North Park University
Institutional Review Board
Institutional Review Board Application
We will NOT accept handwritten and/or incomplete forms (Use 10 to 12 point font throughout application). The
contents of this application and supporting documents will be kept confidential within the limits of the law.
Unless specific approval is given otherwise, all applicants must complete the information on THIS form. Do not
retype the application.
I.
TITLE OF STUDY:
II. PRINCIPAL INVESTIGATOR
Name:
Title:
Mailing Address:
This address is
Home
Work Phone:
Specialty Program:
Work
Home Phone:
E-mail Address:
III. COMMITTEE CHAIRPERSON/Faculty Representative (if Student application)
Name:
Title:
Mailing Address/Mail code (Employer or Home):
Work phone:
E-mail Address:
IV. PROJECTED DATES OF RESEARCH (Subject Recruitment, Data Collection, Data Analyses):
Start Date:
End Date:
V. REVIEW TYPE:
a. NPU IRB Review
Exempt
Expedited
Full (Convened) Review
b.
Other IRB Review #1
Exempt
Expedited
Full (Convened) Review
Other IRB Review #2
Exempt
Expedited
Full (Convened) Review
Other IRB Review #3
Exempt
Expedited
Full (Convened) Review
VI. LOCAL LAWS
If the investigator is not going to submit an application to another IRB, and lives outside the state of Illinois, he/she must
ensure that components of the study comply with local State Laws relating to Human Subject Protections. If applicable,
the investigator must list local state laws that apply to the study, and explain how they have been incorporated for
compliance. If no state laws apply to the study, please indicate this. If you are not submitting to another IRB, do not
leave this section blank.
NPU IRB Application Form (12/11)
Page 1 of 9
VII. OVERVIEW
1. Existing Data: Will this study involve the use of existing data, documents, records, and pathological specimens?
No
Yes
If yes, include a letter of authorization to access data if not publicly available.
Fill in as applicable if you will be recruiting human subjects
2. Subjects to be Recruited (check all that apply)
a.
Adults (18+ years)
b.
Children and Minors (under 18 years)
c.
Cognitively Impaired Persons
d.
Prisoner
e.
Elderly/Aged Persons
f.
Minorities
g.
Others (describe)
3. Data will include… (Check all variables included)
a.
Names of people
h.
Income
b.
Addresses
i.
Student ID #
c.
Phone numbers
j.
Job title
d.
Age
k.
Names of employers
e.
Gender
l.
Types of employers
f.
Ethnicity
m.
Other information
g.
Marital status
Specify
4. Are codes used to link data to the subject?
Yes
No
5. Is Compensation Offered?
Yes
No
7. Does this study involve participants who are not fluent in English
Yes
No
8. Does this Study involve:
a. An intervention or a manipulation?
b. Deception?
Yes
Yes
No
No
6. Number of Subjects:
9. Is this research: Therapeutic?
Non-therapeutic?
Therapeutic research includes study of the efficacy of a therapeutic or diagnostic assessment method when the
intervention is not designed solely to enhance the well being of the participant who is seeking a health benefit
Non-therapeutic research has no likelihood or intent of producing a diagnostic, preventive, or therapeutic benefit to the
participant.
10. Multi-center study: Will multiple institutions participate in this study?
11. Potential Risk Exposure:
Physical
Psychological
12. Instruments
a.
Standardized tests
b.
Questionnaire
c.
Interview
d.
Other (specify)
e.
Other (specify)
f.
Internet
g.
Other
Economic
Recorded by
a.
Written notes/notes
b.
Audiotape
c.
Videotape
d.
Photograph/film
e.
Standard mail
Legal
Yes
No
Social
Administered
Findings used for….
a.
In person (group)
a.
Dissertation, Thesis
b.
In person (individual) b.
Publication
c.
Telephone
c.
Needs assessment
d.
Electronic mail
d.
Evaluation
e.
