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: [email protected] or [email protected] » Telephone: 325-8682 or 325-0400 47 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. 48 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. 49 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 50 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 51 Questions???