ibc meeting minutes boston university i. review of october

IBC Meeting Minutes Boston University

Location: E-720, 72 East Concord Street November 18, 2014

Start time: 12:05 PM End time: 3:08 PM

Present: A. Henderson (Chair), R. Ingalls (left 1:45 PM), W. He, K. Tuohey, J. Barbercheck, R. Morales (arrived 12:25 PM), J. Barton (arrived 12:12 PM), T. Winters, C. Sulis (arrived 12:56 PM), F. Gibson, N. Broude, B. Slack,

D. Stearns-Kurosawa (left 2:50 PM), K. Kirsch (left 1:05 PM), R. Georgiadis (left 2:50 PM), E. Muhlberger, V. Britton, J. Gonsalves, J. Keeney, R. Timmerman.

Absent: N. Bhadelia, E. Helmerhorst, J. Levin, P. Urick. Guests: T. Killeen, S. Monstur.

Staff: S. Ghosh, M. Hatton.

I. Review of October Minutes Recommendation: Approved For: 16 Against: 0 Abstain: 2

II. New Business

A. IBC Training Session: 1. Updates from Environmental Health & Safety - Updates on biological waste disposal –

Stephen Monstur. Director of Environmental Management Mr. Monstur gave a thorough run-down of the waste disposal policies of the BU Charles River Campus, the Medical Campus and the National Emerging and Infectious Disease Laboratories (NEIDL). He specifically pointed out the minor modifications in these policies over the past year that has been introduced because of the demands from various regulatory agencies. Members were asked whether they approve these modifications. Everybody voted in favor of these changes.

B. Chairperson Report: 1. Discussion on Biosafety Culture and Training

The Chairperson expressed concern over comments voiced by several trainees (consisting mostly of undergraduates, graduates and lab managers) in a recent meeting in the Microbiology department that they believe that they are not getting enough appropriate lab safety training. Since the IBC committee and EHS office are trying their best to provide appropriate training to all parties and helping them to remain compliant with all the regulatory requirements, it is believed that there must be miscommunication at some level. The Chair sought suggestions from the members about how to deal with this situation. Many thought it would be important to know whether trainees from other departments feel the same way. There were questions whether the dissatisfaction was over any particular training or it was a general concern. The consensus from the discussion was that PIs should be more proactive in implementing the culture of safety in his/her group on top of the EHS provided trainings. There were suggestions for the development of Focus Group discussion in the trainee community. Vice Chair suggested that may be development of culture of safety should be a mandatory course of GMS training. The Chairperson expressed his wish to hold a more formal discussion on the topic in near future.

IBC Meeting Minutes: November 2014

C. Technical Committees Report: 1. Approved Applications/Amendments

This month 2 new applications, 6 three-yr renewals, 11 amendments and 10 annual renewals have been approved.

2. Policy Updates and Discussion on ‘Verification of the identity of Attenuated Pathogens’ IBC is seeking approval of the policy on “Verification of the Identity of Attenuated BSL-3 and BSL-4 pathogens” from the Boston Public Health Commission (BPHC). The process is going on for sometime. The IBC office has had to modify the language of the policy to address some concerns of the BPHC. To keep the process transparent, the modified policy was circulated to the members of the IBC committee and was asked to comment on it. Some members expressed concern that some restrictions imposed on the strain validation process very likely will be difficult to follow unless a separate dedicated strain verification facility is instituted.

D. Biosafety Report: 1. Research Occupational Health Program Incident Report

There have been four incidents since our meeting in October, 2014.

In the first incident, a laboratory technician sustained a chemical spill of bicuculline on his leg. He rinsed the chemical off without removing his pants and tried to keep the contaminated clothing off the skin. ROHP advised immediate removal of the clothing and emergency shower, change into non-contaminated clothing, and go to the BMC emergency room. ROHP arranged evaluation of the exposure in BMC Emergency Dept where the lab tech was later released.

In the second incident a veterinary technician got a bite from a chinchilla on her left index finger when she lost her grip during examination of the neck area of the animal. The chinchilla was just shipped from the breeder and did not have any biological agents, viruses or bacteria. She was examined and treated in ROHP. She is up-to-date with Tdap vaccination. An animal bite report form was submitted to the Boston Public Health.

