Transcript Office for Research (Research Compliance)

Office for Research
Research Compliance
Research Compliance Officer - Tanta Myles
Research Compliance
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Animal Subjects (IACUC)
Human Subjects (IRB)
Export Control
Conflict of Interest
Scientific Misconduct
Research Compliance
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Animal Subjects (IACUC)
Human Subjects (IRB)
Export Control
Conflict of Interest
Scientific Misconduct
Human Subjects
Institutional Review Board (IRB)
Purpose:
•Review research proposals, projects, and activities
that involve human subjects;
•determine for each activity or proposed activity if
human subjects will be placed at risk;
•if risk is involved, determine if the importance of the
knowledge to be gained warrants allowing the subject
to accept the risks;
•oversee protection of rights and welfare of subjects.
IRB Basics
• Applies to funded and unfunded
research
• Submission of a protocol and approval
by the IRB is mandatory for any faculty,
staff or student who will interact with a
human being for purposes of conducting
research
• Research may not begin before approval
from the IRB is given
New Policy and Procedure
• Annual Training (Required)
• Centralized IRB submission
• All protocols must be submitted to the
Office For Research (OR) -152 Rose
Administration.
Protocol
Sent to
2 Expedited
Reviewers
Revisions
And/or
Approval
Sent to OR
Submit
To
OR
152 Rose
Admin.
Approval
Of
Expedited
Protocol
Sent from OR
Approval
Of
Exempt
Protocol
Protocol
Placed on
Full Board
Agenda
Full Board
Review
(Monthly)
May require
revisions
Approval
(Up to 1 year)
IRB Membership
• Shall have at least five members,
• No IRB may consist entirely of members of one
profession.
• Shall include at least one member whose primary
concerns are in scientific areas.
• At least one member whose primary concerns are in
nonscientific areas.
• At least one member who is not otherwise affiliated
with the institution and who is not part of the
immediate family of a person who is affiliated with the
institution.
• No IRB may have a member participate in the IRB's
initial or continuing review of any project in which the
member has a conflicting interest, except to provide
information requested by the IRB.
Medical IRB Membership
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Marianne Woods PhD, JD, Chairperson
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John Higginbotham, PHD, MPH , Vice Chair
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Phillip Bishop, EdD
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Karen Burgess, MD
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William Owings, MD
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Sharol Jacobson, PhD, RN, FAAN
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Olivia Kendrick, Dr. P.H., RD
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Jan Claisson
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Tom Stem
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Carpantato Myles
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Bishop Earnest Palmer (Community Member)
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Vacant (Faculty Senate Representative)
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Mike Spearing, JD (Non-Voting Liaison Members)
Non-Medical IRB Membership
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Marianne Woods , Chairperson - Associate Vice President for Research
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Tom Stem, Vice Chairperson - Director, Research and Consulting Lab
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Stuart Usdan - Health Sciences, CHES
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K. Michele Kacmar - Durr-Fillauer Chair of Business Ethics and
Professor of Management
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Jennifer Lav - Associate Professor, School of Law
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Sharol Jacobson - Associate Dean for Research and Practice
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Edward Merrill - Associate Professor, Psychology
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James Leeper - Chair and Professor, Psychiatry and Behavioral Medicine
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Lucinda Roff - Professor, School of Social Work
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Thomas Ward - Senior Research Fellow, Center for Creative Media
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Valeria Rudolph-Rivers (Community Member)
Hoyt Winslett, Jr. (Community Member)
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John B. Vincent (Faculty Senate Representative)
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Mike Spearing (Non-Voting Liaison Members)
Keith McDowell (Non-Voting Liaison Members)
Rules and Regulations
• Office for Human Research Protections (OHRP)
The OHRP is a division of the U.S. Department of
Health and Human Services. The homepage contains
news, information, and links relevant to the IRB
policies and procedures, including an IRB member
guidebook.
• Food and Drug Administration (FDA)
FDA's Guidance on Protection of Human Subjects. The
FDA's information sheets regarding the projection of
human participants for IRBs and investigators;
includes a guide on informed consent.
Rules and Regulations
• Title 45 Code of Federal Regulation
(CFR) Part 46, Protection of Human
Subjects, DHHS
• Title 21, CFR, Parts 50, 54, 56, and 312,
FDA,
• U.S. Food and Drug Administration
Information Sheets for the “Guidance for
Institutional Review Boards and Clinical
Investigators.”
OHRP Faults University of Washington
The Office of Human Research Protections (OHRP) has faulted institutional review
boards (IRB) at the University of Washington for failing to aggressively regulate
research trials under their review, according to the Tacoma News Tribune. OHRP
issued a determination letter to the institution that criticized IRBs for failing to
delay studies until objections over consent or monitoring were satisfied. Further,
the IRBs did not properly follow procedures for approving research involving
prisoners and children, the report noted. It faulted the university for allowing
IRB-shopping in the case of one researcher who was not satisfied with the first
review he received on a proposal and questioned whether IRB members have
adequate knowledge of human subjects regulations and adequate authority to
perform their functions. The university has said that it is working with OHRP to
resolve deficiencies in its human subjects research program.
