PALOMAR POMERADO
HEALTH
Investigational Review Committee
(PPH IRC)
Submittal Guidelines
Revised and Approved by the PPH IRC: February 10, 2011
PALOMAR POMERADO HEALTH
INVESTIGATIONAL REVIEW COMMITTEE
SUBMITTAL GUIDELINES
Thank you for your interest in submitting a project for review by the Palomar Pomerado
Health Investigational Review Committee (PPH IRC). This document outlines the process for
submitting studies to the PPH IRC for review. Submissions are required for all research
projects using human subjects in accordance with the Federal Policy for the Protection of
Human Rights, the Food and Drug Administration (FDA) regulations, and the Federalwide
Assurance granted by the Health and Human Services Office of Human Research Protections
(OHRP).
The Principal Investigator is responsible for submitting the appropriate documents to the PPH
IRC office. All documents are to be submitted electronically in either MS Word or PDF
format to [email protected]. The checklist below outlines the documents required for
initial submission. The submission must be in the office of the PPH IRC no later than two (2)
weeks prior to the next scheduled IRC meeting. Projects will not be forwarded to the
Committee for consideration until the submission has been determined to be complete.
Please note that the Principal Investigator must be a member of the medical staff with
admitting privileges at the institution(s) at which the study will take place or an
employee of Palomar Pomerado Health. For further information on obtaining privileges at
either Palomar Medical Center or Pomerado Hospital, contact the Medical Staff Services
office at either Palomar Medical Center at (760) 739-3140 or Pomerado Hospital at (858) 6134358. The Principal Investigator must also attend the meeting at which the study will be
considered and provide a brief (5 minute or less) overview of the study to the Committee prior
to addressing any of their concerns or questions regarding the study.
If you have questions regarding the submission process, please contact Wendy Smith at
Palomar Medical Center, Medical Staff Services office, 555 East Valley Parkway, Escondido,
CA 92025, (760) 739-3141 or by email at [email protected].
Study Submission Checklist:
Item
Study Application
Notes
All documents are to be submitted in electronically in
either MS Word or PDF format to [email protected]
at least two (2) weeks prior to the IRC meeting.
Complete Study Protocol
Informed Consent Form including the California Experimental
Subject’s Bill of Rights accompanied by the completed
Checklist for Review of Informed Consent Compliance ( (refer
to Appendix “A”)
Investigator’s Brochure/Drug Monograph (for studies involving
investigational medications only)
Form 1572 (for studies involving investigational medications
only)
An electronic version in MS Word or PDF format with the
paragraphs numbered and the completed Checklist for
Review of Informed Consent Compliance (see Appendix
“A”).
NOTE: Studies requesting a waiver of the requirement to
obtain informed consent or waiver of documentation of
informed consent should refer to Appendix “F”.
For studies involving investigational medications only.
For studies involving investigational medications only.
Study Budget
Disclosure of Position/Affiliation/Financial Interest
See Appendix “G” for further information.
Documentation of completion of the Clinical Research
Coordinator Application process, if applicable
Contact Kristen Fike in the PPH Human Resources
Department for information on the Shiftwise process. She
can be reached at (760)740-6331.
Curriculum Vitae of Principal Investigator
IRC Submittal Fee
Medication Summary Sheet (for studies involving
investigational medications only)
See Appendix “B” for further information. Contact
Melissa Wallace in the PPH Finance Department for
further information regarding submittal fees. Her number
is (760) 480-7988.
For studies involving investigational medications only.
See page 5 for a list of the information to be provided.
Content of all in-service training and materials to be provided to
affected PPH staff and other personnel participating in the study
Copies of all recruitment materials, advertisements and other
study information that will be provided to potential subjects.
These may include any advertising or publicity information such
as recruitment letters, flyers, posters, public service
announcements, newspaper, radio and television advertisements
and internet content seeking subjects for research
Copies of any questionnaires, interview scripts, subject diaries
or any other item that will be used by subjects or by research
staff to obtain information from subjects
Documentation of completion of Human Subjects Protection
Education for Principal Investigators and Research Coordinators
available at http://phrp.nihtraining.com/users/login.php
Studies requesting an Exception from Informed Consent
Requirements for Emergency Research should refer to the
Checklist for Review of Informed Consent Requirements for
Emergency Research Using the Exception from Informed
Consent Requirements Under 21 CFR 50.24 in Appendix “D”
for further direction
Studies requesting a waiver of HIPAA authorization
requirement (which requires completion of a written
authorization by each subject) should refer to the checklist in
appendix “E”
Studies requesting a waiver of the requirement to obtain
informed consent should refer to the checklist in appendix “F”
One electronic copy of the completion certificate for all
Principal Investigators, Sub-Investigators, Co-Investigators
and Research Personnel involved in the study.
See Appendix “D” for further information.
See Appendix “E” for further information.
See Appendix “F” for further information.
Description of Submission Documents:
Study Application:
The study application will include the following: name and signature of principal investigator, study location,
protocol title, study phase (I, II, III or IV), name of the study sponsor, a few paragraphs describing the
background, goals and overall objectives of the study, brief outline of the study design, number of subjects
anticipated, study length (per subject), overall study duration, description of the protections of human subjects,
detailed financial impact on patients and Palomar Pomerado Health and possible benefits of the protocol. The
form is available on beginning on page 8 of this packet.
Complete Study Protocol:
The study protocol should be comprehensive and include information on the rationale and objective of the study,
complete description of the study procedures including monitoring required, patient inclusion and exclusion
criteria, and potential liability or costs to the institution in which the study will be performed.
