Regulatory Compliance
ORED Seminar Series
October 17, 2013
Welcome & Introductions
Jennifer Easley
Director, Sponsored Programs Administration
Kacey Strickland
Director, Research Compliance
Neil Lewis
Director, Research Security
Today’s Agenda
Regulatory Compliance
Per Wikipedia:
Regulatory compliance describes the goal that
corporations or public agencies aspire to achieve
in their efforts to ensure that personnel are
aware of and take steps to comply with relevant
laws and regulations.
So Many Rules to Follow…
• Office of Management & Budget (OMB)
• Federal Acquisition Regulations (FAR)
• Other Federal, State, Agency, and University
Requirements
• Award Terms & Conditions
Research Compliance
Environmental Health & Safety
53 Morgan Ave
www.orc.msstate.edu
Sponsored Programs Administration
133 Etheredge
www.spa.msstate.edu
Office of Research Security
HPC Building
www.ors.msstate.edu
Office of Research Compliance
Research Compliance
…is dedicated to achieving recognition through
integrity. Every researcher and member of a
research team contributes toward this objective.
Regulatory Areas
• Human Research Protections Program
(IRB)
• Animal Care and Use (IACUC)
• Financial Conflict of Interest (CIRC)
• Biosafety (IBC)
• Radiological Safety (RCLS)
HUMAN RESEARCH
PROTECTIONS PROGRAM
and the
IRB: Institutional Review Board for the
Protection of Human Subjects in Research
HUMAN RESEARCH PROTECTION PROGRAM
…protecting the rights, welfare,
and well-being of the subjects
Significant events impacting regulations:
1946 Nuremburg Military Tribunal
1960’s Thalidomide Tragedy
1972 Tuskegee Syphilis Study Expose
APPLICABLE REGULATIONS
• U.S. Dept of Health and Human Services, Office
for Human Research Protection (OHRP)
– “Common rule”
– Requires Federal Wide Assurance
• Food and Drug Administration (FDA)
– regulates devices, drugs, biologics
• Family Educational Rights and Privacy
Act of 1974 (FERPA)
• Health Insurance Portability and
Accountability Act of 1996 (HIPAA)
WHAT REQUIRES IRB APPROVAL?
IRB Approval Is Needed Only When Human
Subjects Research Is Being Conducted.
• Research means a systematic investigation, including
research development, testing and evaluation, designed
to develop or contribute to generalizable knowledge.
- AND -
• Human subject means a living individual about whom an
investigator (whether professional or student) conducting
research obtains:
– (1) data through intervention or interaction with the individual, or
– (2) identifiable private information.
PI RESPONSIBILITIES
• Prior to initiating research:
– Contact HRPP Staff
– Attend IRB training
• Live training or online training through CITI Program
• Training must be renewed every three years
– Submit IRB application
– Obtain written IRB approval
PI RESPONSIBILITIES
• During the conduct of research:
– Respect the rights of human subjects
– Adhere to the approved protocol
– Submit modification request form
• prior to initiating any changes
– Submit continuing review request form
– Promptly report any adverse events or
unanticipated problems
It’s a rather interesting phenomenon. Every time I press this
lever, that post-doc breathes a sigh of relief.
ANIMAL RESEARCH
and the
IACUC: Institutional Animal Care and Use
Committee
ANIMALS IN RESEARCH
“Proper use of animals, including the avoidance or
minimization of discomfort, distress, and pain when
consistent with sound scientific practices, is
imperative.”
-U.S. Government Principles for the Utilization
and Care of Vertebrate Animals Used in Testing,
Research, and Training , IV
ANIMAL CARE REGULATIONS
• USDA, Animal and Plant Health Inspection Service
– Implements the Animal Welfare Act via the Animal
Welfare Regulations
• DHHS, Office of Laboratory Animal Welfare
– Implements the Policy on Humane Care and Use of
Laboratory Animals
– Requires an Animal Welfare Assurance
• AAALAC
– Voluntary accreditation (CVM and A&S only)
In the United States…
• institutions that use laboratory animals for
research or instructional purposes must
establish an Institutional Animal Care and
Use Committee (IACUC) to oversee and
evaluate all aspects of the institution's animal
care and use program.
