OSF St. Joseph Medical Center
Institutional Review Board Committee
Investigational Project Guidelines
IRB Registration #:IRB00004207
Federalwide Assurance #: FWA00006354
SJMC Institutional Review Board
TABLE OF CONTENTS
INTRODUCTION................................................................................................ 3
RESPONSIBILITIES OF INVESTIGATORS ...................................................... 4
PROJECT/PROTOCOL REVIEW REQUIREMENTS ........................................ 5
PROJECT/PROTOCOL INFORMATION ........................................................... 6
INFORMED CONSENT ................................................................................... 10
1.
2.
3.
BASIC ELEMENTS OF INFORMED CONSENT .............................. 10
ADDITIONAL ELEMENTS OF INFORMED CONSENT .................. 11
SHORT FORM CONSENT ....................................................................12
ANNUAL/STATUS REPORT REQUIREMENTS ............................................. 13
TERMINATION OF PROJECT/PROTOCOL ................................................... 14
CLOSURE OF PROJECT/PROTOCOL .......................................................... 14
APPENDIX 1 – ANNUAL(CONTINUING) REPORT ........................................ 15
APPENDIX 2 – FINAL (CLOSING) REPORT .................................................. 16
INSTITUTIONAL REVIEW BOARD MEMBERSHIP 2007 .. Error! Bookmark not
defined.
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SJMC Institutional Review Board
INTRODUCTION
In accordance with 21 CFR 50, any activity involving human subjects (whether
funded or not) must be reviewed and approved by the Institutional Review Board.
This review and approval must be granted prior to beginning the proposed activity.
One of the Institutional Review Board’s main functions in reviewing such activity is to
determine the degree of risk to subjects. Risk exists when a subject may be
exposed to any possible physical, psychological, or other harm as a result of any
activity that is not an accepted and established psychological, or other harm as a
result of any activity that is not an accepted and established method of meeting the
subject’s needs. In addition to physical risk, any procedures involving discomfort,
anxiety, invasion of privacy, or other threats to the subject’s dignity fall under the
purview of the Institutional Review Board. Thus, the Institutional Review Board will
assess risk for:
1. Experimental activities including surgery, biopsy, new devices, drugs, organ
transplants, and other innovations.
2. Use of materials such as organs, body fluids, and tissues obtained during
routine procedures.
3. Trainee education and/or demonstration projects.
4. Use of stored data, such as medical records, that may have been obtained for
other purposes.
If the Institutional Review Board determines that an activity will expose a subject to
risk, the Board will assure that:
1. The rights and welfare of the subjects are protected.
2. The methods used to obtain the subject’s informed consent are appropriate.
3. The potential benefits for the subject and/or society, to knowledge, outweigh
the risks.
The Institutional Review Board may request information on any aspect of a
proposed activity. As part of the review process, the Institutional Review Board may
seek the advice of consultants, request supplementary information, and may request
demonstration of the activity. All criteria must be met for the Institutional Review
Board to consider approval of the proposed biomedical or behavioral research
activity. The Institutional Review Board will also request regular progress reports for
approved activities and immediate reporting of any unforeseen complications or
adverse reactions.
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RESPONSIBILITIES OF INVESTIGATORS
Approval by the St. Joseph Medical Center Institutional Review Board means that
the Institutional Review Board has agreed to monitor the project. The investigator
assumes a specific set of responsibilities to the Institutional Review Board that are in
addition to those due the human subjects in his/her project.
1. To conduct the research project within the framework described in the
Protocol and Project/protocol Information documents.
2. To adhere to all IRB/HIPPA guidelines for research investigators and submit
to IRB/HIPPA training and making sure evidence of that training is
documented in the Investigators file at St. Joseph Medical Center.
3. To deviate from the approved protocol only for the safety of a patient unless
prior permission has been obtained from the committee.
4. To enter only patients with freely-given informed consent.
5. To use only the Consent Form approved by the IRB.
6. To send to the Chairman, as soon as possible, a written report of any
occurrence of:
a. adverse reaction or untoward response.
b. changes to the protocol or warnings issued by the sponsor or other
agency along with Revised Informed Consent if indicated.
c. Any deviation from the protocol required for patient safety.
7. To submit, in a timely manner, a final overall review of the project upon
completion or termination.
8. To maintain records so that the Board may readily and rapidly review all
medical information on the patients participating in the study, as well as those
patients who declined participation.
9. To fulfill any other reasonable request the Board might make for the
monitoring of research projects.