Informed Consent:
1.
The PPH IRC strongly urges Principal Investigators review the National Institutes of Health website
regarding Guidelines for Writing Informed Consent Documents at
http://ohsr.od.nih.gov/info/sheet6.html.
2.
The informed consent forms must be provided as it will be used in the study utilizing letterhead
stationary of the Principal Investigator.
3.
A copy of the signed patient consent must be placed in the patient’s chart and kept as a permanent part
of the medical record.
4.
The informed consent shall be accompanied by the California Experimental Subjects Bill of Rights as
mandated by California regulations, see Appendix “A” for a sample or access the document at
http://ag.ca.gov/research/pdfs/bill_of_rights.pdf.
5.
The informed consent must have all the paragraphs numbered and be accompanied by the completed
Checklist for Review of Informed Consent Compliance (see Appendix “C”).
Investigator’s Brochure/Drug Monograph:
A complete study drug or product monograph detailing the mechanism of action, indication, dosage,
administration, and toxicity must be submitted for all studies involving investigational medications. Study drugs
must be prepared and dispensed from the hospital pharmacy if the patients are to receive the investigational drug
while in the hospital. The pharmacy will provide information on the administration and potential adverse effects
to the study medication to the nursing staff caring for the patient.
FDA Form 1572
A scan of the completed FDA Form 1572 which was submitted to the study sponsor is required for all studies
involving investigational drugs or biologics. The 1572 is a federal form and is the statement of the investigator
that he will abide by the federal guidelines set forth in the Code of Federal Regulations for the use of drugs in an
investigational setting. The form can be can be found at
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf. The Form 1572 is
only required for studies of investigational drugs and biologics conducted under an IND.
Study Budget
A complete copy of the study budget, as proposed by the sponsor, must be submitted to the PPH IRC.
Disclosure of Position/Affiliation/Financial Interest:
The PPH IRC Disclosure of Position/Affiliation/Financial Interest form must be completed by the Principal
Investigator to assist the Committee in determining if any conflict of interest exists (refer to Appendix “G”).
Clinical Research Coordinator Application:
Please note that clinical research coordinators and other study staff who will have contact with patients or patient
records within Palomar Medical Center and/or Pomerado Hospital must be credentialed through the ShiftWise
process by the Human Resources Department at Palomar Pomerado Health. Please contact Kristen Fike at (760)
740-6331 for further information on this process. Documentation of completion of this process must be provided
to the PPH IRC.
Curriculum Vitae of the Principal Investigator:
Submission of the most recent curriculum vitae of the Principal Investigator demonstrating that he/she has the
appropriate background and training to conduct the required research for the study is mandatory.
IRC Submittal Fee:
A list of the fees charged by the PPH IRC is available in appendix “B”. Contact Melissa Wallace in the PPH
Finance Department for further information regarding submittal fees. She can be reached at (760) 480-7988.
Medication Summary Sheet:
This document will supplement the in-service training required to be provided to staff to ensure that they all have
the necessary information that they need to safely and effectively administer study medications. This medication
summary sheet will accompany each dose of study medication sent to the patient. Please provide the following
pertinent data and any other appropriate information necessary for the safe and proper administration of the study
medication: brief study summary, inclusion/exclusion criteria, drug dose/route/frequency, storage and stability
information, monitoring parameters and required blood draws, special handling requirements and any other
pertinent information.
Content of all In-Service Training and Materials:
Each Principal Investigator is responsible for arranging for in-service education of at least 80% of the affected
staff and other personnel participating in the study prior to implementation of any protocol involving an
investigational drug or device. Copies of the content of the in-service education including any presentations,
handouts, or other materials provided to the trainees will be provided to the Committee at the time of initial study
submission. Documentation of the completion of the training will be submitted as part of the
administrative/business review. The IRC must be promptly informed when all requested training has been
completed.
Recruitment Materials, Advertisements:
Copies of all recruitment materials, advertisements and other study information that will be provided to potential
subjects shall be submitted to the IRC. These may include, but not be limited to, any advertising or publicity
information such as recruitment letters, flyers, posters, public service announcements, newspaper, radio and
television advertisements and internet content seeking subjects for research
Questionnaires, Interview Scripts and/or Subject Diaries:
Copies of any questionnaires, interview scripts, subject diaries or any other item that will be used by subjects or
by research staff to obtain information from subjects shall be included with each study submission.
Human Subjects Protection Education:
Submission of a copy of the completion certificate for the NIH course entitled Human Subjects Protection
Education for the Principal Investigator and Research Coordinators at http://phrp.nihtraining.com/users/login.php
is required for all Principal Investigators, sub-investigators, co-investigators and research personnel involved in
the study.
Exception for Informed Consent Requirements for Emergency Research:
Investigators requesting an Exception from Informed Consent Requirements for Emergency Research should
refer to the checklist in Appendix “D” for guidance.
Waiver of HIPAA Authorization:
Investigators requesting a waiver of completion of HIPAA authorization by each subject should refer to the
checklist in appendix “E” for guidance.
Waiver of Requirement to Obtain Informed Consent:
Investigators requesting a waiver of the requirement to obtain informed consent or waiver of documentation of informed
consent should refer to Appendix “F” for guidance.
General Guidance:
NOTE:
The Palomar Pomerado Health Investigational Review Committee Operational Procedures
govern review of all proposed research and clinical investigations involving human subjects.
The material provided below is for informational purposes only. Reference should be made to
the Operational Procedures of the Investigational Review Committee for more specific and
detailed treatment of the requirements addressed herein.
