/ Human Subjects Research:
Exempt Certification Application / ER Application #
(admin use only)
EM from PI
EM from FA
HS Research Protocol: All research projects, involving human subjects, regardless of funding source must submit an application to the compliance office prior to the initiation of the research. Some research requires IRB review and approval and some research is exempt from complete review,
however, at Miami, the Compliance Office is the only authority that certifies the Exempt Status (ES). If your research meets the requirements (Sections D, below), you may use this application. If it does not, submit an application for IRB review.
Completed ES applications must be emailed as attachments to . If you have questions, contact the Office for the Advancement of Research and Scholarship: (513) 529-3600.
A. Personnel Information (Information):
Primary Investigator Status: Faculty Staff Graduate* Undergraduate*
PRIMARY INVESTIGATOR: / * FACULTY ADVISOR (required for student PI’s):
Name: / Name:
UniqueID (ex: smithja): / UniqueID (ex: smithja):
Department: / Department:
Phone: / (513) 529 - / Phone: / (513) 529 -
Email address: / / Email address: /
CITI Online Training (date): / Date / CITI Online Training (date): / Date
MU Application training (date): / Date / MU Appl. training (date): / Date
Note: All primary 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 3 years. Check to be sure all training is up-to-date before submitting your application: Training Completion Dates
Other project personnel who will interact with subjects or data (CO-PI’s, research assistants, etc.)
List Names and UniqueID’s (add lines as necessary)
Names

B. PROJECT INFORMATION (Info):

Project Title: / Enter Project Title
Human Subjects Research Dates: / Projected beginning date: mmm dd yy(e.g. Jan 01 09)
(and after Compliance Office approval) / Expected ending date: mmm dd yy
Funding Source: / If externally funded, enter OARS Proposal Approval Form number: / PAF ID

C. SUBJECT OF RESEARCH (Info):

Yes No / Is the data being collected primarily about a program or other entity (i.e. not about living humans) and collecting minimal demographic or personal information about the respondents ( e.g. age-class, gender, ethnicity, etc)?

D. EXEMPTION CATEGORIES (Info)

Please indicate the Exemption Category below (1-6) that applies to your research. Check each box for which the statement following it is true, including the boxes in the second column. The descriptions are not all-inclusive, see the guidance for further explanation. Note: research involving prisoners can never be exempted from IRB review. If your research involves taste or food quality, contact the compliance office for further information.

Instructions:

Select the most relevant exemption category below. You only need to select one. Provide an adequate description of your research in Section E to justify the application of this exemption to your research.

1.
(Info) / Research will be conducted in established or commonly accepted educational settings (e.g. schools, training
centers) involving normal educational practices, such asresearch on instructional strategies or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom manage-
-ment methods. The activities in which the students engage will be practices that wouldoccurin the absence of any research.
2.
(Info) / Research will involve the use of: i) educational tests (e.g. cognitive, diagnostic, aptitude, achievement), ii) survey procedures, iii) interview procedures (which includes focus groups), OR iv) observation of public behavior uninfluenced by the research.
Check the appropriate boxes below
This category can apply if:
information obtained will be recorded in such a manner that subjects could not be identified (directly or through information that could identify the subjects) OR
any disclosure of the subjects responses outside the research could not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
(Information on limitations)
this research will not include subjects less than 18 years of age.
This category (2) can be applied when subjects are <18 only when:
the researchinvolves the observation of public behavior and the researcher will not participate in the observed activity (no surveys or interviews and a teacher cannot videotape her students while teaching and qualify for exemption category 2).
3.
(Info) / This research will involve the use of educational tests (cognitive, diagnostic, aptitude, etc), survey
procedures, interviews, or observation of public behavior and is not exempt under (2) above, but
the subjects will be elected or appointed public officials or candidates for public office, OR
federal statutes require without exception that confidentiality of collected information must be maintained beyond the end of the research (e.g. course grades).
4.
(Info) / This research involves the study of existing data or specimens and:
The data is publicly available;OR
Miami researchers have never or will never have access to data with subject identifying information (original collected data may have identifiers but it must be edited before MU researchers have access and
the data must arrive on campus without identifiers to qualify).
5.
(Info) / This research will be funded or conducted at the request of, and approved by the head of a federal agency
for the purpose of studying:
A public benefit or service program, or;
Procedures for obtaining benefits or services under a program, or;
Changes in payment or alternatives to a public benefit or service program.

E. Research Description (Complete all sections. If you believe a section does not apply to your research, you must explain and justify this; Refer to the guidance document for help). (Information)

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). (Information)
Description
ii) / Consent Process: Use the space below to briefly describe the consent process that will be implemented. (Information)
Consent Process
iii) / Materials and Other Information: Use the space below to list survey or interview questions orattach the survey/interview questions (MS-Wordor PDF) in one file along with this document (2nd file) to the email
message when submitting your application. Include some response in the space below, e.g. see attached
file or indicate that this research does not involve interviews or surveys.(Information)
Materials

F. INVESTIGATOR’S ASSURANCE STATEMENT

I have read Miami University's policy concerning research involving human subjects and by signing below:

1.I agree to accept responsibility for the ethical conduct of research conducted in this project;

2.I agree to obtain approval from the Compliance Office prior to modifying any of the procedures that might affect an exempt determination;

3. I attest that the information submitted in this application is true to the best of my knowledge.

Students: send your application to your faculty advisor.

Faculty: submission by attachment using your MU email address

to 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 ______Date: mmm dd yy

Faculty Advisor Signature ______Date: mmm dd yy

Notes: (for administrative use only):

1