36 Adult-Pediatric Treatment Studies

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

ο

New Form: NCI Adult/Pediatric CIRB Application for Treatment Studies
New form combines Forms 5A and 5B to minimize and simplify form process. The
questions being asked are the same for both Adult and Pediatric Applications for
Treatment Studies. This facilitates and simplifies the process by implementing one
form rather then having two separate forms. The form must be completed for either
Adult or Pediatric Trial; therefore, there is not an increase or decrease in time to
complete. The effort of burden remains the same.

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NCI ADULT/PEDIATRIC 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 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 t his address.

This application, when completed, contains information required by CIRB members to
conduct a meaningful review of the study so answer each question as completely as
possible. If an answer to any question cannot be provided, please provide an explanation
for the missing answer. If you have any questions regarding the completion of this
application, please contact the CIRB Helpdesk at 888-657-3711 or
[email protected].

APPLICATION COMPLETION DATE:
GROUP STUDY ID NUMBER:
STUDY TITLE:
PROTOCOL VERSION DATE:
Please provide the protocol and informed consent document with this Protocol Version Date.
CTSU Menu?

Yes

No

STUDY CHAIR
Name
Title
Institution/Address
Phone Number
E- mail
FAX Number
Administrative
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Assistant Name
Administrative
Assistant E- mail
Administrative
Assistant Phone
Number
STUDY CO-CHAIR (If applicable)
Name
Title
Institution/Address
Phone Number
E- mail
FAX Number
Administrative
Assistant Name
Administrative
Assistant E- mail
Administrative
Assistant Phone
Number
CONTACT PERSON (Person to contact with questions about this application)
Name
Title
Institution/Address
Phone Number
E- mail
FAX Number
PLEASE NOTE: CIRB membership includes individuals who are not part of 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.

1.0

Summary of Study
Please answer each of the following questions in 250 words or less per question.
1.1

Indicate the FDA Phase of the study.

1.2

Describe the purpose of this study (i.e. hypothesis or study objectives).

1.3

Provide the rationale for the study, including a summary of the background
research that has led to your hypothesis/objectives.

1.4

Explain the study design and how it is appropriate to obtain an answer to the
hypothesis.

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1.5

2.0

Describe the study intervention. (Include schema.)

1.5.1

Describe the standard of care treatment for this cancer.

1.5.2

How does the proposed intervention differ from the standard of care?

1.6

Describe any exams, tests, and /or procedures that are required for the research and
are part of routine cancer care.

1.7

Describe any exams, tests, and/or procedures that are required for the research and
are NOT part of routine cancer care.

1.8

List inclusion/exclusion criteria for this study.

1.9

Will study participants be required to discontinue or modify current medication or
be denied standard of care for any non-cancer condition?

1.10

Describe the safety monitoring plan for this study.

1.11

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

1.12

How will the research findings be disclosed to study participants?

Participants
2.1

Number of participants to be enrolled in the study:

2.2

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

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2.3

Projected Enrollment Information at Study Institutions
For your convenience, we have retained the NIH formatting so that you can easily
include the information in this application.
2.3.1

Describe the target population in terms of ethnicity:

TARGETED/PLANNED ENROLLMENT: Number of Subjects
Ethnic category

Sex/Gender
Females

Males

Total

Hispanic or Latino
Not Hispanic or Latino
Ethnic Category Total

2.3.2

Describe the target population in terms of race:

TARGETED/PLANNED ENROLLMENT: Number of Subjects
Sex/Gender
Racial Categories

Females

Males

Total

American Indian/Alaska
Native
Asian
Black or African American
Native Hawaiian or Other
Pacific Islander
White
Racial Categories: Total of
all Subjects

2.3.3

2.4

Vulnerable Populations
2.4.1

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If there are zeroes in any of the categories in either chart, provide a
justification for the exclusion.

Which of the following vulnerable populations are eligible to participate in
the study?
a. Children

Eligible

Ineligible

b. Prisoners

Eligible

Ineligible

c. Pregnant women

Eligible

Ineligible

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d. Persons with Impaired Decision-Making Capacity
Eligible

Ineligible

e. Economically Disadvantaged

Eligible

Ineligible

f. Educationally Disadvantaged

Eligible

Ineligible

g. Physically Disabled

Eligible

Ineligible

2.4.2

Rationale for Ineligibility: Federal regulations [45 CFR 46.111(a)(3) and
21 CFR 56.111(a)(3)] require equitable selection of participants. If you
checked “Ineligible” for any of the categories above, provide a scientific
reason for the ineligibility.

