Form 26 CIRB IR Application

CIRB INITIAL REVIEW APPLICATION
OMB#: 0925-xxxx Expiration Date: xx/xx/xxxx

Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of your
participation in the NCI CIRB is protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties
for not participating or withdrawing from the NCI CIRB at any time. Refusal to participate will not affect your benefits in any
way. The information collected will be kept private to the extent provided by law. Names and other identifiers will not appear
in any report of the NCI CIRB. Information provided will be combined for all participants and reported as summaries. You are
being requested to complete this instrument so that we can conduct activities involved with the operations of NCI CIRB Initiative.
NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for this collection of information is estimated to average 1 hour 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-xxxx*). 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
Version Date 04/24/14

Page 1 of 12

CONTACT PERSON (Person to contact with questions about this application)
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.

1.2

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.

1.5

Describe the study intervention.
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 NOT part of routine cancer care.

1.7

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.

1.8

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.

Version Date 04/24/14

Page 2 of 12

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.

2.0

1.10

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

1.11

How will the research findings be disclosed to study participants?

Participants
2.1

Number of participants to be enrolled in the study:

2.2

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

2.3

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

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:

Version Date 04/24/14

Page 3 of 12

b. Prisoners

Eligible

Ineligible

The CIRBs are not constituted to review research for the inclusion
of prisoners. Please indicate eligibility for sites not utilizing the
CIRB.
c. Pregnant women

Eligible

Ineligible

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

Ineligible

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

Eligible

Ineligible

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:
f. Educationally Disadvantaged

Eligible

Ineligible

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:

Version Date 04/24/14

Page 4 of 12

g. Physically Disabled

Eligible

Ineligible

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.

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
2.5.3.1 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.

2.6.2

Version Date 04/24/14

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

Page 5 of 12

If yes, please describe.
3.0

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.

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.

e.

Version Date 04/24/14

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.
Page 6 of 12

f.
4.0

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.
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.)

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.
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 7.0.
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

Version Date 04/24/14

Page 7 of 12

6.1.2

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

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.

7.0

6.4

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

6.5

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.
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.

Version Date 04/24/14

Page 8 of 12

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

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.

8.0

Non-Medical Risks
8.1

Describe measures taken to maintain the confidentiality of identifiable
information.
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.

Version Date 04/24/14

Page 9 of 12

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.
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.

9.2

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, 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

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

How will specimens be accessed and who will have access?

11.1.4

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

Version Date 04/24/14

Page 10 of 12

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

No

If yes, please include copies of any materials or instruments to be completed by
study participants.
13.2

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

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.
14.0

Conflicts of Interest
14.1

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 National Cancer Institute (NCI)/Division of Cancer Treatment and

Version Date 04/24/14

Page 11 of 12

Diagnosis (DCTD) Conflict of Interest Policy for NCI/DCTD-supported
Cooperative Group Randomized Phase 2 and Phase 3 Clinical Trials?
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.

Version Date 04/24/14

Page 12 of 12