The Board has the right and duty to terminate a research project or to prohibit future
research by any Investigator who does not fulfill his/her responsibilities.
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PROJECT/PROTOCOL REVIEW REQUIREMENTS
For Institutional Review Board review of a project/protocol:
1. The Institutional Review Board Chairman should first be notified of your
intent.
2. The following materials will need to be submitted.
a. one copy of the formal protocol to the IRB Secretary
b. one copy of the Principal Investigator’s Curriculum Vita, along with any
additional information on the Investigator’s experience in this research
area, and financial disclosure form.
c. one copy of the Informed Consent.
d. One copy of the completed Project/Protocol Information sheets.
e. Documentation of HIPAA training from each person involved in the
study. A certificate of HIPAA training completion should be
submitted and on file in the IRB office.
Upon receipt of the above material, you will be notified of the date, time,
and place of the Institutional Review Board meeting at which your
project/protocol will be reviewed and if any additional copies are needed.
Your attendance is required.
3. Special Considerations:
a. Investigational New Drugs – If any investigational drug is to be used,
the Principal Investigator will need to obtain the Sponsor’s Manual
which is to be submitted in addition to the items listed in 2 above. The
manual will be retained by the hospital pharmacy for the duration of the
drug trial and distribution of the drug will occur through the hospital
pharmacy.
b. Intraocular Lenses – Each individual intraocular lens manufacturer’s
protocols will be reviewed. Any additional material required by the
individual manufacturers (which may vary from one manufacturer to
another) is the responsibility of the investigator.
c. Funding – If a project is contingent upon funding, the Institutional
Review Board Chairman is to be notified when funding is obtained and
when the project will then begin.
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PROJECT/PROTOCOL INFORMATION
Principal Investigator
Address
Telephone
Co-Investigator(s)
(Use Additional Sheet for other co-investigators)
Address
Telephone
Title of Project/Protocol
Project/Protocol Sponsor
Address
Telephone
Contact
Faculty Sponsor
(If student investigator)
Funding agency to which
project will be submitted
and/or funding sources
Projected date of start-up
Has the project/protocol
been previously reviewed
by the Institutional Review
Board?
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Indicate which of the
following will be involved in _______ Patients as experimental subjects
your project/protocol.
_______ Patents as control subjects
_______ Non-patient volunteers
_______ Students as subjects
_______ Pregnant subjects
_______ Subjects under 18 years of age
_______ Mentally disabled subjects.
_______ Subjects studied away from St. Joseph Medical Center
_______ Filming, recording subjects
_______ Experimental drugs
_______ Approved drugs for new uses
_______ Placebo(s)
_______ Questionnaires, Psychological tests
_______ Data, medical records, etc.
_______ Radiation
_______ Subjects to be paid
_______ Charges incurred by subjects
_______ Charges to third parties
_______ Fetal or placental tissue
_______ Autopsy tissue
_______ Surgical pathology tissue
_______ Experimental devices
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1.
What is the purpose of the study?
2.
Are results of prior investigations adequate to support a conclusion that it
is reasonably safe to begin the study?
3.
How will subject be selected and enrolled in the project/protocol?
4.
How will subject be assigned to the control and experimental groups
(study design)?
5.
Describe the procedures to be performed, with identification of those
considered to be “experimental” or “innovative.”
6.
What are the potential benefits?
7.
What potential side effects or adverse reactions could arise from the
subject’s participation?
8.
What alternatives are available that might benefit the participant?
9.
What method of informed consent do you plan to use to assure that the
rights of human subjects are properly protected and subjects are properly
informed of the significant aspects of the study? (Attach proposed consent
Form).
10.
Will there be any cost to the participant and/or insurer as a result of
participation?
11.
Is there any compensation to be paid to subject (provide full details).
12.
What clinical laboratory facilities and medical support are available to
assure that the study will be conducted properly and in conformance with
the investigational plan and to assure the safety of the subject?
13.
How will medical care be provided in the event of an adverse reaction or
problem arising from the subject’s participation in the project/protocol?
14.
What provisions have been made for informing the subject’s primary
physician of his/her response (if the investigator is not the primary
physician)?
15.
How will confidentiality of data be maintained and how will data be stored
and retained?
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16.
How will records be kept so that the results of the study will be described
clearly?
17.
Statistics, patient accrual, length of stay, schema.
18.
