Eastern Michigan University
University Human Subjects Review Committee (UHSRC)
REQUEST FOR HUMAN SUBJECTS APPROVAL
Use this form for initial approvals and major protocol modifications.
For minor changes, please use the Minor Modification Form.
To renew an approval after one year, please use the Continuing Review Form.
CHECK ONE:
Faculty/Staff
Graduate Student
Undergraduate Student
*If you are a student, your advisor must be listed on this application, review and approve
this application prior to submission, and indicate approval by providing an electronic
signature on the application package in IRBNet.
STUDENT PROJECT TYPES:
Only students check below:
Doctoral Dissertation
Master’s Thesis
Graduate Project
Undergraduate Honors Thesis
Undergraduate Project
INSTRUCTIONS
All applicants must complete sections 1-9. If you are applying for an Exemption, complete
section 10. If your study is greater than minimal risk* complete section 11.
If you have any questions, contact Sonia Chawla, the Research Compliance Officer, at
schawlaw@emich.edu.
* “minimal risk” is defined as “the risks of harm or discomfort anticipated in the proposed
research are not greater, considering probability and magnitude, than those ordinarily
encountered in daily life or during the performance of routine physical or psychological
examinations or tests.” (45 CFR 46.102 (i))
SECTION 1. INVESTIGATOR/PROJECT INFORMATION
Title of Project
Principal Investigator
Department
Phone
Email
Co-PI, if applicable
Co-PI’s email, if applicable
Does background music stay in the background?
John Smith
Psychology
734-­‐487-­‐3090
johnsmith@emich.edu
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Eastern Michigan University
University Human Subjects Review Committee (UHSRC)
REQUEST FOR HUMAN SUBJECTS APPROVAL
Students must complete the following:
Faculty Sponsor
Faculty Sponsor’s email
Program and Status/Year
Other Research Staff (Add rows to the table as necessary):
Name
Title
Affiliation (EMU or other institution)
Jane Doe
Graduate Student
EMU
Other Research Sites:
• Will the research take place at research sites (e.g., universities, hospitals, clinics, schools,
etc.) other than EMU?
Yes
No
• If yes, please list study locations and describe study activities taking place at each location:
Study Site
Activities Taking Place at Study Site
Grant Funded Projects:
Complete this table if external funding is being sought or has been obtained for this project
NIMH
Funding Source
8/1/2014
Submission Deadline
Human Subject Protection Training:
All human subject research staff must complete human subject protection training online
through the Collaborative Institutional Training Initiative (CITI) program before this application
can be approved. You can access the training at: https://www.citiprogram.org. Choose Eastern
Michigan University as your institution. Note to students: your advisor must also complete CITI
training and you must upload their CITI completion report to IRBNet.
* You must upload CITI completion reports to IRBNet for ALL study staff members.
Conflict of Interest:
• Do you or any study staff members have a potential conflict of interest for this study?
Yes
No
•
If yes, please explain who may have the conflict and describe the conflict below.
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Eastern Michigan University
University Human Subjects Review Committee (UHSRC)
REQUEST FOR HUMAN SUBJECTS APPROVAL
SECTION 2. STUDY ABSTRACT AND SUMMARY
•
In the box below, please provide an abstract/brief description of your study procedures in
non-technical terms. Please limit this description to no more than 300 words.
During the Fall 2015 semester, we plan to recruit students to take a general knowledge test.
Half the students will be randomly assigned to take the test in a room with music playing
quietly in the background and half the students will be in a room with no background music
playing. We will then compare average test performance from students in each room.
Participation should take between 45 minutes and one hour.
•
Upload to IRBNet a 1-3 page study protocol. The study protocol should include the
following:
o The purpose of your study
o A description of the consent process (include debriefing if appropriate)
o A step-by-step description of what will happen in the study
o A description of all study measures and assessments
If your study has multiple visits or multiple subject groups, please include a table explaining
what happens at each visit or to each subject group.
•
If you are using pre-existing data, complete the following:
o Provide a description of the data set to be obtained:
o Provide the source of the existing data set:
o Are the data publicly available:
Yes
No
§ If no, upload into IRBNet documented permission to use the data set.
o The data set obtained will be: (check one of the following)
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Eastern Michigan University
University Human Subjects Review Committee (UHSRC)
REQUEST FOR HUMAN SUBJECTS APPROVAL
Anonymous (i.e., no identifiers in the data, no codes linking data to
identifiers, and no elements within the data set that, when combined, could lead
to the identity of individual subjects)
Coded (i.e., subjects in the data set are identified by a unique study ID that is
linked, via a separate document, to identifiers)
Identifiable (i.e., identifiers, such as name, phone number, employer and job
title, are present in the data set)
o How and where will the data set be stored:
o What precautions will be taken to protect subject confidentiality:
SECTION 3. RISKS TO SUBJECTS
•
Describe potential risks involved in this project. Note: all research contains some element of
risk.
