE:
The CIRB will review any new ancillary/companion study regardless of whether participation is
mandatory or optional.
If an ancillary/companion study is already open, the policy is as follows. If a study requires that
its participants also enroll in an ancillary/companion study, the CIRB must review the
ancillary/companion study. A separate, Ancillary Study Application, the ancillary/companion
study, and associated informed consent document(s) must be submitted to the CIRB for review
and approval. Once an ancillary/companion study has been approved, it will not need to be
resubmitted with each treatment study that it accompanies.
The CIRB will review all ancillary/companion studies whose participation is mandatory for
participants enrolled in an associated main treatment study, regardless of when the
ancillary/companion study was activated and open to enrollment.
The CIRB will not review an ancillary/companion study if participation is optional and the study
was activated and open to enrollment prior to the associated main treatment study’s submission
for CIRB review.
SECTION J: CONFLICTS OF INTEREST

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Adult CIRB Review Application
1. Does the Study Chair or any principal involved in the development or coordination of
this study have any significant financial conflicts of interest as defined in the Conflict of
Interest Policy for Cooperative Group Phase 3 Clinical Trials?
Yes

No

If yes, please answer question #2.

2. Does the Cooperative Group have a management plan in place to address the conflicts
disclosed in question #1?
Yes

No

If yes, please provide a copy of the management plan

SECTION K: INFORMED CONSENT
Please submit a copy of the informed consent document(s) for this study along with this
application.
SECTION L: AMENDMENT-SPECIFIC INFORMATION
This section should be completed only when this application is being updated as the result of an
amendment to the study.
1.0
2.0

Briefly describe what prompted this amendment:
Are any of the changes in this amendment significant enough to impact a study
participant’s willingness to continue participation in the research?
Yes
No
2.1

If yes, describe how these findings will be presented to study participants.

2.2

If yes, should the study participants be reconsented?
Yes
No
If yes, indicate how study participants will be reconsented (letter,
addendum, reconsent).
Provide drafts of reconsent documents.

Important Note: Please send the completed CIRB application and the informed consent
document(s) to adultcirb@emmes.com.
Adult CIRB Review Application Version 7–Dated 01/16/07 Updated 01/25/11

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Adult CIRB Review Application

NCI ADULT CENTRAL IRB (CIRB) APPLICATION
FOR TREATMENT STUDIES

OMB#: 0925 – 0625 Expiry Date: 1/31/2014
STATEMENT OF CONFIDENTIALITY
Collection of this information is authorized under 42 USC 285a. Your participation is complet ely voluntary. You are subject to no penalty if you
choose not to provide all or any part of the requested information. Data collected as part of the NCI CIRB review is confidential and protected by
law. Under the provisions of Section 301d of the Public Health Service Act, no information that could permit identification of a participating
individual may be released. All such information will be held in confidence and will be presented only in statistical or summary form.
NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for this collection of information is estimated to average 2 hours per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of
information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda,
MD 20892-7974, ATTN: PRA (0925-0625*). Do not return the completed form to this address.

SECTION A: GENERAL INFORMATION
COOPERATIVE GROUP:
GROUP STUDY NUMBER:
STUDY VERSION DATE:
STUDY TITLE:

STUDY CHAIR
Name
Title
Specialty
Site
Address
Phone #
E-mail
FAX #
STUDY CO-CHAIR (If applicable)
Name
Title
Specialty
Site
Address
Phone #

Adult CIRB Review Application
E-mail
FAX #
CONTACT PERSON
Name
Title
Specialty
Site
Address
Phone #
E-mail
FAX #
WILL THIS BE ON THE CTSU MENU?
PLEASE NOTE: CIRB membership includes individuals who are not part of the oncology
and/or the scientific community. Therefore, you must use lay language (non medical, non
legal terms) and de fine all terms unique to science when completing this application.

SECTION B: SUMMARY OF STUDY
Please answer each of the following questions in 250 words or less per question.
1. State the question that this study will answer (i.e. hypothesis or study objectives):

2. Describe the background research that has led to your hypothesis/study objectives:

3. Describe the study. (Include schema.)

4. How will the research design answer the hypothesis?

5. How will the new information gained from this study impact the treatment for this
disease or condition?

6. Will participants be required to discontinue or modify any current medication, or
be denied any standard of care for any condition, in order to be eligible for
participation?
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7. Is there an interim safety monitoring plan for this study?
Yes

No

If yes, please explain.