1.
All submission documents are to be submitted in electronically in either MS Word or PDF format to
[email protected] at least two (2) weeks prior to the IRC meeting.
2.
A protocol submission must be determined to be complete and contain all of the required information
necessary for a thorough review by the PPH IRC prior to being forwarded to the Committee for
consideration. The Principal Investigator will be informed if a study submission is deemed to be
incomplete.
3.
The Principal Investigator must be present at the IRC meeting when the protocol is submitted for
approval.
4.
A protocol submitted to the Investigational Review Committee will only be deemed acceptable by the
IRC if the study is being conducted with appropriate FDA approval, as applicable, and what is presented
meets the criteria set forth in the PPH Investigational Review Committee Operational Procedures.
5.
A letter from the Chairman of the Investigational Review Committee to the Principal Investigator will
indicate final approval, deferral, denial or request for modification to the protocol. Approval of any
significant research or clinical investigation to be undertaken in one or both Hospitals shall also be
subject to approval by the Executive Committee and Administration of the Hospital(s) involved. The
Board of Directors also retains discretion to approve or disapprove research for clinical investigation.
6.
An administrative review process will be conducted to:
a. Determine what parts of the patient’s care are “standard” versus part of the trial.
b. Agree upon a budget with the sponsor and/or Principal Investigator to reimburse PPH for any care
that is provided, overhead and other expenses.
c. Ensure that the IRC fee is paid.
d. Work out logistics with PPH departments that will be affected by the trial.
e. Create a process for tracking patients so they are not billed for any care that the Sponsor does not
pay for.
f. Negotiate contract terms, complete the legal review process and obtain signatures on the contract
documents.
g. Submit documentation of in-service training for at least 80% of affected staff within 30 days of
study start day.
All studies, but in particular those which may have a financial and/or resource impact on PPH facilities
and departments, may not proceed until after administrative approval is obtained.
7.
The Principal Investigator is responsible for arranging for in-service education of at least 80% of the
PPH staff who will, during the course of their regular patient care duties, assist in patient care for study
patients prior to implementation of any protocol involving an investigational drug or device.
Documentation of completion of this staff training is required to be submitted as part of the
business/administrative review process.
8.
The Principal Investigator will have all clinical research coordinators and staff who will be performing
duties pertaining to the study at either Palomar Medical Center or Pomerado Hospital complete the
ShiftWise credentialing process through the Palomar Pomerado Health Human Resources Department
prior to any interaction or contact with patients or patient records at PPH.
9.
Requests for copies of medical records must be accompanied by an appropriate authorization or waiver
approved by the PPH IRC. These requests should be forwarded to Health Information Services (HIS)
and identified as records pertaining to a study patient. HIS may charge the Principal Investigator for the
cost of copies. For information, contact Kim Jackson, Director of Health Information Services at (760)
739-3290.
10.
No changes except those necessary to eliminate apparent immediate hazards will be made without prior
IRC approval. All deviations from an approved research protocol must be reported to the PPH IRC as
soon as possible but no later than five (5) working days after the deviation or its discovery.
11.
Study amendments and/or modifications to an approved protocol may not be implemented without prior
IRC review and approval. Requests for amendment/modification of an approved protocol must be
turned into the PPH IRC office at least two (2) weeks prior to the next scheduled Committee meeting.
12.
The Principal Investigator is responsible for ensuring that approval of the research to be conducted at
PPH does not expire by submitting a Request for Continuing Review and a copy of the Informed
Consent Form being utilized by the study to the IRC for review and consideration prior to the expiration
of the study (see Appendix “H”). Failure to comply with continuing review requirements will result in
the study being terminated for non-compliance.
13.
No study related activities will be allowed to be performed if study approval by the PPH IRC has
expired unless the discontinuation of the study will bring harm to the patients. Any such situation of
study activity occurring outside the approval period must be reported to the PPH IRC within five (5)
working days.
14.
The IRC must be informed of any serious, unexpected or alarming adverse events that occur during the
approval period, whether related to the study or not. These are reportable if they are events which are
not described or defined in the study protocol. Investigators must also submit Sponsor-generated
reports of adverse events occurring at other investigative sites. These reports should be submitted to the
PPH IRC within five (5) working days of when they occur.
15.
The IRC must be informed of any sponsor notification of safety information within ten (10) days of
receipt of the report by the Principal Investigator.
16.
Informed Consent forms, other than those written in English, will only be approved if they are meet the
criteria outlined by regulatory bodies and are accompanied by a certified Affidavit of Accuracy and the
translation was performed by a qualified translation service or individual.
