Transcript Document 7498356
Office for Research
Research Compliance Research Compliance Officer - Tanta Myles
Research Compliance
• Animal Subjects (IACUC) • Human Subjects (IRB) • Export Control • Conflict of Interest • Scientific Misconduct
Research Compliance
• Animal Subjects (IACUC) • Human Subjects (IRB) • Export Control • Conflict of Interest • Scientific Misconduct
IACUC Organizational Chart Animal Care Program 2005 Vice President for Research
Dr. Keith McDowell
Associate Vice President for Research
Dr. Marianne Woods AA Beverly Kauchick Information Systems Analyst Sheryl Woods AA Deborah Parrott
Research Compliance Officer
Carpantato Myles Veterinarian Dr. Jim Neville Director Animal Resources (AR) Dr. Paul LeBlanc Asst. Dir. of AR (On-call Vet.) Dr. Philip Smith Manager An. Care Facility Keon Allen Lab. Animal Tech.
Jimmy Ramage Research Compliance Specialist Vacant Research Compliance Specialist Ed Shirley
Institutional Animal Care and Use Committee (IACUC)
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)
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)
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
Rules and Regulations
•
Animal Welfare Act: USDA/APHIS/AC, 1966.
•
PHS Policy on Humane Care and Use of Laboratory Animals: NIH/OLAW, 1986.
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Accrediting Organization requirements: Association for Assessment and Accreditation of Lab Animal Care (AAALAC), International.
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
Current Concerns
• • • •
AALAC Site Visit Costs-repairs, replacement minor equipment, HVAC review, etc.
Environmental Enrichment Website Training
Research Compliance
• 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.
• • • • • • • • • • • • •
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) Vacant (Faculty Senate Representative) Mike Spearing, JD (Non-Voting Liaison Members)
• • • • • • • • • • • • • • •
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) John B. Vincent (Faculty Senate Representative) Mike Spearing (Non-Voting Liaison Members) Keith McDowell (Non-Voting Liaison Members)
Rules and Regulations
• Office for Human Research Protections (OHRP)
The OHRP guidebook.
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
• Food and Drug Administration (FDA)
FDA's Guidance on Protection of Human Subjects human participants for IRBs and investigators; includes a guide on informed consent.
. The FDA's information sheets regarding the projection of
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.”
New Policy and Procedure
• Annual Training (Required) • Centralized IRB submission • All protocols must be submitted to the
Office For Research (OR) -152 Rose Administration.
What is research?
A
systematic investigation
develop or contribute to
knowledge
.
designed to
generalizable
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
• 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: – Educational testing – Surveys without individual’s 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
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.
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: » 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
Contact Information
• Tanta Myles
205.348.5152 or 205.348.5746
• Ed Shirley
205.348.5152 or 205.348.5069
•
http://osp.ua.edu/Research_compliance.html
Research Compliance
• Animal Subjects (IACUC) • Human Subjects (IRB) • Export Control • Conflict of Interest • Scientific Misconduct
Export Control
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.
Who controls export?
Export Control
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.htm#ITAR
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/offices/enforcement/ofac/
UA Export Policy
Export control (Flowchart)
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.
Office for Research
Research Compliance Research Compliance Officer - Tanta Myles