2014 EXPEDITED APPLICATION
University of Central Missouri Human Subjects
Warrensburg, MO 64093
researchreview@ucmo.edu
Application: New: ☐
Renewal: ☐
Title of Research Study:
Investigator Name:
Status (faculty, student, etc):
UCM 700#:
University Email:
Phone Number:
Co-Investigators:
Faculty Advisor and Department:
☐ By checking this box, I am providing my electronic signature confirming that I have reviewed the application
with my advisor and we believe that it is scientifically sound. My advisor has an electronic copy of the application
as submitted. My advisor has agreed to:
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Oversee this research by communicating regularly with me;
Assist with the resolution of any problems or concerns encountered during the research;
Assure my research complies with Human Subjects Regulations in the Code of Federal Regulations
Assure that the UCM IRB is notified in the event of an adverse event or protocol deviation.
Failure to work with your advisor as described above will be considered a breach of professional ethics which falls
under the academic honesty policy. The consequences of violating standards of academic honesty are extremely
serious, costly and may result in the loss of academic and career opportunities.
The UCM IRB offers an expedited review for research protocols that satisfies the following conditions:
A. Does the project fall into one of the categories that qualify for expedited review? Please see the list of
Expedited Review Categories on the website.
B.
☐ Yes, Category #
☐ No (requires full review)
C. The research does not involve children, minors, or incarcerated individuals.
Check the appropriate boxes below to indicate characteristics of your potential subjects.
Minors (under age 18)*
Pregnant
Women Childbearing Age
Institutionalized
Cognitively Impaired
Low Income
Ethnic/Racial Minority
Elderly (over age 65)
Updated October 2014
Not Included
May be Included
Targeted
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2014 EXPEDITED APPLICATION
University of Central Missouri Human Subjects
Warrensburg, MO 64093
researchreview@ucmo.edu
C. Does this study meet the definition of minimal risk as defined below?
☐ Yes
☐ No (STOP - A full review is required. Please contact the IRB for additional assistance)
The research does not pose more than a minimal risk to the research participants, where minimal risk is defined as
follows:
“A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not
greater, in and of themselves, than those encountered in daily life or during the performance of routine physical or
psychological examinations or tests.”1
A summary of your project including the following information is needed to determine expedited status:
1. Purpose of Your Project:
a. What are you trying to find out?
b. In 500 words or less, summarize the review of literature. (If this is a replication of a previous study, what
is the benefit? Please do not include your thesis proposal. )
2. Selection of Subjects:
(Ensure that the responses on this section match the consent form)
a. Describe demographic characteristics
b. What are the selection criteria?
c. Number of subjects
d. Time frame that the subjects should expect to participate (e.g. two hours or two sessions of two hours)
e. Explain the procedure to be used to recruit and select research subjects
f. Include a copy of the flyer or exact wording used in emails, texts or verbally
g. Describe any compensation for participation
3. Procedure for obtaining informed consent:
a. Who will obtain the consent
b. Where will this be done
c. When will this be done
d. Include the consent form from the templates on the website. (If you are asking for a modified consent or
waiver of consent, a justification of this must be supplied.)
4.
Data Collection:
a. Describe where the data will be collected
b. Include written permission to collect data at that site. (A template to request written permission is on the
website.)
c. Attach all:
i. Questionnaires or surveys
ii. Interview schedules
iii. Flowcharts, etc.
5. Research Procedures and Risk to Subjects:
a. What will the subject be asked to do?
1
OPRR Guidelines, Chapter 1, p. 1.
Updated October 2014
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2014 EXPEDITED APPLICATION
University of Central Missouri Human Subjects
Warrensburg, MO 64093
researchreview@ucmo.edu
b.
Risks/Benefit Assessment
i. Risk involved:
☐ Economic
☐ Legal
☐ Physical
ii. Describe the level of risk:
☐ Minimal*
☐ Greater than Minimal Risk
☐ Psychological
☐ Social
☐ None
*Note: Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are
not greater in and of themselves that those ordinarily encountered in daily life or during the performance of routine
or physical or psychological examinations or tests.
c.
Does the study design minimize the risks?