Other (specify)
Please check all documents that apply to your study. Please submit each document separately in your proposal.
IRB Application/Proposal Outline
Investigator’s Assurance & Confidentiality Agreement
Instruments (questionnaires, interview guide, tests)
Recruitment Materials (flyers, advertisement copy)
Certificate of Exemption Form
Consent/Assent form(s)
Consent to Participate as a Research Subject (Adults)
Parental Permission/Informed Consent (Parent of Minor/Child)
Assent to Participate–Subjects under 18 Years (children/minors)
NPU IRB Application Form (12/11)
Authorization (letter) from other IRB(s)
A full copy of approved application, consent
forms, other documents submitted to other IRBs
Authorization from participating institutions
Institutional HIPAA Clearance forms
Grant Proposal (cover page and narrative)
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VIII.
GRANT OR CONTRACT INFORMATION
List each proposed and funded grant or contract relevant to this application. For Center or Program project grants, list PI
and Title for each separate project or core. Add sheets if necessary.
If none, check here, and leave the rest blank.
A. Type of Proposal:
Research
Contract
Other, specify:
Fellowship
Training grant
Subcontract
B. Name of principal investigator
C. Name of Funding Agency
D. Agency’s number (if assigned):
E. Title of Proposal:
F. Inclusive dates: from
G. Status:
New
through
Competing renewal
NPU IRB Application Form (12/11)
Non-competing renewal
Page 3 of 9
IX. IRB PROPOSAL OUTLINE
To ensure that the Institutional Review Board Committee receives the information needed to conduct a complete review of
your protocol, please respond to items A-0 listed below as appropriate.
Note: Use SINGLE LINE spacing. Type in your answers in the gray box below each section. (If you cut and
paste from other documents, please make sure your formatting is consistent.) Do NOT submit a dissertation,
master’s thesis or grant proposal in lieu of the IRB Proposal Outline. If this is a funded study, submit the cover
page and narrative of your proposal to IRB Proposal Outline.
A. STUDY ABSTRACT. This is a one-paragraph summary of the protocol that includes a brief description of the study,
purpose, methods, potential risks, and risk management procedures in lay language.
B. BACKGROUND AND PURPOSE OF RESEARCH
1. Briefly (1/2 page maximum) discuss relevant background information and literature reviewed to provide the
rationale for the proposed research. Please cite references in text, as appropriate, to justify background and
hypothesis[es] (include bibliography at the end of the IRB Proposal). State the relevance of this research to and
potential for contribution to the field of study.
2. State the purpose(s) of this study. Specify aims and what question(s) and/or hypotheses this activity is designed
to answer.
C. SUBJECTS
1. How many subjects will you need to complete this study?
Number
Age range
2. Explain how you will achieve equitable subject representation in the following categories. If not applicable, justify
exclusions. If no exclusion will be made, please indicate this. (I.e. no potential subjects will be excluded due to
socioeconomic status.)
a. Age (minors, elderly):
b. Gender:
c. Ethnic and racial minority populations:
d. Socioeconomic status:
3. What characteristics (inclusion criteria) must subjects have to be in this study? (Answer for each subject group, if
different)?
4. What characteristics (exclusion criteria) would exclude subjects who are otherwise eligible from this study?
(Answer for each subject group, if different)
5. Recruitment Source. Identify the location from which subjects will be recruited (e.g., schools, university campus,
fitness facilities, hospitals, etc.). Submit a letter from each institution/organization involved indicating
support of the institution’s involvement in this protocol as separate document(s) in your IRBNET Study
Manager. Such letters must be on the facility’s letterhead and contain the assurance statement that the agency
will “abide by and comply with RMUoHP IRB requirements for the protection of human subjects.”
