Form 26 CIRB IR Application

CIRB INITIAL REVIEW APPLICATION

Attachment B10_IR

OMB# 0925-0753, Expiration Date: 07/31/2021

The purpose of the information collection is to conduct reviews of clinical trial studies. NCI guidelines mandate the participation of
institutions in the CIRB for Network group studies. You are being requested to complete this instrument so that we can conduct
activities involved with the operations of the NCI CIRB Initiative. Although your participation in Network group research and completion
of the forms is voluntary, if you wish to participate in the CIRB, you must complete all questions on the form. The information you
provide will be combined for all participants and reported as summaries. It will be kept private to the extent provided by law.

NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN

Public reporting burden for this collection of information is estimated to average 60 minutes 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 (0925-0753). Do not return the completed form to this address.

This application has been designed to meet the regulatory requirements for review, so answer
each question as completely as possible.
• All answers must be in lay language.
• If an answer to any question cannot be provided, provide an explanation for the missing
answer.
• If you have any questions regarding the completion of this application, contact the CIRB
Helpdesk at [email protected] or 888-657-3711.
STUDY ID:

STUDY TITLE:

PROTOCOL VERSION DATE:
Please provide the protocol and consent form with this Protocol Version Date.
STUDY CHAIR
Name
Institution Name
Phone Number
Email
Administrative
Assistant Name
Administrative
Assistant E-mail
Administrative
Assistant Phone
Number
CONTACT PERSON (Person to contact with questions about this application)

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Name
Title
Institution Name
Phone Number
E-mail

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.

1.3

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

1.2

1.4
1.5

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

Explain the study design and how it is appropriate to obtain an answer to the hypothesis.
Describe the study intervention.
1.5.1 Describe the standard of care treatment for this cancer.

1.6
1.7
1.8

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

Describe any exams, tests, and/or procedures that are required for the research and are
NOT part of routine cancer care.
List inclusion/exclusion criteria for this study.

You may cite the consent form or protocol section and page number as long as the
information is provided in lay language; otherwise provide a lay language description here.
Will study participants be required to discontinue or modify current medication or be
denied standard of care for any non-cancer condition?
Yes
No
If yes, provide rationale.

You may cite the consent form or protocol section and page number as long as the
information is provided in lay language; otherwise provide a lay language description here.
1.9

Describe the safety monitoring plan for this study.
You may cite the consent form or protocol section and page number as long as the
information is provided in lay language; otherwise provide a lay language description here.

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1.10
2.0

1.11

How will the information gained from this study impact the treatment for this disease or
condition?
How will the research findings be disclosed to study participants?

Participants
2.1

Number of participants to be enrolled in the study:

2.3

Provide the protocol section and page number for the Planned Enrollment Report tables for
ethnic and racial categories.

2.2

Are participants under the age of 18 eligible to participate in this study?
Yes
No

2.3.1 Are there zeroes in any of the categories in either chart?
Yes
No
If yes, provide a rationale for the exclusion

2.4

Vulnerable Populations

2.4.1 Indicate which of the following vulnerable populations are eligible to participate in
the study and select the applicable safeguards listed below each eligible vulnerable
population (as required by 45 CFR 46.111(b) and 21 CFR 56.111(b)).
a. Children

Eligible

Ineligible

b. Prisoners

Eligible

Ineligible

c. Pregnant women

Eligible

Ineligible

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

The CIRBs are not constituted to review research for the inclusion of
prisoners. Please indicate eligibility for sites not utilizing the CIRB.
Possible safeguards for 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 consent form pertaining to how study
intervention could impact the woman and the fetus
Risk-appropriate clinical monitoring

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Additional Safeguards:
d. Persons with Impaired Decision-Making Capacity

Eligible

Ineligible

e. Economically Disadvantaged

Eligible

Ineligible

f. Educationally Disadvantaged

Eligible

Ineligible

g. Physically Disabled

Eligible

Ineligible

Possible safeguards for persons with Impaired Decision-Making Capacity:
Protocol permits Legally Authorized Representative
Protocol permits assent
Additional Safeguards:

Possible safeguards for economically disadvantaged participants:
Cost burden is fully explained in the informed consent document.
No financial incentives are provided to study participants.
Additional Safeguards:

Possible safeguards for educationally disadvantaged participants:
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 consent form process at the participant’s request.
Additional Safeguards:

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:
2.4.2

2.5

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.

Recruitment
2.5.1 Have any recruitment materials targeted to potential study participants (videos,
brochures, letters, etc.) been prepared for this study?
Yes
No

2.5.1.1 If yes, please include a copy of the recruitment materials and a description of
the plan for distribution.
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.

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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
2.6

Costs

2.5.3.1 If yes, please describe.

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

2.6.2 Are there any plans to subsidize these extra costs for study participants who cannot
afford them?
Yes
No
3.0

If yes, please describe.

Agents/Drugs/Biologics
3.1

Please provide the following information for all agents/drugs/biologics 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.

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

a.
b.
c.

