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EXPEDITED OR FULL BOARD REVIEW APPLICATION
Review Categories
EXPEDITED REVIEW: Mid‐level reviews for research activities that present minimal risk to the human subjects. Note, however, that qualifying as one of the listed procedures does NOT automatically qualify as being “minimal risk,” and you may therefore need to undergo a more in‐depth review. Projects using subjects from “vulnerable populations” usually do not qualify for Expedited Review. Additional caveats are discussed in the CITI training, and in 45 CFR 46.100, 21 CFR 56.110, and related materials. The list of activities eligible for Expedited Review follows.
Activity 1: Clinical studies of drugs and/or medical devices for which no new FDA application, approval, and/or clearance is required. Examples:
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.
Research on medical devices for which (i) an investigational device exemption application (21
CFR Part 812) is not required; or (ii) the medical device cleared/approved for marketing and
the medical device is being used in accordance with its cleared/approved labeling.
Activity 2: Collection of blood samples by finger stick, heel stick, ear stick or venipuncture, provided the activity meets the CFR‐specified criteria for subject health, frequency of collection, and amount of blood collected in a given time frame as follows:
• from healthy, non‐pregnant adults who weigh at least 110 pounds. For these participants, 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
• from other adults and children considering the age, weight, and health of the participants, the
collection procedure, the amount of blood to be collected, and the frequency with which it will
be collected. For these participants, 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.
Activity 3: Prospective collection of biological specimens for research by non‐invasive means. Examples:
Hair and nail clippings in a non‐disfiguring manner; deciduous teeth at time of exfoliation or if
routine patient care indicates a need for extraction; permanent teeth if routine patient care
indicates a need for extraction; excreta and external secretions; 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; placenta removal at delivery; amniotic fluid obtained at the
time of rupture of the membrane before or during labor; supragingival and subgingival dental
plaque and calculus, provided the collection procedure is not more invasive than routine
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prophylactic scaling of the teeth and the process is accomplished in accordance with accepted
prophylactic techniques; muscosal and skin cells collected by buccal scraping or swab, skin swab,
or mouth washings; and sputum collected after saline mist nebulization
Activity 4: Collection of routine clinical data through non‐invasive procedures typically employed in clinical practice.
NOTE: Procedures involving x‐rays or microwaves are excluded from eligibility for
Expedited Review.
Examples: 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; weighing or testing sensory acuity; magnetic resonance imaging;
electrocardiography, electroencephalograph, thermography, detection of naturally occurring
radioactivity, electroretinoraphy, ultrasound, diagnostic infrared imaging, Doppler blood flow,
and echocardiography; moderate exercise muscular strength testing, body composition
assessment, and flexibility testing where appropriate given the age, weight, and health of the
individual.
Activity 5: Research involving existing materials that were originally collected solely for non‐research purposes (e.g., medical treatment or diagnosis).
NOTE: Some research in this category may be exempt from the HHS regulations for the
protection of human participants. 45 CFR 46.101(b)(4). This listing refers only to
research that is not exempt.
Activity 6: Collection of data from voice, video, digital or image recordings.
Activity 7: Research on individual or group characteristics or behavior.
Examples: 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.
NOTE: Some research in this category may be exempt from the HHS regulations for the
protection of human participants. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only
to research that is not exempt.
Activity 8: Review of “Renewal” applications for research previously approved by the HSC, provided:
the research is permanently closed to the enrollment of new subjects, all research interventions
have been completed, and the only research activity remaining is long‐term follow‐up;
no new subjects have been enrolled and no additional risks identified; or
the remaining activities are limited to research analysis.
Activity 9: Continuing review of research, which 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.
FULL BOARD REVIEW: Any research or training project involving the use of human participants, which does not fall into an exempt or expedited review category, must be submitted for full board IRB review. Research involving more than minimal risk requires full board review.
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Population Screening Questions
Answer Key
Population Screening Questions Answer Required Yes No
Will the research include minors (under age 18)?
Will the research include prisoners?
Will the research include populations vulnerable to coercion or undue influence?
Will the research include cognitively impaired individuals?
Will the research include individuals who are legally blind or physically cannot talk or write?
Will the research include economically disadvantaged individuals?