Do you or any other person “responsible for the design, conduct, or
reporting of this research have an economic interest in, or act as an officer
or a director of any outside entity whose financial interests would
reasonably appear to be affected by the research?” If “yes” please
describe.
19.
Describe where and how information relating to human subjects will be
stored and maintained in order to guard their privacy.
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INFORMED CONSENT
For each project/protocol, the Principal Investigator must submit to the Institutional
Review Board the consent form(s) and/or the script for any verbal explanation given.
Participation in a study will not be permitted unless the subject gives his/her written
consent; retroactive consent will not be permitted. The consent form(s) and verbal
information should be clear, legible, and in simple terms, containing the following
(taken directly from 21 CFR 50.25):
1. BASIC ELEMENTS OF INFORMED CONSENT
In seeking informed consent, the following information shall be provided to
each subject:
a.
A statement that the study involves research, an explanation of the
purposes of the research and the expected duration of the subject’s
participation, a description of the procedures to be followed, and
identification of any procedures which are experimental.
b.
A description of any reasonable foreseeable risks or discomforts to the
subject. In the event of a research related injury the investigator must
“inform the subject of any harmful consequences that may be
experienced.”
c.
A description of any benefits to the subject or to others which may be
reasonably expected from the research.
d.
A disclosure of appropriate alternative procedures or courses of treatment,
if any, that might be advantageous to the subject.
e.
A statement describing the extent, if any, to which confidentiality or
records identifying the subject will be maintained and that notes the
possibility that the Food and Drug Administration may inspect the records.
f.
For research involving more than minimal risk, an explanation as to
whether any compensation and an explanation as to whether any medical
treatments are available if injury occurs, and, if so, what they consist of, or
where further information may be obtained.
The following statement is to be included: “OSF St. Joseph medical
Center does not compensate for injuries incurred as a result of
participating in biomedical or behavioral research. In the event of
injury or illness resulting from research procedures, emergency
medical treatment, necessary medical care and/or hospitalization will
not be provided free of charge but must be paid for in the same way
your regular medical care is paid. The routine follow-up by the nurse
will be provided to you free of charge. We cannot pay you to take
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part in these studies. The parts of the research consisting of keeping
records will be paid by those organizing and conducting the research.
g.
A statement describing the projected time span for this study.
h.
An explanation of whom to contact for answers to pertinent questions
about the research and research subject’s rights, and whom to contact in
the event of a research-related injury to the subject.
(i.e. If you have any questions regarding this study or if you experience
any side effects or medical problems contact your study physician,
physician’s name at phone number). For the IRB please include a
statement in this section: i.e. “If you have questions about your rights
as a research subject, you may call: Robert H. Hoy, PharmD, Chair,
OSF St. Joseph Medical Center, Institutional Review Board at
(309)665-5781.”
i.
A statement that participation is voluntary, that refusal to participate will
involve no penalty or loss of benefits to which the subject is otherwise
entitled, and that the subject may discontinue participation at any time
without penalty or loss of benefits to which the subject is otherwise
entitled.
2. ADDITIONAL ELEMENTS OF INFORMED CONSENT
When appropriate, one or more of the following elements of information shall
also be provided to each subject in the informed consent:
a.
A statement that the particular treatment or procedure may involve risks to
the subject (or to the embryo or fetus, if the subject is or may become
pregnant) which are currently unforeseeable.
(i.e. My physician has explained that this research may be
hazardous to an unborn child. If I/my partner become pregnant
while undergoing this research treatment/therapy, there may be
injury to my baby. It is understood that by my agreement to
participate in this clinical trial I/my partner will continue to take
acceptable means to avoid pregnancy throughout the duration of
the study.)
b.
Anticipated circumstances under which the subject’s participation may be
terminated by the investigator without regard to the subject’s consent.
c.
Any additional costs to the subject that may result for participation in the
research.
d.
The consequences of a subject’s decision to withdraw from the research
and procedures for orderly termination of participation by the subject.
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e. A statement that significant new findings developed during the course of
research which may relate to the subject’s willingness to continue
participation will be provided to the subject.
f.
The approximate number of subjects involved in the study.
3. SHORT FORM CONSENT
A short form written consent document may be utilized provided that:
a.
The elements of informed consent as noted above have been presented
orally to the subjects or legally authorized representative and this is stated
in the document.
b.
There is a witness to the oral presentation.
c.
The Institutional Review Board has approved a written summary of what is
to be said to the subject or representative.
d.
Only the short form is signed by the subject.
e.
The witness shall sign both the short form and a copy of the summary.
