Hello and thank you for accessing this form from the University of
Maryland, Baltimore County Institutional Review Board web site.
Prior to submitting, please ensure that spelling and grammar are
correct; this will assist in the timely review of this form during the
IRB evaluation process. Complete all sections of the protocol
application (indicate N/A in the section not applicable to your
protocol). "See attached proposal" or “See the previous section” are
not an acceptable responses.
Further instruction on the use of this form and guidance about
submission may be found in the Exempt Research link.
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EXEMPTION CERTIFICATION APPLICATION
INSTITUTIONAL REVIEW BOARD
Electronically submit the protocol and any accompanying documents to firstname.lastname@example.org. The Office for Research Protections and
Compliance prefers applications submitted in MS Word format, but Adobe Acrobat versions will be accepted.
Please do not submit “hard-copy” or paper documents.
Has the research study been or will it be submitted to an external or internal funding agency for support?
Yes No Funding Source:
If yes, indicate which agency and attach a copy of the grant/contract application face page.
Will the procedures in this application be used for thesis, masters or dissertation research? Yes No
If yes, please list thesis or dissertation committee member names:
Planned graduation date?
List all personnel associated with this project. Indicate in “Name” who will be the Principal Investigator
Date UMBC or
Name Role Department Phone Number E-mail CITI Education
Role: Principal Investigator (PI), Faculty Advisor (FA) , Research Assistant (RA), Graduate Student (GS), Undergraduate Student(US)
Federal regulations specify that certain types of research pose no or very low risks to participants, a minimal review from the IRB is required. A
project is not exempt if such research involves:
a. Survey or interview procedures where responses are recorded in such a manner that subjects can be identified, directly or through identifiers
linked to that subject(s), the subject's responses, if they became known outside the research, could reasonably place the subject at risk of criminal
or civil liability or be damaging to the subject's financial standing or employability, or the research deals with sensitive aspects of the subject's
own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol
b. Observation (including observation by participants) of public behavior where observations are recorded in such a manner that the human subjects
can be identified, directly or through identifiers linked to the subjects, the observations recorded about the individual, if they became known
outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or
employability, and the research deals with sensitive aspects of the subject's own behavior such as illegal conduct, drug use, sexual behavior, or
use of alcohol
c. Personal records (medical, academic, etc.) will be used with identifiers and without written consent
e. Research will use pregnant women by design
f. Blood/body fluids will be drawn
g. Research which include minors (under the age of 18) as participants
A determination by the IRB that research is exempt does not absolve investigators from ensuring the rights and welfare of human participants in research activities are
protected and that the methods used to obtain consent are appropriate. By signing, the investigator(s) will abide by all UMBC IRB policies and procedures and
understand that no research activities will be conducted with human participants prior to obtaining the required approvals. The investigator(s) certify that the only
involvement of human participants in this research study will be in the exempt categories specified in this application and will inform the IRB at the earliest possible
date of any significant changes in the project with respect to human subject participation
Investigator’s Signature: ____________________________________________________ Date: _______________
Investigator’s Signature: ____________________________________________________ Date: _______________
Faculty Advisor's Signature* ____________________________________________________ Date: _______________
* I have read and reviewed this proposal and certify that it is ready for review by the IRB. I have worked with the student to prepare this
research protocol. I agree to mentor the student during the research project.
This signature page may be scanned as a PDF document and submitted to email@example.com. If that is not
possible, fax this page (and this page only) to (410) 455-3868.