Will the research include educationally disadvantaged individuals?
Will the research include individuals with AIDS/HIV?
Does the research include individuals who are terminally ill?
NOTE: The questions above represent a list of commonly defined ‘Vulnerable Populations.’ The Federal Regulations does not present an exhaustive list of vulnerable populations, but rather vulnerability is based upon ability to consent, risk and reward in the study, potential for coercion, and choice of subjects.
Did you answer ‘Yes’ to any of the ‘Population Screening Questions’? Yes No
If you answered YES to any of the Population Screening Questions, your application does not qualify for expedited review; it must be a full board review.
What type of review are you seeking? Answer Required Expedited Review
Full Board Review
If you answered YES to any of the Population Screening Questions, your application does not qualify for expedited review; your
application must be a full board review.
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SECTION A: General Information
OVERVIEW Answer Required
1. Title of Protocol:
2. Anticipated Start Date: Anticipated End Date:
INVESTIGATORS Answer Required
3. Principal Investigator (PI) (Please refer to the Human Subjects policy on PI Roles & Responsibilities.
Graduate Students PI’s must have a Faculty member/Administrator as a Co‐PI. Undergraduate Students
cannot be PI’s.)
Name:
Status:
Telephone:
Institutional Email:
Department:
CITI Training Number: CITI Training required prior to application submission.
CITI Training Completed: Social & Behavioral Research Biomedical Research
Roles and responsibilities in this study:
4. Co‐Investigator(s)
Name:
Status:
Telephone:
Institutional Email:
Department:
CITI Training Number: CITI Training required prior to application submission.
CITI Training Completed: Social & Behavioral Research Biomedical Research
Roles and responsibilities in this study:
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Name:
Status:
Telephone:
Institutional Email:
Department:
CITI Training Number: CITI Training required prior to application submission.
CITI Training Completed: Social & Behavioral Research Biomedical Research
Roles and responsibilities in this study:
Name:
Status:
Telephone:
Institutional Email:
Department:
CITI Training Number: CITI Training required prior to application submission.
CITI Training Completed: Social & Behavioral Research Biomedical Research
Roles and responsibilities in this study:
5. Is this proposal supported in whole or in part by a grant or contract? Answer Required
No
Yes
Sponsors Name:
PI on Grant:
Grant Title/Contract:
Project Period: From to
Office of Sponsored Programs Proposal Number:
Grant Project Summary Attached
6. Has this protocol previously been considered by Colorado Mesa University IRB? Answer Required
No
Yes
IRB Number:
Date Approved:
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SECTION B: Research Details
OVERVIEW 7. Provide a summary of the purpose of your project. Include information about the background and
rationale for the study and goal(s) of the proposed study. Use language understood by a person
unfamiliar with this area of research. Specific jargon should be avoided or explicitly explained.
Answer Required
8. What is your research question? State your hypothesis. Answer Required
9. What will you do with the results of your study (e.g. contributing to generalizable knowledge, publishing,
sharing at conference, etc.)? If this project is only for internal evaluation or to complete a class
assignment, IRB may not be required. Please contact the Office of Sponsored Programs for additional
information. Answer Required
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PARTICIPANT POPULATION 10. Provide a description of the participant population. Describe the characteristics applicable to your
research, such as gender, age ranges, ethnic background and health status.
11. Will your research involve vulnerable populations, such as children or adolescents under the age of 18,
pregnant women, prisoners or cognitively, economically, or educationally impaired participants?
(Vulnerability is based upon ability to consent, risk and reward in the study, potential for coercion, and
choice of subjects.) Answer Required
No
Yes: If yes, describe additional safeguards planned to protect the rights and welfare of this
population(s).
12. Will you be recruiting students from a class that you teach? Answer Required
No
Yes: If yes, explain why this population is necessary to the study, and how you will ensure
participants do not feel coerced to participate. Coercion is a significant concern.
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13. Will you be recruiting employees who report to you? Answer Required
No
Yes: If yes, explain why this population is necessary to the study, and how you will ensure
participants do not feel coerced to participate. Coercion is a significant concern.
14. Indicate any exclusion criteria for participants.
15. Approximately how many participants are needed to complete your study and what is your rationale for
your sample size?