SECTION C: PARTICIPANTS
1. Number of participants to be enrolled in the study:
2. Participant profile (Check all that apply.)
Gender:
Male
Female

Ethnicity
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American (not of Hispanic origin)
White (not of Hispanic origin)
Hispanic or Latino

3. Specify the age range of eligible participants:
If participants under the age of 18 years old are eligible, an assent form must be submitted.

4. Which of the following vulnerable populations are eligible to be participants (Check
each item yes or no. A “no” indicates that all persons in that category are excluded.):
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Incompetent persons (excluding minors):

Yes

No

(Incompetent persons include those who have a legal guardian or those whose mental
status prevents them from giving truly informed consent and making decisions [such
as those with advanced Alzheimer’s disease]).
Physically or Mentally Disabled/Challenged

Yes

No

(Handicapped persons include those with a physical or mental impairment which
substantially limits one or more major life activities [e.g. speaking, breathing, learning,
working, caring for oneself, performing manual tasks, walking, seeing, hearing, etc.], has
a record of such an impairment, or is regarded as having such an impairment)
Women with reproductive potential:

Yes

No

Pregnant women:

Yes

No

Men with reproductive potential:

Yes

No

Minorities:

Yes

No

Prisoners:

Yes

No

4A. Explanation of Exclusion: Federal IRB regulations require equitable selection of
participant s. In addition, NIH policy requires that minorities and women be adequately
represented as research participants. If you checked “no” to any of the categories above,
you must provide a scientific reason for such exclusion.

5. Recruitment
a) Provide the participant recruitment plan.

b) Provide any recruitment materials (if applicable) that participants will see.

c) Will the participants be paid or receive any other inducements (e.g., free medication, free
medical care) for participating?
Yes
No
If yes, please explain.

Adult CIRB Review Application Version 7–Dated 01/16/07

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6. Will the participants bear any costs which are not a part of standard of care?
Yes

No

If yes,
a) List the relevant tests, procedures, hospitalizations, etc., for which the participants would
be financially responsible.

b) Are there available means of subsidizing these extra costs for participants who cannot
afford them?
Yes

No

If yes, please explain.

SECTION D: DRUGS
1. Please provide the following information for all drugs to be used in this study. (This
includes the study drugs PLUS any othe r medications specified in the study that the
participant will receive while on this study):
Drug/study drug:
Manufacturer:
Supplier:
Is the drug/study drug being used under an IND?

Yes (submit copy of Investigator's Brochure)
IND# :

No

Holder of IND:

Drug/study drug:
Manufacturer:
Supplier:
Is the drug/study drug being used under an IND?

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Adult CIRB Review Application

Yes (submit copy of Investigator's Brochure)
IND# :

No

Holder of IND:

Drug/study drug:
Manufacturer:
Supplier:
Is the drug/study drug being used under an IND?

Yes (submit copy of Investigator's Brochure)
IND# :

No

Holder of IND:

a.) Does this study include an off- label use of an FDA-approved drug?
Yes

No

If yes, please explain. (e.g. Has an IND been applied for? Is this study exempt from an
IND? If exempt, please provide official FDA documentation.)

2. For all study drugs, include the following information:
(Study drugs are all drugs that are investigational or are being studied or compared, alone
or as part of a regimen.)
a) The name of the study drug/regimen:
b) Likely/bothersome effects that are study drug/drug class/regimen specific:
c) Less likely effects that are study drug/drug class/regimen specific:
d) Rare but serious effects that are study drug/drug class/regimen specific:
Risks and side effects related to temozolomide include those that are:
Likely
•
Less Likely
•
Rare but Serious
•

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Adult CIRB Review Application

SECTION E: RADIATION
1. Does this study involve radiation?

Yes

No (If no, skip to Section F.)

2. Specify the type of radiation that the participant will receive:
Diagnostic

Therapeutic

Both

3. Will the participant receive radiation greater than normally received in the course of
standard of care for this disease or condition?
Yes

No

If yes, please explain.

