Text of Regulatory Compliance ORED Seminar Series October 17, 2013
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
Todays Agenda Overview How We Work Together Major Compliance Areas Office of Research Security
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
Office of Research Security HPC Building www.ors.msstate.edu Research Compliance Environmental Health & Safety 53 Morgan Ave www.orc.msstate.edu Sponsored Programs Administration 133 Etheredge www.spa.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.
Human Research Protections Program (IRB) Animal Care and Use (IACUC) Financial Conflict of Interest (CIRC) Biosafety (IBC) Radiological Safety (RCLS) Regulatory Areas
HUMAN RESEARCH PROTECTIONS PROGRAM and the IRB: Institutional Review Board for the Protection of Human Subjects in Research
HUMAN RESEARCH PROTECTION PROGRAM Significant events impacting regulations: 1946 Nuremburg Military Tribunal 1960s Thalidomide Tragedy 1972 Tuskegee Syphilis Study Expose protecting the rights, welfare, and well-being of the subjects
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
Its a rather interesting phenomenon. Every time I press this lever, that post-doc breathes a sigh of relief.
and the IACUC: Institutional Animal Care and Use Committee ANIMAL RESEARCH
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.
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. Hell 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 Integrity of research Outside activities
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)
Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR Part 50, Subpart F) National Science Foundations 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
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.
PHS NSF Other
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 (1) safe handling & (2) containment 2 things of infectious microorganisms and other hazardous biological material rDNA, toxins, venom, prions, raw sewage, animal waste, allergens, plants, transgenic animals, etc Such as
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 Perform risk assessment Determine containment level (BSL-1, BSL-2, etc.) Submit IBC application Develop biosafety manual SOPs for hazardous procedures, equipment Train lab personnel If BSL-2, have BSO certify lab Obtain necessary permits
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 SOPs Ensure compliance with all applicable regs and policies PI RESPONSIBILITIES
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 Safe