6. Recruitment Methods. Describe how subjects will be identified and recruited. If subjects are identified from
private or student records, provide documentation that authorizes your access to those records (HIPAA or FERPA
forms). The official holder of the record must make initial contact of subjects identified through records to initiate
NPU IRB Application Form (12/11)
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involvement in the research protocol. Please submit advertisements, flyers, contact letters, telephone
contact protocols/scripts, web site template, or other recruitment materials proposed for use in subject
recruitment as separate documents through IRBNet Study Manager.
7. Informed Consent Process. Describe recruitment procedures to ensure voluntary participation. Explain who will
make initial contact with the potential subject to take part in the study and how the research will be introduced to
the subject. Include the process used to introduce the informed consent document and procedures used by the
investigator to assess the potential subject’s understanding of the research (i.e., purpose of the study, risks,
benefits confidentiality, investigator’s telephone number to call for questions, etc.). Submit the informed consent
document(s) used to obtain and document consents. This will be done to protect the subjects’ privacy. Please
submit letters of cooperation from agencies, institutions, or others involved in subject recruitment as
separate documents through IRBNet Study Manager.
8. Study Location. Identify the location and describe the setting of where the subjects will participate in this research
(i.e., where will the study procedures be carried out?). Address any special considerations associated with data
collection at the location. For example, if subjects are school children, identify whether class time is used or if
children are participating outside of classroom time (address nonparticipating students, supervision of non
participants, procedures used to pull out children/subjects during class time, etc.). Please submit copies of IRB
approvals or letters of cooperation from non-RMUoHP research sites, if necessary as separate
documents through IRBNet Study Manager.
9. Potential problems. Address any potential problems involving subject identification, recruitment or data collection.
D. RESEARCH DESIGN AND METHODS
1. Research Design. Provide a complete description of
a) the research design
b) sequence and timing of all study procedures that will be performed to test the hypotheses
c) the tasks the subject will be asked to complete. (These tasks and the amount of time needed should be
reflected, in lay language, in the consent form)
d)
the amount of time that the subject will be involved in each aspect of the study (pilot study, intervention, followup).
e) investigational, experimental, or special procedures involving subjects (medical devices, electrical equipment,
etc.).
Please cite references, as appropriate. Submit a study flow sheet if available.
2. Tests, Questionnaires, and Interview Guides. The RMUoHP IRB is required to review all research instruments
such as surveys, questionnaires, etc. Please submit all interview schedules and survey instruments as
separate documents through IRBNet Study Manager. You may submit draft versions of study instruments for
review; however, the IRB must review the final instruments prior to approving the use of those instruments for
data collection.
NPU IRB Application Form (12/11)
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3. Would subjects undergo these or similar procedures (medical, psychological, educational, etc.) if they were not
taking part in this research?
No If “No,” describe how the study procedures differ from what subjects would otherwise undergo.
Yes If “Yes” describe under what circumstances the subject would undergo similar procedures.
E. DECEPTION OR INCOMPLETE DISCLOSURE.
If any deception or withholding of complete information is required for this study, fully explain why this is necessary
and attach a protocol explaining, if, how, when, and by whom subjects will be debriefed. Provide justification for the
inclusion of deception and possible alternatives to the use of deception in this research.
(Check here if no deception )
F. RISKS AND BENEFITS.
1. Identification of Risk. Describe nature and degree of risk of potential injury, stress, discomfort, invasion of
privacy, and other side effects from all study procedures, drugs and devices (standard and experimental),
interviews and questionnaires. Include psychosocial risks as well as physiological risks. Include risks of
withholding standard care or procedures if this is the case. If some risks are rare but dangerous, you must
describe them and indicate that they are rare. Do not reference the consent form.
2. Management of Risk. Explain what steps you will take to minimize risks of harm and to protect subjects’ rights
and welfare. If you will include protected groups of subjects (minors, fetuses in utero, prisoners, pregnant women,
decisionally impaired or economically or educationally disadvantaged subjects) please identify the group(s) and
answer this question for each group.
