Institutional Review Board (IRB)
Overview for Medical, Behavioral
and Educational Research
Jack Medendorp M.S., B.S.N., CIP.
Office of Regulatory Research Compliance
Drexel University
DISCUSSION POINTS
Regulatory Oversight
What is Research?
Levels of IRB Review
Qualifications and Training
Application Process
Investigator Responsibilities
2
Regulatory Research
Environment
The last few years have witnessed increased public and
governmental scrutiny of research involving human subjects
resulting in a move towards significant enhancement in
regulatory and ethical standards to ensure that researchers,
sponsors and funding agencies operate in accordance with all
applicable regulations
Therefore, in this enterprise, researchers, institutions and funding
agencies have the heavy responsibility to keep research subjects
out of harms way.
An important consideration in this environment is:
Grasp of regulatory issues
Compliance by researchers and others involved in this
enterprise
Gain public acceptance and confidence
3
Consequences of Improper Conduct
Reputational damage to:
– Research focus and advancing research
– Researcher and his/her institution = financial
hardship (loss of funding, etc.)
Litigation
Regulatory sanctions
Fundamentally unethical
All of the above force us to reexamine concepts of:
Personal responsibility
Ethical or legal culpability
4
Office of Regulatory
Research Compliance
(ORRC) Objectives
Operate in accordance to all Federal, State, local regulations
 Office for Human Research Protections (OHRP) guidelines
CFR 45.46
HHS/NIH supported clinical and non-clinical research
 Food and Drug Administration (FDA) Code of Federal Regulations
(21 CFR Part 50, 54, 56, and 312)
Drug, Devices, Biologicals, Radiological
 Health Insurance Portability and Accountability Act (HIPAA)
Protection of personal, identifiable health information
 Drexel University policies and IRB guidelines
Encompass all areas of research
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ORRC Objectives
Oversight of all Investigator research activities:
– Provide assistance and guidance to investigators
– Ensure ethical conduct and compliance in
performance of research in the following areas:
Human subject protection
– Adults, Children and Vulnerable Populations
Promote responsible conduct of research
– Consideration for subject safety, ethics, and
integrity
Oversight of Behavioral, Educational and Medical
research
Conflict of Interest (determination and
avoidance)
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What Is Research?
Research means a systematic investigation,
including research development, testing and
evaluation, designed to develop or contribute to
generalizable knowledge. Activities which meet
this definition constitute research for purposes
of this policy, whether or not they are conducted
or supported under a program which is
considered research for other purposes. For
example, some demonstration and service
programs may include research activities.
HHS regulations define research at 45 CFR 46.102(d)
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Types of Research
Requiring IRB Review
STUDIES INVOLVING:
Human subjects or information derived from human subjects that is
about that subject (sensitive surveys and questionnaires)
Human tissues and specimens specifically, and prospectively
collected for purposes of research
Data and confidential information from human subjects which is
identifiable
Any type of research that may place the subject at minimal to more
than minimal risk
Studies involving vulnerable populations
– Prisoners, pregnant women and fetuses, children, emotionally
challenged or deficient.
8
Who decides whether an IRB review and
approval is required?

OHRP has recommended that investigators not be given the
authority to make an independent determination that research
does not involve human subjects

Therefore, all investigators irrespective of whether their study
involves human subjects or not, must submit their application to
the ORRC for a determination to be made whether the proposed
study is research and whether it involves humans subjects

The individuals who are authorized to make this decision at
Drexel University and Drexel University College of Medicine are:
IRB Chairs or Chair’s designees
Vice Provost for Research Compliance
Assistant Director for Research Compliance
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What is an IRB?
Usually, a voluntary administrative board which has the authority
to approve, request modifications to, or disapprove research
involving human subjects or information derived from human
subjects.
IRBs are federally mandated to ensure that human subject
research is conducted in accordance with federal regulations
(Common Rule) and rights of subjects are protected.
Federal regulations require that all research involving human
subjects or analysis of data gathered from human subjects
including data mining, surveys, clinical records and charts,
regardless of funding source/status be reviewed by the IRB PRIOR
to the implementation of any research activity.
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Drexel University College of
Medicine IRB Committees
DUCOM research oversight is registered with
DHHS under the Assurance for Drexel University
College of Medicine.
Four separate IRBs:
IRB #1- Adult Medical/Psychological Trials
IRB #3- Adult Behavioral/Educational/Social
IRB #4- Children Medical/Psychological Trials
Western IRB (WIRB)- Multicenter Sponsored
Clinical Trials
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Meeting Dates
DUCOM IRB’s
IRB #1 meets every 1st and 3rd Wednesday of each
month, alternating between 1601 Cherry St. and
Hahnemann University Hospital/NCB.