PALOMAR POMERADO HEALTH
INVESTIGATIONAL REVIEW COMMITTEE
STUDY APPLICATION
PROTOCOL TITLE:
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
PRINCIPAL INVESTIGATOR:__________________________________________________________
SIGNATURE OF PRINCIPAL INVESTIGATOR:__________________________________________
OTHER INVESTIGATORS: ____________________________________________________________
______________________________________________________________________________________
RESEARCH PERSONNEL: _____________________________________________________________
DATE OF SUBMISSION: _______________________________________________________________
STUDY LOCATION: _____ PALOMAR MEDICAL CENTER
_____ POMERADO HOSPITAL
OTHER PPH LOCATIONS, please specify: _________________________________________________
STUDY SPONSOR:__________________________________
PHASE: ________________________
OTHER NON-PPH FACILITIES PARTICIPATING IN THE STUDY: _________________________
______________________________________________________________________________________
STUDY PATIENTS WILL BE:
_______ INPATIENT
_______ OUTPATIENT
NUMBER OF SUBJECTS ANTICIPATED:________________________________________________
STUDY LENGTH (per subject): __________________________________________________________
STUDY DURATION (overall): ___________________________________________________________
CONTACT INFORMATION (attach additional sheets as necessary):
Principal Investigator:
Name: ___________________________________
Phone or Voice Mail: _______________________
Fax: _____________________________________
Email: ___________________________________
Other Investigators:
Name: ________________________________
Phone or Voice Mail: ____________________
Fax: __________________________________
Email: ________________________________
Research Personnel:
Name: ___________________________________
Phone or Voice Mail: _______________________
Fax: _____________________________________
Email: ___________________________________
Name: ________________________________
Phone or Voice Mail: ____________________
Fax: __________________________________
Email: ________________________________
Address to which correspondence should be sent:
Attn: __________________________________________________________________________________
Address: _______________________________________________________________________________
City, State, ZIP Code: ____________________________________________________________________
Email: _________________________________________________________________________________
PRIMARY OBJECTIVES OF STUDY (discuss the background, goals and overall objectives of the study):
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
METHODS (briefly outline the study design):
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
THIS STUDY INVOLVES (check all that apply):
_____ Chart Review
_____ Use of computer stored clinical information
_____ Use of tissue, lab, or other biologic specimens
_____ Telephone or in-person interviews
_____ Mailed questionnaires
_____ Intervention
_____ Other (specify): _________________________________________________________________
PROTECTION OF HUMAN SUBJECTS:
1.
What are the risks of the research to subjects?___________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
2.
What are the benefits to subjects?______________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
3.
What is the alternative to participation?_________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
4.
How will risks be minimized?__________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
5.
Who will approach the subject and ask about possible participation?_________________________
___________________________________________________________________________________
___________________________________________________________________________________
6.
Will the subject’s physician be asked for permission to contact the subject?___________________
___________________________________________________________________________________
7.
Who will explain the study?___________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
8.
Who will obtain consent?______________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
9.
What procedures will be used to allow the subject to decline to participate?___________________
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
10.
Will the subject receive medical services as a result of their participation?____________________
___________________________________________________________________________________
11.
Will there be any advertising to subject or medical providers for recruitment?________________
___________________________________________________________________________________
If yes, include copies of any advertisements, letters to providers or other recruitment tools with
the submission.
12.
Will there be any financial or other inducement offered to patients to participate in the
study?_____________________________________________________________________________
___________________________________________________________________________________
REQUEST FOR REVIEW OF INFORMED CONSENT REQUIREMENTS FOR EMERGENCY
RESEARCH USING THE EXCEPTION FROM INFORMED CONSENT REQUIREMENTS UNDER 21
CFR 50.24 (if applicable): Complete the checklist in Appendix “D” if your project requires an exception from
informed consent requirements under 21 CFR 50.24.
REQUEST FOR HIPAA WAIVER OF AUTHORIZATION (if applicable): Complete the checklist in
Appendix “E” if your project requires a request for HIPAA waiver of authorization.
REQUEST FOR WAIVER OF REQUIREMENT TO OBTAIN INFORMED CONSENT OR WAIVER
OF DOCUMENTATION OF INFORMED CONSENT (if applicable): Complete the checklist in Appendix
“F” if your project is requesting a waiver of the requirement to obtain informed consent or a waiver of the
documentation of informed consent.
FINANCIAL IMPACT:
1.
Impact on Patients:
A.
Will there be payments to patients?_________________________________________
B.
2.
If so, how much and how often will they be paid?______________________________
________________________________________________________________________
Impact on PPH:
A.
Please check the department (s) which may be impacted by this study:
____
Emergency Room
____
Pharmacy
____
Laboratory
____
Imaging
____
Surgery
____
Respiratory
____
Rehab
____
Nursing floors (i.e. critical care, telemetry, med/surg)
____
Other ____________________________
B.
For each department checked above list the study specific procedures/tests or medicines
which should be charged to the study:
(ie. EKG, CBC, Urine analysis, Diltiazem 25 mg)
______________________________________________________________________
______________________________________________________________________
______________________________________________________________________
______________________________________________________________________
C.
Will there be utilization of personnel time for extra blood draws, more frequent vitals
checked by nurses, clinical pharmacist’s time for mixing and dispensing the study
medications with maintenance of the double blind?
If yes, please describe:
______________________________________________________________________
______________________________________________________________________
______________________________________________________________________
______________________________________________________________________
D.
Will there be personnel time that is required for retrieval of medical records, recording
additional information in study records, etc? Please describe:
______________________________________________________________________
______________________________________________________________________
______________________________________________________________________
______________________________________________________________________
E.
What supplies/medications are being provided by the PI for the study:
______________________________________________________________________
______________________________________________________________________
______________________________________________________________________
APPENDIX “A”
PALOMAR POMERADO HEALTH
INVESTIGATIONAL REVIEW COMMITTEE
CALIFORNIA
EXPERIMENTAL SUBJECT’S BILL OF RIGHTS
You have been asked to participate as a subject in an experimental clinical procedure. Before you decide
whether you want to participate in the experimental procedure, you have the right to:
1.
Be informed of the nature and purpose of the experiment;
2.
Be given an explanation of the procedure to be followed in the medical experiment and any drug or
device to be utilized;
3.
Be given a description of any attendant discomforts and risks reasonable to be expected from your
participation in the experiment;
4.
Be given an explanation of any benefits reasonably to be expected from your participation in the
experiment;
5.