We do not anticipate any physical or psychological risk to students. The general knowledge test
has no bearing on their academic performance or standing at EMU.
We will have to use mild deception so that our results are not biased. We will not tell students
ahead of time that we are manipulating the background music. They will be debriefed
afterward.
•
Explain the procedures that are in place to minimize the risks described above.
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Eastern Michigan University
University Human Subjects Review Committee (UHSRC)
REQUEST FOR HUMAN SUBJECTS APPROVAL
The general knowledge test has no bearing on their standing or status at EMU.
•
If the research involves any of the following procedures, please explain in the box below
how the potential risk will be minimized:
o Deception of the participant
o Punishment of the participant
o Use of drugs or medications
o Electric shock
o Deliberate production of anxiety or stress
o Materials commonly regarded as socially unacceptable
o Use of radioisotopes
o Use of non FDA-approved chemicals
o Drawing blood
o Obtaining samples of bodily fluids
o Sexually explicit materials or questions
o Questions about drug and/or alcohol use
o Questions about illegal behaviors
o Questions about sexual orientation, sexual experience, or sexual abuse
o Physical activity, stress, or strain
o Administration of food or other FDA-approved substances
o Systematic selection or exclusion of a particular group (e.g., age, gender, ethnicity,
etc.)
o A purposeful invasion of privacy
o Disclosure of participants’ names
o Any other procedure that might place subjects at increased risk
There is mild deception because we can't tell the students that the background music, or lack
thereof, is the manipulated variable. All students will be debriefed after their individual
participation explaining the true purpose of the study. The debriefing form is included in the
IRBNet submission documents.
•
Do you think this study involves more than “minimal risk”* to subjects?
Yes
No
* “minimal risk” is defined as “the risks of harm or discomfort anticipated in the proposed
research are not greater, considering probability and magnitude, than those ordinarily
encountered in daily life or during the performance of routine physical or psychological
examinations or tests.” (45 CFR 46.102 (i))
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Eastern Michigan University
University Human Subjects Review Committee (UHSRC)
REQUEST FOR HUMAN SUBJECTS APPROVAL
•
Might participation in this research result in any appreciable negative change in the subjects
emotional state?
Yes
No
o If “Yes,” explain the nature of the change and process for assisting subjects below:
SECTION 4. BENEFITS
•
Describe any anticipated benefits to subjects. Note: benefits are measurable improvements
in health, welfare, or quality of life resulting from the research procedures. Compensation
and learning about or contributing to research are not benefits.
Subjects will not directly benefit. We hope to understand how contextual factors affect
performance.
SECTION 5. SAMPLE SIZE AND DESCRIPTION
•
How many subjects will you enroll? Note: Once subjects have provided consent, they are
considered enrolled. Please account for subject withdrawals in your enrollment total. 300
•
Do you plan on enrolling different groups of subjects or dividing/randomizing subjects into
groups?
Yes
No
o If Yes, upload a brief description or table to IRBNet explaining how many subjects
will be in each group and the randomization process, if applicable.
•
Describe below your eligibility criteria for this study. Provide a list of criteria for who will be
included in and excluded from the study.
We will enroll EMU undergraduate students who are 18 or older. Students who are not
native English speakers will not be eligible to participate because the test will be in English.
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Eastern Michigan University
University Human Subjects Review Committee (UHSRC)
REQUEST FOR HUMAN SUBJECTS APPROVAL
•
Describe the process for recruitment. How do you plan to approach and inform subjects
about your study. Note: You must upload all recruitment documents (e.g., fliers, email texts,
phone scripts, etc.) in IRBNet.
Students will be recruited through the SONA system in the Psychology department and fliers
posted on campus. All recruitment materials will clearly state that students must be 18 or
older and native English speakers to be eligible.
•
•
Do you plan to include any of the following special populations in your study:
Yes
o Under 18 years of age
o Over 65 years of age
o Pregnant women with the purpose of studying the fetus
o Prisoners or detainees
o Persons with a physical or mental disability
o Economically or educationally disadvantaged persons
o Individuals who are unable to provide their own consent
o Victims of crimes or other traumatic experiences
o Individuals in non-prison institutions (e.g., nursing homes,
halfway houses, etc.)
o Students
No
If you checked “yes” to any special population above, describe below the additional
precautions that are in place to protect their rights.
The consent form will make clear that the general knowledge test will not have any bearing
on the student's standing or transcript at EMU, that the test is for research purposes only and
has no academic purpose. The consent form will also state that participation is voluntary and
refusal to participate will not adversely affect students' standing at EMU.
