SVSU IRB APPLICATION 5/6/2014
SVSU INITIAL IRB APPLICATION
REQUEST FOR PROJECT APPROVAL (RPA)
Instructions: Completing this form (RPA) is the first step in requesting IRB review and approval for new
research projects involving human subjects. Please upload an electronic version of this application and
all research materials (consent form, surveys, interview guides, etc.) to www.irbnet.org. (For information
on how to successfully complete and submit an IRB application, go to www.svsu.edu/irb and click on
“Prepare an IRB Application.”)
NOTE TO STUDENT RESEARCHERS AND FACULTY ADVISORS:
Students should consult with Faculty Advisors and use the IRB Decision Tree to determine if projects
require IRB review. Faculty Advisors are responsible for:
 Reviewing student applications to ensure that they are complete and the research is sound.
 Signing IRB packages before submission to indicate that the application is ready for IRB review.
 Monitoring projects until completion to ensure the approved protocol is followed.
 Encouraging students to complete and upload the IRB closure form in IRBNet when projects are
completed.
Special considerations for research in Public Schools:
 Review Protection of Pupil Rights Amendment requirements at:
http://www.ed.gov/policy/gen/guid/fpco/ppra/index.html
 Submit copies of the permission to perform research from appropriate school personnel.
 Submit copies of IRB approval if the school has an IRB.
Special considerations for research at sites other than Saginaw Valley State University:
 Submit copies of the permission to perform research from administrator.
 Submit copies of IRB approval if site has an IRB.
For Federally or other funded research:
 Wait until you have been funded before submitting an IRB Application. (For sponsors requiring
Just-In-Time IRB review, please consult SVSU’s IRB manager at jadecker@svsu.edu).
 Submit documentation of funding status with this protocol application.
 Submit a complete copy of the federal grant application including face page.
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SVSU IRB APPLICATION 5/6/2014
Special considerations for research in hospitals or HIPAA covered entities:
 If using Protected Health Information (PHI) submit a statement on HIPAA PHI protocol (see
below).
Principal investigators who wish to collect data that involve personal identifiers must go through
the covered entity’s HIPAA rules to obtain data, including Authorizations, Waiver of Authorization,
Data De-identification or Limited Data Sets. Please consult with each research site and include the
necessary forms and/or permissions required with your SVSU IRB application.
Authorization: If the principal investigator will be using or collecting health information and
personal identifiers from his or her research subjects, then he or she will be obtaining informed
consent from them as well. An authorization form is required in addition to informed consent.
Waiver of Authorization: Principal Investigators may apply for a full waiver of authorization
when a signed authorization cannot be reasonably obtained, such as for emergency medical records
research, or when the principal investigator (PI) of the research study has legitimate access to the
desired medical information insofar as he or she is a staff member and/or has been granted
privileges and provides related care (i.e., related to the information desired) to the patients, or is in
the position to provide related care (including treatment, and/or diagnostic services) to the
patients.
Data De-identification: The HIPAA Privacy Rule allows principal investigators to conduct research
with health information that has been stripped of elements that could identify the research subject.
However, under HIPAA, the list of “identifiers” is extensive. The following data elements must be
stripped for HIPAA de-identification:
 Names
 Geographic subdivisions smaller than a state (i.e., no city, no zip code), except for the initial
three digits of the zip code if, according to the current publicly available data from the
Bureau of the Census, the geographic unit contains more than 20,000 people
 Any date (except year; i.e., no month or day of month)
 For subjects older than 89 years of age, specific age may not be mentioned
 Telephone number
 Fax number
 E-mail address
 Social security number
 Medical record number
 Health plan beneficiary number
 Any other account numbers
 Certificate or license numbers
 Vehicle identification number
 Medical device identification or serial number
 Personal website URL
 Internet protocol (IP) address
 Fingerprint, voiceprint, or other biometric identifiers
 Full-face photographic images
 Any other unique identifying number, characteristic, or code
What is Protected Health Information (PHI)?
 Medical Records: Medical History, Diagnosis, Treatment
 Payment Information: Bills, Receipts, EOBs
 Ancillary Services: X-Rays, Labs
 Demographic Information: (When stored and maintained with health information): Date of
Birth, Social Security Number

If necessary, submit copies of the IRB approval letter and IRB approved consent form(s) from the
participating institution(s).
