Download A. Clinical studies of drugs and medical devices only when condition

IRB#
Institutional Review Board
Protocol Review Form for Research Involving Human Subjects
INCOMPLETE SUBMISSIONS WILL BE RETURNED. TYPE ALL ENTRIES. (see suggestions at end)
PRINCIPAL INVESTIGATOR:
DEPARTMENT/HOSP AFFILIATION:
ADDRESS:
PHONE:
FAX:
PAGER:
E-MAIL:
AHC Coinvestigator (if non-affiliate PI):
SUB-INVESTIGATOR(S):
DEPARTMENT/ AFFILIATION:
REGULATORY COORDINATOR
(contact name and address if not the PI):
E-MAIL:
Phone
Fax
STUDY TITLE:
REVIEW REQUESTED (chircle one)
RESEARCH
DATES:
Full
Expedited
To
Full Study From:
(MM/YY)
Exempt
Check if Rapid Response? ($500+)
One Subject’s
Maximum Time:
(Hours, Days,
Weeks, Months)
SPONSOR / FUNDING SUPPORT:
RESEARCH CONTRACT ATTACHED:
Or
Yes
Not applicable
PROTOCOL ORIGINATOR:
STREET ADDRESS:
CITY, STATE ZIP:
CONTACT PERSON FOR ABOVE:
$2500 IRB FEE (Attach one of)
PHONE:
Check
Billing/transfer arrangements
Waiver Request
Please read the following statements and acknowledge by signing below:
 I certify that the protocol and method of obtaining informed consent as approved by the Advocate Health Care
Institutional Review Board (AHCIRB) will be followed during the period covered by this research protocol. Any future
changes will be submitted for AHCIRB review and approval prior to implementation. All protocol approvals must be
renewed per the schedule asserted in the initial approval notice sent to the principal investigator.
 I accept full responsibility for the ethical and scientific conduct of this research and assure that all applicable
regulations, by-laws, policies and procedures of Advocate Health Care relative to the protection of human subjects
involved in this research will be followed.
 All sponsored research contracts /budgets are being submitted to the AHC VP for Research (847.384.3621).
The documented billing plan (DBP) required for every research project conducted at Advocate is being submitted to
the Research Compliance Officer (630.990.5519)
Principal Investigator (signature)
AHCIRB Application 08/31/09
Date
Submit with any Full Protocol in triplicate – Questions: 847.384.3534
1
IRB# __________
INSTITUTIONAL ENDORSEMENTS:
(office use only)
Your endorsement is required to assure the Advocate health Care Institutional Review Board (AHCIRB) that you have
reviewed this research protocol and approve it for submission, that the investigator(s) are qualified by training, credentials and
experience to conduct the proposed human subject research and that this protocol will be supported by your department(s) and
local, institutional resources if it is approved by the AHCIRB.

PI’s Departmental Chair (signature)
Date
Print Name, Title, Department and Institution

Local Oversight Committee Chair
Date
Print Name, Title and Institution of Local Oversight Committee Chair

Institutional Biosafety Committee Chair (If applicable)
Date
Print Name, Title, Department and Institution

Support Department Head (If applicable)
Date
Print Name, Title, Department and Institution

Support Department Head (If applicable)
Date
Print Name, Title, Department and Institution
(below for office use only)
Primary Reviewer
Date
Signature below indicates the proposed research has been approved as ethically and scientifically sound and is
appropriate to be conducted at Advocate.
Chair, AHCIRB or designee
Date
Print Name, IRB Title
AHCIRB Application – IRB-09/07/11.doc
Submit with any Full Protocol in triplicate – Questions: 847.384.3534
2
INSTITUTIONAL ENDORSEMENTS – Additional Advocate Sites:
(duplicate as necessary for additional sites)
IRB# __________
(office use only)
Your endorsement is required to assure the Advocate Health Care Institutional Review Board (AHCIRB) that you have
reviewed this research protocol and approve it for submission, that the investigator(s) are qualified by training, credentials and
experience to conduct the proposed human subject research and that this protocol will be supported by your department(s) and
local, institutional resources if it is approved by the AHCIRB.

