Human Research Review Committee
New Project Initial Review Application – Exempt
Please use this Word version of the online application if you have technical difficulties that cannot be resolved. Please do not change this
application other than as necessary to complete the application. Thank you.
Your Information
First Name:
Last Name:
Email:
Phone:
Department:
Status:
Questions marked with *are required.
1. Application Title *
2. Co-Investigator(s) (add more if necessary)
*:
First Name:
Last Name:
Email:
Phone:
Status:
New Project Application - Exempt (01/2015) – Word Version (08/2015)
1
1
3. Authorizing Official
As authorizing official for this project proposal, my signature indicates I believe all of the following are true for
this project.
o
o
o
o
o
o
The Principal Investigator has the proper qualification through a combination of experience
and training to conduct this study safely and in compliance with all applicable r egulations,
laws, and university policies.
The risks to study participants have been appropriately minimized to a reasonable level
relative to the anticipated benefits.
The design of the study and planned analysis of information collected meets the standar ds
of our discipline for scientific merit and validity.
Any deviation or violation of the approved protocol will be promptly reported to the HRRC.
Any changes to the protocol or its key personnel will be submitted to the HRRC for approval
prior to implementation.
Any harm to participants or others related to this project will be promptly reported to the
HRRC.
*
Last Name * :
Email * :
Phone* :
Position * :
Department * :
First Name :
4. Key Personnel (Key personnel are study team members who have direct interaction or intervention with
study participants or access to their personally identifiable information.)
[insert information here]
*
5. Research Goals & Objectives
Briefly describe in non-technical terms each of the following.
a. PARTIAL ABSTRACT: Explain the general purpose of the research project including specific aims &
objectives. State the research question(s) or hypotheses OR explain why it is not relevant to this study. 500
word limit. *
[insert information here]
b. For the HRRC to determine whether your project is human subjects research as defined by the federal
regulations, briefly explain how your study is designed to develop or contribute to generalizable knowledge,
i.e., the results are intended to be applicable to similar others not included in the studied population. Include a
description of your planned use of the study results. 1000 word limit.
[insert information here]
New Project Application - Exempt (01/2015) – Word Version (08/2015)
2
2
*
6. Review Level. EXEMPT Categories
Under which of the six exempt categories below does this study most clearly fit? If more than one, check all
that clearly apply.
NOTE: No research can be exempt if (a) it involves prisoners OR (b) FDA regulations and policies apply.
Whether studies are exempt from the federal regulations is determined by the HRRC. Determination does not
mean approval and information provided to participants should not indicate HRRC approval, only determination
that the study is exempt from federal regulations.

Category 1: Research conducted in established or commonly accepted educational settings, involving
normal educational practices such as: 1) research on regular and special education instructional
strategies or 2) research on the effectiveness of or the comparison among instructional techniques,
curricula or classroom management methods.

Category 2: Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public behavior UNLESS: a.
The information taken from these sources is recorded in such a manner that 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. NOTE: This exempt
category cannot be used for research involving children (i.e., in Michigan under 18 years of age),
except for use of educational tests as described in Category #1 above.

Category 3: Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement),survey procedures, interview procedures or observation of public behavior IF the human
subjects are elected or appointed public officials or candidates for public office.

Category 4: Research involving the collection or study of existing data, documents, records,
pathological specimens or diagnostic specimens, if these sources are publicly available 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.

Category 5: Research and demonstration projects which are conducted by or subject to the approval of
the DHHS and which are designed to study, evaluate or otherwise examine: 1) public benefit or service
programs; 2) procedures for obtaining benefits or services under those programs; 3) possible changes
in or alternatives to those programs or procedures; or 4) possible changes in methods or levels of
payment for benefits or services under those programs.

Category 6: Taste and good quality evaluations and consumer acceptance studies, IF wholesome foods
without additives are consumed OR if 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 FDA or approved by the EPA/USDA.
7. Study dates and duration. Check only one.
*
Indicate your target start date: Check ONE answer below indicating duration of entire study from initial
enrollment to closure.
New Project Application - Exempt (01/2015) – Word Version (08/2015)
3
3
Participant enrollment start date. If more than one location will be used, provide start dates for each location.
200 word limit
[insert date here; if more than one location, insert location and date]




1 to 6 months.
6 to 12 months.
More than 1 year.
8. Study location. Check all that apply. *
Sites where participants will be recruited and research activities will be conducted. Check all that apply.
Note: For research purposes, school buildings are not considered public spaces when school is in
session.

Private residence or other secure location. May apply to interviews, observations or use of an online
survey. If online survey, identify commercial vendor used or other method of collecting information.
Indicate whether you have read the data security and terms of agreement for the services used.
Indicate whether the planned data security includes not collecting the IP address of the respondents'
computers.100 word limit.
[insert information here]

GVSU campuses.