Be given a disclosure of any appropriate alternative procedure, drugs or devices that might be
advantageous to you and their relative risks and benefits;
6.
Be informed of the avenues of medical treatment, if any, available to you after the experimental
procedure if complications should arise;
7.
Be given an opportunity to ask any questions concerning the experiment or the procedures involved;
8.
Be instructed that consent to participate in the experimental procedure may be withdrawn at any time
and that you may discontinue participation in the medical experiment without prejudice;
9.
Be given a copy of this form and the signed and dated written consent form; and
10.
Be given the opportunity to decide to consent or not to consent to the medical experiment without the
intervention of any element of force, fraud, deceit, duress, coercion or undue influence on your decision.
I have carefully read the information contained in the “Experimental Subject’s Bill of Rights” and I understand
fully my right as a potential subject in a medical experiment involving people as subjects.
______________________
Date
______________________________________
Patient
______________________
Date
______________________________________
Parent/Legal Guardian
(If applicable)
If signed other than parent, indicate relationship:
_______________________
Date
______________________________________
Witness
APPENDIX “B”
PALOMAR POMERADO HEALTH
INVESTIGATIONAL REVIEW COMMITTEE
FEE SCHEDULE
Submission
Fee
Initial Protocol Review for industry sponsored inpatient studies
and outpatient studies in which PPH facilities and resources are
utilized
$3,500
Resubmission of Studies not approved within 18 months of Initial
Protocol Review – Review of industry sponsored inpatient studies
and outpatient studies in which PPH facilities and resources are
utilized that have been previously submitted to the PPH IRC
within the past eighteen (18) months
Initial Protocol Review for industry sponsored outpatient studies in
which no PPH facilities and resources are utilized
$1,750
Initial Protocol Review for non-industry sponsored studies and
chart review studies
Initial Protocol Review by IRC and Administration for PPH
employee-led studies
Amendments – administrative changes only
$1,000
$50
No fee
No fee
Amendments – clinical changes
$200
Continuing Review for industry sponsored inpatient studies and
outpatient studies in which PPH facilities and resources are
utilized
$250
Continuing review for industry sponsored outpatient studies in
which no PPH facilities and resources are utilized
$100
Continuing review for non-industry sponsored studies and chart
review studies
No fee
Continuing review for PPH employee-led studies
No fee
Expedited Approval
No fee
Emergency Compassionate Use Approval
No fee
Please make check payable to Palomar Pomerado Health and submit with your paperwork to Palomar Medical
Center Medical Staff Services, 555 East Valley Parkway, Escondido, CA 92025. If you have any questions
regarding the fee schedule or the administrative/business review process, please contact Melissa Wallace at (760)
480-7988.
APPENDIX “C”
PALOMAR POMERADO HEALTH
INVESTIGATIONAL REVIEW COMMITTEE
CHECKLIST FOR REVIEW OF INFORMED CONSENT COMPLIANCE
Study Title: ____________________________________________________________________________
Principal Investigator: ___________________________________________________________________
Manufacturer: _________________________________________________________________________
Sponsor or funding source, if any: __________________________________________________________
Will some of the subjects in this investigation be given a placebo?
______ YES
______ NO
Approximate number of subjects in this investigation at this site: _________________________________
Must include the “California Investigational Subjects’ Bill of Rights”
Date of review: ________________
NOTE: All paragraphs in the Informed Consent Form should be numbered for reference purposes.
1. GENERAL PROVISIONS
Location in Informed
Requirement
Consent Form
(Paragraph Number)
Is there a general description, in lay terms, of the nature and purpose of this clinical
investigation and procedures to be used?
Is there a statement that this study may involve risks and discomforts that are
currently unforeseeable?
Is there a description of the study procedures?
Is there a statement regarding if the subject is a woman of child-bearing age and is or
may become pregnant during the study, include and a statement regarding the
potential risks, foreseeable and unforeseeable, to an embryo or fetus.
Is there a statement regarding the potential benefits of this study (describe in detail):
to the subject or to humanity?
Is there a statement regarding new information on the study?
Is there a statement that the subject understands that all or some of the benefits
described above may not occur in their case and that the possibility exits that their
condition may be worsened?
Is there place for the date and subject’s signature, or the personal representative’s
signature and a description of the representative’s authority to act for the individual?
Is there a place for the name of the person explaining the consent?
Is there a statement regarding payment to the subject for participation in the study by
the sponsor?
Is there a statement regarding payment to the Principal Investigator by the sponsor?
2. PARTICIPATION IS VOLUNTARY
Location in Informed
Requirement
Consent Form
(Paragraph Number)
Is there a statement that the subjects participation in the study is voluntary and that
their refusal to participate will involve no penalty or loss of benefits to which they are
otherwise entitled?
Is there a statement that if I the subject decides to participate in this study, they may
withdraw at any time without penalty or loss of benefits to which they am otherwise
entitled?
If appropriate, is there a statement regarding the consequences of subject's decision to
withdraw and procedures for the orderly termination of participation by the subject?
If appropriate, is there a comment regarding circumstances under which the subject's
participation may be terminated by the investigator, without regard to the subject's
consent?
3. ALTERNATIVE TREATMENTS
Location in Informed
Requirement
Consent Form
(Paragraph Number)
Is there a statement that if the subject does not participate in this study, what
conventional procedures and treatments are available to them?
4.
TREATMENT FOR POSSIBLE PHYSICAL INJURY RESULTING FROM RESEARCH
PROCEDURES
Location in Informed
Requirement
Consent Form
(Paragraph Number)
Is there a statement that if the subject suffers any physical injury as a result of their
participation in this study, they should immediately contact the principal investigator
or the Emergency Department if the investigator is unavailable?
