Institutional Biosafety Committee

Transcription

1 Biosafety Program Institutional Biosafety Committee IBC JOHN A. BURNS SCHOOL OF MEDICINE & UH CANCER CENTER RESEARCH COMPLIANCE WEEK OCTOBER 20, 2016 H U B E R T O L I P A R E S A N I M A L W E L F A R E A N D B I O S A F E T Y P R O G R A M S O F F I C E O F R E S E A R C H C O M P L I A N C E 1

2 Learning Objectives for IBC Presentation What is the IBC? When. is IBC involved? Who is the IBC? How does IBC work? Protocol Requirement Training Requirement Increase Protocol Approval Probability Suggestions for Preventing Delays or Non-approval Where is the UH IBC found? Know Your Biosafety Compliance Professionals IBC Guidance Documents 2

3 What is the IBC? According to Federal Regulation. Institutions that conduct research involving recombinant DNA, more specifically, activities involving recombinant or synthetic nucleic acid molecules must establish a self-regulating entity (the IBC) to provide oversight and evaluate proposed and ongoing research to conform with NIH Guidelines 3

4 When is IBC involved? Federal Requirements RECOMBINANT OR SYNTHETIC NUCLEIC MOLECULES. The NIH Guidelines administered by the NIH Office of Biotechnological Activities, Office of Science Policy. 4

5 When is IBC involved? Federal Requirements NIH FUNDING Research conducted at or sponsored by an institution that receives support for recombinant or synthetic nucleic acid research for NIH. An individual who receives NIH support must be associated with or sponsored by an institution that assumes responsibilities of the NIH Guidelines. 5

6 When is IBC involved? Federal Requirements NIH FUNDING Research that involves testing in humans of materials containing recombinant or synthetic nucleic acids developed with NIH funds, if the institution that developed those materials sponsors or participates in the projects. Participation includes research collaboration or contractual agreements, not merely provision of research materials. 6

7 When is IBC involved? Federal Requirements NIH FUNDING As a condition for NIH funding of recombinant or synthetic nuclei acid molecule research, institutions shall ensure that research conducted at or sponsored by the institution, irrespective of funding, shall comply with the NIH Guidelines. 7

8 When is IBC involved? Federal and State Requirements OTHER EXPECTATIONS NIH Office of Program on Biosecurity and Biosafety Policy (PBBP) Dual Use Research of Concern (DURC) Centers for Disease Control and Prevention/US Dept. of Agriculture (CDC/USDA) Select Agent Program for BL2 and BL3 research usage. No BL4 usage at Univ. of HI. Hawaii State Dept. of Agriculture Importation regulations, guidance, and lists for permit issuance of restricted and nonrestricted microorganisms, animals, and plants for research. 8

9 Who is the IBC? Committee Composition Minimum Five Members Appropriate recombinant and synthetic nuclei acid expertise collectively Plant, Plant Pathogen, or Plant Pest Containment Expertise Animal Containment Expertise Biological Safety Officer (as appropriate) Human Gene Therapy Expertise (as appropriate) At least two individuals not affiliated with institution Community interest with respect to health and protection of the environment Officials from State or local public health or environmental agencies UH IBC has 19 active members in addition to 6 ad hoc members. 9

10 Who is the IBC? Expectations Evaluate recombinant or synthetic nucleic acid molecules research for conformity with NIH Guidelines. Assess potential risks to employees, students, public, and environment. Knowledge of institutional policies and procedures, regulations, professional standards, community attitudes and environment. Ensure biological safety and containment practices are in place and effective. 10

11 How. does IBC work? Duties and Responsibilities IBC Protocol Registration. Prior to recombinant or synthetic nucleic acid research. Review and approve research and conducted at or sponsored by the institution for compliance with NIH Guidelines specified in Section III, Experiments Covered by the NIH Guidelines. Registration must be approved in full prior to initiating research. Evaluate potential risk to environment and public health. Assess adequacy of biocontainment levels. Condition of facilities, experimental procedures and laboratory practices, and research personnel training. 11

12 How. does IBC work? Duties and Responsibilities Human Gene Transfer Research IBCs must comply with Appendix M of the NIH Guidelines. No participant is permitted to be enrolled in a trial until RAC review, IBC and IRB approval are secured. Concerns identified by RAC in public review are considered. IBC approval may occur only after RAC review. Investigator complies with surveillance, data reporting, and adverse incident reporting. RAC = Recombinant DNA Advisory Committee [Federal Level] 12

13 How. does IBC work? Duties and Responsibilities Authorized to determine whether research may be exempt from committee oversight in accordance to NIH Guidelines. Required to perform expanded oversight determined by institutional discretion. Select Agents and toxins Blood borne pathogens Stem cell research DURC Dual Use Research of Concern Nanotechnology Xenotransplantation 13

14 How. does IBC work? Duties and Responsibilities IBCs and other institutional research oversight committees (IACUCs and IRBs) engage in collaborative review; thus, share responsibility for certain types of research. Generation or development of transgenic or cloned animals. [IBC and IACUC] Recombinant or synthetic nucleic acid molecules in animal models. [IBC and IACUC] Pathogenic microorganisms or Select Agents in animal models. [IBC and IACUC] Human gene transfer protocols and enrollment of human participants. [IBC and IRB] 14