☐ Yes
☐ No
Note: Risks to subjects are minimized: 1) by using procedures which are consistent with sound research design and
which do not unnecessarily expose subjects to risk or 2) whenever appropriate, by using procedures already being
performed on the subjects for diagnostic or treatment purposes.
If No, address the conditions for approval:
i. Benefits to the subject?
☐ Direct
☐ Indirect
☐ Both
☐ None
ii. Are there societal benefits?
☐ Yes
☐ No
iii. Are the risks to subjects reasonable in relation to direct anticipated benefits (if any) to subjects,
and the importance of the knowledge that may reasonably be expected to result?
☐ Yes
☐ No
Note: Consider physical, psychological, social, legal and economic risks. Is the research likely to achieve its
proposed aims? Is the importance of the aims clear? In evaluating risks and benefits, the IRB should consider
only those risks and benefits that may result from the research as distinguished from risks and benefits of
therapies subjects would receive even if not participating in the research (for example, the possible effects of
the research on public policy) as among those research risks that fall with purview of its responsibility.
d. Describe any compensation for harm to research subjects:
☐ Economic
☐ Psychological
☐ Legal
☐ Social
☐ Physical
☐ None
Updated October 2014
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2014 EXPEDITED APPLICATION
University of Central Missouri Human Subjects
Warrensburg, MO 64093
researchreview@ucmo.edu
6. Consent and Data Management Plan:
a. Describe the specific data that will be recorded.
b. How will the consent and data be secured?
☐ Locked in a cabinet or office
☐ Password secured PC, thumb drive or laptop
☐ Encrypted when transmitted
☐ Other - explain:
c. Does this data pose more than minimal risk?
☐ No
☐ Yes
If yes, describe how you will monitor the data to ensure the safety of subjects
d. Method of destruction of consent and data:
☐ Erase from computer, audio tapes and/or videos
☐ Shred paper documents
☐ Other - explain:
7. Privacy of Subjects: (On the consent form, the privacy description must match this response.)
a. Explain how privacy will be assured or why the subjects would not be at risk if their identity were
accidentally disclosed.
Data collection is:
☐ Anonymous – no direct contact with subject or identity
☐ Confidential – direct contact with subject or identity
Data analysis is:
☐ Anonymous or De-identified
☐ Coded (with link to identify)
☐ Identified
8. Funded Research
a. ☐ Yes
b. ☐ No
If yes, address financial conflict of interest and congruence with grant application
i. Is there a completed FCIO on record in the Office of Sponsored Programs?
1. ☐ Yes
2. ☐ No
ii. Identify any external funders of the study.
iii. Provide copy of grant application
Updated October 2014
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2014 EXPEDITED APPLICATION
University of Central Missouri Human Subjects
Warrensburg, MO 64093
researchreview@ucmo.edu
http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm
Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an
Expedited Review Procedure1
Research Categories
(1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed
drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible
for expedited review.)
(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the
medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
(2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in
an 8 week period and collection may not occur more frequently than 2 times per week; or
(b) from other adults and children2, considering the age, weight, and health of the subjects, the collection procedure, the amount of
blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser
of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
(3) Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care
indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external
secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or
wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of
rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection
procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with
accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j)
sputum collected after saline mist nebulization.
(4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in
clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be
cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally
eligible for expedited review, including studies of cleared medical devices for new indications.)
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant
amounts of energy into the subject or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance
imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity,
electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular
strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the
individual.
(5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch
purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be
exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to
research that is not exempt.)
(6) Collection of data from voice, video, digital, or image recordings made for research purposes.
(7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception,
cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or
research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or
quality assurance methodologies.
(8) Continuing review of research previously approved by the convened IRB as follows:
(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related
interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
(b) where no subjects have been enrolled and no additional risks have been identified; or
(c) where the remaining research activities are limited to data analysis.
(9) Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where
categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no
greater than minimal risk and no additional risks have been identified.
Updated October 2014
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2014 EXPEDITED APPLICATION
University of Central Missouri Human Subjects
Warrensburg, MO 64093
researchreview@ucmo.edu
Updated October 2014
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