Is there a statement regarding medical treatment will or will not necessarily be
provided free of charge or at subject’s expense?
Is there a statement regarding any additional costs that may result to the subject from
participation in this study?
Is there a statement regarding the availability of medical treatment and compensation
for injury suffered as a result of participating in this study may be obtained from
(Office at Hospital)?
Is there a statement regarding the availability of financial compensation for any
physical injury the subject might suffer as a result of their participation in this study?
5. CONFIDENTIALITY OF DATA
Location in Informed
Requirement
Consent Form
(Paragraph Number)
Is there a description of the PHI to be used?
Is there identification of who PHI will use by or disclosure to?
Is there statement regarding the subjects right to see and copy their medical
information?
Is the purpose of the use or disclosure identified?
Is there an expiration date for the authorization (may use “end of study” or if the
study is establishing a database, may use “none”)?
Is there an expiration that PHI may be subject to re-disclosure or release to a third
party
Comments:
APPENDIX “D”
PALOMAR POMERADO HEALTH
INVESTIGATIONAL REVIEW COMMITTEE
CHECKLIST FOR REVIEW OF INFORMED CONSENT REQUIREMENTS
FOR EMERGENCY RESEARCH USING THE EXCEPTION FROM INFORMED CONSENT
REQUIREMENTS UNDER 21 CFR 50.24
Study Title:____________________________________________________________________________
______________________________________________________________________________________
Principal Investigator: ___________________________________________________________________
Date of Review: ________________________________________________________________________
Concurring Licensed Physician (not otherwise participating in the clinical investigation):
______________________________________________________________________________________
Date
Documented
by the PPH
IRC
Requirements of 21 CFR 50.24
The human subjects are in a life-threatening situation, available
treatments are unproven or unsatisfactory, and the collection of valid
scientific evidence, which may include evidence obtained through
randomized placebo-controlled investigations, is necessary to determine
the safety and effectiveness of particular interventions.
Obtaining informed consent is not feasible because:
a.
The subjects will not be able to give their informed consent as a
result of their medical condition;
b.
The intervention under investigation must be administered
before consent from the subjects’ legally authorized
representatives is feasible; and
c.
There is no reasonable way to identify prospectively the
individuals likely to become eligible for participation in the
clinical investigation.
Participation in the research holds out the prospect of direct benefit to
the subjects because:
a.
Subjects are facing a life-threatening situation that necessitates
intervention;
b.
Appropriate animal and other preclinical studies have been
conducted, and the information derived from those studies and
related evidence support the potential for the intervention to
provide a direct benefit to the individual subjects, and;
c.
Risks associated with the investigation are reasonable in relation
to what is known about the medical condition of the potential
class of subjects, the risks and benefits of standard therapy, if
any, and what is known about the risks and benefits of the
proposed intervention or activity.
Supporting
Documents
Date
Documented
by the PPH
IRC
Requirements of 21 CFR 50.24
The clinical investigation could not practicably be carried out without
the waiver.
The proposed investigational plan defines the length of the potential
therapeutic window based on scientific evidence, and Investigator has
committed to attempting to contact a legally authorized representative
for each subject within that window of time and, if feasible, to asking the
legally authorized representative contacted for consent within that
window rather than proceeding without consent. The investigator will
summarize all efforts made to contact legally authorized representatives
and the results of such efforts and make this information available to the
IRC at the time of continuing review.
The IRC has reviewed and approved informed consent procedures and
an informed consent document consistent with 21 CFR 50.25. These
procedures and the informed consent document are to be used with
subjects or their legally authorized representatives in situations where
use of such procedures and documents is feasible. The IRC has
reviewed and approved procedures and information to be used when
providing an opportunity for a family member to object to a patient’s
participation in the clinical investigation consistent with this section.
Additional protections of the rights and welfare of the subjects will be
provided, including, at least:
a.
Consultation (including, where appropriate, consultation carried
out by the IRC) with representatives of the communities in
which the clinical investigation will be conducted and from
which the subjects will be drawn. Review of community
consultation plans will ensure that they: 1) are designed to
reach the communities identified in the investigational plan, 2)
will adequately inform the communities about the risks and
expected benefits of the research, 3) will provide an
opportunity for community members to express their views and
ask questions about the proposed research, 4) will provide a
summary of how concerns of the community members were
addressed, 5) are comprehensive enough to ensure complete
disclosure of the study during the community consultation, 6)
will offer the opportunity for individuals who wish to be
excluded from the study to indicate this preference. Some or
all of the members of the IRC may attend the consultation
activities in order to hear firsthand the perspectives and
concerns of the communities. The IRC shall provide
consideration of the community concerns and/or objection to
the research following community consultation. The IRC shall
document that consultation has occurred and consider
community discussion when reviewing the investigational
plans.
b.
Public disclosure to the communities in which the clinical
investigation will be conducted and from which the subjects
will be drawn, prior to initiation of the clinical investigation, of
plans for the investigation and its risks and expected benefits.
The IRC shall review the information that the investigator or
sponsor will publicly disclose to assure that: it will reach the
broader communities involved, will adequately inform them of
Supporting
Documents
Date
Documented
by the PPH
IRC
Requirements of 21 CFR 50.24
c.
d.
e.
the plans to conduct the investigation, will adequately
communicate the risks and expected benefits, contains adequate
information to describe the nature and purpose of the study,
and clearly describes the fact that informed consent will not be
obtained for most study subjects. The IRC shall document that
public disclosure has taken place prior to the initiation of the
investigation and following its completion.