IRB# 3 meets every 3rd Thursday of each month
scheduled at Drexel University and 1601 Cherry St.
IRB#4 meets every 3rd Wednesday of each month at St.
Christopher’s Hospital for Children.
WIRB has 14 committees and meets weekly
12
IRB MEETING DEADLINES
Meeting dates and deadlines for submission for full
board meetings are posted on the Office of Regulatory
Research Compliance Website
www.research.drexel.edu/compliance
There are NO deadlines for Exempt and Expedited
review applications.
WIRB deadlines: Contact WIRB directly at
www.WIRB.com
13
IRB Levels of Review
Study may fall within the guidelines of one of
the following levels of review:
Case study or case review
Exempt from IRB review (less than minimal risk)
Expedited review (minimal risk)
Full review (more than minimal risk) requiring
rigorous review of risks and benefits by
convened IRB
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IRB Levels of Review
Case study and Case reports
– Three or fewer patients, are prepared for the purpose
of illustrating some points in the care of a patient, to
educate and formulate new research questions which
may eventually lead to generalizable knowledge.
Examples:
–
–
–
–
–
–
Uncommon observations
Report of a new condition, treatment and follow up
Report of a familial condition with a proposed mode of inheritance
Questions regarding a new theory
Unusual combination of conditions or events that cause confusion
Adverse responses to therapies
15
IRB Levels of Review
Exempt:
–
–
–
–
–
Category
Category
Category
Category
Category
1:
2:
3:
4:
6:
Categories 1-6
Research involving normal educational practices
Educational tests, surveys, questionnaires
Survey and interview of public officials
Use of existing records/data/biological samples
Taste and food quality evaluations
– Rarely will involve consent of subject, may require use of HIPAA
waiver of authorization (biologic samples/specimens)
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IRB Levels of Review
Expedited Review
– No more than minimal risk to the human
subjects,
– According to Health and Human Services, 45 Code of Federal
Regulations, Part 46.102i, "minimal risk" means that the probability and
magnitude of harm or discomfort anticipated in the proposed research
are not greater in and of themselves from those ordinarily encountered
in daily life or during the performance of routine physical or
psychological examinations or tests. "Minimal Risk" does not include
administration of medication or use of any device placed inside the
body.
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IRB Levels of Review
Types of Expedited Review:
– Retrospective chart review with waiver of
consent and HIPAA waiver
– Prospective collection of health information
with informed consent inclusive of HIPAA
– Minimally invasive collection of human
specimens (venipuncture, prospective
collections of discardable tissue)
– Questionnaires and surveys of a sensitive
nature or with identifiers (may qualify for full)
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IRB Levels of Review
Full IRB review:
Projects for which the level of risk is determined by the principal
investigator or Chair of the IRB to be greater than minimal. (Minimal risk
means that the probability and magnitude of harm or discomfort anticipated
in the research are not greater in and of themselves than those ordinarily
encountered in daily life or during the performance of routine physical or
psychological examination(s) or test(s).
Examples: projects which involve deception, sensitive or protected
populations; e.g. minors, prisoners, fetuses, mentally disabled, test subjects
for new drugs or clinical devices, pregnant women, illegal behavior, or
legally incompetent persons
Investigational New Drugs
Investigational Devices
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QUALIFICATIONS AND TRAINING
Who can be a PI?
– Policy at DU/DUCOM requires a PI to be
Attending Physician
Faculty
Staff
Who can be a sub-investigator?
Fellows
Residents
Students
Research assistants
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Mandatory Training
Every Investigator, faculty member, staff or student directly
involved in the proposed research activity must complete the
appropriate Collaborative Institutional Training Initiative (CITI)
training modules before a research protocol is approved.
Beginning July 1st 2010, CITI training specific to your type of
protocol is required regardless of the type or level of IRB review
and approval.
Approval letters for new applications to the IRB, Periodic renewals
for continued enrollment or data analysis, and amendments to
protocol to add new personnel will not be released until the
necessary CITI training modules are complete.
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CITI Training Courses
DUCOM offers four (4) CITI training courses
1.
2.
3.
4.
CITI Human Subject Research (HSR) Training
• (All Investigators/Key Personnel)
CITI Good Clinical Practice (GCP)
• (drug, device or conducting clinical trials)
CITI Responsible Conduct of Research (RCR)
• (required for applicants to National Science
Foundation)
CITI Health Information Privacy and Security (HIPS)
• (All personnel accessing PHI)
All applicable CITI training courses require
recertification every two (2) years.