3. Is it possible that you will discover a subject’s previously unknown condition (disease, suicidal intentions, genetic
No
Yes. If “Yes,” explain how you will handle
predisposition, etc.) as a result of the study procedures?
this situation.
4. Describe the anticipated benefits of this research for individual subjects in each subject group. If none, state
“None.” Do not include compensation or incentives offered to subjects as a “benefit” to be gained from the
research.
5. Describe the anticipated benefits for society, and explain how the benefits outweigh the risks.
G. ADVERSE EVENTS OR EFFECTS
1. Who will handle adverse effects?
Investigator
Referral or Other, explain:
2. Are your facilities and equipment adequate to handle possible adverse events?
If “No”, explain:
Yes
No.
3. Who will be financially responsible for treatment of physical injuries resulting from study procedures? (Check all
that apply)
Investigator
Study Sponsor
Subject or subject’s insurer
NPU IRB Application Form (12/11)
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Veterans Affairs
Other, explain:
H. CONFIDENTIALITY OF RESEARCH DATA
1. Will you record any direct subject identifiers (names; Social Security numbers; patient, hospital, laboratory or
No
Yes.
claim numbers; addresses; telephone numbers; email addresses; locator information; etc.)
If “Yes,” explain why it is necessary and specifically describe the coding system you will use to protect against
disclosure.
2. Will you retain a link between study code numbers and direct identifiers after the data collection is complete?
No
Yes. If “Yes,” explain why this is necessary and for how long you will keep this link. If appropriate,
please specify that any master file containing the subject identifiers to numeric codes will be stored in a separate
locked file.
3. Describe
a.
How you will protect data against disclosure to the public or to other researchers or non-researchers.
(For example, subjects’ names will not be recorded on any information or reported in any scientific paper or
professional meeting to protect subject identity. All data will be reported in aggregate, if used at a professional
meeting or in a scientific journal, so that no one can identify any information about a specific subject.)
b.
Explain who (other than members of the research team) will have access to the data (e.g., sponsors,
advisers, government agencies, etc.)
c.
How you will destroy the data at the end of the study. In general, it is RMUoHP IRB policy to store
hard copy data for 7 years in a locked file in the investigator’s workplace for seven (7) years, then shred all
hard copy data and shred/erase all videotape data.
4. Will you place a copy of the consent form or other study information in the subject’s medical or other personal
No
Yes. If “Yes,” explain why this is necessary.
record?
5. Do you anticipate using any data (information, specimens, etc.) from this study for other studies in the future?
No
Yes. If “Yes,” explain and include this information in the consent form.
I.
COSTS. Describe the costs that the subject may incur as a result of participation (charges for tests, travel, etc.).
J. COMPENSATION AND INCENTIVES
1. Will you give subjects gifts, payments, services without charge, or extra course credit?
No
Yes. If “Yes,”
provide details of this compensation. For example, describe whether the subject is compensated by the number
and type of procedures performed, the amount of time involved, or for each sample collected. Indicate whether
compensation is made with a check, cash or gift certificate and whether a prorated amount is available should the
subject discontinue participation. Provide the estimated value of the incentive. Discuss how the value of the
incentive offered was determined.
2. Will any of the subjects or their third-party payers be charged for any study procedures?
If “Yes,” explain:
NPU IRB Application Form (12/11)
No
Yes.
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K. CONFLICT OF INTEREST
The RMUoHP IRB considers the investigator’s financial interests when evaluating the protection of human subjects. If
a financial interest is reported, the RMUoHP IRB Committee will assess the investigator’s objectivity in communicating
risks, selecting subjects, promoting informed consent, and gathering, analyzing, and reporting data. The RMUoHP
IRB Committee may also review disclosures where a financial interest is reported.