Public disclosure of sufficient information following
completion of the clinical investigation to apprise the
community and researchers of the study, including the
demographic characteristics of the research population, and its
results. Disclosure of sufficient information may require
multiple efforts to publicize the study results in order to
provide adequate public access to as much information as
possible. The IRC shall be fully informed of the methods and
content of the public disclosures both prior to and following
completion of the study. Any feedback received following the
public disclosure shall also be provided to the IRC for review
and consideration.
Establishment of an independent data monitoring committee (or
DSMB) to exercise oversight of the clinical investigation; and
If obtaining informed consent is not feasible and a legally
authorized representative is not reasonably available, the
investigator has committed, if feasible, to attempting to contact
within the therapeutic window the subject’s family member
who is not a legally authorized representative, and asking
whether he or she objects to the subject’s participation in the
clinical investigation. The investigator will summarize efforts
made to contact family members and make this information
available to the IRC at the time of continuing review.
The IRC will ensure that procedures are in place to inform, at the earliest
feasible opportunity, each subject, or if the subject remains
incapacitated, a legally authorized representative of the subject, or if
such a representative is not reasonably available, a family member, of
the subject’s inclusion in the clinical investigation, the details of the
investigation and other information contained in the informed consent
document. The IRC will also ensure that there is a procedure to inform
the subject, or if the subject remains incapacitated, a legally authorized
representative of the subject, or if such a representative is not reasonably
available, a family member, that he or she may discontinue the subject’s
participation at any time without penalty or loss of benefits to which the
subject is otherwise entitled. If a legally authorized representative or
family member is told about the clinical investigation and the subject’s
condition improves, the subject is also to be informed as soon as
feasible. If a subject is entered into a clinical investigation with waived
consent and the subject dies before a legally authorized representative or
family member can be contacted, information about the clinical
investigation is to be provided to the subject’s legally authorized
representative or family member, if feasible. Details regarding the
method and content of all communication to legally authorized
representatives or family members shall be provided to the IRC for
review and consideration.
Supporting
Documents
Date
Documented
by the PPH
IRC
Requirements of 21 CFR 50.24
The IRC determinations required by the leading paragraph of this section
and the documentation required by this section are to be retained by the
IRC for at least three (3) years after completion of the research or
clinical investigation.
Protocols involving an exception to the informed consent requirement
under this section must be performed under a separate investigational
new drug application (IND) or investigational device exemption (IDE)
that clearly identifies such protocols as protocols that may include
subjects who are unable to consent. The submission of these protocols
in a separate IND/IDE is required even if an IND for the same drug
product or an IDE for the same device already exists. Applications for
investigations under this section may not be submitted as amendments.
If the IRC determines that it cannot approve a clinical investigation
because the investigation does not meet the criteria in the exception
provided under this section or because of other relevant clinical
concerns, the IRC will document its findings promptly in writing to the
clinical investigator and to the sponsor of the clinical investigation. The
sponsor of the clinical investigation must promptly disclose this
information to the FDA and to the sponsor’s clinical investigators who
are participating or are asked to participate in this or a substantially
equivalent clinical investigation of the sponsor, and to other IRBs that
have been, or are, asked to review this or a substantially equivalent
investigation by that sponsor
Comments:
Supporting
Documents
APPENDIX “E”
PALOMAR POMERADO HEALTH
INVESTIGATIONAL REVIEW COMMITTEE
CHECKLIST FOR REQUEST FOR HIPAA WAIVER OF AUTHORIZATION
STUDY TITLE: _________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
Requirements of §164.508 for use or disclosure of protected health information:
The PPH IRC must determine that the alteration or waiver of authorization to PHI, in whole or part, satisfies the
following criteria:
A. The use or disclosure of protected health information involves no more than a minimal risk to the
privacy of individuals, based on, at least, the presence of the following elements:
i. An adequate plan to protect the identifiers from improper use and disclosure;
ii. An adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the
research, unless there is a health or research justification for retaining the identifiers or such
retention is otherwise required by law; and
iii. Adequate written assurances that the protected health information will not be reused or disclosed to
any other person or entity, except as required by law, for authorized oversight of the research study,
or for other research for which the use or disclosure of protected health information would be
permitted by regulation;
B. The research could not practicably be conducted without the waiver or alteration; and
C. The research could not practicably be conducted without access to and use of the protected health
information.
Please complete the following checklist:
1.
Completely describe the identifiable health information that will be accessed under this waiver:
2.
Who will have access to the information?
3.
Are the persons who have access to the information required to sign confidentiality
statements?
What identifiers are included on the information you plan to use and/or disclose?
4.
5.
In what form will the information be maintained?
Paper
Electronic
Both
Yes
No
6.
If the information is in paper format, describe the precautions you are taking to protect the identifiers
from improper use and disclosure:
NA
7.
If information is in an electronic medium, are passwords required?
NA
Yes
No
8.
Is access to the information restricted to only those who have a need to know for performance
of their job?
Yes
No
9.
Is this electronic system used to transmit data outside of your site?
Yes
No
10.
If information is transmitted, what safeguards does your system have to prevent inadvertent access to this data?
11.
When do you plan to destroy the identifiers? (Identifiers must be destroyed at the earliest opportunity)
End of Study
years after the end of the study.
Other (please specify):
12.
Other than you and your research staff, who else will have access to this information?
13.
Please explain how your research meets the following criteria for a waiver:
1.