The third incident involved unwanted exposure of five veterinary staff members to mice that were dosed with tamoxifen and left at CCL-1 condition. The CCL-1 condition requires single gloves, lab coat, face mask and non-medical waste handling/disposal procedure. Tamoxifen treated animals, on the other hand needs to be handled in CCL-3 conditions which include double gloves, Tyvek coat, N95 mask, head cover and medical waste handling/disposal procedure. Access to continue the work was promptly revoked.

In the fourth incident a veterinary stuff was bitten by an infant macaque while he was being removed from his mom. The bite site was immediately washed and showered with prodidine iodine surgical scrub for 20 minutes. He is up to date with Tdap, was provided prophylaxis and will be followed-up with ROHP. Animal bite report will be sent to Boston Public Health Department.

2. Updates from Environmental Health & Safety Biosafety Officer reported that they joined the weekly lab meeting of the lab where drinks were previously found in BSL2 lab space and was reported in previous month’s IBC meeting. They reiterated the regulations about food and drinks in the lab to all the lab members. PI assured that such incidents will not happen again. EHS also helped another PI (who was reportedly non-compliant) in maintaining proper lab safety records. Follow-up visit will be initiated to check progress.

III. Protocol Review: Meeting is not closed

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A. New Applications 1. Bhz Protocol 1975

“Exploring the use of adult neural crest stem cells derived from non-ocular sources to treat corneal endothelial disease” Primary Reviewer: Kathrin Kirsch Secondary Reviewer: Wei He Biosafety Level: 2 Animal Biosafety Level: N/A Campus: BUMC Layman’s Description: Corneal endothelial cells are the cells that line the backside of the cornea, and are critical to keeping the cornea clear. Diseases that affect these cells lead to decreased vision due to swelling of the cornea. Human corneal endothelial cells do not naturally regenerate if they are lost or damaged. The goal of this project is to regenerate corneal endothelial cells by isolating adult (non-embryonic) stem cells from easily accessible sources, such as hair or mouth tissues, and turn them into corneal endothelial cells. Pre-Meeting Comments: Reviewer I: This is a straightforward project that involves the use of discarded human tissue - either procured from BMC or from a tissue bank - to isolate neurocrest derived adult human stem cells for the generation of human cornea cells. I have few comments: The tissue procured from BMC, "will be collected in 50 mL conical screw-top leak-proof shatter-proof tubes containing PBS.... The collection tube will be placed in a plastic biohazard bag and transported on ice in a covered ice bucket to the laboratory." I am concerned that if these are regular 50 ml falcon tubes that these are not leak prove and I would recommend a different collection vial e.g. such as specially designed for surgical specimens. Also, IRB approval has not yet been granted. Reviewer 2: This is a very straightforward biohazard-only type of protocol and I only have some minor comments. IRB approval for the work with human samples from patient need happen before final IBC approval. PI has a draft IRB protocol (H-33522) and please submit it soon and keep us informed when it’s approved. Under PPE section “liquid waste”, PI mentioned disinfection of surgical instruments in a bath of Wescodyne for 30 minutes and then carefully clean with soap and water using a brush. Please clarify if those instruments will be autoclaved for recycled use. Meeting Comments: In this protocol the PI is interested to develop methodologies whereby corneal endothelial cells can be regenerated from easily available adult non-embryonic stem cells. PI will isolate neural crest cells from adult hair follicles or oral mucosa from consenting individuals via Boston Medical Center surgeons or from cadaveric corneas from tissue banks and will then differentiate them in to corneal endothelial cells. Transformation of neural crest cells to corneal endothelial cells will be monitored by standard molecular biological approach. Nicely written straightforward protocol with only minor concerns. The PI needs to: Investigator Contact Information: Q3- If the 0571 is a pager number, please indicate so. Research Project Description: Q3- Transportation of human material in 50 ml Screw-cap tube wrapped in biohazard and place on ice bucket is not a recommended transportation method. Use a secondary leak-proof and shatter-proof transport container specifically designed for surgical specimens. Please modify your statement appropriately. PPE and SE: Q7A- Please indicate that the described method for disinfection of surgical instruments is only for materials to be used in the laboratory and not for clinics (as clinic use would need a more thorough cleaning followed by sterilization).