What is research?
A systematic investigation designed to
develop or contribute to generalizable
knowledge.
45 CFR 46.102(d)
A Human Subject is defined as:
A living individual about whom an
investigator obtains data through
intervention or interaction or obtains
identifiable private information.
45 CFR 46.102(d)
Categories of Review
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The type of review your project needs
rests solely with the IRB.
– Exempt Review
– Expedited Review
– Full Board Review
Categories of Human Research
• Exempt Research:
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Educational testing
Surveys without individual’s identification
Use of existing data, documents, and
Records with no identifiers
No links to subjects
• The IRB makes the determination that a
study is exempt not the individual
investigator
Categories of Human Research
Expedited Research
• IRB review performed by two designees.
• Criteria for IRB review and approval are
the same for Expedited and Full review.
• Study may either be approved or
referred to the full IRB for review.
• The review is reported to full Board.
• The study is subject to continuing
review at least annually.
Categories of Human Research
Full IRB Review
•Conducted at a convened meeting
•Must have a majority of members present including at
least one member who is a non-scientist
•IRB actions
»Approve
»Approve with revisions
»Table
»Disapprove
»Resubmit with revisions
•Investigator notified in writing of actions and comments
IRB Review
To approve research the IRB must determine
that:
– Risk to subjects are minimized
– Risks to subjects are reasonable in relation to
subject benefit
– Subject selection is equitable
– Informed consent obtained
– Provisions are adequate for monitoring safety
– Provisions to protect subject privacy and data
confidentiality are adequate
– When subjects are likely vulnerable to coercion or
undue influence additional safeguards to protect
subject rights and welfare have been included
IRB Review and Approval
• Approval is for up to one year, may be less
depending on level of risk
• All approved research is subject to
continuing review
• Required documentation for Continuing
Review
» number of subjects accrued
» description of any adverse events or
unanticipated problems
» summary of any recent literature
» copy of the current informed consent
IRB Review and Approval
• ANY change in the protocol, consent form
or other study documents must be
reviewed and approved by the IRB before
they are implemented
• ANY unanticipated problems, adverse
events or protocol deviations must be
promptly reported to the IRB
Advertising for Research Subjects
• IRB review and approval for ads in paper,
TV, radio, flyers, videos, internet postings
• Compensation, if any, may be mentioned
• Required:
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Lay language
Purpose and eligibility criteria
Mention research
Not coercive
Contact information
Informed consent is a process of
information exchange that takes
place between the prospective
subject and the investigator,
before, during and sometimes
after the study.
Written Informed Consent
Mandatory Elements
– study involves research
– purpose of the research
– description of procedures, identifying those that are
experimental
– description of risk
– description of benefit
– disclosure of alternatives
– extent confidentiality will be maintained
– if compensation and treatment from injury are available
– contact for research, subjects’ rights and adverse event issues
– participation is voluntary, refusal to participate will involve no
penalty or loss of benefits to which the subject is otherwise
entitled, and the subject may discontinue participation at any
time without penalty or loss of benefits to which the subject is
otherwise entitled.
When May IRB Waive Consent Process?
• Minimal risk
• Rights and welfare not adversely
affected
• Not practical without waiver
• Provide information after
participation
• Procedures do not require written
consent outside of research
New Policy and Procedure
• Annual Training (Required)
– http://osp.ua.edu/irbtraining.html
– Medical or Non-Medical
• Centralized IRB submission
All protocols must be submitted to the
Office For Research (OR)
-152 Rose Administration or to
[email protected].
Current Concerns
• Updating of IRB website to become
more user friendly.
• Revision of IRB Policies and Procedures
• Revision of Forms
• IRB Accreditation
• Implementing eProtocol software
eProtocol
eProtocol protocol submission
• Investigators have the ability to create and submit the protocol
online utilizing such features as: templates to Create a Protocol,
Protocol Updates, Save Protocols, Check for Completeness, Clone
Submitted or Approved protocols, and Submit Renewals or Revisions.
• Dashboard based interface to access latest
events/status of protocols
• Automatic recommendation of the mandatory and suggested
guidelines for the protocol.
• View and Print Approval Letters
• Online View/Response to comments by Reviewers
Contact Information
• Tanta Myles – Research Compliance Officer
205.348.5152 or 205.348.5746
[email protected]
• Ed Shirley – Research Compliance Specialist
205.348.5152 or 205.348.5069
[email protected]
• Jeanelle Graham – Research Compliance Specialist
205.348.5152 or 205.348.6457
[email protected]
• http://osp.ua.edu/Research_compliance.html
Office for Research
Research Compliance
Research Compliance Officer - Tanta Myles