Site Departmental Chair (signature)
Date
Print Name, Title, Department and Institution

Local Oversight Committee Chair
Date
Print Name, Title and Institution of Local Oversight Committee Chair

Institutional Biosafety Committee Chair (If applicable)
Date
Print Name, Title, Department and Institution

Site Support Department Head (If applicable)
Date
Print Name, Title, Department and Institution

Site Departmental Chair (signature)
Date
Print Name, Title, Department and Institution

Local Oversight Committee Chair
Date
Print Name, Title and Institution of Local Oversight Committee Chair

Institutional Biosafety Committee Chair (If applicable)
Date
Print Name, Title, Department and Institution

Site Support Department Head (If applicable)
Date
Print Name, Title, Department and Institution
AHCIRB Application – IRB-09/07/11.doc
Submit with any Full Protocol in triplicate – Questions: 847.384.3534
3
I. RESEARCH PROTOCOL DESCRIPTION
A. The proposed research activity requires a (check as appropriate):
- if applying for Exempt review, go to Page 5.
____
__
1. FULL REVIEW – RESEARCH PRESENTING POSSIBLE RISK TO SUBJECTS
- if full review is required, check here and continue on Page 6
2. EXPEDITED REVIEW – RESEARCH PRESENTING MINIMAL RISK TO
SUBJECTS as defined by the entries below
- check among (A – G) all that apply then continue on Pg 6
The proposed research entails minimal risk and the only involvement of human subjects will be
in one or more of the following categories (check as needed):
A. Clinical studies of drugs and medical devices only when condition (1) or (2) is met.
____
(1) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not
required. (Note: Research on marketed drugs that significantly increase the risks or decrease the
acceptability of the risks associated with the use of the product is not eligible for expedited review).
(2) Research on medical devices for which (a) an investigational device exemption application (21 CFR
____
Part 812) is not required; or (b) the medical device is cleared/approved for marketing and the medical
device is being used in accordance with its cleared/approved labeling.
B. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
____
(1) 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;
____
(2) 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.
C. Prospective collection of biological specimens for research purposes by noninvasive means.
Examples include:
____
(1) hair and nail clippings in a non-disfiguring manner;
____
(2) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
permanent teeth if routine patient care indicates a need for extraction; 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
techniques;
____
(3) excreta and external secretions (including sweat); 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;
AHCIRB Application – IRB-09/07/11.doc
Submit with any Full Protocol in triplicate – Questions: 847.384.3534
4
____
(4) placenta removed at delivery; amniotic fluid obtained at the time of rupture of the membrane prior to
or during labor;
____
(5) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; sputum
collected after saline mist nebulization.
D. 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 Indications). Examples include:
____
(1) 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 subject’s privacy;
____
(2) weighing or testing sensory acuity;
____
(3) magnetic resonance imaging;
____
(4) electrocardiography, electroencephalography, thermography, detection of naturally occurring
radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and
echocardiography;
____
(5) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing
where appropriate given the age, weight, and health of the individual.
___
____
____
E. 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). (NOTE: Some research in this category may be exempt from the HHS
regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers
only to research that is not exempt.)
F. Collection of data from voice, video, digital, or image recordings made for research
purposes.
G. 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. (NOTE: Some research in this category may be exempt from the HHS
regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This
listing refers only to research that is not exempt.)
AHCIRB Application – IRB-09/07/11.doc
Submit with any Full Protocol in triplicate – Questions: 847.384.3534
5
____
3. EXEMPT REVIEW - RESEARCH PRESENTING NO RISK TO SUBJECTS.
as defined by the entries below (A – F) – check all that apply
and then continue on next page
____
A. Research conducted in established or commonly accepted educational settings, in
accordance with normal educational practices, e.g. i) research on regular and special
education strategies or, ii) research on the effectiveness of or the comparison among
instructional techniques, curricula or classroom management techniques.
B. Research involving the use of educational tests (cognitive, diagnostic, aptitude,
____
achievement), survey procedures, interview procedures or observation of public behavior
