Transcript No Slide Title

IRB 101
An introduction to the federal
regulations and how they
relate to institutional policy
and procedures.
Springfield Committee for
Research Involving Human
Subjects (SCRIHS)
SCRIHS is an Institutional
Review Board (IRB)
Commonly Used Acronyms
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Code of Federal Regulations (CFR)
Investigational New Drug number (IND)
Investigational Device Exemption number (IDE)
Primary Investigator (PI)
Informed Consent Form (ICF)
Authorized Study Personnel (ASP)
Adverse Event (AE)
Amendment Summary (AS)
Continuing Review (CR)
Investigator’s Brochure (IB)
REGULATION OF HUMAN SUBJECTS
RESEARCH
 DHHS- Department of Health and Human
Services
OHRP- Office of Human Research
Protections
FDA- Food and Drug Administration
NIH- National Institute of Health
ORI- Office of Research Integrity
Who is the IRB?
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SCRIHS is currently made up of 19 appointed
members: physicians & surgeons – including 1
resident member, pharmacists, medical
students, nurses, attorneys, and community
members
Areas of specialization include: oncology,
surgery, psychology, neurology, cardiology, and
medicine-as well as other areas
Dr . Elvin Zook, Chief of the Division of Plastic
Surgery , is the current SCRIHS chair
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Who ?
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45CFR46.107 regulates IRB membership
Each IRB must be comprised of at least 5
members with varying backgrounds, “to
promote complete and adequate review of
research commonly conducted by the
institution”
1 member -scientific, 1 member –nonscientific,
and 1 member-not affiliated with the institution
What is the IRB?
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The IRB is a group of “appropriately
constituted” people which has been
formally designated to review and monitor
biomedical research involving human
subjects and ensure that the appropriate
steps are taken to protect the rights and
welfare of human participants
When ?
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SCRIHS currently meets once / month,
on the 2nd Wednesday of each month
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Erin, Alisha, Gary and Susan are in the
office daily
Where is the IRB?
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The SCRIHS office is located in room 2049, 2053
and 2061 on the 2nd floor of 801 N. Rutledge (the
building with the medical library)
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Erin 545-7602 or [email protected]
Alisha 545-7256 or [email protected]
Gary 545-2184 or [email protected]
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Monthly meetings are held in the Dirksen
Conference Room (in the library) starting at
5:30p.m.
WHY ?
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Because the government says so:
45CFR part 46
21CFR parts 50, 56, 312, and 812
Belmont Report: Justice, Beneficence, Respect
Declaration of Helsinki
Nuremberg Code
THE “COMMON RULE”
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45CFRpart46
• Subpart A- Basic Policy for Protection of
Human Subjects
VULNERABLE POPULATIONS
• Subpart B- Pregnant Women, Fetuses, In Vitro
• Subpart C- Children
• Subpart D- Prisoners
IRB review of protocols involving prisoners
FDA
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21CFR:
part 50 – human subjects protections
part 54 – financial disclosure
part 56 – IRB’s
part 312 – IND (drugs)
part 600 – Biological Products
part 812 - IDE (devices)
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Special Publications:
FDA Information Sheets
HHS Publication FDA 96-4159 “IDE Manual”
What is Research?
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45CFR46.102(d) defines research as “a
systematic investigation, including
research development, testing, and
evaluation, designed to develop or
contribute to generalizable knowledge.”
What is a Human Subject?
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45 CFR46.102(f) defines a human
subject as “a living individual about
whom an investigator (whether
professional or student) conducting
research obtains…data”
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Chart Reviews
Medical Students & Residents
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Who made you boss?
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45CFR.109
“An IRB shall review and have authority to
approve, require modifications in (to
secure approval), or disapprove all
research activities covered by this policy”
Ok, so now what do I have to do?
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Exempt - the IRB must “certify” that the
research is indeed exempt, the PI does NOT
get to make this determination
Expedited Review - see pages 2-3 on
application for approval
Full Board Review - any study involving
greater than minimal risk
Full Board Review (45CRF46.111)
CRITERIA FOR IRB APPROVAL OF RESEARCH:
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Risks to subjects are minimized
Risk / Benefit ratio is balanced
Selection of subjects is equitable
Informed Consent and HIPAA Authorization will be sought
and documented
Adequate provisions for monitoring data to ensure safety
Privacy and confidentiality will be protected
Additional safeguards are in place to protect vulnerable
populations
Full Board Review
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Application for approval (SIU vs. Non-SIU)
ASP form
HIPAA Application
HIPAA Authorization- 23 copies
Informed Consent- 23 copies w/ protocol #
Protocol- 23 copies w/ protocol #
Investigator’s Brochure / Tech. Manual- 3 copies
Billing Papers: unless you are given a waiver
Common Issues/ Problems
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OBTAIN PROTOCOL NUMBER (and use it)
ENOUGH COPIES
COLLATE
MEETING THE DEADLINE (always last
Wednesday of the month)
NIH GRANT REVIEW
PROTECTED CLASSES
WAIVER OF CONSENT- 4 points
NIH Grant Application Review
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45CFR46.103(f)
Requires that each application or proposal for
HHS supported human subject research be
reviewed & approved by the IRB.