15 IBC Protocol Requirement NIH Guidelines On behalf of the institution, the Institutional Biosafety Committee is responsible for reviewing recombinant or synthetic acid molecule research conducted at or sponsored by the Institution for compliance with the NIH Guidelines specified in Section III, Experiments Covered by the NIH Guidelines, and approving those research projects that conform with the NIH Guidelines. [Section IV-B-2-b-1] Assessment of biocontainment levels Evaluate facilities, experimental procedures, laboratory practices, expertise and training of research personnel. Appendix M Design and Submission of Protocols for the Transfer of Recombinant or Synthetic Nucleic Acid Molecules into One or More Human Research Participants 15

16 IBC Protocol Requirement Office of Research Compliance Biosafety Program Webpage Click on tab IBC Protocol Form Complete the 8-page form-fillable IBC Protocol Registration Form Use the form for new projects, revisions or amendments of ongoing projects, and three-year renewals , fax, or deliver the completed form Fax : (808) Campus or postal delivery: Attn: IBC Coordinator Office of Research Compliance, Biosafety Program 1960 East West Road Biomedical Sciences Tower T-110 Honolulu, HI

17 IBC Training Requirement NIH Guidelines Evaluate facilities, experimental procedures, laboratory practices, expertise and training of research personnel. Schedules for initial General Biosafety and Bloodborne Pathogen classroom training sessions are found online

18 IBC Training Requirement ORC 101 General Biosafety NIH requires documented in person (classroom) training for the initial session. Annual follow-up training sessions are conducted online. Institutional policies regarding biological safety Principles of safe laboratory practices Appropriate Storage Transport and disposal Decontamination of biological substances Personal protective equipment usage 18

19 IBC Training Requirement ORC 102 Bloodborne Pathogen Standards and Sharps Hazard Prevention OSHA requires documented in person (classroom) training for the initial session. Annual follow-up training sessions are conducted online. Human and animal blood products, body fluids (blood, semen, synovial fluid, amniotic fluid, pericardial fluid, etc.), organs and tissues. Unfixed human tissues Primary cell lines Hepatitis B virus and other bloodborne pathogens Shared laboratory space or entry into areas were aforementioned biomaterials are used. 19

20 IBC Training Requirement ORC 3 Transportation of Biological Commodities Personnel who ship or receive biological substances and infectious material substances must be current in their training of transportation of biological commodities. In person training is required every two years or when substantive changes in the Dept. of Transportation (DOT) regulations occur. Classification Packaging Marking Labeling 20

21 IBC Training Requirement ORC 4 Select Agent and Toxins Online training is provided to those research personnel involved in the CDC select agent program. Select agent program regulations Biosafety principles and practices Biosecurity Biocontainment 21

22 Increase Protocol Approval Probability Suggestions for Preventing Delays or Non-approval Complete training requirements prior to IBC review. Refrain from using scientific jargon in protocol. Use language a 12 th grade educated person can understand. Do not incorporate grant proposal scientific language in protocol. Whenever possible simplify. Use flowcharts and schematics to present complicated procedures. Provide clear descriptions of Standard Operating Procedures and laboratory safety practices. Ensure laboratory safety devices are certified regularly and not expired. Biosafety Cabinets, Autoclaves

23 Increase Protocol Approval Probability Suggestions for Preventing Delays or Non-approval Submit protocol amendments for all changes, such as the addition of new personnel, change in locations, addition of microorganisms.etc. o Amendment is not effective until committee approves. o Failure to secure approval prior to implementation of modification is a noncompliance. Be mindful of protocol expiration dates. o Renew protocols before they expire. o At least two reminders are forwarded to the investigator months/weeks prior to expiration date. o Continued work on expired protocols is a noncompliance. Fulfill other research compliance requirements concurrently. 23

24 Increase Protocol Approval Probability Suggestions for Preventing Delays or Non-approval IBC meets every month of the year. o Protocol application submission dates and monthly committee meeting dates are posted 4 months prior to the new year. The IBC generally meets on the last Wednesday of each month. Year 2017 schedule is already posted. During the committee review process, provide requested information, and respond by correction schedules and resubmission timelines. o Failure to adhere to guidance may delay final review and possible approval of your protocol by a month. When unsure, contact the ORC Biosafety Program professionals before proceeding. 24

25 Where is the UH IBC found? Office of the Vice President for Research and Innovation Office of Research Compliance (ORC) Biosafety Program Physical Address: (effective October 31, 2016) 2425 Campus Road Sinclair 10 Honolulu, HI Webpage:

26 Know Your Biosafety Program Professionals Hubert Olipares, MSPH, RBP(ABSA), SLS(ASCP) Biosafety Officer, Inspection and Audits Specialist, Alternate Responsible Official Phone: Stephen Case, MSPH, RBP(ABSA) Biosafety Education Coordinator, Alternate Responsible Official (Primary) Phone: Caryn Hashimoto IBC Coordinator, PAM Specialist Phone:

27 Know Your Biosafety Program Professionals 27

28 IBC Guidance Documents Resources NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules CDC-NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5 th Edition OSHA Bloodborne Pathogen Standard and Needlestick Prevention Hey, we don t make these things up! 28