• and provide these animals with “adequate
veterinary care.”
PI RESPONSIBILITIES
• Prior to initiating research:
– Obtain training either online or live session (must
be renewed every 4 years)
– Complete online OHSP forms
• update when changes occur
– Submit IACUC application
• after pre-review by IACUC member and consultation
with LAV
– Obtain written IACUC approval
– Have facilities certified by IACUC
PI RESPONSIBILITIES
• During the conduct of research:
– Submit annual update form
– Submit amendment form prior to any changes
occurring
– Monitor compliance of project personnel with
approved protocol
Say hello, everyone, to Bert Phelps.
He’ll be taking the job of Security
Manager for the entire Poultry
Products Division!
FINANCIAL CONFLICT OF INTEREST
and the
CIRC: Conflict of Interest Review
Committee
Conflict of Interest:
a situation in which financial or other personal
considerations have the potential to
compromise or bias professional judgment and
objectivity.
Source: Office of Research Integrity, Department of Health and Human Services, RCR Courses Portal
(http://ori.hhs.gov/education/products/columbia_wbt/index.html)
FCOI Regulations
• Responsibility of Applicants for Promoting
Objectivity in Research for which PHS Funding
is Sought (42 CFR Part 50, Subpart F)
• National Science Foundation’s Investigator
Disclosure Policy, 60 F.R. 132, pp. 35810-823
• MSU Policy and Procedure Statement on
Financial Conflict of Interest in Sponsored
Activities (OP 79.09)
In a Nutshell
“…investigators [must] disclose any
financial conflicts of interest related to
the proposed research, or certify that no
conflict exists, at the time of proposal
submission.”
Other
NSF
PHS
Investigator Disclosure
• PHS-funded: All SFIs related to the
investigators institutional responsibilities
• All other sponsors: Only SFIs related to the
proposed research
BIOSAFETY
and the
IBC: Institutional Biosafety Committee
BIOSAFETY
Discipline that
addresses
2 things
(1) safe handling &
(2) containment
of
other hazardous
biological material
Such
as
rDNA, toxins, venom, prions, raw
sewage, animal waste, allergens,
plants, transgenic animals, etc…
and
infectious
microorganisms
ACTIVITIES THAT REQUIRE
OVERSIGHT
• Use of materials that require BSL-2/ABSL-2
facilities
• Research with ANY human specimen (blood,
tissue, body fluid, cell culture, etc.)
• Use of rDNA technology
• Field work with transgenic:
• plants, invertebrates, vertebrates
• genetically modified microorganisms and their
products
REGULATORY REQUIREMENTS
• NIH Guidelines for Research Involving Recombinant
DNA Molecules
• Standards and procedures for rDNA research
• Requires an Institutional Biosafety Committee (IBC)
• Biosafety in Microbiological and Biomedical
Laboratories (BMBL), 5th Edition
• Recommendations for working with infectious agents at
Biological Safety Levels 1 through 4
• Mississippi State Department of Health
• “Adopted Standards for the Regulation of Medical Waste”
• OSHA Bloodborne Pathogens
• Concept of universal precautions, etc.
PI RESPONSIBILITIES
•
Prior to initiating research:
•
Consult Biosafety Officer
•
•
•
•
Submit IBC application
Develop biosafety manual
•
•
•
•
Perform risk assessment
Determine containment level (BSL-1, BSL-2, etc.)