RECRUITMENT 16. Describe the recruitment process. Include how, where, when and who will contact potential research
participants.
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17. Attach all applicable recruitment materials. (Check all that apply.)
Recruitment Scripts
Letter/Cover Letter
Flyers
Advertisements
Recruitment Emails
Other:
18. Are you directly emailing or mailing participants?
No
Yes: If yes, how are you obtaining emails and/or mailing addresses?
METHODS OF DATA COLLECTION 19. Attach copies of all data collection tools to be used. (Check all that apply.)
Questionnaire/Survey
Interviews (attach questions, interview script)
Observations
Focus Groups
Reviewing Medical / Education Records
Videotaping
Photographing
Audiotaping
Using Direct Quotes
Deception
Other:
20. List all biomedical procedures that apply to your research (e.g., Physical activity, Body Mass Index,
Collection of blood samples, X‐rays, Anthropomorphic evaluations, etc.):
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21. If applicable, describe the procedure being performed already for diagnostic or treatment purpose.
22. Where will the study take place? (i.e., explain where you are distributing surveys, conducting interviews,
etc.) Answer Required
23. Does your study include plans to recruit participants from or collect data at an external site? (i.e., off
Colorado Mesa University campus. For example, an elementary school, hospital, etc.) Answer Required
No
Yes: If YES, indicate the external site(s) and you must attach an acknowledgement (letter or
email) indicating you have permission to use their facility and personnel.
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24. Provide a description of the research methods for data collection that will be employed. For example,
what are participants going to do? Provide a step‐by‐step description of each procedure, including the
frequency and duration of each procedure. If analyzing existing data, describe steps taken to obtain and
analyze data. Answer Required
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INFORMED CONSENT 25. Are you requesting an alteration or waiver to any informed consent requirements, including
documentation of informed consent (signed consent)? Answer Required
No: If NO, skip to question 26.
Yes: If YES, complete the section below.
INDICATE THE TYPE OF WAIVER YOU ARE REQUESTING
I am requesting to waive the required documentation of informed consent (i.e. waive
obtaining the signature for anonymous internet‐based survey, telephone survey,
mailed survey, etc.). Check the box next to the condition that best fits your research
study.
Condition 1: The consent form is the only record linking the subject to the
research, and the principal risk would be potential harm resulting from a breach
of confidentiality. Each participant will be given the choice whether or not to
sign, OR
Condition 2: The research present no more than minimal risk and involves no
procedures where written consent is normally required outside of the research
context.
Provide a justification based on the selected condition above.
I am requesting to waive or alter the required elements of the informed consent
process.
Explain why the research involves no more than minimal risk to the participants.
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Explain why the waiver / alteration will not adversely affect the rights and
welfare of subjects.
Explain why the research could not practicably be carried out without the
waiver / alteration.
If applicable, explain how additional information will be provided to subjects.
26. Describe the consent process. Describe how, when and where the informed consent process will take
place and who will obtain informed consent. (Do not answer, “See attached consent form,” as this does
not describe the process of obtaining informed consent.)
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27. If the participants are not able to give legal consent (e.g., minors), explain how parent / guardian assent
will be secured.
28. The consent document must contain all required elements of consent. Please refer to the IRB policy on
Informed Consent Options, Processes and Documentation. (Check all that apply.)
Which of the following will you use to present the consent process? Please attach the following:
Not applicable (existing data or specimens)
Debriefing script
Informed consent – oral script, online, unsigned
Informed consent – form
Assent (Participants under 18) – form
Assent (Participants under 18) – oral script, online, unsigned
Parental permission – form
Parental permission – oral script, online, unsigned
Translated consent/assent – form(s), script(s), etc.
Other – Please explain:
29. Into what languages will these documents be translated? (A copy of the English and translated consent
documents must be submitted for IRB review.)
30. If your research involves collecting a combination of demographic data (e.g., a combination of gender,
age, race, and ethnicity) that may make a participant identifiable, you must inform the participants the
following:
“For this research project, the researchers are requesting demographic information.
Due to the make‐up of certain populations, the combined answers to these questions
may make an individual person identifiable. The researchers will make every effort to
protect your confidentiality. However, if you are uncomfortable answering any of these
questions, you may leave them blank.”