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SVSU IRB APPLICATION 5/6/2014
Table of Contents
A. PROTOCOL INFORMATION
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B. CONFLICT OF INTEREST
6
C. LEVEL OF RISK/TYPE OF REVIEW REQUESTED/RECRUITMENT
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D. DATA STORAGE PROTOCOL
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E. RESEARCH PLAN
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SVSU IRB APPLICATION 5/6/2014
A. Protocol Information
Submission Type:
New Protocol
Modified Protocol (changes made before IRB approval)
Revised Protocol (changes made after IRB approval)
Reopening expired protocol
Protocol Title:
Principal Investigator:
(List one person –co-PIs should be listed under “Other
Investigators” on the next page.)
Professional Title:
College/Division:
Department:
Campus Address:
Mailing Address (Only if Off Campus):
Telephone:
E mail address (no aliases, please):Use
the same email address as IRBNet.
Preferred e-mail address for
correspondence (if applicable):
Your status:
Faculty
Staff
Graduate Student
Undergraduate Student
This research is for:
Class project
Capstone project
Undergraduate Thesis
Master’s Thesis
Doctoral Dissertation
Faculty Research
Other (please describe):
Primary contact for the protocol (if
other than the principal
investigator):Note: Faculty advisor
must be the primary contact on student
projects.
Primary Contact’s Email:
Primary Contact’s Phone:
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SVSU IRB APPLICATION 5/6/2014
Faculty Advisor:
College:
Department:
Campus Address:
Telephone:
Email address (no aliases, please):Use
same email address as IRBNet.
Other Investigators*:
List all researchers in this study that
are associated with SVSU.* Please
provide the following information for
each researcher: name, email address
(no aliases, please.)
List all researchers not associated with
SVSU.* Please provide the following
information for each researcher: name,
institution, phone number, mailing
address.
Funding Source: If research is
funded, please provide the following:
Grant name (or name of the funding
source):
Funding period (month/year):
Short summary of grant activities:
Paying Research Subjects: If you
are paying subjects using Federal,
Foundation, State or SVSU funds
(including grants), you are required to
verify rules regarding these funds.
Anticipated start and
completion dates for collecting
and analyzing data:
I am paying subjects
using Federal, Foundation,
State or SVSU funds
(including grants).
I am not paying subjects or
I am not using Federal,
Foundation, State or SVSU
funds (including grants).
Click here to enter a date. To Click here to enter a date.
* List researchers who will work directly with human subjects and/or their data. All researchers listed on the protocol must
complete the required human subjects research ethics training or provide proof of completion of comparable training at their
institution. If you have any questions about whether a researcher should be listed on the protocol or if a researcher has completed
the correct training, please contact the IRB Manger at jadecker@svsu.edu.
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SVSU IRB APPLICATION 5/6/2014
B. CONFLICT OF INTEREST (COI)
If the response to any of these questions is “YES,” please include detailed information in the text
box below. Providing details about who has the conflict of interest and why will permit the IRB to
determine if such involvement should be disclosed to potential research subjects.
Does any researcher involved in this study: (i.e., member of the study team who participates in the design, conduct, or
reporting of this research, as well as their spouse, registered domestic partner, dependents, or other members of their
household.)
a. Possess an equity interest in the publicly-traded entity that either sponsors this research or owns
Yes
No
the technology being evaluated that exceeds 5% ownership interest or a current value of $10,000?
b. Possess an equity interest in the non-publicly-traded entity that either sponsors this research or
Yes
No
owns the technology being evaluated?
c. Receive salary, consulting fees, honoria, or other payment from the entity that either sponsors this
Yes
No
research or owns the technology being evaluated that is expected to exceed $10,000 in any twelvemonth period?
d. Have rights to the intellectual property (IP) being evaluated, as either the inventor of the IP for
Yes
No
which a patent has been issued, or as the inventor of the IP that has been optioned or licensed to a
company?
e. Have a financial relationship with a Licensed Start-up Company (which is being monitored by the
Yes
No
COI Committee) that has an option or license to utilize the technology being evaluated?
f. Receive compensation of any amount when the value of the compensation would be affected by the
Yes
No
outcome of the research, such as compensation that is explicitly greater for a favorable outcome than
for an unfavorable outcome or compensation in the form of an equity interest in the entity that
either sponsors this research or owns the technology being evaluated?