unless: i) information obtained is recorded in such a manner that subjects can be identified,
either directly or through identifiers linked to the subject, and ii) any disclosure of subject’s
responses outside the research could reasonably place the subject at risk of criminal or civil
liability or be damaging to the subjects financial standing, employability or reputation.
C. Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement) survey procedures, interview procedures, or observation of public behavior
that is not exempt under above (b.ii), if I) subjects are elected or appointed officials or
candidates for public office, or ii) federal statutes require without exception that the
confidentiality of personally identifiable information will be maintained throughout the
research and thereafter.
____
D. Research involving the collection or study of existing data, documents, records, pathological
specimens or diagnostic specimens if the information is recorded by the investigator in such
a way that subjects cannot be identified either directly or through identifiers linked to the
subjects.
____
E. Research and demonstration projects which are conducted by or subject to the approval of
the appropriate federal official and which are designed to study, evaluate, or otherwise
examine: i) public benefit or service programs, ii) procedures for obtaining benefits or
services under those programs, iii) possible changes or alternatives to those programs or
procedures or iv) possible changes in methods or levels or payment for benefits or services
under those programs.
____
F.
____
Taste and food quality evaluation and consumer acceptance studies i) if wholesome foods
without additives are consumed ii) 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 or
the Food Safety and Inspection Service of the USDA.
Note: Studies approved as Exempt by the IRB may still require a Waiver of Authorization (a HIPAA waiver) to
access private health information (PHI). Self-report surveys will require a brief consent statement at the
beginning asserting that participation is voluntary and that the data (survey form) are to be submitted
anonymously. If the responses are to be matched up later with clinical or outcomes data (thus making
anonymity impossible), the investigator should secure a patient signature on AHC PHI Authorization
form. Retrospective chart review studies will require a PHI waiver. Both forms are available on this
website or from the IRB office.
AHCIRB Application – IRB-09/07/11.doc
Submit with any Full Protocol in triplicate – Questions: 847.384.3534
6
I. B.
1. This research involves the use of an INVESTIGATIONAL DRUG(S):
(A new drug, new combination of drugs, or new uses for an approved drug, chemicals
or biological agents.)
No
Yes
If yes, specify on a separate sheet any known restrictions or concerns:
Drug Name:
Company:
Address:
IND Number:
Gene therapy protocols: Has NIH/OBA approval via the FDA been received?
No
Yes
Phase:
1
2
3
4
Which applies?
New drug
New combination of drugs
New dosage
New use for an approved drug
2. This research involves the use of an INVESTIGATIONAL MEDICAL DEVICE:
No
Yes
If yes, specify on a separate sheet any known restrictions or concerns:
Will device in question, or any part of it, be custom built?
No
Yes
Does this research involve a novel use for this device?
No
Yes
Is this a “significant risk” device as defined by FDA regulations?
No
Yes
Device Name:
Company:
Address:
IDE Number:
3. This research involves the use of RADIATION or RADIOISOTOPE THERAPIES:
No
Yes
4. HUMAN SUBJECTS from the following population(s) will be involved in this study
(enter estimated numbers for all that apply or check None):
Pregnant Women
Minors (<18)
Hospitalized Patients
Fetuses
Dementia afflicted
Students, Residents, Interns
Employees of any Advocate
related facility or practice
Abortuses
Prisoners
Mentally Ill or Disturbed
None of the above
5. TOTAL NUMBER OF SUBJECTS to be studied:
At Advocate site(s)
AHCIRB Application – IRB-09/07/11.doc
At all site(s) nationally
Submit with any Full Protocol in triplicate – Questions: 847.384.3534
7
II. ABSTRACT (Brief description of purpose, methods and expectations in 200 words or less).
AHCIRB Application – IRB-09/07/11.doc
Submit with any Full Protocol in triplicate – Questions: 847.384.3534
8
For sections III through XIX, insert and number additional pages as needed. Label each section with the relevant
title and section number.
III.
INTRODUCTION/LITERATURE REVIEW: Describe the rationale and relevant background
for the proposal, citing published studies. Insert additional pages as necessary.
AHCIRB Application – IRB-09/07/11.doc
Submit with any Full Protocol in triplicate – Questions: 847.384.3534
9
IV.
SUMMARY OF METHODS: Description of study design including: population to be sampled,
method(s) of subject selection and assignment, sample size determination (power),
exclusion and inclusion criteria, rationale for exclusion of specific subject populations,
treatments, procedures, measurements, and data analyses (statistical methodology) that
are planned. Include questionnaires, surveys and other instruments that will be employed.