1. Does any member of the research team have a significant financial interest in the research or its products or in
No
Yes. If “No”, but if you own/direct a medical/physical
the study sponsor according to RMUoHP policy?
therapy clinic, a letter stating that there is no significant financial interest in the research or its products in the
study should be submitted to the IRB with the application. If “Yes,” within your protocol, identify whether you
(including your spouse or dependent child) or any person affiliated with any entity that is providing funds for or
which has rights to intellectual property resulting from this study. Please explain in detail any financial interest
involved (a letter stating the nature of the financial interest may be requested by the IRB):
L. ADDITIONAL INFORMATION
1. Will you need access to subjects’ medical, academic, or other personal records for screening purposes or during
this study?
No
Yes. If “Yes,” specify types of records, what information you will take from the records, how will you
use them, and how HIPAA and/or FERPA guidelines have been followed.
2. Will you make audio-visual, tape recordings, or photographs of subjects?
No
Yes. If “Yes,” explain what
type of recordings you will make, how long you will keep them, and if anyone other than the members of the
research team will be able to see them.
3. Will your study involve use of equipment involving energy input to the subjects (NCS, MRI, Ultrasound, etc.) or
No
Yes. If “Yes,” attach documentation that all
muscle/nerve measurements (EKG, EMG, etc.)?
equipment will be tested regularly by the manufacturer or describe safety testing procedures you will use. Please
also specify how much how much energy the subjects will receive per measure.
M. DRUGS, SUBTANCES, AND DEVICES
1. List all non-investigational drugs or other substances used to conduct this research (analgesics, anesthetics,
drugs used to treat side effects, etc.)
Not applicable
Yes. If “Yes,” include products used for standard
clinical care (e.g. standard gels for ultrasound or wound care) if they are used in this study for research purposes.
Name
Source
Dose
How Administered
2. List all investigational new drugs or other investigational substances to be used in the study. .)
Not applicable
Yes. If “Yes,” include marketed products used “off-label” (different formulation, dose,
route of administration, or indication). Submit through IRBNet Study manager:
• one copy of a concise summary of information about the drug prepared by the investigator
(including animal and human toxicity data, studies done in animals and humans to date);
• one copy of the Investigator’s Brochure;
• one copy of the study protocol
• Important Note: you must register an IND with the appropriate institutional pharmacy before
using the drug in research
NPU IRB Application Form (12/11)
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Name
Source
Dose
How
Administered
IND Number
Phase of Testing
3. List all investigational devices you will use.
Not applicable
Yes. If “Yes,” provide the information requested
below and submit one copy of the company protocol. If there is not Investigational Device Exemption (IDE), explain
why. Include a statement as why the device qualifies as non-significant risk. Submit a copy of the FDA letter(s)
which states the device classification (PMA, 510K, Class I, II, or III, or custom device) and categorization (Category A
or B). “Category A” means that Medicare may not be billed for the device or for services related to its use. “Category
B” means that Medicare may be billed for services related to its uses if the U.S. Health Care Finance Administration
(HCFA) grants authorization. Important Note: Register IDE devices with the appropriate Manager of Surgical
Support services or the Business Manager of Surgical Services to obtain authorization for use.
• Name of Device:
• Name of the Manufacturer:
• Description of its purpose and how you will use it in this study:
• Descriptions of previous studies in humans and animals:
• Investigational Device Exemption (IDE) number or FDA status.
N. INVESTIGATOR EXPERIENCE.
Provide a brief summary of the investigator’s relevant research experience/training (Do NOT include a vitae). Also
include a summary of the committee member who is supervising the research.
O. CONSENT FORMS
Written (Submit all consent and assent forms for each subject group. Include a footer identifying the version, date
of each form and a header or title that identifies each different form.) If the study involves participants who are
not fluent in English, please submit an English consent form and the translation in the appropriate
language.
Oral (Submit written scripts of oral consent and assent for each subject group.)
Waiver (Submit written justification for waiver of consent per 45 CFR 46.116(d) –see Web site NIH)
Not applicable, study does not involve obtaining consent from subjects.
NPU IRB Application Form (12/11)
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