SOP’s for hazardous procedures, equipment
Train lab personnel
If BSL-2, have BSO certify lab
Obtain necessary permits
PI RESPONSIBILITIES
• During the conduct of research
• Submit annual update form
• Notify BSO/IBC of any significant
changes or accidents
• Schedule annual BSL-2/ABSL-2 lab certification
• Schedule training (if required)
• Monitor compliance of personnel with SOP’s
• Ensure compliance with all applicable regs and
policies
RADIOLOGICAL SAFETY
and the
RCLS: Radiological, Chemical, and Laboratory
Safety Committee
REQUIREMENTS
• Radioactive materials work is conducted under the
requirements of the MSU radioactive materials license
– MS Dept of Health, Division of Radiological Health
• X-ray devices are operated in accordance with registration
requirements
– Issued to department and authorized user
• MSU Policy on Radiological, Chemical, and Laboratory Safety –
OP 79.8
PI RESPONSIBILITIES
• Complete an application
– The PI is approved to used radioactive material
• Students, technicians, etc. work under PI approval
– Individual projects typically do not require approval
• PI, students, technicians must complete radioactive
materials users training
• Budget for
– Waste disposal charges
– Personnel monitoring services (if required)
CONTACT INFORMATION
•
•
•
•
•
•
•
Kacey Strickland, Director
Mary Brooks, Staff Assistant
Dr. Jodi Roberts, IRB Officer
Trina Smith, IACUC Administrator
Nicole Morse, IRB Administrator
Dr. Patricia Cox, Biosafety Officer
Donna Rogers, Radiological Safety Officer
53 Morgan Avenue
325-3294
Mail stop 9563
PROTOCOL
APPROVED!
Most researchers regarded the new streamlined
compliance-approval process as ‘quite an improvement.’
Office of Research Security (ORS)
ORS: Intro
• Research Security
– Purpose
• Oversee/assist with security requirements with research
• Responsibilities – 3 main areas
– National Industrial Security Program
– Export Compliance
– Laptop Loan Program
– Personnel
• Neil Lewis & Debra Hicks
• Location
– Room 101, HPC2
– Contact info
» E-mail: nelewis@fso.msstate.edu or
dhicks@fso.msstate.edu
» Telephone: 325-8682 or 325-0400
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ORS: Intro
• Responsibilities
– National Industrial Security Program (NISP)
• Partnership between private industry & the USG to safeguard
classified information & work
• NISP established in 1993 by E.O. 12829
• Defense Security Service
• MSU has been involved with classified working from the 1950s
– Export Compliance
• To assist MSU personnel understand and comply with the EAR,
ITAR & OFAC regulations for projects
• Why must MSU comply with export regs as no tangible products
are being made
• But information & technical data is resulting from research, that
could be export controlled.
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ORS: Intro
• Responsibilities cont’d
– Export Compliance
• Export controlled info has requirements on who can access
– Not releasable or to be accessed by certain FNs
• If you need to have an FN to work on a project or have access to
info then a license (formal written USG approval) may be required
– Laptop Loan Program
• Provide “clean” laptops to MSU personnel going overseas on MSU
sponsored travel.
• Units are “IBM” clone and have basic programming –
Word/Excel/PP/Adobe/Internet card. Anything beyond that it is up
to borrower to add
• Need two weeks notice to reserve a unit – more time is better
• Do not deliver units – units must be picked up/returned to ORS
office.
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ORS: Intro
•
How do we provide service
– Work with SPA – reviewing certain proposals for probable issues
and advise SPA to watch for an issue if award received
• If an award has export compliance issues, we work with the respective
PI, Bus. Manager, Contract & Grants and other personnel
– Provide training
• Currently in training “blitz” on 2 topics – “Working with ITAR” &
“OPSEC”, & ORED seminar topics 11/5 (Project Issues & Violations) &
11/18 (Game of Pawns - The Glenn Duffie Shriver Story)
• On-call training or briefing requirements – will accommodate almost
any request
– Newsletters
• Quarterly “Employee Security Connections”
• Jackson FBI newsletter
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ORS: Intro
• Providing service
• Notes of Interest
• Come out any time.
• Latest concerned Umass Lowell EAR fine - $100K (failed
on restricted party screening), 2102 DSS Technology
Targeting Report.
• If you or your department want to get on the
mailing list for the newsletter and notes of
interest, please send me (nelewis@fso.msste.edu)
a note with the appropriate addresses
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Questions???