Insert additional pages as necessary.
AHCIRB Application – IRB-09/07/11.doc
Submit with any Full Protocol in triplicate – Questions: 847.384.3534
10
V.
BENEFITS: Describe the benefits to the individual and/or mankind.
VI.
RISKS: Describe the risks to the subject and the precautions that will be taken to minimize
them. Note that the concept of risk goes beyond physical risk and includes psychological,
social and financial risk(s).
VII. ALTERNATIVE THERAPY: Describe any alternative therapy (ies) available to the subject.
VIII. CONFIDENTIALITY OF DATA: Describe the methods to be used to ensure the confidentiality of data
obtained. Include plans for final disposition or destruction of written or computer files, audio and/or video
tapes if applicable; debriefing procedures, etc. If any Private Health Information (PHI) is to be collected,
whether as part of a chart review or prospectively, even if the PHI is used only to match records and then
deleted from the analysis dataset (eg. Time 1 and Time 2 measures or in-patient and out-patient data),
either a HIPAA Authorization or a Request to Waive HIPAA should accompany your IRB submission.
Both forms are available from the IRB office. Truly anonymous datasets, typically surveys ruled Exempt
by the IRB, may not require a HIPAA form of any kind. Inquire if you are unsure about the need for
either form.
IX.
RESEARCH BUDGET: For each item below, list and describe: 1. the expenses to be incurred by this
project and, 2. the sources of revenue, supplies or services to be used to cover them.
a. Materials, medications and/or devices
b. Outline the direct labor costs (professional, technical, secretarial) of the project
c. Support services such as office supplies, photostats, telephone, computer hardware or software, travel and
any ancillary expenses…. To what extent will the hospital be requested to provide these items?
d. Estimate the per patient expenses for participation in this research. Distinguish routine care (eg. tests,
procedures) that would be received by similar, non-research patients, from expenses attributable to the
requirements of the research. For each, list the expected source(s) of revenue to cover patient costs.
A final, signed, sponsor budget page may be attached to elaborate this item (if used, number appropriate
sections as item(s) IX.{a},{b},{c} or {d}).
AHCIRB Application – IRB-09/07/11.doc
Submit with any Full Protocol in triplicate – Questions: 847.384.3534
11
Complete for commercially sponsored or supported studies only!!!
IRB# ______________
(office use only)
X. RESEARCH PERSONNEL CONFLICT OF INTEREST DISCLOSURE STATEMENT:
A separate copy of this form is to be completed and signed by each investigator and co-investigator as well as by each
staff or research team member involved in recruitment, subject consent or any aspect of the proposed research. Per the
Advocate Health Care Conflict of Interest Policy, “immediate family” refers to any spouse, child, parent, grandparent, brother,
sister, cousin, uncle, aunt, niece, nephew, grandchild or in-law.
The Advocate Health Care Institutional Review Board (AHCIRB) agrees to treat as confidential all information revealed
below and in any referenced attachments. The investigator acknowledges and agrees that AHCIRB will disclose any such
information only as required by law and/or relevant Federal regulations pertaining to its charter and mandated
responsibilities.
1. Do you or any member of your immediate family have any financial interest, including but not limited to royalties and
patent rights, or other ownership interests, in the results of the research or in the research drug and/or device or article?
Yes ___ No ___
2. Does any relationship exist between yourself, your employer or professional corporation and the Sponsor, other
investigators, service providers or other interested parties involved in the proposed research for which disclosure is
required under the Advocate Health Care Conflict of Interest Policy?
Yes ___ No ___
If Yes to either of the above, provide additional details as to the nature of the interest(s) or relationship(s) and any
measures taken or planned to minimize or eliminate any sources of potential bias.
3. Is any commercial entity participating in the proposed research, as either sponsor of the research or as provider of drugs,
devices, reagents, test kits, etc?
Yes ___ No ___
If Yes to1, 2 or 3 above, complete item 4 below.
4. Do you or any member of your immediate family receive or anticipate receiving financial support, gifts or reimbursement
of any kind (cash, services, equipment, stock or stock options), in excess of $100 value, directly or indirectly, from the
research Sponsor or producer of the study article (such as a device, drug, reagent, test kit, etc.), its parent or affiliate
corporations or from any intermediary with which the Sponsor has contracted, such as a Contract Research Organization
(CRO)?
Yes ___ No ___
If Yes, complete the following:
a. Is payment made directly to you?
b. Is payment made to an entity in which you, or any member of your immediate family
