IBC Best Practice Meeting November 30, 2016

Training Requirements Sarah Zamzow IBC Best Practices Meeting November 30, 2016

Committee Member Training Requirements According to the NIH Guidelines: Section IV-B-1-h.  Ensure appropriate training for the Institutional Biosafety Committee Chair and members…..regarding laboratory safety and implementation of the NIH Guidelines.  The Institutional Biosafety Committee Chair is responsible for ensuring Institutional Biosafety Committee members are appropriately trained. 

How Member Requirements are Met One on one training with IBC chair and administrator prior to joining committee Required to read FAQs for NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules Training at meetings Attend local meetings New chair is further trained by previous chair

PI Training Requirements According to the NIH Guidelines: Section IV-B-1-h - Ensure appropriate training for….Principal Investigators….regarding laboratory safety and implementation of the NIH Guidelines.  The institution is responsible for ensuring that the Principal Investigator has sufficient training; however, this responsibility may be delegated to the Institutional Biosafety Committee.

How PI Training Requirements are Met Required to complete three trainings Respirator Training Bloodborne Pathogens Training Environmental Health and Safety Has Specific Training

Laboratory Personnel Training Requirements According to the NIH Guidelines: Section IV-B-1-h.  Ensure appropriate training for….laboratory staff regarding laboratory safety and implementation of the NIH Guidelines. The Principal Investigator is responsible for ensuring that laboratory staff are appropriately trained.  According to the BMBL: The director or person in charge of the laboratory is responsible for providing or arranging the appropriate training of personnel.

How Lab Personnel Training Requirements are Met Must complete the same three trainings as PIs Respirator Training Bloodborne Pathogens Training Environmental Health and Safety Training PI must provide specific training Training records

Dual Use Research of Concern Training DURC Training

One Size DOESN'T fit all NIH Guidelines and BMBL are vague on the specifics of training Find what works for your institution

Discussion

Meeting Minutes – Institutional Policies and Practices

Goals and Objectives Understand the requirements Identify the resources Consider policies Guidance based on the NIH Guidelines, and The OBA FAQs

What are the requirements? NIH rDNA Guidelines (Section: IV-B-2-a-(7)) OBA FAQ: http://osp.od.nih.gov/sites/default/files/resources/IBC_Meetings_and_Minutes_FAQs.pdf

Let’s Summarize The minutes template will include:   The date and place of the meeting Whether the meeting was opened or closed including the reasoning for the decision Those in attendance Whether the minutes from the prior meeting were approved The minutes will include all major motions and whether each was approved The time that the meeting was called to order and adjourned. Protocol discussions will include: The project title and the name of the Principal Investigator (PI) Verification that the PI and laboratory staff have been appropriately trained In the case of recombinant DNA research, the classification of the NIH Guidelines the research falls under (e.g. Section III-D-1, Section III-E-1, etc.) The containment conditions to be implemented (biosafety level and any special provisions.

Public Accessibility of the Meeting Minutes IBC meeting minutes and any documents submitted to or received from funding agencies are made available to the public (i.e. all people and entities) upon request. Minutes may be sent by U.S. mail, email or made available on the institution’s Web site (either openly, or through special access provided to requestors only). The institution may charge an amount sufficient to cover the costs of providing minutes if necessary.

Redaction of Meeting Minutes In most circumstances, meeting minutes requested by the public are not redacted. However in certain situations, for example to protect private or proprietary information or when disclosure would directly compromise institutional or national security, documents may be judiciously and consistently redacted. Some examples of information that may be redacted include trade secret information and other confidential commercial information, home telephone numbers and home addresses of IBC members.

Discussion

Break-Time

The Role of each IBC Member

Objective Discuss and understand the role of each IBC member IBC Chair BSO Scientist Compliance Director Community Member Veterinarian

Project assessment – primary role of each committee member The strength of the committee is the combined expertise to handle identified concerns Risks to the community Risk identification and mitigation Project oversight Compliance Scientific merit Is the mitigation is acceptable/effective Risks associated with the animals (when involved)

Group Discussion Groups IBC Chair BSO Scientist Compliance Director Community Member Veterinarian

Members’ Roles Discussions

Project Assessment

Objectives Review the scenario Identify the associated hazards and the potential risks Based on you knowledge of the hazard identify mitigation methods Identify additional information required to complete the assessment

Protocol Review/Risk Assessment Break into six groups (A-F) Remember to stay focused on your role Discuss the project as an IBC Present you assessment: Risks – to people/environment Mitigation/Containment Any reviews beyond the IBC needed Identify the primary differences between committee member concerns Groups: IBC Chair BSO Scientist Compliance Director Community Member Veterinarian

Scenario – Protocol Review The purpose of the research is to evaluate a novel liver cancer therapy, which utilizes nanotechnology to deliver cancer fighting drugs to specific cells. Through past studies, the PI discovered a gene sequence that codes for a protein that when present in liver cells results in a malignancy. This new therapy will be evaluated in mice expressing the protein known to cause the cancer as well as in animals with liver tumors. The PI has coupled nanotechnology and neoplastic therapy to establish a nanoparticle (carbon based, nanodiamonds) that has an affinity to the protein of interest. Using this technology the PI will deliver a controlled release of Fluorouracil (5-FU) specifically to those cells expressing the protein known to result in cancer. The results will be evaluated by either measuring existing tumors, or monitoring animals for the onset of liver tumors. To evaluate the novel approach to curing and/or preventing liver cancer, the PI will conduct two series of experiments, which are described below.

Study 1 Immunodeficient mice will be injected with clinical specimens collected from patients suffering from liver cancer. Tumors will develop about 10 days after the injection. On day 10, animals will be anesthetized with isoflurane, and the development of tumors will be verified through MRI scans. Mice experiencing tumors will receive intravenous treatments of the 5-FU using nanotechnology. Tumors will be measured every other day using an MRI scan. Upon completion of the study, the mice will be euthanized and tissues will be analyzed.

Study 2 A replication deficient lentivirus system will be used to insert a gene sequence (derived from human liver cancer cells) that codes for the protein that produces liver tumors in mice   A blood test will be conducted on mice to identify those producing the protein associated with the cancer. Mice expressing this protein are expected to develop liver tumors in approximately 30 days. Two groups of mice will be studied. The first group will receive no treatment and will be followed using MRI scanning through the progression of liver cancer. Blood collections will also occur to monitor the level of the protein. The second group will receive the nanotreatments. These animals will be screened using MRI scanning, and blood samples will be collected every five days and analyzed for the presence of the protein associated with the cancer. Upon completion of the study, the mice will be euthanized and tissues will be analyzed.

Risks Common Hazards Project 1 Nanoparticles Mice expressing a protein know to cause liver cancer Fluorouracil (5-FU) Project 1 Human derived clinical specimens (liver cancer cells) Isoflurane MRI

Risks Common Hazards Project 2 Nanoparticles Mice expressing a protein know to cause liver cancer Fluorouracil (5-FU) Project 2 Replication deficient lentivirus system will be used to insert a gene sequence (derived from human liver cancer cells) that codes for the protein that produces liver tumors in mice   Mice blood samples MRI

Time for Lunch!!

Human Gene Transfer Protocols and a new HGT guidance document

Please, complete your Evaluation Forms and offer suggests! Wrap-up Please, complete your Evaluation Forms and offer suggests!