Please explain any conflict of interest that exists. Upload any additional documentation in IRBNet if applicable. For
specific information, see: a) Public Health Service (PHS) 42 CFR 50 Subpart F, which applies to research funded in
whole or in part by a PHS agency (NIH, NIMH, etc.); b) National Science Foundation (NSF) please refer to NSF Grants
Policy Manual §510, which applies to institutions with more than 50 employees that receive NSF funds; and c) Food
and Drug Administration (FDA) 21 CFR 54, which applies to any party that has submitted a marketing application and
that submits the results of the study as a proposed basis for FDA approval.
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SVSU IRB APPLICATION 5/6/2014
C. LEVEL OF RISK/TYPE OF REVIEW REQUESTED/RECRUITMENT
LEVEL OF RISK/TYPE OF REVIEW REQUESTED
Indicate the level of risk:
Minimal
Greater than Minimal
Minimal risk is (From 45 CFR 46.102(i)): Non-Institutionalized Adults: Where the probability and
magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of
themselves, than those ordinarily encountered in daily life or during the performance of routine
physical or psychological examinations or tests. (e.g., the risk of drawing blood from a healthy
individual for research purposes is no greater than the risk of doing so as part of routine physical
examinations).
Institutionalized Adults/Prisoners: Risk of physical or psychological harm that is no greater in
probability and severity than that ordinarily encountered in the daily lives, or in the routine medical,
dental, or psychological examinations of healthy persons.
Does this study involve any of the following procedures:
Procedures that may risk physical/mental harm; generally regarded as socially unacceptable;
regarded as invasion of privacy; pertain to illegal conduct; individual mental health; or if released
could damage individual’s financial standing, employability, or reputation within their community.
Deception Use of Drugs Covert Observation
Induction of Mental/Physical Stress
Information related to sexual attitudes/preferences/practices
Information related to alcohol/drugs or other addictive products
Genetic information that may be linked to subjects health status
None of the Above
Please provide details on any
procedures from above and how
integral they are to your study:
Special Study Populations
(Check all that apply)
Minors (under 18 years)
Pregnant Women/Fetuses or products of labor & delivery
Prisoners
Physically or mentally challenged
Diminished capacity for consent
Other:
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SVSU IRB APPLICATION 5/6/2014
If research is greater than MINIMAL RISK, please check all procedures that apply:
Research involving materials (data, documents, records, specimens), which were collected, or will
be collected solely for non-research purposes.
Collections of data from voice, video, digital, or image recording made for research purposes.
Research on individual or group characteristics/behavior or research employing survey,
interview, oral history, focus group, or program and human factor evaluations.
Continuing review of research previously approved by the SVSU/Other IRB that was (1) closed;
(2) subjects completed all research interventions; and (3) research remains active for:
(a) long-term follow-up, (b) no new subjects have enrolled, (c) no additional risks added, and
(d) research activities are limited to data analysis.
Clinical studies of drugs and medical devices. Please Attach Explanation.
Collection of blood samples. Please Attach Explanation.
Prospective collection of biological specimens for research purposes (noninvasive means).
Collection of data through noninvasive procedures routinely employed in clinical practice
(not including xrays or microwaves).
None of the Above.
RECRUITMENT INFORMATION
Number of subjects to be enrolled at this site (SVSU): (Note that the SVSU IRB
considers a subject to be enrolled if s/he signs an informed consent document or
agrees to participate. If a higher number of subjects must be enrolled for
screening in order to hit a targeted accrual number, please indicate the higher
number.)
List all sites other than SVSU where research procedures will be performed.
If other sites were listed above, indicate the number of subjects to be enrolled at
each site.
List the principal site that will serve as the coordinating center for this study.
List the principal site that will serve as the data coordinating center for this study.
Indicate the gender of all subjects in this research study.
Indicate the age range of all subjects in this research study.
Indicate the total amount of time it will take for each subject to complete the
study.
Indicate the amount of time it will take to complete the entire study.
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Male
Other:
Female
SVSU IRB APPLICATION 5/6/2014
Yes
1.
