27 CIRB IR Exempt Application

CIRB INITIAL REVIEW APPLICATION
FOR EXEMPT STUDIES
Attachment_B11_IR_Exempt_App

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 30 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 is designed to help determine whether or not the study qualifies for exemption
from CIRB review. If he study is determined to be exempt you will receive a letter from the CIRB
Operations Office documenting the determination. If CIRB review is required, a separate
application will be sent.
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)
Name
Title
Institution Name
Phone Number
E-mail

July 2018

1.0

Determining Whether the Activity is Human Subjects Research

Please answer each of the following questions. Space is provided with each question to provide a
brief explanation. Providing an explanation may assist in making a timely determination with
minimal need for follow-up.
1.1

Is the study a systematic investigation designed to develop or contribute to generalizable
knowledge?
Yes, proceed to question 1.2.
No. The activity is not research. Skip to section 3
You may provide an explanation for your answer in the space below:

1.2

Does the study involve obtaining information about living individuals?
Yes. Proceed to question 1.3
No. The activity is not research involving human subjects. Skip to section 3.
You may provide an explanation for your answer in the space below:

1.3

Does the study involve prospective intervention or interaction with the individuals?
Yes. The activity is research involving human subjects. Skip to section 2.
No (proceed to question 1.3.1)
You may provide an explanation for your answer in the space below:

1.3.1 Is the information individually identifiable (i.e. the identity of the subject is or
may readily be ascertained by the investigator or associated with the information)?
Yes (proceed to question 1.3.2)
No. The research is not research involving human subjects. Skip to section 3.
You may provide an explanation for your answer in the space below:
1.3.2 Is the information private? (about behavior that occurs in a context in which an
individual can reasonably expect that no observation or recording is taking place, or
provided for specific purposes by an individual and which the individual can
reasonably expect will not be made public.)
Yes. Unless the note below applies, the activity is research involving human
subjects, proceed to question 2.0.
No. The activity is not research involving human subjects. Proceed to
section 3.0.
You may provide an explanation for your answer in the space below:
Note: Per OHRP’s “Guidance on Research Involving Coded Private Information or
Biological Specimens”, OHRP does not consider research involving only coded private
information or specimens to involve human subjects as defined under 45 CFR 46.102(f) if the
following conditions are both met:

July 2018

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1. the private information or specimens were not collected specifically for the currently
proposed research project through an interaction or intervention with living
individuals; and
2. the investigator(s) cannot readily ascertain the identity of the individual(s) to whom
the coded private information or specimens pertain.

2.0

Determining Whether the Research is Exempt from CIRB Review
Please answer each of the following questions. Space is provided with each question to provide a
brief explanation. Providing an explanation may assist in making a timely determination with
minimal need for follow-up.
2.1
2.2

Does the research involve prisoners?
Yes (STOP – the research cannot be exempt. Contact the CIRB Coordinator to
request an application for initial review by the CIRB.)
No (proceed to question 2.2)
Does the research involve children?
Yes (proceed to question 2.2.1)
No (skip to question 2.3)

2.2.1 Does the research involving children include survey or interview procedures or
observation of public behavior?
Yes (proceed to question 2.2.2)
No (skip to question 2.3)

2.3

2.2.2 Will the investigators participate in the activities being observed?
Yes (STOP – the research cannot be exempt. Contact the CIRB Coordinator to
request an application for initial review by the CIRB.)
No (proceed to question 2.3)
Will the only involvement of human subjects be in one or more of the following categories?
NOTE: If there is involvement of human subjects in activities beyond those described in
the categories below, the research cannot be exempt. Contact the CIRB Coordinator to
request an application for initial review by the CIRB.

Space is provided with each category to provide a brief explanation. Providing an explanation
may assist in making a timely determination with minimal need for follow-up.
2.3.1 Research conducted in established or commonly accepted educational settings,
involving normal educational practices, such as (i) research on regular and special
education instructional strategies, or (ii) research on the effectiveness of or the
comparison among instructional techniques, curricula, or classroom management
methods.
Yes
No
You may provide an explanation for your answer in the space below:
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2018
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Date 01/19/16

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2.3.2 Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public
behavior, unless: (i) information obtained is recorded in such a manner that human
subjects can be identified, directly or through identifiers linked to the subjects; and
(ii) any disclosure of the human subjects' responses outside the research could
reasonably place the subjects at risk of criminal or civil liability or be damaging to
the subjects' financial standing, employability, or reputation.
Yes
No
You may provide an explanation for your answer in the space below:
2.3.3 Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public
behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human
subjects are elected or appointed public officials or candidates for public office; or
(ii) federal statute(s) require(s) without exception that the confidentiality of the
personally identifiable information will be maintained throughout the research and
thereafter.
Yes
No
You may provide an explanation for your answer in the space below:
2.3.4 Research involving the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens, if these sources are publicly
available or if the information is recorded by the investigator in such a manner that
subjects cannot be identified, directly or through identifiers linked to the subjects.
Yes
No
You may provide an explanation for your answer in the space below:
2.3.5 Research and demonstration projects which are conducted by or subject to the
approval of department or agency heads, and which are designed to study, evaluate,
or otherwise examine: (i) Public benefit or service programs; (ii) procedures for
obtaining benefits or services under those programs; (iii) possible changes in or
alternatives to those programs or procedures; or (iv) possible changes in methods
or levels of payment for benefits or services under those programs.
Yes
No
You may provide an explanation for your answer in the space below:

July 2018

2.3.6 Taste and food quality evaluation and consumer acceptance studies, (i) if
wholesome foods without additives are consumed or (ii) if a food is consumed that
contains a food ingredient at or below the level and for a use found to be safe, or
agricultural chemical or environmental contaminant at or below the level found to
be safe, by the Food and Drug Administration or approved by the Environmental

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Protection Agency or the Food Safety and Inspection Service of the U.S. Department
of Agriculture.
Yes
No
You may provide an explanation for your answer in the space below:
3.0

Additional Documentation
If sections 1 and 2 of this application indicate that the activity is not human subjects research or is
exempt human subjects research, submit this application along with additional documentation
(e.g. protocol or research plan) to include the following information:
•

•
•
•
•

The rationale for the study, including a summary of the background research that has led to
your hypothesis/objectives.
An explanation of the study design and how it is appropriate to obtain an answer to the
hypothesis.
A description of procedures including efforts to maintain confidentiality of data (such as how
data will be de-identified and measures to prevent re-identification of individuals).
Copies of any surveys or scripts for interviews.
A description of possible risks of the research and efforts to mitigate risks.

Submit the completed application and the required supporting documents via email to
adultcirb@emmes.com, earlyphasecirb@emmes.com, pediatriccirb@emmes.com, or
cpccirb@emmes.com.

July
2018
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Date 01/19/16

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