Approvals of exemptions will take approximately one (1) week
IRB Action: Exemption approved ___________ Exemption not approved ___________
Approved - IRB Chair ________________________________________ Date ________________
(exempt application form) – 02/28/2011
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Federal regulations permit research activities in the following categories to be exempted from
continuing review by the IRB. Review the Exempt Category Example Chart and mark the
category or categories below which describe your research:
EDUCATIONAL RESEARCH: Research conducted in established or commonly
accepted educational settings, involving normal educational practices. This is research
that is concerned with improving educational practice and does not include variables
traditionally investigated in clinical and counseling research (self-esteem, anxiety,
aggression, withdrawal, shyness, social skills, etc.) [(§46.101(b)(1)]
EDUCATIONAL TESTS: Research involving the use of educational tests (cognitive,
diagnostic, aptitude, achievement), information taken from these sources is recorded in
such a manner that subjects cannot be identified, directly or through identifiers linked to
the subjects. [(§46.101(b)(2)]
SURVEYS, QUESTIONNAIRES, INTERVIEWS, OR OBSERVATION OF PUBLIC
BEHAVIOR: To meet this exemption, the subject matter must not involve "sensitive"
topics, such as criminal or sexual behavior, alcohol or drug use on the part of the
participants, unless they are conducted in a manner that guarantees anonymity for the
participants and informed consent cannot be reasonably obtained (such as in anonymous
SURVEYS, QUESTIONNAIRES, INTERVIEWS OR OBSERVATION OF PUBLIC
BEHAVIOR: Surveys that involve sensitive information and participants identities are
known to the researcher may still be exempt if (1) the participants are elected to
appointed public officials or candidates for public office; or (2) federal statute(s) specify
without exception that confidentiality will be maintained throughout the research and
thereafter. Otherwise, such research requires expedited status. [(§46.101(b)(3)]
ARCHIVAL RESEARCH: Research involving the collection or study of existing data,
documents, records, pathological or diagnostic specimens, if these sources are publicly
available or if the information is recorded by the investigator in such a manner that
participants cannot be identified, directly or through identifiers linked to the participants.
These data/samples must be preexisting, which means they were collected prior to the
current project. [(§46.101(b)(4)]
RESEARCH EXAMINING PUBLIC BENEFIT OR PUBLIC SERVICE PROGRAMS:
To qualify for this exemption, the research must also be conducted by or subject to
review by an authorized representative of the program in question. Exemption Category
5 is reserved for Federal Government Research and is not available for local IRB
review and is rarely applied to research at UMBC. [(§46.101(b)(5)]
TASTE EVALUATION RESEARCH: Studies of taste and food quality evaluation.
Studies of taste evaluation qualify for this exemption only if (1) wholesome foods
without additives are consumed; or (2) if a food is consumed that contains a food
ingredient at or below the level of and for a use found to be safe. [(§46.101(b)(6)]
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Anticipated Duration of Study: From to
may state “upon IRB approval”
1) Describe the research objectives:
2) Is the information obtained recorded in such a manner that you or anyone else could identify the
human participants, directly or through codes or demographic information linked to the participants?
3) Will identifiable private information be collected from other sources (e.g., medical records)?
4) Will participant data be gathered anonymously? Yes No
If not, please describe what identifiers will be used and how confidentiality will be maintained.
5) Describe the research procedures. Please include copies of questionnaires, surveys or other
measures related to the proposed project:
6) Describe who will conduct the consent process and how consent will be obtained. Although a study is
granted an exemption from IRB review, investigators are ethically bound to follow the principles listed
in the Belmont Report, particularly the first principle, respect for persons, which emphasizes the
importance of ensuring that subjects are fully informed about the nature of a research project in order to
make an informed decision to participate. The use of a signed consent document, for example in cases of
anonymous data collection, would not be required, but those participants must be informed about the
purpose of the study. An investigator will provide a participant an IRB approved information sheet or
use an oral consent script explaining the purpose of the study, how the data will used, how the data will
be kept anonymous, etc. Please attach a copy of the proposed consent document or consent script.
7) Describe the participants you plan to recruit and the criteria used in the selection process. Indicate if
there are any special inclusion or exclusion criteria. Include the expected number of participants and
age range (those under the age of 18 may not be enrolled in exempt studies):
8) Describe the plans for the recruitment of participants and how will contact be made.
9) Describe how the proposed study presents no more than minimal risk to the participants. Could any
disclosure of the human participants’ responses outside the research reasonably place the participants at
risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or
reputation? (Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those
ordinarily encountered in daily life or during the performance of routine physical or psychological examinations.)
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10) If you are requesting permission to collect or study existing data, documents, records, or biological
specimens (category #4), complete the below (see IRB guidance):
What are the types of data or specimens?
What is the source of the data or specimens?
Are the data or specimens publicly available? (That is, can the general public obtain the data or
specimens? Data are not considered publicly available if access is limited to researchers.)
If the data or specimens are not publicly available, are you required to obtain permission to access these?
Yes No If the answer is “yes,” attach a copy of the correspondence granting you permission.
If using existing datasets from faculty research how is data recorded? (i.e. in such a manner that subjects
cannot be identified, directly or through identifiers linked to the subjects.
Note: research using existing or archival does not qualify for exemption from IRB review under
category 4 if data that the investigator will receive is in an identifiable format or that will remain
identifiable in the research records.
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