2.
3.
4.
5.
6.
7.
8.
9.
No
D. Data Storage Protocol
N/A REQUIREMENT
Does this study involve protected health information (PHI), and/or
identifiable information from human subjects?
If you are using PHI/identifiable information, has it been de-identified by
removal of personal identifiers as required by HIPAA Privacy Regulation
/OHRP protocols? If yes, proceed to Data Storage Section below.
Is the storage location for PHI/identifiable information on a secure device
(e.g., encrypted)? If No or Uncertain, contact ITS to request assistance in
security control of data prior to approval.
Is PHI/identifiable information shared with entities external to SVSU? If
Yes, outline procedures for sharing PHI externally in the Data Storage
section below.
Access to the data is only by those who are authorized to access it and the
access is related to SVSU-approved research.
A list of those authorized users will be documented and reviewed at a
minimum annually by the data owner.
Procedures for reporting theft or loss of sensitive data or any media
containing sensitive data such as a laptop are in place and have been
communicated to the principal researcher and all others who have access
to use, store, or transport the data.
Is the de-identified research data stored on a device that meets
appropriate security controls? (For information, contact SVSU ITS at 989964-4225.)
Does the study involve the use of Office of Institutional Research (OIR) for
research support for projects that involve human subjects, including
survey work? Please see OIR policy:
http://www.svsu.edu/oir/rolespolicies/
Data Storage
Name the physical location where data will
be stored (e.g. building and room number):
Name the device where data will be stored
(e.g. M Drive, IT Server Name, My Desktop,
My Laptop, etc.):
For any personal device where data will be
stored, describe the security controls
implemented (encryption, passwords, etc.)
to protect the data.
Provide the name and contact information
of the person on the research team who is
responsible for data security.
If you are storing paper copies, CDs, DVDs
or other medium, describe the security
controls to manage access to and protect
the physical well-being of the data (e.g.
locked filing cabinets with access logs).
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SVSU IRB APPLICATION 5/6/2014
Is new software or hardware for the
storage of data needed?
If yes, has a request been submitted to the
IT Department for review of the security
controls for the new software/hardware?
Yes
No
Yes
No
Yes
No
How is data transferred/transmitted? (e.g.
If sent electronically, indicate what type of
encryption is used. If the data is on paper
forms, is it sent via campus mail? Etc.)
Describe the process to provide a secure
copy of the research data if the original
data storage or device is lost (e.g. If Drive
is backed up nightly). NOTE: Backup must
maintain same level of security as original
data.
When the study is completed, will the data
be retained?
Is the data retention required by law?
Yes
No
If so, please specify the law or statute:
If data is to be retained, how long will it be
retained? Please note that all research
records must be retained for a minimum of
three years. Please see FAQ SVSU IRB
Record Keeping.
How will the data be destroyed once it is
no longer required to be retained?
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SVSU IRB APPLICATION 5/6/2014
E. Research Plan
I. PURPOSE OF STUDY: State the purpose of this study, including the extent to which the results of the
project may contribute to existing knowledge. This should be explained in non-technical language, but should
include an indication as to how the results of the project may add to the existing literature. If you cite
literature in your responses to items in this Request for Project Approval (RPA), please also provide the full
citations/references in the space provided. Your purpose in this section is to convince IRB members that the
project can reasonably be expected to answer one or more questions of interest to others.
Purpose of the Study?
Research literature/How does the project
contribute to existing knowledge?
Citations/References?
II. RESEARCH METHODS/ANALYSIS: DESCRIBE THE DATA COLLECTION PROCEDURE(S), INCLUDING THE DESIGN OR
METHODOLOGY, OF THE PROJECT. BE SURE TO INCLUDE DESCRIPTIONS OF ALL INTERACTIONS WITH SUBJECTS. BE SURE TO
INCLUDE THE EXPECTED NUMBER OF SUBJECTS TO BE INCLUDED IN THE PROJECT. Your purpose in this section is to
provide sufficient information so that IRB members are able to judge the extent to which the data collection
procedure(s) are adequate to accomplish the purpose(s) stated in item I.
Be specific in how you (1) Describe
procedures; (2) materials/tools to collect
data; (3) Timeline of the procedures.