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Other Potentially Infectious Materials: IRB approval for the work with human must be received before the final IBC approval. You have a draft IRB protocol (H-33522) for this project. Please submit it soon and keep us informed when it is approved. ROHP & LST: LST and ROHP are clear for both personnel BUA Site Assessment: The PI, who is a new recruit to the department, was advised on multiple safety requirements. She was very responsive. No remaining issues. Recommendation: Approved Pending. For: 20 Against: 0 Abstain: 0

2. Bhz Protocol 1981

“Correlation of THBS1 polymorphisms and TSP-1 expression” Primary Reviewer: Robin Ingalls Secondary Reviewer: Jim Keeney Biosafety Level: 2 Animal Biosafety Level: N/A Campus: BUMC Layman’s Description: Thrombospondin 1 (TSP1) is a protein that is important to the regulation of inflammation on the surface of the eye. Specific sequences in the human thrombospondin gene (THBS1) have been found to correlate with reduced levels of thrombospondin on the surface of the eye, and with an increased risk of developing chronic dry eye syndrome. The goal of our study is to determine whether the same correlation between the levels of thrombospondin expression and the presence of specific gene changes in THBS1 exists in the peripheral blood of human volunteers because if so, a blood test to determine a patient's risk for problems of eye inflammation could be developed. Pre-Meeting Comments: Investigator Contact Information: Q3- If the 0571 is a pager number, please indicate so. PI revised the application to correct BSL2+ designation of L-914 laboratory. Reviewer 1: Final approval will need to wait for IRB approval. Query: if they are collecting blood from patients seen in the ophthalmology clinic, is this a hospital-based project. Reviewer 2: It is a BSL-2 study that also is non hospital-based. It proposes to study whether levels of thrombospondin 1 (TSP1) in the eye can be matched with blood levels of a corresponding gene found in blood, and, thus, lead to a more predictive blood test for dry eye syndrome. No BSC will be used, and the training of researchers in the study appears up-to-date. Therefore, as the community safety representative on the study, I have no objections to the commencement of this protocol. Meeting Comments: PI is interested to study whether the expression of the thrombospondin gene (THBS1) in the ocular surface cells is related to its expression in the peripheral blood cells of the same individual. Specific sequences in the THBS1 gene have been found to correlate with reduced levels of thrombospondin on the surface of the eye and an increased risk of developing chronic dry eye syndrome. PI wants to test if thrombospondin expression in the peripheral blood matches to that in the ocular surface cells, so that a diagnostic blood test can be developed to predict inflammatory disorders of the eye. This second new application from the same PI is also a straight-forward application. Only minor concerns remain. The PI needs to: Investigator Contact Information: Q3- If the 0571 is a pager number, please indicate so. Materials Used in Research: If you are collecting blood from patients seen in the ophthalmology clinic, this should be a hospital-based project. If a phlebotomist is collecting blood there is no problem but if lab members are collecting samples, then Dr Carol Sulis needs to be contacted at 617-414-5037) and she may need to train those personnel. Please clarify in the Research Project Description Q-3 section.

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Other Potentially Infectious Materials: Your IRB protocol (H-33154) has been approved with an expiry date of 10/26/15. Please update it in this section. ROHP & LST: LST clear for both but ROHP is clear for only one. BUA Site Assessment: The PI, who is a new recruit to the department, was advised on multiple safety requirements. She was very responsive. No remaining issues. Recommendation: Approved Pending For: 20 Against: 0 Abstain: 0

3-Year Resubmission (this 3-year submission was reviewed out of sequence to allow the primary reviewer complete her reviews together) 3. Bhz Protocol 883

“Fusion of cancer and dendritic cells as an anti-tumor vaccine” Primary Reviewer: Robin Ingalls Secondary Reviewer: Jim Levin Biosafety Level: 2 Animal Biosafety Level: 2 Campus: BUMC Layman’s Description: One of the immune systems normal functions is to prevent the development of malignant diseases. However, in people who develop cancer the immune system is not successful at recognizing and destroying cancer cells. Scientists are trying to develop ways to help the body’s immune system attack cancer cells. To do this, they have created a vaccine by fusing cancer cells with the immune systems natural "teacher" cells, called dendritic cells. We now assess the effect of fusion cell vaccine or its derivatives as part of combined approach in the treatment of cancer. Pre-Meeting Comments: Overview and Grant Funding Information: Please remove the text from the “summarize changes” box as this box is only for annual renewal and amendments. Personnel Information: Check ROHP clearance date Research Project Description: Q1- Check typos in the layman’s description section. PPE and SE: Please check the animal handling box Materials Used in Research: Need to check ABSL level for the project (ABSL-2) Meeting Comments: One popular hypothesis in that cancer develops as a result of failure of body’s immune system in recognizing and destroying cells with unrestricted growth characteristics. PI in this protocol wants to develop anti-tumor vaccines by fusing so called natural teacher immune cells (dendritic cells) to specific cancer cells. PI describes the strategies for the generation of these fusion cells and methodologies to determine their function. Animal models will be used extensively to determine the efficacy of these fused cells against induced tumors in animal models. The science and experimental details are described well. Administrative aspects of the application are also completed nicely. Only very minor issues left to be clarified. The PI needs to: Overview and Grant Funding Information: Please remove the text from the “summarize changes” box as this box is only for annual renewal and amendments. Research Project Description: Q1- Check typos in the layman’s description section. PPE and SE: Since you have extensive animal work in your protocol, please check the animal handling box as well. Materials Used in Research: Please check the highest ABSL level for the project (should be ABSL-2 in your case). ROHP & LST: All clear BUA Site Assessment: All good Recommendation: Approved Pending For: 20 Against: 0