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Training Requirements
The required CITI training courses may be found at:
– www.research.drexel.edu/compliance or
– www.citiprogram.org
DUCoM specific guidance and FAQs may be found at
http://drexel.edu/research/compliance/training
Personnel with CITI training certificates completed at
non-DU/DUCOM institutions will be honored, though
additional modules may be required, and be renewed
every 2 years.
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Drexel Core Training Modules
Additional training courses may be required depending
upon:
– Use or access to Protected Health Information (HIPAA I & II)
– Use of surrogate, substitute or proxy consent process
DUCOM Core HIPAA and Surrogate consent training do not require
recertification
– Collection and processing of human specimens/tissues, (blood borne
pathogen, laboratory safety training)
– Shipping of human or animal specimens/tissues off campus,
Blood borne pathogen, Lab safety, and Shipping courses require
annual recertification
These Drexel Core training modules may be found at
www.research.drexel.edu/compliance OR
http://drexel.edu/research/compliance/training/
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The Process
Who can Assist you?
– Each committee has a specifically assigned IRB
Coordinator
Office of Regulatory Research Compliance
www.research.drexel.edu/compliance
Phone: 215 255-7857
Address:
1601 Cherry Street,
3 Parkway Bldg., Suite 10-444
Philadelphia, Pa 19102
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Working with the IRB
Pre-submission questions
Set up an appointment with ORRC
Attend monthly “lunch and learn” workshops, 2nd
Tuesday of every month with Jack Medendorp at 12
noon
Request for departmental meeting
Ask questions
Obtain information on how to complete forms
Obtain information on levels of review
Review status and follow up assistance for assistance with
your IRB Coordinator
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What does an IRB expect of
an application?
Consideration of how the substantive issues
& methods fit with ethical guidelines & IRB
requirements
Clarity in statement of problem, Research
Questions & Methods of data collection
Consistency in content of all documents
Completeness of all materials
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What Forms Do I Submit?
Case Study: (Original)
– CS application, HIPAA waiver, copy of the Case Study
Exempt: (Original and 1 copy)
–
–
–
–
–
–
Checklist
Category 1-6 application
Written proposal
Data collection tool/survey/questionnaire
Any advertisement/announcement
Letter of approval from the “Owner” of data/material
when the data is owned by an individual or entity
other than DU/DUCOM/Tenet
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What Forms Do I Submit?
Expedited Review: All applications must include
the following (Original and 3 copies)
–
–
–
–
–
–
–
–
Checklist
Transmittal form (ONLY IF FUNDED)
Written proposal
Full review/Expedited review form
Expedited certification form
Data collection tool/survey/questionnaire
Any advertisement or announcement
Internal indemnification form
SPECIAL NOTE:
– If your application is for pathologic samples, or chart review, use
their specific application form and NOT the combined form
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What Forms Do I Submit?
Expedited special circumstances:
– If your interaction and/or data collection is in
any way prospective you MUST consent the
subject by use of a consent form inclusive of
HIPAA authorization
– If your data collection is ONLY retrospective
then you MUST include a consent waiver and
HIPAA waiver of authorization
– Minors? Consent/Permission form and Assent
form
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What Forms Do I Submit?
Full Review: (Original and 3 copies)
–
–
–
–
–
–
Checklist
Transmittal form (ONLY IF FUNDED)
Written proposal
Investigator Brochure
Full review/Expedited review combined form
Consent for with HIPAA authorization
Minors? Consent/Permission form and Assent Form
– Data collection tool/survey/questionnaire
– Any advertisement or announcement
– Internal indemnification form
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Investigator Initiated Clinical
Trials and Research
New Committee: Investigator Initiated Study Advisory
(IISA) Committee
IISA reviews Investigator Initiated Clinical Trials and
Research proposals independently in advance of an IRB
application
– Committee evaluates investigator initiated protocols and
provides guidance to the investigator and university related to:
Risk and or need for university indemnification
Conflict of Interest
Funding and Cost Analysis
Need for infrastructure or manpower
Identify possible need for FDA/OHRP registrations (IND, IDE, Certificate of
Confidentiality)
May recommend Drexel IRB vs. WIRB review
Contact Jack Medendorp at 215-255-7859 for additional clarity.
