Human Subjects Research:
Application for Level 1
Screening and Approval
Protocol #
e
(MU admin use only)
HS Research Protocol: All research projects, involving human subjects, regardless of funding source must submit an application to
the Research Ethics and Integrity Office (MREI) and obtain approval from the appropriate authority prior to the initiation of the
research. Some research requires IRB review and approval (Level 2) and some research will be deemed to qualify for exemption
from review (Level 1).
Completed applications should be emailed as attachments to [email protected]. Questions about methods or the
status of an application may also be sent to this email address.
A. Personnel Information (online help):
PRIMARY CONTACT (Corresponding Researcher):
* Faculty Advisor (required for Student PC’s):
Name:
Name:
Department:
Department:
Phone:
Phone:
Email address:
Email address:
CITI Online Training (date):
Date
CITI Online Training (date):
Date
MU Application training (date):
Date
MU Appl. training (date):
Date
Primary Contact Status:
Undergraduate Student
Graduate Student
Faculty/Staff
Other Personnel: persons who will interact with subjects or data that include explicit or implicit identifiers
must be listed on a Personnel Form submitted with the application.
Note: All investigators and personnel that will be in contact with subjects or data that can be linked to subjects must complete initial online
human subjects research training and then refresher training every three years. Please check to be sure all training is up-to-date before
submitting your application: Training Completion Dates
B. Project Information (online help):
Application Title:
Your Research Project Title:
Human Subjects Research Dates:
Specific title for the activites associated with this activity.
Optional (This is for your records to link the protocol to a research project or grant).
Anticipated projected beginning date: mmm dd yy (e.g. 1 Jan 17)
(and after MREI approval)
Funding Sources if Federal, State,
or otherwise external to MU:
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C. RESEARCH OVERVIEW (online help):
All subjects from whom data will be collected or consent obtained will be over 18 years of age:
Yes
No The research activities of the subjects < 18 will occur in a normal classroom environment and involve normal
classroom curriculum (i.e. research metrics include analysis of data that would be produced in the absence of
research, e.g. test scores etc.)
If “No” Above
Yes (required to be normal curriculum)
Note: If you cannot check “Yes” to either of the above descriptors, then you should be using the Level 2 application form.
Data Collection Methods Research activities include:
Survey Instruments (online or paper where the researcher does not have direct
interactions with subjects)
Interviews (in person, online, and or by phone)
Observations of public behavior
Materials collected as part of the normal life of the subject (e.g. standardized test scores)
Data is publicly available (does not require a data use agreement with owner).
Miami researchers have never or will never have access to ALL data with subject identifying
information (original data may have identifiers when collected outside of Miami but it must
be provided to Miami researchers without identifiers).
Data is about:
Personal facts about or experiences of the subject (beyond simple demographics).
Effectiveness of a program or course.
Factual information about a program, institution, or agency.
Opinions about an institution (e.g. employer, school)
Opinions about an issue (e.g. politics).
Confidentiality:
Participation will include direct identifiers or identity could be readily deduced (if so,
use of this form requires that the information collected pose a minimal risk to subjects).
Data includes information that is protected through other regulations (FERPA, HIPPA).
Participation will be anonymous without potential identification (e.g. an online survey
where the IP address for a computer/lab could not easily be linked to subject identity and
insufficient demographic information that could be linked to identity)
Information will be recorded confidentially in such a manner that subjects could not
be identified (directly or through information that could identify the subjects). e.g. an
interview will be conducted but notes will not include identity and the interview will not
be audio/video recorded.
Data may reasonably include personal or opinion information that if accessed by
anyone outside the research team could be a source of harm or embarrassment to the
subject (whether it is meant to be anonymous or confidential).
Risk:
Disclosure of the subjects responses outside the research team might place the subjects
at risk of criminal or civil liability or be damaging to the subjects’ social or financial standing,
employability, or reputation. This includes disclosure to peers and family.
If checked, data security should be addressed in section D(i) below.
Disclosure of the subjects responses outside the research team reasonably would not
place the subjects at risk of criminal or civil liability or be damaging to the subjects’ social or
financial standing, employability, or reputation. This includes disclosure to peers and family.
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D. Research Description (Complete all sections. If you believe a section does not apply to your research, you must
explain and justify this or reference an attachment; Refer to the guidance document for help). (online help)
i)
Purpose, Population and Methods: Use the space below to briefly describe the purpose, nature of the
research, e methods to be used, and describe the subject population (demographics and approximate number
of subjects). If necessary for more complex projects, descriptions can be expanded upon in appendices.
General Research question/objectives (online help):
Brief Description (<1000 characters)
Research Subject Population (online help):
Description: e.g. target age range and breakdown, particular vulnerabilities (<800 characters).
Estimated/Target number of subjects
Research Methods (online help):
Brief description of data collection methods (<1000 characters).
Confidentiality/security methods:
Brief description of data security methods (<1000 characters).
ii) Consent Process: Use the space below to briefly describe the consent process that will be implemented. It is most
expedient to compose a draft of your consent form and attach it to your application submission message or copypaste it here.
Invitation content and method (s): e.g. social media posting text, in-person script, etc. (online help)
Brief Description (<1000 characters)
Consent Presentation: i.e. how consent information will be presented to the potential subject/parents. (online help)
Brief Description (<1000 characters)
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Consent Information (online help and sample templates):
Replace with Consent Information or reference to consent form in appendices
iii) Appendices: Use the space below to indicate the materials/documents that are included in the application.
Please name the files in the order they are referenced in the description above or combine them into a single
document (e.g. pdf, Word, or RTF) to submit as an attachment to the application message.
(online help)
Additional Personnel Form
Invitations
Consent Form(s) or Information Sheets – subject or parental consent
Assent (Forms) or Information Sheets – for subjects < 18 years of age
Survey Questions (for online surveys, we prefer to have questions, not screen shots of webpages)
Baseline Interview questions to include demographics recorded (whether in person, online, or by phone)
Other (list)
List of other documents
E. INVESTIGATOR’S ASSURANCE STATEMENT
1. I agree to accept responsibility for the ethical conduct of research conducted in this project;
2. I agree to obtain approval from the Miami Research Ethics and Integrity Office prior to
significantly modifying any of the procedures;
3. I attest that the information submitted in this application is true to the best of my knowledge.
Students listed as the PC must send their applications and appendices to their
faculty advisor for the project using their institutional email account. The faculty
advisor will endorse and send the application to [email protected]
using your institutional email account. Use of your institutional email account
serves as your signature and pledge to abide by the conditions stated above. This
cover page document should be sent in it’s current format (Word Doc), no original
signatures are required
Primary Investigator Signature
Staff Advisor Signature
(Submitting by MU email serves as your signature) _______ Date: mmm dd yy
(Submitting by MU email serves as your signature) _____ _ Date: mmm dd yy
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