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Abstain: 0 New Applications: 4. rDNA/Bhz Protocol 1944

“Manipulation of stem cell activity and cell death by intracellular bacteria” Primary Reviewer: Natasha Broude Secondary Reviewer: Bob Timmerman Biosafety Level: 2 Animal Biosafety Level: N/A Campus: CRC Layman’s Description: We are studying the gut commensal bacteria in mosquitoes(Culex pipiens) and how an intracellular bacteria, Wolbachia can effect the other microbial populations. Mosquitoes carrying Wolbachia have altered host biology, possibly resulting in changes in gut environment. It is known that Wolbachia can change host immunity and we also have shown that Wolbachia interferes with stem cells in the insect ovary. Stem cells in the insect gut are known to respond to microbial infection. Our experiments aim to identify Wolbachia - gut commensal bacteria interactions. Pre-Meeting Comments: Marked DURC concern (#3) – Introducing Amp resistance in bacteria Novel BSL-2 pathogen (LAI concern)?: Yersinia frederiksenii and Sphingobacterium multivorum Overview and Grant Funding Information: Please remove the text from the “summarize changes” box as this box is only for annual renewal and amendments. PPE and SE: Q8- Indicate bleach will be 10% freshly made. Recombinant DNA: Please name the plasmid vector/s to be used in the protocol. Indicate appropriate NIH guidelines for using BSL-2 level bacteria. Reviewer 1: 1. Please simplify the Layman's description 2. Please expand the description of the project, explain why do you need sterilization of embryos 3. How do you overcome the possibility that some bacteria in the gut is not culturable. Reviewer 2: PI has level 3 and Select Agent training but is not experienced with the Level 2 work for this experiment – this is confusing. No data for Level 1 and 2 training. No lab safety training. No ROHP. Lay description might well be edited to remove some technical terms. Brief description of research and detail description seem OK. Meeting Comments: The PI is interested to study the interaction of insect bacterial parasite Wolbachia with other bacteria in mosquito guts. Wolbachia is known to affect several biological characteristics of their insect hosts including reproduction and resistance to virus and other parasites. They also affect growth of other bacteria in mosquito gut, which may hold the clue to many of the features of Wolbachia infection of the mosquitos. PI will analyze microbial content of the mosquito guts by nucleotide sequencing of the 16S ribosomal RNA gene to understand which microbes co-exist with Wolbachia. He will also introduce genetically engineered bacteria (expressing GFP) in mosquitos that are either Wolbachia positive or negative to understand how Wolbachia influences the growth of other microbes in mosquito guts. Two bacterial species they have identified in mosquito guts (Shingobacterium multivorum and Yersinia frederiksenii) are of BSL-2 type although they rarely cause disease in humans. The PI marked the application as a source of potential DURC because he is introducing GFP expression plasmid that also contain ampicillin resistance gene, into some of the mosquito gut bacteria. Upon review of the protocol by BU DURC subcommittee, it was determined that presence of ampicillin resistance gene in the GFP expression plasmid does not constitute a DURC concern. The PI needs to: Overview and Grant Funding Information: Please remove the text from the “summarize changes” box as this box is only for annual renewal and amendments.