have an ownership, consultancy, employment or other beneficial interest?
(Examples: a CRO or similar entity; a Professional Services Corporation)
c. Do you or any member of your immediate family have any one of the following with
respect to the Sponsor or, if applicable, the CRO?
i. significant equity or membership interest in the company, its parent or affiliates?
ii. an interest as a paid consultant or speaker (including stock options or other
financial interests whose value cannot be readily determined through reference
to public prices, or publicly traded stock that exceeds $25,000 in value)?
iii. an interest as a member of the company’s management or its board?
Yes ___ No ___
Yes ___ No ___
Yes ___ No ___
Yes ___ No ___
Yes ___ No ___
If Yes to any of a, b, or c, please provide additional details including disclosure of the payment amount
and if capitated, the amount per screened, enrolled and/or completed subject.
During the time of the proposed research, if approved, and for one year after its completion, I agree to promptly notify the
AHCIRB in writing of any change to the information above or in any referenced attachments.
According to the best of my knowledge and belief, I certify that the above information and relevant attachments are accurate
and complete.
_____________________________________
Signature
_____________________
Date
_________________________________________________________________________
(Print name and role within the proposed research)
AHCIRB Application – IRB-09/07/11.doc
Submit with any Full Protocol in triplicate – Questions: 847.384.3534
12
XI. CONSENT: Attach a copy of the consent form to be signed by the subject (or parent, guardian) and/or any
statements(s) to be read to the subject, or informational letter(s)/pamphlets to be directed to the subject.
Include a copy of a letter of assent to be used with minors. Advocate template and consent guidelines
available from the same sources as this document.
XII. HUMAN RESEARCH QUALIFICATIONS: All researchers and their staff (co-investigators, all
those involved in study direct patient care, the consent process or confidential data access) must
demonstrate that they are familiar with the laws and ethical standards governing the
responsible conduct of research. Attach evidence documenting completion of the NIH / NCI web
based ethics tutorial (a certificate is printed upon completion) which is titled ‘Human Participant Protections
for Research Teams’) or similar evidence of formal training in research ethics offered by a qualified
educational institution or sponsored by a professional organization, or other similar evidence.
The web site for the NCI course and credential is located at the NCI site (cme.cancer.gov), then follow the
Clinical Trials link and choose Education. The topic is titled “Protecting Human Research Participants.”
The complete url is:
http://phrp.nihtraining.com
All credentials attached ___
Credentials are already on file ___
XIII. PROCESS OF CONSENT / CONFIDENTIAL DATA ACCESS: List below who will obtain consent or
handle any research data containing PHI. The process of informed consent should be structured without
any element of coercion or undue influence so as to be conducive to rational and thoughtful decision
making by the subject and/or the subject’s legally authorized representative. Type entries.
Only individuals who are listed in the section below will be authorized to obtain consent or handle Private
Health Information within the context of this research study.
Name
Role within this Study
XIV.
Will subjects receive any compensation, reward or reimbursement before, during or after the study?
No ___
Yes ___
If Yes, how much and in what form? (Cash, taxi fares, medical care, meals, gifts, etc.)
If Yes, describe pro rata method of payment, if any, for early withdrawal from the study.
XV.
Those procedures, if any, that are not a part of routine patient care will be subsidized by:
Patient/Patient’s Insurer
Department
Grant (eg, NIH, NCI)
Hospital
Corporation (pharmaceutical)
Other
If Other, describe:
AHCIRB Application – IRB-09/07/11.doc
Submit with any Full Protocol in triplicate – Questions: 847.384.3534
13
XVI.
ABBREVIATIONS: Include on a separate page a complete alphabetic listing of all acronyms and
abbreviations employed in the proposal along with definitions and commonly understood synonyms or
alternative phrasings.
AHCIRB Application – IRB-09/07/11.doc
Submit with any Full Protocol in triplicate – Questions: 847.384.3534
14
XVII. METHODS OF RECRUITMENT (where applicable):
Advertisements/Flyers *
Informational Letter/Pamphlets *
Website ad or form *
Records (Medical, school, employment, etc.)
Other – describe:
Clinical Practice
Physician Referral
Registry/Bank
* If you intend to use any print advertising or public announcement aimed at potential subjects, include a copy of any
such advertisement, announcement or patient brochures for AHCIRB review and approval.
XVIII. RESOURCES OR SUPPORT DEPARTMENTS:
Identify Advocate Health Care Hospital(s) and system resources needed to successfully complete this