Describe how you will analyze data;
describe the type and procedures of
analysis, including statistics/
scientific/scholarly justification for the use
of analysis; and the anticipated use of
results.
If applicable, describe how you will debrief
the participants after completing the
research.
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SVSU IRB APPLICATION 5/6/2014
Online/Internet Survey Checklist: This checklist is intended to assist researchers plan, develop, and
implement computer/online/internet-based research protocols to protect human subjects. The checklist relies on
IRB policies and protocols for all research involving human subjects. An answer of No to any of the questions below
disqualifies your survey software system from being used for IRB approved research.
Note: SVSU’s currently approved survey software can be configured to meet all of the requirements below. Please
ensure that appropriate protocols will be followed/enacted within the software to meet the standards set below.
For assistance on survey software, please contact Instructional Technology Support at 989-964-7471.
Please check one of the boxes below:
No software is being used to carry out this study (proceed to Section III).
SVSU’s currently approved survey software is being used exclusively to carry out this study (Complete the
checklist below).
The study is using survey software other than SVSU's currently approved software (please list the name of the
software here and complete the checklist below).
Informed consent
Software provides record to the researcher that respondent consented to the survey
before the survey.
Record has a time stamp (i.e., Respondent x consented at time y on date z).
Yes
No
Yes
No
Yes
No
Yes
Yes
No
No
Yes
Yes
No
No
Yes
No
Yes
No
Secure Transmission
Information sent to and from websites/servers could be transmitted in either an
http protocol for non PHI (eg. Could be read by a third party) or https protocol for
PHI (encrypted so that it could not be read by a third party).
Survey has https encryption.
Can the survey respondent be prevented from entering data via the http protocol
instead of the https protocol (there is an error or disqualification message)?
Database Security
Researchers have access to data in database by using a username/ password.
Software company that maintains research database has protocols/agreements
preventing improper access/use of data in database.
Server Security
Whether maintained on or off site, the server that stores research data has physical
and environmental security controls.
IP Addresses
Respondent IP address is masked from researcher(s).
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SVSU IRB APPLICATION 5/6/2014
III. RECRUITMENT/RESEARCH POPULATION: DESCRIBE how subject(s) will be recruited for the
project. In the IRBNet package, include a copy of each advertising document (posters, announcements, emails
etc.) that might be used to recruit the subject(s). LIST the criteria for selection of subject(s) for this project, as
well as any criteria that might be used to exclude subject(s) from the project. Be sure to MENTION explicitly
whether or not any minors (under age 18) will be included among the subject(s). Your purpose in this section
is to enable IRB members to determine a) whether or not any protected classes of individuals are to be included
in the project, b) whether or not the risks and potential benefits of the project are fairly distributed across all
prospective subjects, and c) whether or not the prospective subjects are appropriate to the purpose(s) of the
project.
Recruitment procedure (if applicable),
including who will recruit the subjects.
List the tools that will be used to recruit
(e.g., payments, advertisements, etc.).
Remember to upload any advertisements
in the IRBNet package. Reimbursement of
subjects must adhere to IRB, SVSU, and
legal rules and policies.
Inclusion and Exclusion Criteria: What
subjects’ characteristics/attributes are
needed to be part of the study? Which
characteristics/attributes will exclude
subjects?
What is the scientific/scholarly
justification for the number, gender, race,
age, etc. of the population you will recruit
for your study?
How did you choose the source of subjects
or data for your study (e.g., Census, SVSU
Students, Medical Records, etc.)?
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SVSU IRB APPLICATION 5/6/2014
IV. INFORMED CONSENT: DESCRIBE how and where consent will be obtained and upload a copy of the
materials used to obtain consent in IRBNet. Please examine the Consent Form Checklist to ensure that the
document(s) used to obtain consent (whether a waiver of written documentation of consent is requested or
signatures are being collected) includes all necessary components. If minors are involved, be sure to include
copies of informed assent materials. Your purpose in this section is to enable IRB members to determine
whether or not these procedures meet the requirements for informed consent described in 45 CFR 46.
Who will perform the consent procedures?
How was/will the person collecting the
consent trained?
How will the researchers assess the
prospective subjects’ competence or
understanding of the procedures? Will
they be asked questions about the
procedures or encouraged to ask
questions?