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Personnel Information: Please revisit the statements in this section and correct or clarify as appropriate. The PI must be experienced with the scientific and technical aspects of the protocol. If not, alternate faculty member with requisite experience should be brought in as Co-PI. Dual Use Research of Concern: The BU DURC subcommittee has reviewed your application and determined that presence of ampicillin resistance gene in the GFP expression plasmid does not constitute a DURC concern. Please remove the statements in question 3 and click the “No” checkbox. Research Project Description: Q3- Include the following statement – ‘Two bacterial species we have identified in mosquito guts (Shingobacterium multivorum and Yersinia frederiksenii) are BSL-2 pathogens although they rarely cause disease in humans.’ Note: ROHP clearance for the PI is still due. Please contact ROHP office at 617-414-7647 directly to get this clearance. ROHP & LST: LST is clear for all but ROHP is not for anyone. BUA Site Assessment: Lab inspected during last month’s protocol review and is OK. Recommendation: Approved Pending For: 20 Against: 0 Abstain: 0

5. Bhz Protocol 1988 “Gene-RADAR Pilot Trials” Primary Reviewer: Andy Henderson Secondary Reviewer: Sajal Ghosh Biosafety Level: 2 Animal Biosafety Level: N/A Campus: BUMC Layman’s Description: The goal of the project is to characterize the ability of a Nanobiosym (NBS) product, named GeneRadar, to accurately quantify Ebola and HIV. In the initial phase of the project, inactivated/non-infectious Ebola and HIV will be shipped to Dr. Sagar's laboratory. Dr. Sagar's laboratory will spike inactivated/non-infectious virus into human blood samples, and these samples will be tested concurrently using quantitative PCR and GeneRadar. Pre-Meeting Comments: Investigator Contact Information: Check appropriate box for Dept Admin’s employee status. Personnel Information: PI must include himself in the personnel list and complete ALL associated sections. PPE and SE: Please check appropriate boxes in Question 1. Q5- Complete the biosafety cabinet information and recent certification date. Q7A- Liquid waste generated in BSL2+ lab (X-633) is treated with wescodyne for >1 hr and disposed down the drain without autoclaving – is this correct? Materials Used in Research: Room X-633 is marked as BSL2+ facility but highest BSL level is indicated as BSL2. Please clarify. Meeting Comments: The purpose of this new protocol is to standardize the efficacy of machine by the name GeneRadar that is supposed to quantify Ebolavirus and HIV in field samples. The will test the machine with commercially available blood samples that is spiked with inactivated Ebolavirus or HIV. Proprietary technology involved in the processing of the samples by the machine is not disclosed. However, details about the lab procedure have not been described. RNA from these spiked samples will also be extracted and analyzed by real-time PCR and compared with GeneRadar data to determine the efficacy of the machine. Some details about how the record of inactivation of virus samples received from outside sources will be maintained are missing. The PI needs to: Investigator Contact Information: Check appropriate box for Dept Admin’s employee status. Personnel Information: PI must include himself in the personnel list and complete ALL associated sections. This include rDNA/Infectious Agents/Select Agents, Experience and State how many years experience, when and where questions.

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Research Project Description: Q3- Please provide technical detail of how inactivated virus samples are spiked with human blood and how exactly it is being put into the machine emphasizing the hazardous component of the work. Please specify that you will obtain inactivation record for each batch/lot of sample of Ebola that you receive from bei Resources and will maintain them for evaluation by EHS as needed. PPE and SE: Please check appropriate boxes in Question 1. Q5- Complete the biosafety cabinet information and recent certification date. Q7A- Liquid waste generated in BSL2+ lab (X-633) is treated with wescodyne for >1 hr and disposed down the drain without autoclaving – is this correct? Please clarify. Materials Used in Research: Room X-633 is marked as BSL2+ facility but highest BSL level is indicated as BSL2. Please clarify. Note: EHS site visit of your lab is not done yet. Please coordinate with the EHS office (Joe Barbercheck – 617-638-8842) to have this done. Please check with ROHP office (617-414-7647) if they need anything else from you both for granting clearance for this particular protocol. ROHP & LST: Working on it. BUA Site Assessment: not done yet. Recommendation: Conditional approval –revision to be sent to reviewers and EHS/Joe Barbercheck. For: 20 Against: 0 Abstain: 0

