21a NCI Pediatric CIRB Application

Protocol Application Form

NCI’s
CENTRAL IRB (CIRB) INITIATIVE
APPLICATION FORM FOR TREATMENT PROTOCOLS
FOR THE PEDIATRIC CIRB (PedCIRB)

OMB#: 0925 – 0625 Expiry Date: 1/31/2014
STATEMENT OF CONFIDENTIALITY
Collection of this information is authorized under 42 USC 285a. Your participation is completely 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.

For CIRB Use Only:
Receipt Date:

SECTION A : GENERAL INFORMATION
FORM COMPLETION DATE (Initial submission): _________________________________

DATE OF CURRENT REVISIONS TO FORM INFORMATION: ____________________

COOPERATIVE GROUP: _____________________ PHASE OF STUDY _____________

GROUP STUDY NUMBER: _________________ CTSU PROTOCOL:

Yes

No

PROTOCOL VERSION AND DATE: ___________________________________________

STUDY TITLE:
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Protocol Application Form

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

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
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SUMMARY OF STUDY
1. State the question that this study will answer (i.e. hypothesis or study objectives):

2. Briefly describe the background research that has led to your hypothesis/study
objectives Note: The background section of the COG protocol must contain enough
additional information for review by the CIRB.

STUDY DESIGN
1. Briefly describe the study design, and include a schema.
2. Describe sequentially all procedures, interventions and evaluations to be applied to
subjects, and identify any that are experimental or performed exclusively for
research purposes. Note: A biomedical research protocol may involve interventions
that are strictly experimental or may involve some aspect of research (e.g.,
randomization among standard treatments for collection and analysis of routine clinical
data for research purposes). It is important for this section to distinguish between
interventions that are experimental and/or carried out for research purposes versus those
procedures that are considered standard therapy. In addition, routine procedures
performed solely for research purposes (e.g., additional diagnostic or follow-up tests)
should be identified.

3. Describe the follow-up of subjects and identify any procedures that are performed
exclusively for research purposes, or performed more frequently than would
normally be clinically indicated (e.g. additional or more frequent radiologic
evaluations)

4. Will the participant be withdrawn from or denied standard of care for any
condition in order to participate in the study?
Yes

No

If yes, please provide justification.

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5. How would this participant be treated 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.

6. Describe the interim safety monitoring plan for this study, including the specific
stopping rules for the research? If there is no interim safety plan, please provide
justification.

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SECTION C
PARTICIPANTS
1. Number of participants to be enrolled in the study: ___________________________
2. Participant profile
a) Are there any enrollment restrictions based on gender? If so, provide justification.
b) b. Are there any enrollment restrictions based on child-bearing potential? If so,
provide justification.
c) c. Are pregnant or breast feeding women excluded from participation? If so,
provide justification.
d) d. Are there any subject enrollment restrictions based upon race or ethnic origin?
If so, explain the nature of the restrictions and provide justification.
3. What is the age range of the subjects, and what is the rationale for selecting this age
range?

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

*Note: Incompetent persons include those who have a legal guardian or those whose
mental status prevents them from giving truly informed consent and making decisions.
Inclusion of such subjects may require additional protections, such as appointment of
a legal guardian.*
Handicapped

Yes

No

*Note: 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.*
*Note: Exclusion of handicapped persons requires specific justification.*

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Prisoners:

Yes

No

*Note: Research involving prisoners must comply with HHS regulations at 45CFR46
Subpart C. Subpart C provides additional protection for prisoners enrolled in research
because they are considered to be a vulnerable subject population. *
5. Recruitment
a) Provide any recruitment materials (if applicable) that participants will see.
b) Will the participants be paid or receive any other inducements (e.g., free
medication, free medical care) for participating?
Yes (If yes, please explain)

No

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 (If yes, please explain)

No

SECTION D
DRUGS
1. Please provide the following information for all drugs to be used in this study. This
includes the study drugs and other medications specified in the protocol that the
participant will receive while on this study (attach additional page if necessary):
a) Are the drugs/study drugs being conducted under an IND?
(If no, skip to (b) below)

Yes

No

b) If yes, include each IND #, the name of the organization that holds each IND, the
manufacturer of the drug, and the supplier of the drug. Submit one copy of any
applicable Investigator's Brochure(s) with this application.
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IND#___________________ Holder of the IND: ________________________
Manufacturer: ____________________________________________________
Supplier: _________________________________________________________

IND#___________________ Holder of the IND: ________________________
Manufacturer: ____________________________________________________
Supplier: _________________________________________________________

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

No

d) If yes, is an IND required for this drug?
Yes, already applied for (provide documentation)

Exempt

*Note: In general, an IND is not required for an approved drug unless the results of
this study be used by the manufacturer to support (a) a new indication for the drug, (b)
a significant change in the labeling for the drug, or (c) a significant change in the
advertising for the drug.*

SECTION E
RADIATION
1. Does this study involve radiation?

Yes

No (If no, skip to Section F.)

2. Briefly describe the radiation therapy to be administere d (type, dose, field).

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3. Will the participant receive a radiation dose that is substantially different from that
normally received in the course of standard of care for this disease or condition?
Yes

No

If yes, please describe and provide justification.

