Form 29 CIRB Ancillary Application

NCI Adult/Pediatric CIRB Application for Ancillary Studies

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

Attachment_B13_Anc_Studies_App

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.

PART A
GENERAL INFORMATION
FORM COMPLETION DATE (Initial submission):
DATE OF CURRENT REVISIONS TO FORM INFORMATION:
COOPERATIVE GROUP:
GROUP STUDY NUMBER: CTSU PROTOCOL:
PROTOCOL VERSION AND DATE:
STUDY TITLE:
STUDY CHAIR
Name:
Title:
Specialty:
Site:
Address:
Phone Number:
E-mail Address:
FAX Number:
STUDY CO-CHAIR
Name:
Title:
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Yes

No

Specialty:
Site:
Address:
Phone Number:
E-mail Address:
FAX Number:
CONTACT PERSON (Person to contact about this application if Chair not available)
Name:
Title:
Specialty:
Site:
Address:
Phone Number:
E-mail Address:
FAX Number:
PLEASE NOTE: CIRB membership includes individuals who are not part of the oncology and/or the
scientific community. Therefore, you must use lay language and define all terms unique to science
when completing this form.
PART B
SUMMARY OF STUDY
1. Briefly state the question that this study will answer (i.e. state the hypothesis):
2. Briefly describe the background research that has led to your hypothesis:
3. Briefly describe the study. (Include schema.)
4. How will the research design answer the hypothesis?
5. What significance will the new information gained from this study have?

PART C
SUBJECTS
1. Number of subjects to be enrolled in the study:
2. What is the age range of eligible subjects?
If subjects under the age of 18 are eligible, an assent form must be attached.
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3. Which of the following groups are eligible to be subjects (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 understanding the consent and making
decisions [such as those with advanced Alzheimer’s disease]).
Women of reproductive potential:
Pregnant women:
Men of reproductive potential:
Minorities:
Prisoners:

Yes
Yes
Yes
Yes
Yes

No
No
No
No
No

Explanation of Exclusion
Federal IRB regulations require equitable selection of subjects. In addition, NIH policy
requires that minorities and women be adequately represented as research subjects. If you
checked “no” to any of the categories above, you must provide a scientific reason for such
exclusion:
4. Will the subject have specimens collected that would not be collected as part of standard care?
Yes
No
(Either type or amount)
If yes, describe the means by which these specimens will be collected:
5. Will the subject have to make extra visits for specimen collection?
Yes
No
If yes,
a) Number of visits:
b) Frequency of visits:
c) Duration of visits:
6. Will the subjects bear any costs that are not a part of routine clinical care:
Yes
No
If yes, explain:
a) Please list the relevant tests, procedures, hospitalizations, etc., for which they would be
liable.
b) Are there means of subsidizing these extra costs for subjects who cannot afford them?
Yes
No
If yes, explain:
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PART D
RISKS, BENEFITS AND ALTERNATIVES
1. Describe any reasonably foreseeable risks or discomforts to the patient. Describe the frequency
and complications associated with each.
2. Discuss measures taken to minimize risks.
3. How do you justify the risks inherent in participating in the study?
4. Describe any benefits to the subject or to others, which may be expected from the research
(personal, social, scientific, etc.).
PART E
GENETIC RESEARCH
Does this study include genetic research on samples or tissues?*
If no, go to Part F.

Yes

No

*Human genetic research involves the study of inherited human traits. Much of this research is
aimed at identifying DNA mutations that can help cause specific health problems, developing
methods of identifying those mutations in patients, and improving the interventions available to
help patients address those problems. Such research includes a) the analysis of human
chromosomes or DNA from an individual and/or family members for the purpose of deriving
information concerning the individual or family about the presence, absence, or mutation of
genes, DNA markers, gene products or inherited characteristics or b) biochemical measurements
of proteins and metabolites with the INTENT of collecting and evaluating information about
heritable diseases and/or characteristics within a family.
If yes:
a) Why is this patient population appropriate for genetic research?
b) Will results be disclosed to the subjects?
If yes, describe in what way:

Yes

No

c) Will subjects 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 subjects? Please explain.
e) Will subjects be informed about the possibility of incidental findings?
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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 subjects’ physicians for clinical use? Will this plan be
discussed with the subjects and their consent obtained?
h) Will vulnerable populations be adequately protected?

Yes

No

If yes, how?
i) What provisions have been made for protecting against misuse of tissue samples?
j) What provisions have been made for the treatment of data and tissue samples in the event of
subject withdrawal from study?
k) Describe ways that subject’s privacy and confidentiality will be protected when
publications are planned.
PART F
STORAGE OF SPECIMENS FOR UNSPECIFIED FUTURE RESEARCH STUDIES
Does this study involve collection of specimens for unspecified future research studies?
No If no, go to PART G.

Yes

If yes:
a) What are the types and amounts of specimens to be collected? Justify the types and
amounts.
b) Will you maintain identifying information or links to identifiers?
c) What information will be recorded?
d) Where will the tissue be stored?
e) For what types of research do you anticipate using the samples in the future?
f) Who will be responsible for distributing the tissue?

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g) What steps will be taken to protect confidentiality?
h) What arrangements will you make with the clinical laboratories to guarantee that all
clinically indicated procedures are completed?

PART G
FINANCIAL CONFLICT OF INTEREST
Definition: A financial conflict of interest exists or may appear to exist when a person has an
economic interest in, receives funding or compensation from (for speaker’s bureaus, advisory
boards, research support, etc.), or acts as an officer of or a consultant to any organization or
company whose financial interests would reasonably appear to be affected by this research.
1. Does any person who has a substantial role in: a) the decision about whether or not the study
should be done; b) the design of the study; or c) the analysis or the management of the data from
the study, have a financial conflict of interest or the appearance of a financial conflict of interest
as defined above?
Yes
No
If yes, please explain.
2. Does any person as described in question #1 have a family member (spouse or dependent
Yes
No
child) who has a financial interest in the study?
If yes, please explain.
3. Do individual investigators or sites receive additional funding for patient accrual to this study
beyond that provided by the NCI?
Yes
No
If yes, please explain.
PART H
INFORMED CONSENT
Please attach a copy of the informed consent form for this protocol to this application form.
Please note: A Word or Word Perfect file containing the informed consent form(s) must also be
emailed to the CIRB Project Office in order for this application to be considered complete.
Kindly send the CIRB application and the consent document in care of CIRB Contact at
[email protected] or [email protected]. Thank you!

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