The person obtaining the informed consent shall sign a copy of the
summary.
f.
A copy of the summary and the short form shall be given to the subject or
representative.
4.
THE INFORMED CONSENT REQUIREMENTS IN THESE REGULATIONS
ARE NOT INTENDED TO PREEMPT ANY APPLICABLE FEDERAL, STATE,
OR LOCAL LAWS WHICH REQUIRE ADDITIONAL INFORMATION TO BE
DISCLOSED FOR INFORMED CONSENT TO BE LEGALLY EFFECTIVE.
5.
NOTHING IN THESE REGULATIONS IS INTENDED TO LIMIT THE
AUTHORITY OF A PHYSICIAN TO PROVIDE EMERGENCY MEDICAL CARE
TO THE EXTENT THE PHYSICIAN IS PERMITTED TO DO SO UNDER
APPLICABLE FEDERAL, STATE, OR LOCAL LAW.
6.
PATIENTS WHO ARE PARTICIPATING IN A RESEARCH PROTOCOL
SHALL HAVE A COPY OF THE PROJECT/PROTOCOL INFORMED
CONSENT FORM AS PART OF THE MEDICAL RECORD ON ADMISSION.
Note:
Each subject participating in a study is to receive a signed copy of the
informed consent [required per 21 CFR 50.27(c)].
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ANNUAL/STATUS REPORT REQUIREMENTS
A written Annual Report or Status Report will be required for the duration of each
project/protocol, the frequency of which will be determined at the time of Institutional
Review Board approval, but under no circumstances less than once per year [per 21
CFR 56.109 (c)]. One copy of Appendix 1 information will be required:
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TERMINATION OF PROJECT/PROTOCOL
CLOSURE OF PROJECT/PROTOCOL
When a project is completed, discontinued or other circumstances arise requiring
the principal investigator to withdraw from an approved study, the Institutional
Review Board Chairman is to be notified in writing of such completion,
discontinuation or withdrawal within thirty (30) days.
After notification a final report is to be submitted containing the following information
from Appendix 2.
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APPENDIX 1
ANNUAL (CONTINUING) REPORT
Sponsored by:
Principal Investigator:
Sub-Investigator(s):
[ STUDY TITLE: ]
1. Consent form currently in use (note any changes made since the last report to the
IRB).
2. Description of any changes made to the protocol since the last report to the IRB.
Protocol Date
Amendment Number
IRB Approval Date
3. A detailed Continuing (Annual) Review report, including: (We expect there to be a
statement for each of the following)
a. Number of subjects enrolled (male / female breakdown)
____ (Total number enrolled) ____ (female) ____ (male)
b. Of those subjects enrolled, it should be noted if any subject falls into any of the
following categories: minors, pregnant women, prisoners, mentally retarded or
mentally handicapped.
c. Whether or not there were problems encountered with obtaining subjects for
enrollment or in obtaining informed consent.
d. Whether or not there have been any adverse reactions, compliance, or problems
encountered during this period.
e. Whether or not there have been any benefits obtained to date?
f. A description of any protocol deviation(s) that may have occurred during this
period.
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APPENDIX 2
FINAL (CLOSING) REPORT
Sponsored by:
Principal Investigator:
Sub-Investigator(s):
[ STUDY TITLE: ]
1. Consent form currently in use (note any changes made since the last report to the
IRB).
2. Description of any changes made to the protocol since the last report to the IRB.
Protocol Date
Amendment Number
IRB Approval Date
3. A detailed Final (Closing) Report, including: (We expect there to be a statement for
each of the following)
g. Number of subjects enrolled (male / female breakdown)
____ (Total number enrolled) ____ (female) ____ (male)
h. Of those subjects enrolled, it should be noted if any subject falls into any of the
following categories: minors, pregnant women, prisoners, mentally retarded or
mentally handicapped.
i. Whether or not there were problems encountered with obtaining subjects for
enrollment or in obtaining informed consent.
j. Whether or not there have been any adverse reactions, compliance, or problems
encountered during this period.
k. Whether or not there were any benefits obtained?
l. Procedure for follow up of enrolled patients. (This information may need to be
available to the SJMC IRB upon their request.)
m. Any other information of interest.
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Ex-Officio Member:
Kenneth J. Natzke, Administrator
St. Joseph Medical Center
Recording Secretary: Linda Zimmerman
OSF St. Joseph Medical Center
2200 E. Washington Street
Bloomington, IL 61701
(309)665-5781
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