4. Is any radiation modality experimental?
Yes

No

If yes, list the risks associated with the experimental modality.

SECTION F: RISKS, BENEFITS AND ALTERNATIVES
1. List any known or fore seeable risks or discomforts to the participant from procedures
or treatment associated with the study intervention(s). List the frequency and
complications associated with each.

2. List measures planned to minimize risks identified in Question # 1.

3. How do the potential benefits outweigh the risks inherent in participating in the study?

4. How would you treat this participant in a non-investigational setting? Please describe
the treatment that is considered standard of care, as well as any alternative procedures
or drugs or other courses of therapy that might be used, if such alternatives exist.

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SECTION G: GENETIC RESEARCH
Will the research identify genetic characteristics?*

Yes

No

If no, go to Section H.
*It may be useful to think of genetic research as being carried out on a continuum comprising of
four stages: (1) to discover the pattern of inheritance of a disease and to catalog the range of
symptoms involved (pedigree studies); (2) to localize and identify specific genes (positional
cloning studies); (3) to develop techniques for determining the presence of specific DNA
mutations (DNA diagnostic studies); and (4) to develop treatments for genetic disease at the
DNA level (gene therapy research).
If yes:
a) Will results be disclosed to the participants?
Yes

No

If yes, describe in what way:
If yes, how will they be given the option to not receive the results?
b) Will research findings be disclosed to participants’ physicians for clinical use?
Yes

No

If yes, Will this plan be discussed with the participants and their consent
obtained?
c) Will the possible psychological and social risks of genetic research be adequately
considered in the consent process? Will appropriate counseling be provided,
both as part of the consent process and also when communicating test or other
research results to participants? Please explain.

d) Will the data be protected from disclosure to third parties, such as
employers and insurance companies? Describe confidentiality measures.

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e) How are tissue samples secured?

f) What will happen to the tissue samples in the event that a participant
withdraws from the study?

SECTION H: STORAGE OF SPECIMENS FOR FUTURE RESEARCH STUDIES
Does this study involve collection of specimens for future research studies?
Yes

No

(If no, skip to Section I.)

If yes:
a) What are the types and amounts of specimens to be collected? Justify the types and amounts.

b) How will the specimens be linked to the participants?

c) For what types of research do you anticipate using the samples in the future?

d) How will access to the specimens be governed?

e) What procedure will be used if the participant withdraws consent after the specimen has been
collected and stored?

SECTION I: ANCILLARY STUDIES
Will participants enrolled in this study be asked to register in any ancillary/companion
studies?
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Yes

No

If yes, are these studies:
Mandatory
Optional
Both
PLEASE NOTE:
The CIRB will review any new ancillary/companion study regardless of whether participation is
mandatory or optional.
If an ancillary/companion study is already open, the policy is as follows. If a study requires that
its participants also enroll in an ancillary/companion study, the CIRB must review the
ancillary/companion study. A separate, Ancillary Study Application, the ancillary/companion
study, and associated informed consent document(s) must be submitted to the CIRB for review
and approval. Once an ancillary/companion study has been approved, it will not need to be
resubmitted with each treatment study that it accompanies.
The CIRB will review all ancillary/companion studies whose participation is mandatory for
participants enrolled in an associated main treatment study, regardless of when the
ancillary/companion study was activated and open to enrollment.
The CIRB will not review an ancillary/companion study if participation is optional and the study
was activated and open to enrollment prior to the associated main treatment study’s submission
for CIRB review.
SECTION J: CONFLICTS OF INTEREST
1. Does the Study Chair or any principal involved in the development or coordination of
this study have any significant financial conflicts of interest as defined in the Conflict of
Interest Policy for Cooperative Group Phase 3 Clinical Trials?
Yes

No

If yes, please answer question #2.

2. Does the Cooperative Group have a management plan in place to address the conflicts
disclosed in question #1?
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Yes

No

If yes, please provide a copy of the management plan

SECTION K: INFORMED CONSENT
Please submit a copy of the informed consent document(s) for this study along with this
application.
Important Note: Please send the completed CIRB application and the informed consent
document(s) to pediatriccirb@emmes.com.

Adult CIRB Review Application Version 7–Dated 01/16/07

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