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Investigator Initiated Clinical
Trials and Research
IISA guidelines and application instructions/forms may
be found at
http://www.research.drexel.edu/compliance/IRB/iisa.aspx
The IISA membership:
–
–
–
–
Clinical Research Group (CRG)
Office of General Counsel
Office of Regulatory Research Compliance
Additional experts/consultants as necessary
This process:
–
–
–
–
Should be done in advance of an IRB application,
The PI is invited to take part in the review,
The IISA is not an editorial review, and
IISA is independent of the IRB review process.
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How Long Does IRB Approval Take?
IT DEPENDS upon the level of review and the
investigator’s responses to IRB conditions.
Exempt and Expedited reviews generally take less
time than full board reviews.
In general, the turn around time may be improved
if investigators respond to IRB/ORRC questions.
Need assistance in responding to questions or
clarifications on questions, contact ORRC so the
office can help you resolve those questions
34
WHEN CAN I BEGIN MY
RESEARCH?
NO RESEARCH ACTIVITIES MAY
COMMENCE UNTIL:
 YOU HAVE RECEIVED YOUR IRB LETTER
OF APPROVAL, AND IF APPLICABLE,
 YOUR APPROVED AND STAMPED
CONSENT FORM
35
WHO CAN ASSIST WITH MY RESEARCH
ACTIVITIES AND CONSENTING OF
SUBJECTS?
Only investigators, sub-investigators and
research coordinators or assistants who
have been approved by the IRB for the
study, and have completed all relevant
training requirements.
36
WHO IS PERMITTED TO OBTAIN A
RESEARCH SUBJECT’S CONSENT?
ONLY THOSE QUALIFIED INDIVIDUALS
WHO:
– HAVE COMPLETED THEIR HUMAN SUBJECTS
RESEARCH TRAINING,
– HAVE SIGNED A CONFLICT OF INTEREST
STATEMENT,
– HAVE BEEN APPROVED BY THE IRB, AND
– WHOSE NAMES APPEAR IN THE SIGNATURE
SECTION OF THE CONSENT FORM.
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WHO IS RESPONSIBLE OF FOR THE
RESEARCH ACTIVITIES AND OUTCOMES?
THE PRINCIPAL INVESTIGATOR IS
RESPONSIBLE FOR ALL ACTIONS AND
ACTIVITIES OF ALL INDIVIDUALS WHO
CONTRIBUTE TO THE STUDY.
ANY MISCONDUCT, FAILURE TO FOLLOW THE
APPROVED PROTOCOL OR FAILURE IN
COMPLIANCE AND REPORTING IS THE
PI’s RESPONSIBILITY!
38
What happens after initial Approval?
How can I change the protocol after it is approved?
– Researcher submits for review all modifications or amendments
(if any and however trivial they may be)
Every project is approved for the duration of one year;
Yearly (at least) continuing review and approval is required for the
continuation of the research
Protocol Expiration: 364 Days after date of approval
If continuing review is not done, the project expires on the
expiration date, no new subjects should be enrolled into
the study, (reporting obligations to the ORRC remain).
Expired protocols for reactivation requires brand new
review.
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Reports, Records and
Continuing Reviews
Activation notice sent by the PI to the IRB once the
study begins enrollment
Continuing Reviews are done as often as necessary, but
not less than once per year
Adverse Event reporting
Reporting non-compliance and suspensions to
regulatory authorities, Institutional Officer and funding
agencies
Accurate record keeping is critical (all documents
related to the study must be kept in the regulatory
binder)
Final reports
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Non-compliance
Consequences
Serious Noncompliance
Human subject research being carried out without IRB review and approval
by institution’s IRB. Serious noncompliance also includes substantive
modifications to IRB-approved research without IRB approval.
Continuous Noncompliance
This involves a principal investigator making the same mistake several times
repeatedly, particularly after an IRB has informed him or her and his/her
team member(s) of the problem. Continuous noncompliance also includes if
the principal investigator has multiple problems with noncompliance over a
long period of time or has a problem with multiple projects.
Suspension or Termination
The IRB and the Signatory Official and the Humans Subject Protection
Administrator have the authority to suspend or terminate approval of human
subject research that is not being conducted in accordance with the IRB’s
requirements
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In Summary
When in doubt, ask questions; seek help
Remember: consideration for clarity,
consistency, completeness
On-going process – keep dialogue open
All committees use “reasonable person”
standard to ensure high standards of ethical
research
These committees help facilitate responsible
of conduct of research
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Questions?
Contact the Office of Regulatory
Research Compliance at
215-255-7857
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Complexities of Research - Drexel University College of Medicine