Greater Grand Rapids.

Four-county area (KOMA).

Michigan.

K-12 schools. Specify US state(s) where schools may be located. Indicate whether GRPS will
be included.
[insert information here]

USA outside Michigan. Specify state(s) and territories. 100 word limit
[insert information here]

Foreign (non-US territories; specify). Indicate whether you have an in-country co-investigator and
appropriate authorization to conduct the study in the planned location in response to the last question
on this form. Upload copies of permissions as separate documents to the protocol file on IRBNet. 100
word limit
[insert information here]
New Project Application - Exempt (01/2015) – Word Version (08/2015)
4
4
9. Participants targeted for enrollment. If vulnerable groups will be targeted for enrollment, specify
under inclusion/exclusion criteria. See HRRC policy #720: Assessing risk to vulnerable participants. *

Study is limited to normal adults as defined by the local jurisdiction.

If there are any inclusion or exclusion criteria, specify and justify here. Describe how eligibility will be
determined in each case, e.g. required declaration, testing, documentation, etc. 500 word limit.
[insert description here]

Some vulnerable participants will be targeted for recruitment. Describe vulnerable status and specify
approximate total number in each vulnerable group desired to have enrolled. 200 word limit.
[insert description here]
10. Personally identifiable information. *
Describe or list information be collected other than the participant's name on the consent form. Note: some
demographic clusters can be individually identifiable without names. CHECK ONLY ONE BOX

None collected OR any personally identifiable information collected will be immediately uncoupled from
all other study data collected. Resulting data set will be permanently de-identified.

All personally identifiable information collected will be permanently encrypted during collection,
transmission and storage.

At least some personally identifiable information collected will not be encrypted at some times. Explain
in detail. 500 word limit.
[insert explanation here]
11. Participant recruitment. *

Specify total study enrollment target range. If a multi-phase study indicate total enrollment target for
each phase. 100 word limit.
[insert information here]

If private (non-public) personal information is used for recruitment, describe and justify your ethical
access to the information. 200 word limit.
[insert description and justification here]
Method of contacting prospective study participants. Check all that apply.

Posting recruitment materials in public places. Describe the locations & indicate that materials are
attached as a separate document. If posting in private locations describe authorization to do so. 100
word limit.
[insert information here]

If recruitment methods include written text (e.g., letters, e-mail, phone text) or verbal (e.g., voice phone
call) to identifiable persons, include copy of text or script in box below. Indicate ethical access to
contact information. 500 word limit.
[insert information here]

If using personal contacts & their subsequent referrals (e.g. snowball, convenience, etc.), describe
New Project Application - Exempt (01/2015) – Word Version (08/2015)
5
5
initial communication method and use of referrals provided. 200 word limit.
[insert information here]

Third party contact. Describe communication and referral plan. 200 word limit.
[insert information here]
If more volunteers are available than can be accommodated, describe your plan for selecting participants to be
enrolled. 100 word limit.
[insert information here]
12. Involvement of human subject participants. Check all that apply. *

Survey or questionnaire, either paper or electronic.

Interview or focus group.

Observational study. No other study related interactions between researcher and study
participants.

Chart or record review. Participants will not be asked for consent to review their records. If records are
HIPAA or FERPA protected the justification must be explained below in question #15.

Clinical trial: any study that includes the following three components is a clinical trial. (a) prospectively
assigns participants (b) to one or more health related interventions (c) to evaluate the effects on health
related outcomes. Describe how participant assignments will be made. Indicate whether the trial will be
registered on ClinicalTrials.gov (only required if using a FDA regulated drug or device). 500 word limit.
[insert information here]

Experiment that is not a clinical trial.

Research on human specimen (tissue, fluid, etc.) using physical or virtual data. Describe method and
volume of sample material to be collected below in question #11.

Research involving use of a medication or medical device on living human participants.

Other (specify). 100 word limit.
[insert information here]
13. Research procedures performed. *
Use non-technical language that can be readily understood by someone outside the discipline. Address data
analysis. Describe study design & participant assignments, procedures & interactions. Note: avoid copying
formulas and diagrams as they lose formatting. Enter directly or attach as a separate document. If
survey/interview are used indicate they are attached as labeled appendix. If study involves an experiment
with a control group describe procedures for both groups. 2500 word limit.
[insert information here]
14. Total risk level for study participants. *
New Project Application - Exempt (01/2015) – Word Version (08/2015)
6
6
MUST select one). Base response on your answers to Qs#10-13 above. Address data security risk separately
in question #17 below.
Minimal risk is defined as research related procedures or activities with comparable likelihood & severity of
harm as found in the routine activities of daily living for normal persons including routine medical and
psychological examinations or tests.
SeeHRRCpolicies#710,720,730

Level I. (Minimal risk). Routine activities and no personal identifiers will be collected. All study
information is anonymous.

