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Regulatory Compliance ORED Seminar Series October 17, 2013

Regulatory Compliance ORED Seminar Series October 17, 2013

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Page 1: Regulatory Compliance ORED Seminar Series October 17, 2013

Regulatory ComplianceORED Seminar Series

October 17, 2013

Page 2: 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

Page 3: Regulatory Compliance ORED Seminar Series October 17, 2013

Today’s Agenda

Overview

How We Work

Together

Major Compliance

Areas

Office of Research

Security

Page 4: Regulatory Compliance ORED Seminar Series October 17, 2013

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.

Page 5: Regulatory Compliance ORED Seminar Series October 17, 2013

So Many Rules to Follow…

• Office of Management & Budget (OMB)• Federal Acquisition Regulations (FAR)• Other Federal, State, Agency, and University

Requirements• Award Terms & Conditions

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Office of Research SecurityHPC Buildingwww.ors.msstate.edu

Research ComplianceEnvironmental Health & Safety53 Morgan Avewww.orc.msstate.edu

Sponsored Programs Administration133 Etheredgewww.spa.msstate.edu

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Page 8: Regulatory Compliance ORED Seminar Series October 17, 2013

Office of Research Compliance

Page 9: Regulatory Compliance ORED Seminar Series October 17, 2013

Research Compliance

…is dedicated to achieving recognition through integrity. Every researcher and member of a research team contributes toward this objective.

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• Human Research Protections Program (IRB)

• Animal Care and Use (IACUC)• Financial Conflict of Interest (CIRC)• Biosafety (IBC)• Radiological Safety (RCLS)

Regulatory Areas

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Page 12: Regulatory Compliance ORED Seminar Series October 17, 2013

HUMAN RESEARCH PROTECTIONS PROGRAM

and theIRB: Institutional Review Board for the

Protection of Human Subjects in Research

Page 13: Regulatory Compliance ORED Seminar Series October 17, 2013

HUMAN RESEARCH PROTECTION PROGRAM

Significant events impacting regulations:1946 Nuremburg Military Tribunal1960’s Thalidomide Tragedy1972 Tuskegee Syphilis Study Expose

…protecting the rights, welfare, and well-being of the subjects

Page 14: Regulatory Compliance ORED Seminar Series October 17, 2013

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)

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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.

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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

Page 17: Regulatory Compliance ORED Seminar Series October 17, 2013

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

Page 18: Regulatory Compliance ORED Seminar Series October 17, 2013

It’s a rather interesting phenomenon. Every time I press this lever, that post-doc breathes a sigh of relief.

Page 19: Regulatory Compliance ORED Seminar Series October 17, 2013

and theIACUC: Institutional Animal Care and Use

Committee

ANIMAL RESEARCH

Page 20: Regulatory Compliance ORED Seminar Series October 17, 2013

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

Page 21: Regulatory Compliance ORED Seminar Series October 17, 2013
Page 22: Regulatory Compliance ORED Seminar Series October 17, 2013

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)

Page 23: Regulatory Compliance ORED Seminar Series October 17, 2013

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.”

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• 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

Page 25: Regulatory Compliance ORED Seminar Series October 17, 2013

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

Page 26: Regulatory Compliance ORED Seminar Series October 17, 2013

Say hello, everyone, to Bert Phelps. He’ll be taking the job of Security

Manager for the entire Poultry Products Division!

Page 27: Regulatory Compliance ORED Seminar Series October 17, 2013

FINANCIAL CONFLICT OF INTEREST

and theCIRC: Conflict of Interest Review

Committee

Integrity of

researchOutside activities

Page 28: Regulatory Compliance ORED Seminar Series October 17, 2013

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)

Page 29: Regulatory Compliance ORED Seminar Series October 17, 2013

• 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)

FCOI Regulations

Page 30: Regulatory Compliance ORED Seminar Series October 17, 2013

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.”

Page 31: Regulatory Compliance ORED Seminar Series October 17, 2013

PHS

NSF

Other

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Investigator Disclosure

• PHS-funded: All SFIs related to the investigators institutional responsibilities

• All other sponsors: Only SFIs related to the proposed research

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BIOSAFETY

and theIBC: Institutional Biosafety Committee

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BIOSAFETYDiscipline that addresses

(1) safe handling &(2) containment

2 things

of

infectious microorganismsand

other hazardous biological material

rDNA, toxins, venom, prions, raw sewage, animal waste, allergens, plants, transgenic animals, etc…

Such as

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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

Page 37: Regulatory Compliance ORED Seminar Series October 17, 2013

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.

Page 38: Regulatory Compliance ORED Seminar Series October 17, 2013

PI RESPONSIBILITIES

• Prior to initiating research:• Consult Biosafety Officer

• Perform risk assessment• Determine containment level (BSL-1, BSL-2, etc.)

• Submit IBC application• Develop biosafety manual

• SOP’s for hazardous procedures, equipment• Train lab personnel• If BSL-2, have BSO certify lab• Obtain necessary permits

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• 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

PI RESPONSIBILITIES

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RADIOLOGICAL SAFETY

and theRCLS: Radiological, Chemical, and Laboratory

Safety Committee

Page 42: Regulatory Compliance ORED Seminar Series October 17, 2013

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

Page 43: Regulatory Compliance ORED Seminar Series October 17, 2013

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)

Page 44: Regulatory Compliance ORED Seminar Series October 17, 2013

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 Avenue325-3294

Mail stop 9563

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Most researchers regarded the new streamlined

compliance-approval process as ‘quite an improvement.’

PROTOCOL

APPROVED!

Page 46: Regulatory Compliance ORED Seminar Series October 17, 2013

Office of Research Security (ORS)

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47

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: [email protected] or [email protected]» Telephone: 325-8682 or 325-0400

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48

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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49

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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50

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 ([email protected]) a note with the appropriate addresses

Page 52: Regulatory Compliance ORED Seminar Series October 17, 2013

Questions???