Form 22 Adult/Pediatric CIRB Application - Ancillary Studies

Attachment 5C:

NCI ADULT/PEDIATRIC CIRB APPLICATION
FOR ANCILLARY STUDIES

OMB#: 0925 – xxxx Expiry Date: xx/xx/xxxx
STATEMENT OF CONFIDENTIALITY
Collection of this information is authorized under 42 USC 285a. Completion of this form is
required as per the NCI CIRB Standard Operations Procedures based on 45 CFR 46.103 (b)
(4). If you choose not to complete this form, you will not be able to participate in the CIRB. Data
collected as part of the NCI CIRB review is private 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 kept private under the
Privacy Act 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-xxxx*). Do not
return the completed form to this address.

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NCI ADULT/PEDIATRIC CIRB APPLICATION
FOR ANCILLARY STUDIES
PART A
GENERAL INFORMATION
FORM COMPLETION DATE (Initial submission):
DATE OF CURRENT REVISIONS TO FORM INFORMATION:
COOPERATIVE GROUP:
GROUP STUDY NUMBER: CTSU PROTOCOL:

Yes

No

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:
Specialty:
Site:
Address:
Phone Number:
E-mail Address:
FAX Number:

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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? (Either type or amount)
Yes
No
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.

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b) Are there means of subsidizing these extra costs for subjects who cannot
afford them?
Yes
No
If yes, explain:

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 pro teins 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?

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Yes

No

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If yes, describe in what way:

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?

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?
Yes
No If no, go to PART G.
If yes:

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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?

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 econo mic 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.

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2. Does any person as described in question #1 have a family member (spouse or
dependent child) who has a financial interest in the study?
Yes
No
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]. Thank you!

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