This research cannot be practicably carried out without the Waiver of Authorization.____________
________________________________________________________________________________
_
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
_____
2.
Comments:
This research cannot practicably be conducted without the participants’ PHI.
________________________________________________________________________________
_
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
_____
APPENDIX “F”
PALOMAR POMERADO HEALTH
INVESTIGATIONAL REVIEW COMMITTEE
CHECKLIST FOR REQUEST FOR WAIVER OF
REQUIREMENT TO OBTAIN INFORMED CONSENT OR
WAIVER OF DOCUMENTATION OF INFORMED CONSENT
STUDY TITLE: _________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
The IRC may waive the requirement for the investigator to obtain a signed consent form for some or all subjects
or grant a waiver of the documentation of informed consent.
If the answer to any items is “no” then the study does not meet the criteria for waiver of informed consent or
waiver of documentation of informed consent.
Yes
No
The research involves no procedures for which written consent is normally
required outside the research context.
Yes
No
Either:
1.
The only record linking the subject and the research would be the consent
document and the principal risk would be potential harm resulting from a
breach of confidentiality. Each subject will be asked whether the subject
wants documentation linking the subject with the research, and the
subject's wishes will govern, or
2.
That the research presents no more than minimal risk of harm to subjects,
and involves no procedures, for which written consent is normally required
outside of the research context.
Yes
No
The waiver or alteration will not adversely affect the rights and welfare of the
subjects. Explain:
Yes
No
The research could not practicably be carried out without the waiver or
alteration. Explain:
Yes
No
Whenever appropriate, the subjects will be provided with additional pertinent
information after participation. Explain and provide a sample:
Yes
No
The IRC may require a written statement regarding the research be provided to
subjects. Enclose a sample of what would be provided to subjects should this be
required by the IRC.
APPENDIX “G”
PALOMAR POMERADO HEALTH
INVESTIGATIONAL REVIEW COMMITTEE
DISCLOSURE OF AFFILIATION / POSITION / FINANCIAL INTEREST
If a principal investigator has a position or affiliation with the sponsoring organization of the investigational
study, this does not automatically prevent approval of the protocol and informed consent. However, in
accordance with the Investigational Review Committee Operational Procedures, the investigator shall disclose
any affiliation or position held with (paid or unpaid) or any financial interest in the sponsoring company whose
product is involved with the study to the PPH Investigational Review Committee.
Study Title:_______________________________________________________________________
_________________________________________________________________________________
Sponsoring Company: ______________________________________________________________
_________________________________________________________________________________
___________
I do not hold any affiliation or position with or have any financial interest in the sponsoring
company of the investigational study for which I will be serving as the principal investigator.
Signature: __________________________________________
____________
Date: ___________________
I do hold an affiliation or position with or have a financial interest in the sponsoring company
of the investigational study for which I will be serving as the principal investigator.
Affiliation/Financial Interest
____________
____________
____________
____________
Recipient of Research Support
Consultant
Shareholder
Other Affiliation or Financial Interest: ____________________________________
Position Held with Sponsoring Company
____________________________________________________________________
Explain in detail the nature of the affiliation, position or financial interest on a separate sheet.
Sign, date and attach it to this form.
Signature: __________________________________________
Date: ____________________
APPENDIX “H”
PALOMAR MEDICAL CENTER/POMERADO HOSPITAL
INVESTIGATIONAL REVIEW COMMITTEE
ANNUAL INVESTIGATOR’S UPDATE REPORT FORM
PROTOCOL TITLE: _____________________________________________________________________
PRINCIPAL INVESTIGATOR: ____________________________________________________________
ASSOCIATE INVESTIGATORS: __________________________________________________________
SPONSOR: ____________________________________________________________________________
STUDY LOCATION:
_____
Palomar Medical Center
_____ Pomerado Hospital
DATE STUDY IMPLEMENTED: __________________________________________________________
DATE OF LAST REPORT TO IRC: ________________________________________________________
Investigator’s Signature: ______________________________________________
Submission Date: _____________________________________________________
Please answer the following questions and return this form to the Medical Staff Services office at Palomar
Medical Center prior to the date of the next Investigational Review Committee meeting. Please plan on
attending this meeting or sending a representative who can discuss the study with the Committee members.
1.
How many patients have been enrolled in your study? _____________________
2.
How many patients have been dropped from the study? ___________.
Why were they dropped? _________________________________________________________
_____________________________________________________________________________
3.
Do you anticipate additional patients being enrolled? _____ Yes
If yes, how many? _____________
4.
Have any unexpected adverse effects been experienced by your patients?
____ Yes ______ No
If yes, describe any events that in your opinion were possibly or directly related to the protocol.
______________________________________________________________________________
______________________________________________________________________________
_____________________________________________________________________________
5.
Have any adverse effects been described in the medical literature, by the
manufacturer or from any other source and brought to your attention?
_____Yes
______ No
If yes, describe those adverse effects that were brought to your attention. ___________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
_____ No
6.
Have these adverse effects been added to your consent form?
______ Yes
______ No
If yes, enclose a copy of the revised consent form.
7.
Do you intend to continue this protocol?
______ Yes
______ No
If yes, approximately what date do you anticipate closure of enrollment? ____________________
______________________________________________________________________________
8.
Has this drug, device or procedure been approved by the FDA for commercial
use?
______ Yes
______ No
9.
Are the informed consents adequate?
______ Yes
______ No
Please provide a copy of the informed consent that you are currently using.
10. Are any results of the study available to date?
______ Yes
______ No
If so, please briefly summarize the results. ____________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________