*Note: if the justification is already described in the background section of this
application, please refer to that section.*

4. Will the participant receive radiation therapy that is delivered in a manner that is
substantially different from standard of care for this disease or condition? Note: this
includes dose rate, fractionation, field, or source?
Yes

No

If yes, please describe and provide justification.

*Note: if the justification is already described in the background section of this
application, please refer to that section.*

SECTION F
RISKS, BENEFITS AND ALTERNATIVES
*Describe only the risks of interventions that are part of the experimental portion of the study
(that is, those interventions which contribute to answering one or more of the research
questions designed in the aims of the study). Risks associated with standard supportive care,
with non-experimental surgical procedures or radiotherapy need not be included here.*
1. Risks of Study Interventions
a) Describe any risks associated with study drugs that is part of the experimental
portion of this protocol. For each study drug, provide the following information:
i.

The name of the study drug:_____________________________________

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ii.

Common/bothersome effects that are study drug/drug class/regimen
specific:

iii.

Known serious or life-threatening effects that are study drug/drug
class/regimen specific:

*Note: If data are available, estimate the probability that a given harm may occur and
its potential reversibility.*
b) Describe risks associated with any radiation therapy that is part of the
experimental portion of this protocol. Note: If data are available, estimate the
probability that a given harm may occur and its potent ial reversibility
c) Describe risks associated with any surgical procedures that are part of the
experimental portion of this protocol. Note: If data are available, estimate the
probability that a given harm may occur and its potential reversibility
2. Other Risks
a) List any known or foreseeable risks or discomforts to the participant from
procedures or treatment unrelated to study interventions like drugs, radiation or
surgery (such as randomization, placebo, withdrawal or withholding standard
treatment). If known, list the frequency and severity of each risk.

3. What is the risk classification of this research? Note: A research protocol may
include multiple research interventions, which may fall into different categories.
Please provide the highest risk level, or classify each of the interventions separately.
Minimal Risk (Minimal risk means risks that are not greater in and of themselves
than those ordinarily encountered in the daily life of normal children or during the
performance of rout ine physical or psychological examinations or tests).
Minor Increase over Minimal Risk - (A minor increase in risk which, while it goes
beyond the boundaries of minimal risk, poses no significant threat to the child's health
or well being)
Greater than Minimal Risk (All other risks)

4. What specific procedures will be utilized to prevent or minimize potential risks or
discomforts associated with study interventions and procedures?

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5. What are the specific subject withdrawal criteria?
6. What are the potential benefits to the subject associated with the research? Note: A
research protocol may include multiple research interventions, which may have
different types or levels of benefit. Please classify each of the interventions
separately.

7. How will the new information gathered from the study impact the treatment of this
disease or disorder?

SECTION G
GENETIC RESEARCH
1. Does this study include genetic research on samples or tissues?
Yes

No (If no, go to Part H)

*It may be useful to think of genetic research as being carried out on a continuum
comprising of four stages: (1) pedigree studies (to discover the pattern of inheritance of
a disease and to catalog the range of symptoms involved); (2) positional cloning studies
(to localize and identify specific genes); (3) DNA diagnostic studies (to develop
techniques for determining the presence of specific DNA mutations); and (4) gene
therapy research (to develop treatments for genetic disease at the DNA level).*
If yes:
a) Why is this patient population appropriate for genetic research?
b) Will results be disclosed to the participants?
Yes (If yes, describe in what way)

No

c) Will participants be given the option of not receiving information about
themselves?
d) 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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e) Will participants be informed about the possibility that incidental findings may be
made?

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

g) Will research findings be disclosed to participants’ physicians for clinical use?

h) Will this plan be discussed with the participants and their consent obtained?

i) Will vulnerable populations be adequately protected? (See Part C, Question # 4.)
Yes (If yes, how?)

No

j) What provisions have been made for protecting against misuse of tissue samples?

k) What provisions have been made for the treatment of data and tissue samples in
the event of participant withdrawal from study?

l) Describe ways that participants’ privacy and confidentiality will be protected
when publications are planned.

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

No (If no, skip to SECTION I.)

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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?
f) Will research findings be disclosed to participants or to participant’s physicians?

SECTION I
ANCILLARY STUDIES
2. Will participants enrolled in this protocol be asked to register in any
ancillary/compa nion protocols?
Yes

No

If yes, are these protocols:
Mandatory
Optional
Both
*NOTE: If a protocol requires that its participants also enroll in an ancillary/companion
protocol, the CIRB must review the ancillary/companion protocol. A separate, Ancillary
Protocol Application, the ancillary/companion protocol, and associated informed consent
document(s) must be submitted to the CIRB for review and approval.
Once an
ancillary/companion protocol has been approved, it will not need to be resubmitted with each
treatment protocol that it accompanies.

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The CIRB will review all ancillary/companion protocols whose participation is mandatory for
participants enrolled in an associated main treatment protocol, regardless of when the
ancillary/companion protocol was activated and open to enrollment.
The CIRB will not review an ancillary/companion protocol if participation is optional and the
protocol was activated and open to enrollment prior to the associated main treatment
protocol’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 fina ncial 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
1. Please submit a copy of the informe d consent document(s) for this protocol 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

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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: A Word® file containing the informed consent document(s) must
also be emailed to the CIRB Project Office in order for this application to be
considered complete. Kindly send the completed CIRB application and the informed
consent document(s) to pediatriccirb@emmes.com.*

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