Office for Research

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Office for Research

• Research Compliance
• Research Compliance Officer - Tanta Myles

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Research Compliance
                           

• Animal Subjects (IACUC)
• Human Subjects (IRB)
• Export Control
• Conflict of Interest
• Scientific Misconduct

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Research Compliance
                           

• Animal Subjects (IACUC)
• Human Subjects (IRB)
• Export Control
• Conflict of Interest
• Scientific Misconduct

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(No Transcript)
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Institutional Animal Care and Use Committee
(IACUC)
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Institutional Animal Care and Use Committee
(IACUC)
Purpose To oversee and evaluate all aspects of
the institution's animal care and use program
according to U.S. Federal Law.
Members Marianne Woods , Chairperson Hal
Barrett Joe Benson Paul LeBlanc James
Neville Stephen Secor Phillip M. Smith John B.
Vincent Betty Thompson (community
member) Alternates Marcy Whitney Tanta
Myles Kevin Cauley (community member)
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Specific IACUC Functions

• Review and consider for approval proposed animal
  use
• Review the animal care facilities and program
• Ensure personnel training and safety
• Make recommendations to the Institutional
  Official regarding the program and facilities
• Review concerns about animal care and use
• Suspend non-compliant animal care and use
  activities (suspension requires reporting)

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Responsibilities (Animal Care and Use)

• Ensure legal procurement of animals
• Provide daily animal care
• Monitor health status
• Provide facilities and trained personnel for
  technical procedures
• Assist in planning and conducting animal research
  and teaching programs

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Rules and Regulations

• Animal Welfare Act USDA/APHIS/AC, 1966.
• PHS Policy on Humane Care and Use of Laboratory
  Animals NIH/OLAW, 1986.
• Accrediting Organization requirements
  Association for Assessment and Accreditation of
  Lab Animal Care (AAALAC), International.

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Penalties for Non Compliance

• Animal Welfare Act
• Institution fined
• Cease desist order issued
• License suspended

• PHS Policy
• Assurance revoked
• Loss of funding for entire institution

AAALAC Loss of accreditation or probation
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Current Concerns

• AALAC Site Visit Costs-repairs, replacement minor
  equipment, HVAC review, etc.
• Environmental Enrichment
• Website
• Training

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Research Compliance
                           

• Animal Subjects (IACUC)
• Human Subjects (IRB)
• Export Control
• Conflict of Interest
• Scientific Misconduct

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Human SubjectsInstitutional 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.

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Medical IRB Membership

• Marianne Woods PhD, JD, Chairperson
• John Higginbotham, PHD, MPH , Vice Chair
• Phillip Bishop, EdD
• Karen Burgess, MD
• William Owings, MD
• Sharol Jacobson, PhD, RN, FAAN
• Olivia Kendrick, Dr. P.H., RD
• Jan Claisson
• Tom Stem
• Carpantato Myles
• Bishop Earnest Palmer (Community Member)

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Non-Medical IRB Membership

• Marianne Woods , Chairperson - Associate Vice
  President for Research
• Tom Stem, Vice Chairperson - Director, Research
  and Consulting Lab
• Phillip Bishop - Professor, Kinesiology
• K. Michele Kacmar - Durr-Fillauer Chair of
  Business Ethics and   Professor of Management
• Jennifer Lav - Associate Professor, School of
  Law
• Sharol Jacobson - Associate Dean for Research and
  Practice
• Edward Merrill - Associate Professor, Psychology
• James Leeper - Chair and Professor, Psychiatry
  and Behavioral Medicine
• Lucinda Roff - Professor, School of Social Work
• Thomas Ward - Senior Research Fellow, Center for
  Creative Media
• Valeria Rudolph-Rivers (Community Member)
• Hoyt Winslett, Jr. (Community Member)

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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.

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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.

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New Policy and Procedure

• Annual Training (Required)
• Centralized IRB submission
• All protocols must be submitted to the Office For
  Research (OR) -152 Rose Administration.

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What is research?

• A systematic investigation designed to develop
  or contribute to generalizable knowledge.

45 CFR 46.102(d)
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• 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)
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Categories of Review

• The type of review your project needs rests
  solely with the IRB.
• Exempt Review
• Expedited Review
• Full Board Review

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Categories of Human Research

• Exempt Research
• Educational testing
• Surveys without individuals identification
• Use of existing data, documents, and
• Records with no identifiers
• No links to subjects
• At UA, the IRB makes the determination that a
  study is exempt not the individual investigator

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Categories of Human Research

• Expedited Research
• IRB review performed by two designee.
• 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 committee.
• The study is subject to continuing review at
  least annually.

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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

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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

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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

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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

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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
• Lay language
• Purpose and eligibility criteria
• Mention research
• Not coercive
• Contact information

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• 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.

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Written Informed ConsentMandatory 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.

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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

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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 cmyles_at_fa.ua.edu.

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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

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Contact Information

• Tanta Myles
• 205.348.5152 or 205.348.5746
• cmyles_at_fa.ua.edu
• Ed Shirley
• 205.348.5152 or 205.348.5069
• EShirley_at_aalan.ua.edu
• http//osp.ua.edu/Research_compliance.html

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Research Compliance
                           

• Animal Subjects (IACUC)
• Human Subjects (IRB)
• Export Control
• Conflict of Interest
• Scientific Misconduct

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Export Control
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The export regulations define an export as Any
oral, written, electronic or visual disclosure,
shipment, transfer or transmission outside of the
United States to anyone, including a U.S.
citizen, of any commodity, technology
(information, technical data, or assistance) or
software/codes Any oral, written, electronic or
visual disclosure, transfer or transmission to
any person or entity of a controlled commodity,
technology or software/codes with an intent to
transfer it to a non-U.S. entity or individual,
wherever located (even to a foreign student or
colleague at The University of Alabama) Any
transfer of these items or information to a
foreign embassy or affiliate.
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Export Control
Who controls export?
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Export Control
Who controls export?
US Department of State               Office of
Defense Control http//www.pmdtc.org/       
        ITAR (International Traffic in Arms
Regulations)                         
http//pmdtc.org/reference.htmITAR  US
Department of Commerce               Bureau of
Industry and Security http//www.bxa.doc.gov/    
           EAR (Export Administration
Regulations)                       
http//www.access.gpo.gov/bis/index.html  US
Department of Treasury              OFAC
(Office of Foreign Assets Control)
                         http//www.treas.gov/off
ices/enforcement/ofac/
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UA Export Policy
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Export control(Flowchart)
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Current Concerns

• Award Review Record Document
• Foreign Travel
• Deemed Export - Deemed export occurs when
  technology or research results are released to a
  foreign national within the United States.

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Office for Research

• Research Compliance
• Research Compliance Officer - Tanta Myles