2.4.3

If vulnerable populations are eligible to participate in the study, indicate
safeguards included in the protocol to protect their rights and welfare per
45 CFR 46.111(b) and 21 CFR 56.111(b).
List of possible safeguards by vulnerable population:

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a.

Children
Youth Information Sheets to facilitate assent
Risk-appropriate clinical monitoring
Researchers participating in the study are credentialed in
pediatrics
Additional Safeguards:

b.

Pregnant Women
Inclusion is scientifically appropriate based on preclinical
studies
Information is provided in the protocol pertaining to how
study intervention could impact the woman and the fetus
Information is provided in the informed consent document
pertaining to how study intervention could impact the
woman and the fetus
Risk-appropriate clinical monitoring
Additional Safeguards:

c.

Persons with Impaired Decision-Making Capacity
Protocol permits Legally Authorized Representative
Protocol permits assent
Additional Safeguards:

d.

Economically Disadvantaged
Cost burden is fully explained in the informed consent
document.
No financial incentives are provided to study participants.
Additional Safeguards:

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2.5

e.

Educationally Disadvantaged
Investigators are encouraged to provide verbal explanation
of the research in lay language
Investigators are encouraged to provide extra time to
answer questions
Investigators are encouraged to include family
members/significant others in the informed consent process
at the participant’s request.
Additional Safeguards:

f.

Physically Disabled
Investigators are encouraged to consider the unique needs
of the disabled when considering them as study
participants.
Risk-appropriate clinical monitoring
Additional Safeguards:

Recruitment
2.5.1

Have any recruitment materials targeted to potential study participants
(videos, brochures, letters, etc.) been prepared for this study?
Yes
No
If yes, please include a copy of the recruitment materials.
NOTE: As a reminder, any recruitment material targeted to potential
study participants must be CIRB-approved prior to distribution. We
encourage you to submit drafts for review prior to final production.

2.5.2

Will the participants receive agents/drugs/biologics, tests, procedures, or
medical care without charge? Yes
No
2.5.2.1 If yes, please describe.

2.5.3

Are there any incentives for participating in this study?
Yes
No
2.8.3.1 If yes, please describe.

2.6

Costs
2.6.1

Will the study participants be responsible for any research-related costs?
Yes
No
If yes, please describe.

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2.6.2

Does the Cooperative Group have any plans to subsidize these extra costs
for study participants who cannot afford them?
Yes
No
If yes, please describe.

3.0

Agents/Drugs/Biologics
3.1

Please provide the following information for all agents/drugs/biologics to be used
in this study. Sections for three agents/drugs/biologics have been provided. Copy
and paste additional sections if needed.
Information for Agent/Drug/Biologic
a.
b.
c.
d.

e.
f.

Agent/drug/biologic name (generic and trade):
Manufacturer:
Provided by:
NCI
Manufacturer
Other,
For this study, is the agent/drug/biologic being used under an IND?
Yes
No
If yes, please provide:
IND#:
Holder of IND:
Is there an Investigator’s Brochure?
Yes
No
If yes, please provide a copy of the Investigator’s Brochure.
Is the agent/drug/biologic being used off- label? Yes
No

Information for Agent/Drug/ Biologic
a.
b.
c.
d.

e.
f.

Agent/drug/biologic name (generic and trade):
Manufacturer:
Provided by:
NCI
Manufacturer
Other,
For this study, is the agent/drug/biologic being used under an IND?
Yes
No
If yes, please provide:
IND#:
Holder of IND:
Is there an Investigator’s Brochure?
Yes
No
If yes, please provide a copy of the Investigator’s Brochure.
Is the agent/drug/biologic being used off- label? Yes
No

Information for Agent/Drug/ Biologic
a.
b.
c.
d.

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Agent/drug/biologic name (generic and trade):
Manufacturer:
Provided by:
NCI
Manufacturer
Other,
For this study, is the agent/drug/biologic being used under an IND?
Yes
No
If yes, please provide:
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e.
f.
4.0

IND#:
Holder of IND:
Is there an Investigator’s Brochure?
Yes
No
If yes, please provide a copy of the Investigator’s Brochure.
Is the agent/drug/biologic being used off- label? Yes

No

Radiation
4.1

Does this study involve radiation?
(If no, skip to Section 5.0.)

Yes

No

If yes, specify the type of radiation that the participant will receive:
Diagnostic
Therapeutic
Both
4.2

Is any radiation modality or dose experimental?
Yes
No
If yes, describe.

5.0

Surgery
5.1

Does the study question involve experimental surgery?
(If no, skip to Section 6.0.)