Please check one:
A consent form containing the required pro forma elements (see Consent Form Checklist) has been uploaded in
the IRBNet package.
I am requesting a waiver of written documentation of consent. A consent form/consent document with the
required pro forma elements has been uploaded in the IRBNet package.
I am requesting a waiver of consent.
If you wish to request a waiver of written
documentation of consent (i.e., you do not
want subjects to have to sign a consent
form), please explain here why you believe
such a waiver should be granted and
include materials to be presented to
subjects to inform them about the project.
If you wish to obtain a waiver of consent
(i.e., you do not want subjects to know that
they are participating in research), please
explain here why you believe such a
waiver should be granted.
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SVSU IRB APPLICATION 5/6/2014
V. CONFIDENTIALITY/PRIVACY: DESCRIBE the provisions for the confidentiality of records and/or
anonymity of the subjects. Your purpose in this item is to enable IRB members to determine whether or not the
provisions are adequate to fulfill any promises of confidentiality or anonymity you may make to the subjects.
Describe the provisions for data
confidentiality, including data storage (see
Section D), coding of identity, and if
additional guidelines are guiding your
study (HIPAA, FERPA, etc.). If you are
using online survey instruments, please
state procedures.
Describe the provisions for the adequate
protection of participants’ privacy. How
will the individual’s assumption of privacy
(e.g., medical information) be protected in
terms of sharing themselves with the
research.
VI. POTENTIAL RISKS & DISCOMFORTS TO SUBJECTS/PROTECTION OF SUBJECTS:
DESCRIBE the nature and degree of all reasonably possible risks to the subject(s) who may participate in the
project. INCLUDE an assessment of the likelihood and seriousness of each of these risks. DESCRIBE all
reasonably possible risks, even if you have plans to minimize that risk or make it improbable. Your purpose
in this section is to enable IRB members to determine whether or not the potential risks to subjects are
outweighed by the potential benefits to the subjects or society at large.
Indicate the type of risk that may result
from participation in the study. Consider
all risks (See Section C). Please note that
“risk” refers to any negative experience,
including, but not limited to, physical,
psychological, social, and economic/or
legal.
Consider all risks. How likely is it that
each risk will occur? What impact would
the risks or discomforts have on the
individual?
Describe any precautions that are planned
to minimize risks, or make them
improbable, in order to protect the rights
and welfare of the individuals. If there are
no expected risks, indicate that here.
If study involves treatment, what are the
risks compared to other treatments in
terms of “STANDARD OF CARE?”
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SVSU IRB APPLICATION 5/6/2014
VII. BENEFITS: Describe the potential benefits of this investigation. Benefits refer to those gained by the
individual subject as well as those that may accrue to society in general as a result of the project. Your
purpose in this section is to further enable IRB members to determine whether or not the potential risks to
subjects are outweighed by the potential benefits to the subjects or society at large.
Indicate the type of benefit that may result
from participation in the study to the
individual subject(s). Consider all benefits,
including psychological/
emotional/learning, etc. Discuss how the
benefits will directly affect the research
subject(s) (if at all), and/or if the study is
meant to gather generalizable knowledge,
and/or provide information on a topic that
may benefit society. DO NOT OVERSTATE
THE BENEFIT TO THE SUBJECT.
VIII. RESEARCHER QUALIFICATIONS: Describe the relevant qualifications of each of the investigators
pursuant to his or her role in the project. You must attach proof that each investigator has obtained training
relevant to the protection of human research subjects from an IRB-approved training source within the past
three years. Your purpose in this section is to enable the IRB members to determine whether or not each
investigator has adequate expertise to fulfill his or her role in the project as well as to determine whether or not
each investigator has adequate expertise to protect the rights of human research subjects.
Relevant Scholarship/Research.
Coursework/Training Completed (Beyond
CITI or other human subjects research
ethics training.)
A certificate indicating the completion of SVSU approved training in human subjects research ethics is required for
the PI, co-PIs and advisors. (See www.svsu.edu/irb for required courses; training must be renewed every three
years).
Please check all that apply:
PI’s training certificate is uploaded in IRBNet.
All co-PIs have uploaded their training certificates in IRBNet.
All advisors listed on this study have uploaded their training certificates in IRBNet.
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