research; Identify Advocate sites from which subjects will be recruited or data will be acquired – check all
applicable. Note: If any services (eg. Nursing, Respiratory Care, Physical Therapy, etc.) are expected to
provide MORE THAN standard of care support in order to fulfill the requirements of this protocol,
appropriate sign-offs should be acquired before submitting to the IRB (pgs 2 & 3 as needed).
Data or Need support from or need to inform, educate or train; check as appropriate
AHC
Subjects
Sites
From Laboratory Nursing Pharmacy Radiology Nutrition Oth 1
Oth 2 Oth 3
Bethany
Christ.
Good Sam.
Good Shep.
Home Hlth.
Hope Child.
LGH
LGH Child.
Masonic
South Sub.
Trinity
Site A
Site B
Site C
Site D
Site E
Site A, B, etc. might be specific Advocate Health Centers, Advocate Medical Group or specific Dreyer practice sites,
home visit services, etc. List all sites at which subjects may be involved in this research. Other 1, 2, etc. refer to
other system resources such as Cath Lab, GI Lab, etc.
Complete as needed:
Other 1 refers to:
Other 2 refers to:
Other 3 refers to:
Site A is:
Site B Is:
Site C is:
Site D is:
Site E is:
XIX. ADDITIONAL INFORMATION which may be useful to the reviewers – attach.
AHCIRB Application – IRB-09/07/11.doc
Submit with any Full Protocol in triplicate – Questions: 847.384.3534
15
Advocate Health Care Institutional Review Board
Protocol Review Form for Research Involving Human Subjects
Application Check List – Detach the following pages before duplicating and submitting
Procedure:
Upon receipt of the protocol copies in the IRB office, an e-mail will be sent to the designated recipient listed
under ‘Study Coordinator (contact)’ on page 1 of the application. The protocol’s internally assigned number will
be provided. Use this number to e-mail an electronic copy of the consent (in Word format) to
[email protected]. The attachment should be named xxxx-con.doc where xxxx is the IRB provided
study number.
If any parts of the submission are missing (credentials, attachments, signatures, conflict of interest, etc.), you will
be informed in the same communication.
Guidelines:
Submit this application form, the consent (assent) form(s) and any full protocol in triplicate with required, original
signatures on pages 1 and 2. Both application and any full protocol must include: a literature review, a detailed
description of all research methods, subject related procedures, analyses, all data collection forms and/or
questionnaires/surveys, an abbreviation/acronym list and the subject consent form with a description of the
consent process (if applicable).
Concerning Sponsored Protocols: It is not acceptable to photostat the sponsor’s entire protocol into the AHC
template. The purpose of this application is to present an abbreviated summary of the full protocol that is
accessible to all Board members. You should be aware that IRB panels consist not only of physicians and
healthcare workers but community members and some non-medically trained persons as well. These latter
members must receive an application in a form that they can interpret to make judgments.
The protocol’s designated primary reviewer and the research analyst in the IRB office receive the sponsor’s entire
submission and any additional submitted materials to use in preparing a review presentation for the Board. All
other members receive only the Advocate template-ased application and the consent form.
Therefore, abstract the original sponsor protocol into this template with the intended audience in mind. An
abstract, intro / abbreviated literature review, summary of methods, risks, relevant attachments (for instance,
survey questionnaires but not a doctor’s case report form), etc. should be included but without the level of detail
and full description of procedures to be employed, definition and measurement of adverse events, power analyses,
reporting arrangements, etc. A completed AHC IRB application usually should not exceed 30 pages while the
sponsor protocol can run over 100 with an investigator’s brochure consisting of a further 100-200 pages.
If you maintain the margins and fonts of the downloaded original template, each new section (eg. all of pg 1, all pg
2 signatures, all of Item X, the Conflict of Interest statement) will start on a fresh page. Obviously as you copy
and paste text into the sections such as abstract, methods, etc., the page numbers will change. All signatures
required throughout the protocol however can always appear on the same page as the text to which they belong.
Be sure the final copy displays page numbering!
Independent of but parallel to the IRB review of a research proposal, the principal investigator should
Note:
submit materials appropriate for Advocate Business Review and Approval. Details of the requirements
for financial and legal approval are available via the intranet at
http://advocateonline.advocatehealth.com/page.cfm?id=2374 on the intranet or,
http://www.advocatehealth.com/system/jobsedu/edu/research/ via the internet or,
call the Dept. of Medical Education and Research at 847.384.3614
AHCIRB Application – IRB-09/07/11.doc