B. 3-Year Resubmissions

6. rDNA/Bhz Protocol 1445 “Effects of sensory learning on neural circuit structure and function in mammalian cortex” Primary Reviewer: Debbie Stearns-Kurosawa Secondary Reviewer: Jim Levin Biosafety Level: 2 Animal Biosafety Level: 2 Toxin: Tetrodotoxin Campus: CRC Layman’s Description: Understanding the biological basis of learning and memory is a long-standing goal in neuroscience. How is information about our experiences stored in the patterns of connections between neurons in the brain? Our experiments directly evaluate several well-established but poorly-tested theories for information storage in neural circuits. These experiments could also provide information useful for understanding disorders such as Alzheimers' and PTSD. Pre-Meeting Comments: Overview and Grant Funding Information: Please remove the text from the “summarize changes” box as this box is only for annual renewal and amendments. Personnel Information: Please re-place the descriptive role statements in to the Title section and provide descriptive role for all personnel as suggested just below those boxes in RIMS. Please complete the “State how many years experience, when and where” section for Yuan and Ellen. Carl, Yuan and Ellen have been listed as experienced, but not clear with what task relevant to this proposal. Is PI the only one who will do rDNA work? Research Laboratory Facility Information: LSEB 432 has been marked as ABSL2. Do you do any BSL2 level animal work in that room? Please also list the functions of all other rooms listed in your protocol. Research Project Description: Q3- Please expand the abbreviations for CNQX, APV, and TEA . Please list ACSF and TTX abbreviations next to their first use in the text. Please put the descriptive detail of vector and donor information (that is listed in the rDNA animal section) in the project description Q3 to help their proper evaluation.

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Please review the IBC updated policy on laboratory use of certain toxins including tetrodotoxin in Appendix H in the BU Biosafety manual available on the IBC web site: http://www.bu.edu/orc/policies-procedures/environmental-health-safety/ibc-policies-procedures/ When tetrodotoxin is manipulated in powder form, this should be done in a certified biosafety cabinet. A toxin that is in powder form should be dissolved in solution, through the septum, without opening the container. Please revise the protocol description of laboratory procedures to state these changes. PPE and SE: Q1- Please check the animal handling and cage changing box and animal inoculation box. Q4- PI listed disposable scrubs and double gloves for animal handling. This is unnecessary and should be unchecked. Q5- Use of BSC is indicated in Q2 but this section is empty. Either clarify in project description or complete this Q5. Q7A- While Wescodyne has good penetration, it would be preferable to use disposable instruments when possible, or rinse reusable instruments to remove any solids that have caked onto the instruments before attempting the decontamination process. Modification of the statement in this regard is requested. Q7B- Please describe treatment and disposal of solid wastes. The experiments will use solid disposables (pipettes, tips, tubes, Kimwipes, etc) and animal tissues. Q10- Please indicate the location of -80°C freezer. Materials Used in Research: Please check the “Synthetically derived nucleic acid molecules” box. Hazardous Biological Agent, Section A: Include AAV in the box 1 list. Change ABSL level for lentivirus in box 4 to ABSL2. Include AAV-related info in all appropriate boxes. Include current approval date for your animal protocol. Recombinant DNA: Please correct the IACUC protocol approval date. Meeting Comments: This protocol involves studies to understand how learned memories are stored in the brain. Experimental mice are trained to learn smell that leads to meaningful behavioral changes. Brain tissues from these trained animals are then analyzed to test how the pattern of synaptic connections between neurons is altered as a result. These experiments are done in perfused brain tissues from the animals in artificial cerebrospinal fluid or directly in live anesthetized animals. Chemical stimulants including tetrodotoxin are used in some studies. Some of the electrophysiology and imaging analysis of the brain are also done in animals whose brain was labeled with green fluorescence protein using replication incompetent adenovirus or lentivirus vectors. Few issues were noted that include use of unclear abbreviations and lack of details on the use of toxins. Specific information on viral vectors is also needed. The application however is written nicely. The PI needs to: Overview and Grant Funding Information: Please remove the text from the “summarize changes” box as this box is only for annual renewal and amendments. Personnel Information: Please re-place the descriptive role statements in to the Title section and provide descriptive role for all personnel as suggested just below those boxes in RIMS. Please complete the “State how many years experience, when and where” section for Yuan and Ellen. Carl, Yuan and Ellen have been listed as experienced, but not clear with what task relevant to this proposal. Is PI the only one who will do rDNA work? Research Laboratory Facility Information: LSEB 432 has been marked as ABSL2. Do you do any BSL2 level animal work in that room? Please also list the functions of all other rooms listed in your protocol. Research Project Description: Q3- Please expand the abbreviations for CNQX, APV, and TEA . Please list ACSF and TTX abbreviations next to their first use in the text. Please put the descriptive detail of vector and donor information (that is listed in the rDNA animal section) in the project description Q3 to help their proper evaluation. Although PI cited multiple references, the committee wants the name of the specific vector/s that is/are being used in this IBC protocol.

