FORM: Institutional Certifications
NUMBER / DATE / PAGE
HRP-226 / Ver. 02/23/16 / 1 of 4
Submit with new proposals
AHC IRB Number: (if known) / AHC System Number - SID / ______
Protocol Title:
Principal Investigator:
If the Principal Investigator is in a Fellowship Program, obtain the Program Director’s endorsement in addition to others below
Primary (Regulatory) Contact:
As Department Chair, I certify the following:
  • The Principal Investigator is qualified by education, training and experience to personally conduct and/or supervise the research described in the protocol.
  • The Principal Investigator has completed all applicable institutional credentialing processes to conduct this research.
  • The Principal Investigator will conduct this protocol in accordance with requirements in the INVESTIGATOR MANUAL (HRP-103) listed in the section “What are my obligations after IRB approval?”
As Protocol Review Committee Chair, I certify the following:
  • The Principal Investigator has sufficient resources to carry out this research as proposed.
  • The protocol is scientifically valid and employs research procedures which are consistent with sound research design.
  • Meets the Advocate Mission, Values, Philosophy.
As Program Director, I assert the Fellow is prepared to assume the duties of Principal Investigator.
Acknowledgements

Department Chair Signature

/ Date
Sign:
Print:
Print Name, Title, Department and Institution below signature

Protocol ReviewCommittee Signature

/ Date
Sign:
Print:
Print Name, Title, Department and Institution below signature
FellowshipProgram Director’s Signature / Date
Sign:
Print:
Print Name, Title, Department and Institution below signature

To evaluate the protocol, it is important to understand where the research described will take place as well as the institutional resources required to support it. Multiple sites might be involved in a single protocol. For instance, subjects may be initially recruited and screened in a physician’s office; investigational interventions and short-term follow-up might occur in a hospital or clinic and long term follow-up might revert to the physician’s office. Retrospective studies might utilize charts from one or more sites.

I. STUDY CONDUCT LOCATION(S):

On one line each, indicate performance sites for major phases of the protocol / List site activities: e.g. chart review for retro study, chart screening for recruiting, surveys, initial device/drug procedure/ interventions, long term follow-up, other (describe)

Place an X where appropriate; leave blank for Not Applicable.

  1. Protocol is: Retrospective ______Prospective ______Both ______
    (Retrospective means that all data have already been collected at the time of protocol submission.)
  2. Protocol involves only devices/drugs used within approved labelling: True ___ False ___
  1. Protocol requires: IND ____ IDE ____ Off-label use of approved device/drug ______
  1. Protocol utilizes CT-scans, x-rays or other radiation exposure: True ___ False ___
  1. Subjects will be randomized? True___ False ___
  1. Protocol plans to retain specimens (e.g. blood, tissue) for future use: True___ False ___
  1. What is the maximum number of uniquelocal subjects to enroll in thisprotocol? Retro____ Prospective ____

(Consider charts / medical records as subjects for retrospective studies. If subject is signing
a consent that person counts only as a prospective case)

h. Is this a multicenter study? Yes____ No_____

If Yes, what is the maximum number of subjects anticipated study-wide?Retro ____ Prospective ____

i. Planned Healthy subjects ___ Minors ____ Students ___ AHC Employees ___ Elderly (>65) ___
Inclusions Pregnant women/fetuses: ____ Nonviable neonates ____ Decisionally impaired ___

  1. RESOURCE IDENTIFICATION:

Identify Advocate Health Care Networkresources needed to successfully complete this research. Identify sites from which subjects will be recruited or data will be acquired

CHECK ALL AS APPLICABLE

AHC
Sites / Cases
/Data from / Need support from or need to inform, educate or train; check as appropriate
Lab / Nurs ing / Pharmacy / Radiology / Nutrition / Resp Care / Cath Lab / Oth 1 / Oth 2 / Oth 3
BroMenn
Christ
Condell
Eureka
Good Sam
Good Shep
Home Hlth
Child – OL
Child – PR
LGH
Masonic
Sherman
South Sub
Trinity
Site A
Site B
Site C
Site D
Site E

Site A, B, etc. might be specific Advocate Health Centers or Advocate Medical Group practice sites, home visit services, etc. List all sites at which subjects may be involved in this research. Other 1, 2, etc. refer toother system resources such as GI Lab, Rehab Services, 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:
  1. INSTITUTIONAL ENDORSEMENTS FOR PROPOSED RESEARCH

Acquire institutional endorsement signatures based upon protocol needs and areas identified in Section II (Resource Identification).

Acquire the relevant endorsement 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.

Your endorsementbelow is required to assure the Advocate Health Care Institutional Review Board that you have reviewed this research protocol and that this protocol will be supported by your department/service as it requires activities related to the research outside and/or in addition to your standard of care practice.

Duplicate as needed

A VALID SIGNATURE requires: Date and Printed Name with Title in addition to the Signature

______

Supporting Dept. Chair / Director (signature)Date

______

Print Name, Title, Department and Institution

______

Supporting Dept. Chair / Director (signature)Date

______

Print Name, Title, Department and Institution

______

Supporting Dept. Chair / Director (signature)Date

______

Print Name, Title, Department and Institution

______

Supporting Dept. Chair / Director (signature)Date

______

Print Name, Title, Department and Institution