If applicable, indicate where and how participants will be informed of this.
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PRIVACY Privacy refers to persons during data collection. It is the control over the extent, timing, and
circumstances of sharing oneself (physically, behaviorally, or intellectually) with others (e.g.,
surveys are completed in the privacy of their own home; interviews will be done in a location of
their choosing where it is unlikely they will be overheard).
31. Describe the provisions to protect the privacy of the participants during the data collection procedures.
CONFIDENTIALITY Confidentiality refers to how DATA is handled after collection. It is the treatment of information
already revealed and states that there is an expectation that it will not be divulged to others in
ways that are inconsistent with the understanding of the original disclosure without permission
(e.g., data is secured on a password‐protected computer or locked file cabinet, data is de‐
identified or coded, only the researchers have access to the data).
32. Indicate how the investigator will receive and record the research data. Research related records must
be retained for at least three years after the research has been completed (per federal regulations).
(Check all that apply.)
Identifiable data not collected.
Identifiable data will be received and recorded by investigators.
Coded data received and investigators will not have access to a code key.
Coded data received and investigators will have access to a code key.
Other – Please explain:
33. Provide details as to how you plan to protect the data while on site and during travel. (e.g., from data
collection site back to data storage site). Answer Required
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34. Describe how you will maintain the data once it has been collected, including measures to protect the
identity of the participants (if applicable) and their responses. Answer Required
35. Where will you store the data? Answer Required
36. Who will have access to the data? Answer Required
37. In what format will the data be stored (e.g., paper, electronic, etc.)? Answer Required
RISKS 38. Describe all known anticipated psychological, physical, sociological, financial, and economic risk to
participants (e.g., loss of confidentiality, emotional stress or discomfort, physical injury or discomfort,
etc.). Answer Required
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39. Describe how you will minimize these risks and their impact to the participant. Answer Required
40. Describe your plan for an emergency situation. Answer Required
BENEFITS 41. Describe the potential benefits of this research to participants (if any) as well as the potential broader
benefits to society. Answer Required
INCENTIVES 42. Will participants receive compensation or other incentives (e.g., gift certificates, extra credit, etc.) to
participate in the research study? Answer Required
No
Yes: If YES, describe the incentive, including the amount and timing of payment. If offering extra
credit, an equal alternative must be provided.
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SECTION C: Reminder Checklist
1. Have you completed the correct protocol form for your research project (i.e., Exempt, Expedited or
Full Review)?
Yes No
2. Have you reviewed the protocol form to ensure that it is properly and accurately completed?
Yes No
3. Have you attached all of the required documents (e.g., consent, script, survey, etc.)?
Yes No
4. Have all Investigators completed the required CITI training?
Yes No
SECTION D: Investigator Assurance and Acknowledgement
PRINCIPAL INVESTIGATOR
1. As Principal Investigator, I understand the proposed study cannot begin until the Colorado Mesa
University IRB has provided a letter of approval. Answer Required
Yes No
2. As Principal Investigator, I understand that only I can submit the protocol application and its
associated documents. Answer Required
Yes No
3. The protocol form and all supporting documents have been proofed for typos and grammatical errors.
Answer Required
Yes No
I certify that the information I provided in the Request for IRB Review is correct and complete. I also
pledge that I will not change any of the procedures, forms, or protocols used in this study without first
seeking review and approval from the Institutional Review Board. Answer Required
_________________________________________ ___________________
Name / Signature of Principal Investigator Date
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CO-INVESTIGATOR(S) I certify that the information I provided in the Request for IRB Review is correct and complete. I also
pledge that I will not change any of the procedures, forms, or protocols used in this study without first
seeking review and approval from the Institutional Review Board.
_________________________________________ ___________________
Name / Signature of Co‐Investigator Date
_________________________________________ ___________________
Name / Signature of Co‐Investigator Date
_________________________________________ ___________________
Name / Signature of Co‐Investigator Date
OFFICIAL OFFICE USE ONLY
Date Received: Notes:
Protocol Number:
Reviewer:
Date Reviewed:
Revised: June 2019
All fields marked as ‘Answer Required’ must be completed before you can submit a protocol to the Colorado Mesa University IRB.