45CFR46.122
“Federal funds…may not be expended for research
involving human subjects unless the
requirements of this policy have been satisfied.”
Vulnerable Populations
“vulnerable to coercion or undue influence”
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Fetuses and Human In Vitro Fertilization
Women
Children & Minors
Cognitively Impaired Persons – new SCRIHS policy
Prisoners
Traumatized and Comatose Patients
Terminally Ill Patients
Elderly/Aged Persons
Minorities
Students, Employees, Normal Volunteers
International Research
You mean I don’t have to get
Informed Consent? The 4 points
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A PI may seek a waiver or alteration of informed
consent if the IRB can find that the PI has justified
(in writing) the 4 points of justification.
45CFR46.116
• No more than minimal risk
• Waiver or alteration will not adversely affect rights /
welfare
• Research could not practicably be carried out without
the waiver / alteration
• Subjects will be given additional pertinent information
after participation, whenever appropriate
Expedited Review (45CFR46.110)
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Application for approval
ASP
HIPAA Application
ICF- 3 copies (unless waived)
Protocol - 3 copies
HIPAA Authorization- 3 copies (unless exempted or
waived)
ALSO, you must submit any questionnaires, interview
questions, etc. that you may be using in your study
Common Issues / Problems
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No monthly deadline for submission
Waiver of Consent and/or Authorization must meet all points of justification
2 committee members assigned to review
and allowed 2 weeks to return comments
See 45CFR46.110 and DHHS “Notice to
Federal Register” for expedited categories
Exempt from Review (45CFR46.101)
• A letter, addressed to Dr. Elvin Zook
containing the following:
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title of your research project
a brief proposal of what you wish to do
purpose, why are you doing the research?
state whether any identifiers will be used, or not
Waiver of HIPAA Authorization or HIPAA De-Identification Form
any other pertinent information such as surveys or
questionnaires
• INCLUDE YOUR NAME AND PHONE NUMBER
Common Issues / Problems
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Submit your letter and information to the
SCRIHS office, NOT Dr. Zook’s office
No monthly deadlines for submission
A letter will be issued to you/PI stating that
your proposal has been reviewed and is
indeed exempt from IRB review, DO NOT
proceed until you hear from us
And so, it continues…
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Amendment Summaries - if you need to make a
change to your research, informed consentincluding the process, protocol, IB, Tech. Manual,
or wish to advertise for participants
• minor changes can be reviewed administratively
• other changes may by required to go to the full board
for review
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All changes must be approved by the IRB prior to
implementation
Yes, we Do have written
guidelines for AE submission
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Adverse Event Reports: The reporting
guidelines are in the SCRIHS procedures
manual, pages 41-44, which outline the
“what”(event) is required to be turned in
“when”(time deadlines)
These requirements have changed and will
be updated in the new Procedures Manual
No, the fun is NOT over YET
• Continuing Review Statements: (45CFR46.109)
• This happens at least once/year regardless of whether
your research needed full board or expedited review.
The IRB can require that a project be reviewed on a
more frequent basis, usually based on the risk
involved. These ALWAYS go to the full board for review
• Letters / monthly deadlines
• It is the responsibility of the PI to know the continuing
review deadline for his/her studies and ensure that all
necessary paperwork is sumbitted on time to the IRB
office
Finally, a light at the end of the
research tunnel
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Termination forms - if your study is
complete, fill one of these out and submit to
our office
Miscellaneous Topics
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Call ahead for a protocol number and USE it
IND / IDE # is required PRIOR to IRB review
Submission of correct number of copies
Submit verification if the company/sponsor is
requesting changes with an an amendment
summary
Submit a list of changes to protocol/IB
Try to use the computer or type your forms
Remind me AGAIN why I am doing
research!
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Please call and ask if you don’t know or
need help. Contrary to what you may think
we are here to help.
COMING SOON
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BRAAN- paperless IRB
Conflict of Interest
IRB Accreditation