Submit with any Full Protocol in triplicate – Questions: 847.384.3534
16
Checklist for IRB Submission:
1. ( ) All sections of application completed, including Department Chair, supporting Department Chairs and the
institution’s Local Oversight Committee signatures. (A statement to the effect "see attached protocol" in
any section of the application is unacceptable).
2. ( ) Per page 1, Research Contract or Sponsor Agreement as appropriate is attached.
3. ( ) Per page 1, Review fee or waiver request (compose an explanatory memo addressed to the Advocate IRB
Chairman as to why fee should be waived or reduced) is attached. If you mark “Billing or Transfer
Arrangement” attach a memo indicating whether the bill should be sent to you or a sponsoring entity. If it
is to be directed to the PI, please indicate whether an internal funds transfer between accounts will be
employed or some other means.
4. ( ) A complete description of the research proposed including a detailed explanation of:
research design and methods/all instruments
subject inclusion/exclusion criteria
subject selection and assignment procedures
risks and benefits
sample size determination
proposed statistical analyses
review of pertinent literature
attached references and bibliography
5. ( ) If the research is externally sponsored or motivated, a complete copy of the sponsor’s protocol, including
any forms, surveys, questionnaires or sample consents.
6. ( ) Protocol page 2 - Department Chair's Signature, hospital’s Local Oversight Committee Chair’s signature.
If gene therapy protocol, signature of Biosafety Committee Chair. (Other cooperating department/division
heads must also sign.)
7. ( ) A completed Conflict of Interest form with relevant attachments for each investigator, co-investigator and
all relevant (IX., Pg. 11) personnel. These forms are required for commercially sponsored or supported
studies only!
8. ( ) Consent/assent form and description of consent process attached (if applicable).
(Guidelines and sample consent/assent forms with Advocate format and standard language are available
upon request). Once you have received an e-mail confirming the IRB’s receipt of your protocol, submit a
copy of the consent (assent) only in Word format as an e-mail attachment USING AS A SUBJECT LINE
the protocol’s designated number and the word CONSENT to [email protected]. Clearly
identify the principal investigator and the protocol title in the body of the e-mail.
9. ( ) Attach documentation of research ethics training for relevant personnel (XI, Pg. 12) – all investigators,
persons involved in consent process or care, all persons with data access.
10. ( ) Copy of proposed advertisements/recruitment notices/web pages/etc., if applicable. Any materials intended
to directly or indirectly (notification of other practices about the trial) recruit patients, including
informational brochures, supplementary trial materials (eg. “What is a tissue bank? pamphlet), news
releases, bulletin board posters, etc. should be forwarded as e-mail attachments in like manner as the
consent discussed in item #8 above.
11. ( ) Ancillary Departments involved are notified and training/education sessions planned. Reference protocols
to be provided to appropriate units and Pharmacy are included.
12. ( ) Be sure the entire protocol is sequentially and legibly page numbered. Print page one such that the
signature box remains on the first page.
AHCIRB Application – IRB-09/07/11.doc
Submit with any Full Protocol in triplicate – Questions: 847.384.3534
17
13. ( ) Attach the “Authorization to Access Private Health Information” form or the “Request to Waive
Authorization” application. These are the documentation / request necessary to be compliant with the
Federal HIPAA regulations in effect as of 04/14/03.
The authorization should be a SEPARATE FORM requiring patient signature rather than integrated into the
consent document. While the IRB does not need to approve a protocol’s PHI Authorization, a copy must
be on file with the IRB.
An Advocate approved template is available from the IRB office or on Advocate Online.
Reminder:
Studies approved as Exempt by the IRB may still require a Waiver of Authorization (a HIPAA
waiver) to access private health information (PHI). Self-report surveys will require a brief consent
statement at the beginning asserting that participation is voluntary and that the data (survey form) are to be
submitted anonymously. If the responses are to be matched up later with clinical or outcomes data (thus
making anonymity impossible), the investigator should secure a patient signature on AHC PHI
Authorization form. Retrospective chart review studies will require a PHI waiver. Both forms are
available on this website or from the IRB office.
14. ( ) Submit the application and its attachments in triplicate to:
Advocate Health Care Institutional Review Board
205 W. Touhy Ave., Suite 203
Park Ridge, IL 60068-4202
Advocate internal mail address is:
IRB – Suite 203
Touhy Support Center
AHCIRB Application – IRB-09/07/11.doc
Submit with any Full Protocol in triplicate – Questions: 847.384.3534
18