Yes

No

If yes, describe.
6.0

Genetic Research
Genetic research is 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).

6.1

Will the research identify genetic characteristics?

Yes

No

If yes, complete this section. If no, go to Section 11.0.
6.1.1

Will the identified genetic characteristics be disclosed to the study
physician?
Yes
No
If yes, will study participants be given the option to not have the identified
genetic characteristics disclosed to the study physician?
Yes
No

6.1.2

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Is it the plan to disclose the identified genetic characteristics to the study
participant?
Yes
No
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7.0

8.0

6.1.2.1

If yes, will study participants be given the option to not
receive the results?
Yes
No

6.1.2.2

Describe how the identified genetic characteristics will
be communicated to the study participant.

6.2

Describe the confidentiality measures taken to protect the data from disclosure to
third parties.

6.3

Describe the storage and security measures taken to protect the tissue samples.

6.4

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

Medical Risks
7.1

Describe the known or foreseeable risks or discomforts, including reproductive
risks for both women and men, by agent/drug/biologic or regimen for all
agents/drugs /biologics to be used in this study as listed in section 3.0.

7.2

Describe the known or foreseeable risks or discomforts, including reproductive
risks for both women and men, associated with the radiation modality to be used
in this study as listed in section 4.0.

7.3

Describe the known or foreseeable risks or discomforts, including reproductive
risks for both women and men, associated with the surgery to be performed in this
study as listed in section 5.0.

7.4

Describe the known or foreseeable risks or discomforts, including reproductive
risks for both women and men, associated with procedures pertaining to the
research question.

7.5

List measures planned to minimize known or foreseeable risks or discomforts
identified in Questions 7.1, 7.2, 7.3, and 7.4.

7.6

What are the medical criteria for withdrawing a participant from the study?

Non-Medical Risks
8.1

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Describe measures taken by the Cooperative Group to maintain the confidentiality
of identifiable information.
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8.2

Describe the possible psychological and social risk associated with the genetic
research, if applicable.
8.2.1

8.3

Describe measures taken to minimize these risks.

Are there any other non- medical risks associated with participation in this
research (for example, psychological, social, economic, or legal risks)?
Yes
No
If yes, describe.

9.0

Benefits
9.1

Describe the potential benefits of participating in the study.

9.2

Do the potential benefits outweigh the risks inherent in participating in the study?
Yes
No
If yes, explain.

10.0

Alternatives
10.1

Other than standard of care, are there any alternative procedures or other courses
of therapy for this cancer that could be used outside of the research?
Yes
No
If yes, explain.

11.0

Storage of Specimens for Future Research Studies
11.1

Does this study involve collection of specimens for future research studies?
Yes

No

If no, skip to Section 12.0. If yes, complete this section.
11.1.1

Describe and justify the types of specimens to be collected, the
procedure for collecting the specimen, and the amount of the specimen
to be collected.

11.1.2

Will the specimens be linked to the study participants?
Yes
No
If yes, explain.

11.1.3

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For what types of research are study participants consenting to have
the tissues used?
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12.0

11.1.4

How will access to the specimens be governed?

11.1.5

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

Ancillary Studies
12.1

Will study participants be asked to register in any ancillary/companion studies?
Yes

No

If yes, describe the study(ies) and indicate if the study(ies) is mandatory or option.

NOTE ABOUT ANCILLARY STUDIES:
The CIRB reviews new ancillary/companio n studies that have not been included in the main
research study. Complete the Cooperative Group Ancillary Protocol Review Application Treatment Studies.
13.0

Conflicts of Interest
13.1

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

13.2

No

If yes, please answer question 13.2.

Does the Cooperative Group have a management plan in place to address the
conflicts disclosed in question 13.1?
Yes

No

If yes, provide a copy of the management plan.

Summary of CIRB-Requested Supporting Documents
Protocol upon which this application is based (REQUIRED)
Informed consent document with the same Protocol Version Date as the protocol
(REQUIRED)
Recruitment material (Question 2.5.1, if applicable)
Investigator’s Brochure (Question 3.1.e, if applicable)

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Management plan to address new or revised conflicts (Question 13.2, if
applicable)
Materials for reconsenting partic ipants (as outlined below, if applicable)
** Special Section: 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.

If you have any questions regarding the completion of this application, please contact the CIRB
Helpdesk at 888-657-3711 or [email protected].
Thank you for completing the NCI Adult/Pediatric Application for Treatment Studies. Please
submit the completed application and the required supporting documents via email to
[email protected] or [email protected].

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