Level II. (Minimal risk). Routine activities and some personal identifiers will be collected but no other
sensitive information. Note: demographic clusters sometimes may constitute personal identifiers.

Level III. (slight increase over minimal risk of Moderate Harm). Describe risk calculation method.
Consider procedural & informational risks. Describe risk minimization plan including planned
emergency response to harm as applicable. NOTE Study data containing personal identifiers and
either (a) personal health information extracted from medical records protected by HIPAA or (b)
academic records protected by FERPA or (c) employment or criminal records are usually Level III risks.
The risk may be reduced to minimal risk by use of encryption, documented confidentiality agreements,
and other procedures. Describe in detail. 1000 word limit.
[insert information here]

Level IV. (Significant risk of harm to one or more participants). Describe risk calculation and
minimization methods including emergency response to any harm. 1000 word limit.
[insert information here]
15. Benefits. *

There are no direct benefits to participants anticipated from this study.

There is potential for direct benefit to participants or for benefits to society from the knowledge gained.
Describe in detail. Note: cash or other incentive to participate or compensation for expenses incurred
while participating are not benefits. The benefit of learning about human subjects research by
participating in a single, brief study is a very limited benefit. 500 word limit.
[insert information here]
16. Monetary costs to participants, *

None

Participants may incur some monetary costs. Specify and justify here. Include travel, parking, food, etc.
if any. Indicate if reimbursement or other compensation for these expenses is planned, and source of
that financial support.100 word limit.
[insert information here]
17. Data security and management *
Describe data security plan in detail. Studies that include collection of personally identifiable information should
New Project Application - Exempt (01/2015) – Word Version (08/2015)
7
7
(1) List all study partners and key contact info; (2) Describe data in detail, including data dictionary/variable
lists; (3) Document flow of data from start of study to end among all study partners; (4) Identify tools to protect
data for each step; (5) Include data use agreements; (6) Include retention/destruction requirements; (7)
Identify applicable security/privacy regulations; (8). List training staff will take (CITI, HIPAA, study specific, etc.)
and provide copy of data security plan to all staff. 1000 word limit.
[insert information here]
18. Funding (funded or pending notification). Must select at least ONE. *

Not funded. There are no new costs to conducting
this study.

Personal funds of the researcher.

Grant Funded. Attach as a separate document copies of the grant application and sponsor agreement,
as applicable.
If the research project is federally funded in whole or in part, describe any discordance between the two
descriptions in the grant and the protocol. If the two descriptions are not entirely consistent, explain fully.
500 word limit. (a file is required)
[insert explanation here]
Check all that apply

GVSU grant or award from a college, unit, program or department.

GVSU Research & Development grant.

GVSU Faculty Teaching & Learning Center (FTLC) grant.

GVSU Presidential grant.

GVSU Student Summer Scholar grant or award.

GVSU other grant type or source (specify):

Federal grant: DHHS, DoD, DoJ, EDUC (incl. McNair), EPA, Homeland Security, NCI, NEA,
NIH, NSF, etc.

External grant: Other (specify):
19. Conflict of Interest Statement. Check only ONE. *

I declare I have no known conflicted financial, management, academic or other interests affecting
the design, conduct or outcome of this research study.

Conflict of Interest Disclosure Statement [COI] 200 word limit. OR indicate it is attached as a
separate document.
insert information here]
New Project Application - Exempt (01/2015) – Word Version (08/2015)
8
8
20. I have the proper qualifications in training and experience to conduct this study competently
and safely for all participants. *

I agree to the above statement.

I do not agree to the above statement
21. I have the required time and materials to conduct this study in a reasonable period of time as
described above. *

I agree to the above statement.

I do not agree to the above statement.
22. Additional approvals required.
If approval from another IRB is required, indicate which one(s). If other authorizations are required, e.g. school
principal, employment supervisor or institution, etc. Indicate whether additional approval(s) have been granted
or are still pending and when they are expected to be available. NOTE: Not having needed approvals on hand
at the time of HRRC review application will not delay the approval of the study, but the approved start date of
enrolling participants in the study will be contingent upon having the additional approvals in the protocol file on
IRBNet. If additional materials are appended to the file, please list them here, e.g. consent, assent, permission
forms, procedures description, survey instruments, diagnostic tools, professional credentials as appropriate,
external investigator agreements, CITI documentation, etc. 500 word limit.
[insert information here]
Note: The Human Research Protections Program conducts random and for cause audits of approved studies.
Failure to comply with any component of the Statement of Compliance may result in study closure by the
HRRC.
New Project Application - Exempt (01/2015) – Word Version (08/2015)
9
9