•
You must upload to IRBNet all recruitment documents.
SECTION 6. INFORMED CONSENT
•
Consult the Human Subject Research website Guidance page for consent/assent
templates and assistance in creating consent/assent forms.
(http://www.emich.edu/research/compliance/human-subjects/developing.php)
•
Describe the process you will use to obtain informed consent from your subjects. Explain
how and when consent will be obtained.
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Eastern Michigan University
University Human Subjects Review Committee (UHSRC)
REQUEST FOR HUMAN SUBJECTS APPROVAL
Upon arriving to the study site, students will be given the consent form. The researcher will
discuss the consent form with the student, answer the student's questions, and ask the student to
sign the consent form once all questions have been answered.
•
Will consent be obtained from all relevant parties?
o If No, explain why not.
Yes
No
•
Will subjects physically sign a consent form?
Yes
No
o If No, you are requesting a waiver of signed consent. A waiver of signed consent can
only be granted if one of the following two conditions is met. Please check the
condition below that applies:
“The only record linking the subject and the research is the consent document”
and “the principal risk is the potential harm resulting from a breach of
confidentiality.” Each subject must individually be asked if they want documentation
linking them to the research. (45 CFR 46.117(c)(1))
“The research presents no more than minimal risk of harm to subjects” and
“involves no procedures for which written consent is normally required outside of the
research context.” (45 CFR 46.117(c)(2)) See above for the definition of “minimal
risk.”
•
If you are enrolling children (under age 18):
o Describe how you plan to obtain assent from each child
o Describe how and when you plan to obtain parental consent/permission. Note: if you
do not plan to obtain parental consent/permission, please explain below.
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Eastern Michigan University
University Human Subjects Review Committee (UHSRC)
REQUEST FOR HUMAN SUBJECTS APPROVAL
•
If you plan to use deception or if study debriefing is otherwise required:
o Describe the debriefing process below
After participation, the researcher will hand the student the debriefing form
and will discuss the form and the deception with the student. The researcher
will ask the student if, given the deception, the student still wants to
participate.
•
You must upload to IRBNet ALL consent, assent, and debriefing forms.
SECTION 7. PRIVACY AND CONFIDENTIALITY
•
Explain how you plan to protect subject privacy. Note: “privacy” refers to the individual
person and not the data. Examples include holding interviews in a private office (i.e., not the
library or Starbucks), limiting individuals involved in group activities to enrolled subjects,
and completing assessments in a private location.
The consent process and test will occur in a private room. Each student will take the test
alone. There will be no group tests or consent. Students will not write their names on the
tests.
•
Data collected will be: (check the appropriate box below)
Anonymous (i.e., no identifiers in the data, no codes linking data to identifiers,
and no elements within the data set that, when combined, could lead to the identity of
individual subjects)
Coded (i.e., subjects in the data set are identified by a unique study ID that is
linked, via a separate document, to identifiers)
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Eastern Michigan University
University Human Subjects Review Committee (UHSRC)
REQUEST FOR HUMAN SUBJECTS APPROVAL
Identifiable (i.e., identifiers, such as name, phone number, employer and job title,
are present in the data set)
•
Explain how and where data will be kept confidential and stored. Note: include special
precautions for identifiable or coded data, the medium (e.g., paper, electronic files,
audio/video tapes), and confidentiality protections (e.g., password-protected computer,
The tests will be stored in a locked filing cabinet in the principal investigator's locked
office. All electronic data will be stored in password-protected files on the principal
investigator's computer.
locked filing cabinet, etc.).
•
How will your results be disseminated? Include explanations of how you plan to protect
subject/organization confidentiality in dissemination and whether or not subjects will be
informed of study results.
We plan to publish in journals and present at conferences.
SECTION 8. COSTS/PAYMENTS
•
Describe below any costs that must be paid by subjects for research procedures.
There is no cost to participate.
•
Describe below any payments to subjects or other compensation (e.g., course credit) for
participation.
Students will receive a $10 gift card to Sweetwater's.
SECTION 9. HIPAA/FERPA
•
HIPAA
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Eastern Michigan University
University Human Subjects Review Committee (UHSRC)
REQUEST FOR HUMAN SUBJECTS APPROVAL
o Are you collecting identifiable Protected Health Information under a HIPAAcovered entity?
Yes
No
§
If Yes, you must include HIPAA Authorization language in your consent
form. Please consult Amanda Lefeld, the HIPAA Privacy Officer, at
alefeld@emich.edu or Sonia Chawla, the Research Compliance Officer, at
schawlaw@emich.edu for assistance.
o Are you collecting Protected Health Information from a HIPAA-covered entity (e.g.,
health plan, health care clearinghouse, or health care provider who bills insurers)?
