Human Research Review Committee
New Project Initial Review Application – Expedited or Full Board
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:
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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 regul ations,
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 standards
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.) 1000 word limit.
[insert information here]
5. Background
*
a. Provide the reviewer with a historical context for this study by describing its scientific importance in
a narrative format. Include references to reports of relevantly similar or related studies. 500 word
limit.
*
[insert information here]
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6. 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]
*
7. Review Level – EXPEDITED OR FULL BOARD
EXPEDITED CATEGORIES
For expedited review your study must be no greater than minimal risk *and* clearly fit 1 or more of the 9
expedited categories. See HRPP web portal for all review categories. http://www.gvsu.edu/hrrc/faq-the-hrrcreview-approval-process-32.htm.

a. Expedited - Study must be no greater than minimal risk. Check the expedited review
category below (#1-9) that best describes the study. Check all that apply. If you are not sure
which category applies, explain why in the text box. 100 word limit.
[insert explanation here if needed]

Category 1: Clinical studies of drugs and medical devices only when (a) research on drugs for which an
investigational new drug application is not required. Research on marketed drugs that significantly increases the risks
or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.
OR (b) research on medical devices for which (i) an investigational device exemption application is not required; or
(ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its
cleared/approved labeling.

Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from
healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed
550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; OR (b) from other
adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of
blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not
exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2
times per week.

Category 3: Prospective collection of biological specimens for research purposes by noninvasive means. Examples:
(a) hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient
care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d)
excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion
or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at
delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and
subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine
prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic
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techniques; (I) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j)
sputum collected after saline mist nebulization.


Category 4: Collection of data through noninvasive procedures (not involving general anesthesia or sedation)
routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices
are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and
effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared
medical devices for new indication.) Examples: (a) physical sensors that are applied either to the surface of the body
or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the
subjects privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging(MRI); (d)
electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity,
electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate
exercise, muscular strength testing, body composition assessment, flexibility testing where appropriate given the age,
weight, and health of the individual.

Category 5: Research involving materials (data, documents, records, or specimens) that have been collected, or will
be collected solely for nonresearch purposes (such as medical treatment or diagnosis).

Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes that are
not exempt.

Category 7: Research on individual or group characteristics or behavior (including, but not limited to,research on
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior)
or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or
quality assurance methodologies.

Category 8: Continuing review of research previously approved by the convened IRB as follows: (a) Where (i)
theresearch is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all researchrelated interventions; and (iii) the research remains active only for long-term follow-up of subjects; OR (b) Where no
subjects have been enrolled and no additional risks have been identified; OR (c) Where the remaining research
activities are limited to data analysis.

Category 9: Continuing review of research, not conducted under an investigational new drug application or
investigational device exemption where categories 2-2 through 2-8 do not apply but the IRB/HRRC has determined
and documented at a convened meeting that the research involves no greater than minimal risk and no additional
risks have been identified.
b. FULL BOARD REVIEW. Justify full board review, e.g., study is greater than minimal risk or
does not fit any of the 6 exempt or 9 expedited review categories. 300 word limit.
[insert justification here]
8. 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.
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.
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9. 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 (non­US territories; specify). Indicate whether you have an in­country co­investigator 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]
10. Participants targeted for enrollment. If vulnerable groups will be targeted for
enrollment, specify under (b). 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]

c. 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]
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11. Personally identifiable information.
*
Describe or list information to 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]
12. 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 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]
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If more volunteers are available than can be accommodated, describe your plan for selecting participants to
be enrolled. 100 word limit.
[insert information here]
13. 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]
14. Research procedures performed.
*
Use non-technical language that can be readily understood by someone outside the discipline. Address data
analysis below in Q#21. 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]
15. Type of potential harm
*
Hazard, discomfort, inconvenience, or embarrassment to study participants constituting greater than minimal
risk as experienced in routine activities of daily living. Check all that apply and indicate type, likelihood,
severity, & duration of each form of harm as reported in the relevant literature or other credible
sources.

NONE: research related procedures pose no more than the minimal risk as encountered by normal
individuals in normal daily activities and as included in routine medical exams and psychological tests.
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
PSYCHOLOGICAL HARM. Describe the type and degree of emotional upset, psychological stress, or
other related harmful effects that may affect one or more participants.