Agent/drug/biologic name (generic and trade):
Manufacturer:
Provided by:
NCI
Manufacturer
Other,

e.

Information for Agent/Drug/Biologic

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d.
e.
f.

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.
4.0

f.

Radiation

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

4.1

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

Yes

No

4.2

If yes, specify the type of radiation that the participant will receive:
Diagnostic
Therapeutic
Both
Is any radiation modality or dose experimental?
Yes
No
If yes, describe.

You may cite the consent form or protocol section and page number as long as the
information is provided in lay language; otherwise provide a lay language description here.
5.0

Surgery
5.1

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

Yes

No

You may cite the consent form or protocol section and page number as long as the
information is provided in lay language; otherwise provide a lay language description here.
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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?

If yes, complete this section. If no, go to Section 7.0.

Yes

No

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 Is it the plan to disclose the identified genetic characteristics to the study
participant?
Yes
No
6.1.2.1
6.1.2.2
6.2
6.3

If yes, will study participants be given the option to not receive the
results?
Yes
No
Describe how the identified genetic characteristics will be
communicated to the study participant.

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

third

For genetic research, describe the possible psychological and social risks.
6.3.1 Describe measures taken to minimize these risks.

You may cite the consent form or protocol section and page number as long as the
information is provided in lay language; otherwise provide a lay language description here.
6.4
6.5

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

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

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7.0

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.
You may cite the consent form or protocol section and page number as long as the
information is provided in lay language; otherwise provide a lay language description here.

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.

You may cite the consent form or protocol section and page number as long as the
information is provided in lay language; otherwise provide a lay language description here.
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.
You may cite the consent form or protocol section and page number as long as the
information is provided in lay language; otherwise provide a lay language description here.

7.4

Describe the known or foreseeable risks or discomforts, including reproductive risks for
both women and men, associated with procedures that are done for research purposes as
listed in question 1.6.
You may cite the consent form or protocol section and page number as long as the
information is provided in lay language; otherwise provide a lay language description here.

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.
You may cite the consent form or protocol section and page number as long as the
information is provided in lay language; otherwise provide a lay language description here.

7.6
8.0

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

You may cite the consent form or protocol section and page number as long as the
information is provided in lay language; otherwise provide a lay language description here.

Non-Medical Risks
8.1

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Describe measures taken to maintain the confidentiality of identifiable information.

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You may cite the consent form or protocol section and page number as long as the
information is provided in lay language; otherwise provide a lay language description here.
8.2

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.

You may cite the consent form or protocol section and page number as long as the
information is provided in lay language; otherwise provide a lay language description here.
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

You may cite the consent form or protocol section and page number as long as the
information is provided in lay language; otherwise provide a lay language description here.

If yes, explain.

10.0 Alternatives
10.1

Other than standard of care, what alternatives to participating in the research are
available?
You may cite the consent form or protocol section and page number as long as the
information is provided in lay language; otherwise provide a lay language description here.

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
11.1.2

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11.1.3

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

How will specimens be accessed and who will have access?

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11.1.4

What will happen to the specimen if the study participant withdraws consent
after the specimen has been collected?

12.0 Ancillary Studies
12.1

Will study participants be asked to participate in any ancillary studies?
Yes

No

If yes, describe the study(ies).
You may cite the consent form or protocol section and page number as long as the
information is provided in lay language; otherwise provide a lay language description here.
12.2

Is participation in any other study required for participation in this study?
Yes

No

If yes, describe the study(ies).
You may cite the consent form or protocol section and page number as long as the
information is provided in lay language; otherwise provide a lay language description here.
13.0

Materials Directed to Study Participants
13.1

Will study participants be asked to complete any forms such as Quality of Life (QOL)
instruments?
Yes

13.2

If yes, please include copies of any materials or instruments to be completed by study
participants.

At time of enrollment will study participants be given any educational materials specific to
the study?
Yes

14.0

No

No

If yes, please include copies of any educational materials specific to the study to be given to
study participants as well as a description of the plan for distribution of the materials.

Conflicts of Interest
14.1

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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 National Cancer
Institute (NCI)/Division of Cancer Treatment and Diagnosis (DCTD) Conflict of Interest
Policy for NCI/DCTD-supported Cooperative Group Randomized Phase 2 and Phase 3
Clinical Trials?

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Yes
14.2

No

If yes, please answer question 14.2.

Is there a management plan in place to address the conflicts disclosed in question 14.1?
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)
Consent form with the same Protocol Version Date as the protocol (REQUIRED)

The following materials are required, if applicable:
Recruitment material and distribution plan (Question 2.5.1)
Investigator’s Brochure (Question 3.1.e)
Management plan to address new or revised conflicts (Question 14.2)
Forms intended to be completed by study participants (Question 13.1)
Study-specific educational materials (Question 13.2)

Submit the completed application and the required supporting documents via email to
[email protected], [email protected], [email protected], or
[email protected] within 10 days of CTEP Approval-On-Hold date.

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