Yes
No
§
•
If Yes, you must provide approval documentation from the HIPAA-covered
entity indicating that you have permission for data collection. You may also
need to include HIPAA Authorization language in your consent form.
FERPA
o Are you requesting access to EMU educational records?
Yes
No
§
If Yes, you must contact the Office of Records and Registration and submit,
with this application, documented approval for use of student records.
§
Explain below the nature of the records you plan to access and how you will
obtain permission from subjects to use their educational records for research.
o Are you requesting access to K-12 educational records?
Yes
No
§
If Yes, you must obtain both school and parent/guardian permission.
§
Explain below the nature of the records you plan to access and how you will
obtain permission from students and/or parents to use educational records for
research.
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Eastern Michigan University
University Human Subjects Review Committee (UHSRC)
REQUEST FOR HUMAN SUBJECTS APPROVAL
SECTION 10. REQUEST FOR EXEMPTION
ONLY COMPLETE THIS SECTION IF YOU ARE REQUESTING EXEMPT REVIEW.
IF YOUR STUDY DOES NOT QUALIFY FOR EXEMPT REVIEW, SKIP AHEAD TO
SECTION 11.
•
All Exempt research activities must fall into at least one of the following categories.
Check the appropriate category or categories for your research:
1. Research conducted in established or commonly accepted educational settings,
involving normal educational practices, such as (a) research on regular and special
education instructional strategies, or (b) research on the effectiveness of or the
comparison among instructional techniques, curricula, or classroom management
methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public behavior,
unless:
a. Information obtained is recorded in such a manner that human subjects can be
identified, directly or through identifiers linked to the subjects; AND
b. Any disclosure of the human subjects' responses outside the research could
reasonably place the subjects at risk of criminal or civil liability or be damaging to the
subjects' financial standing, employability, or reputation.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public behavior
that is not exempt under Criterion 2, above, if:
a. The human subjects are elected or appointed public officials or candidates for
public office; OR
b. Federal statute(s) require(s) without exception that the confidentiality of the
personally identifiable information will be maintained throughout the research and
thereafter.
4. Research involving the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens, if these sources are publicly available
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Eastern Michigan University
University Human Subjects Review Committee (UHSRC)
REQUEST FOR HUMAN SUBJECTS APPROVAL
or if the information is recorded by the investigator in such a manner that subjects cannot
be identified, directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by or subject to the
approval of department or agency heads, and which are designed to study, evaluate, or
otherwise examine:
a. Public benefit or service programs;
b. Procedures for obtaining benefits or services under those programs;
c. Possible changes in or alternatives to those programs or procedures; or
d. Possible changes in methods or levels of payment for benefits or services under
those programs.
6. Taste and food quality evaluation and consumer acceptance studies, if:
a. Wholesome foods without additives are consumed, or
b. A food is consumed that contains a food ingredient at or below the level and for a
use found to be safe, or agricultural chemical or environmental contaminant at or
below the level found to be safe, by the Food and Drug Administration or approved
by the Environmental Protection Agency or the Food Safety and Inspection Service of
the U.S. Department of Agriculture.
If your study qualifies as Exempt, you are done with this application. Upload this form
and the supplemental materials in the Protocol Submission Checklist below.
SECTION 11. DATA MONITORING
ONLY COMPLETE THIS SECTION IF YOUR STUDY IS GREATER THAN MINIMAL
RISK OR IF YOU ARE COLLECTING SENSITIVE/RISKY INFORMATION
•
Provide a plan for data monitoring. In this plan, include the following information:
o Who will review/monitor data for changes in risk to subjects
o How often data will be reviewed
o If an increase in risk is found, how will this risk be mitigated for the individual
subject and for the entire study
PROTOCOL SUBMISSION CHECKLIST
13
Eastern Michigan University
University Human Subjects Review Committee (UHSRC)
REQUEST FOR HUMAN SUBJECTS APPROVAL
All of the following documents MUST be uploaded to IRBNet with this application:
1-3 page study protocol/description
ALL recruitment materials
Consent/Assent form(s) in Microsoft Word
Copies of ALL instruments, questionnaires, interview/focus group questions
Copies of CITI completion reports for ALL investigators
Copies of permission documents from non-EMU study sites (if applicable)
Grant proposal or Sub-award Scope of Work statement (if applicable)
Thesis/Dissertation/Capstone proposal (if applicable)
STUDENTS ONLY: a copy of your signed Committee or Department Approval
Form
STUDENTS ONLY: your faculty mentor must e-sign the IRBNet submission
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