PHYSICAL HARM: Potential exists for greater than minimal risk of physical harm. Describe in detail.
Note Blood draw by venipuncture is considered minimal risk so long as subjects are (a) healthy,
non-pregnant adults weighing at least 110 pounds and (b) no more than 2 draws per week and no
more than 550 ml total drawn over 8 weeks. 250 word limit.
[insert information here]

SOCIAL or ECONOMIC HARM: Potential exists for greater than minimal risk of diminished reputation
or social standing, loss of employment or future employability, current or future health insurance
coverage, etc. Describe in detail.
[insert information here]
16. Total risk level for study participants.
*
MUST select one). Base response on your answers to Qs#11-15 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. See HRRC policies #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]
17. 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
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participating in a single, brief study is a very limited benefit. 500 word limit.
[insert information here]
18. 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]
19. Consent Process. Check all that apply.
*
Describe processes for consent (adults/proxies), assent (minors), and permission (parents/guardians) for
participants and others. Include planned adjustments for subgroups(e.g., adults vs. minors). Describe
relevant training of research personnel.
Check all that apply.

Waiver or alteration of normal consent process. Justify request here after reviewing the regulations
pertaining to consent. See HRRC Policy 820. 300 word limit.
[insert information here]

Verbal dialogue with each participant will be conducted by trained key personnel as identified above
in Q #4. Describe setting & location of dialogue and summarize personnel training in research
protections and confidentiality in text box. 200 word limit. *
[insert information here]

Incentives or compensation for participation. Describe payment plan in text box. See GVSU
Business & Finance policy on paying research subjects. 200 word limit.
[insert information here]

Mandated Reporters. If any study key personnel are mandated to report violations or perceived risks
per state law or GV unit policy, describe plan for disclosing reporting requirements to study participants
prior to enrollment here. 100 word limit.
[insert information here]

Deception. Describe and justify any intentional deception of one or more participants in text box.
Include whether de- briefing is planned that will reveal the deception to each participant. If not, justify
durable deception.100 word limit.
[insert information here]

Special accommodations. Describe and justify any accommodations planned for one or more
participants to enable their participation or retention in the study. 200 word limit.
[insert information here]
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
Non-English speakers. Describe your plan for participants without fluency in written or spoken
English. If written translations of documents or verbal interpreters will be used, include translator(s)
qualifications for assuring linguistic accuracy & cultural sensitivity, including that of the researcher(s),
as appropriate. 500 word limit.
[insert information here]
20. Consent Documentation. Check all that apply. Do not check both (a) and (b).
*
Note re: protected health information (PHI). HIPAA protections apply only to covered entities. GVSU is a
hybrid: only those GV programs that directly provide health care services to clients or who electronically
transmit medical or payment records pertaining to health care services are considered covered entities for
these purposes.

a. Waiver or alteration of consent documentation is requested and justified here. See regulations
subsection 45 CFR 46.117. 500 word limit.
[insert information here]

b. Signed forms. Note: this is a default requirement. Participant/proxy signed consent forms must be
retained and participant provided a copy. Attach consent form as a labeled appendix. (a file is
required)

c. Private health or academic information protected under HIPAA or FERPA will be collected. Provide
copy of personal authorizations used by each participant OR justify request for waiver of required
authorizations. 500 word limit.
[insert information here]

d. If using an on-line survey include standard disclaimer re: data security per vendor's terms of
agreement. See HRRC FAQs for suggested language. Include statement that respondent's
participation implies informed consent for research purposes. 200 word limit.
[insert information here]
*
21. Analytic Methodology. Check all that apply.
Describe planned analysis of information collected from participants. Check all that apply below.

Quantitative analysis. Explain how the sample size was determined to be sufficient and describe the
planned analytic methodology (statistical tests or measurements). 200 word limit.
[insert information here]

Qualitative analysis. Explain the basis for scientific merit & validity of the proposed study design
consistent with established standards. 500 word limit.
[insert information here]

Other Analysis. Explain the basis for scientific merit and validity of the proposed study using
non-quantitative, non- qualitative design and analytic methodology. 200 word limit.
[insert information here]
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22. Data security and management
*
Describe data security plan in detail. Studies that include collection of personally identifiable information should
(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]
23. 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 in the
text box. 500 word limit. (a file is required)
[insert explanation here]

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).
[insert information here]

Federal grant: DHHS, DoD, DoJ, EDUC (incl. McNair), EPA, Homeland Security, NCI, NEA,
NIH, NSF, etc. \

External grant: Other. (specify)
[insert information here]
24. 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
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document.
[insert information here]
25. 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
26. 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.
27. 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.
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