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http://www.bu.edu/orc/policies-procedures/environmental-health-safety/ibc-policies-procedures/



Please review the IBC updated policy on laboratory use of certain toxins including tetrodotoxin in Appendix H in the BU Biosafety manual available on the IBC web site: http://www.bu.edu/orc/policies-procedures/environmental-health-safety/ibc-policies-procedures/ When tetrodotoxin is manipulated in powder form, this should be done in a certified biosafety cabinet. A toxin that is in powder form should be dissolved in solution, through the septum, without opening the container. Please revise the protocol description of laboratory procedures to state these changes. PPE and SE: Q1- Please check the animal handling and cage changing box and animal inoculation box. Q4- PI listed disposable scrubs and double gloves for animal handling. This is unnecessary and should be unchecked. Q5- Use of BSC is indicated in Q2 but this section is empty. Either clarify in project description or complete this Q5. Q7A- While Wescodyne has good penetration, it would be preferable to use disposable instruments when possible, or rinse reusable instruments to remove any solids that have caked onto the instruments before attempting the decontamination process. Modification of the statement in this regard is requested. Q7B- Please describe treatment and disposal of solid wastes. The experiments will use solid disposables (pipettes, tips, tubes, Kimwipes, etc) and animal tissues. Q10- Please indicate the location of -80°C freezer. Materials Used in Research: Please check the “Synthetically derived nucleic acid molecules” box. Hazardous Biological Agent, Section A: Include AAV in the box 1 list. Change ABSL level for lentivirus in box 4 to ABSL2. Include AAV-related info in all appropriate boxes. Include current approval date for your animal protocol. Recombinant DNA: Please correct the IACUC protocol approval date. ROHP & LST: LST clear for all. ROHP is due for only one. BUA Site Assessment: In good shape. Recommendation: Approved Pending. For: 20 Against: 0 Abstain: 0

7. Bhz Protocol 1977

“National Clinical Trials Network” Primary Reviewer: Natasha Broude Secondary Reviewer: John Gonsalves Biosafety Level: 2 Animal Biosafety Level: N/A Campus: BUMC Layman’s Description: The purpose of the project is to collect specimens from patients taking part in cancer studies to be shipped to central laboratories for testing related to cancer and other diseases. Pre-Meeting Comments: Overview and Grant Funding Information: Please remove the text from the “summarize changes” box as this box is only for annual renewal and amendments. Personnel Information: Please provide the descriptive role for all personnel (suggested statements are available in the boxes below the question in RIMS). Please update the question “State how many years experience, when and where” for the PI and answer for other members. Only Dr. Faller and Ms. Forman’s are available now. Research Laboratory Facility Information: Please correct the BSL designation of R-906 to BSL2 (not BSL2 w/BS3 practices). Meeting Comments: This protocol is a hospital base study where the PI and his group is engaged in collecting clinical samples such as blood, rectal swabs, urine and cerebrospinal fluids from cancer patients enrolled

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in several clinical trials the umbrella of National Cancer Trials Network. These clinical samples will be shipped to central laboratories for various biochemical assays. Simple and straightforward application - Just a few issues need to be addressed. The PI needs to: Overview and Grant Funding Information: Please remove the text from the “summarize changes” box as this box is only for annual renewal and amendments. Personnel Information: Please update the question “State how many years experience, when and where” for all members. Only Dr. Faller and Ms. Forman’s are available now. Research Laboratory Facility Information: Please correct the BSL designation of R-906 to BSL2 (not BSL2 w/BS3 practices). Research Project Description: Q3- Please delete the repetition on Anal Swab collection. PPE and Safety Equipment: Q7B- Please describe what are these solid wastes and how exactly you dispose of them. Some examples on what to write are available with the help/hint button next to this question in RIMS. Materials Used in Research: Because this is a hospital-based study, PI needs to complete the associated question on this section (Physician contacted and date). If clinicians, phlebotomists or NPs collect these specimens, indicate so in the research project description section (section VII.3). Please contact Hospital Epidemiologist Dr. Carol Sulis (617-414-4958) for clarification on this requirement. NOTE: ROHP clearance for all personnel is required for approval of this protocol. Please contact ROHP office directly (617-414-7647) to get this clearance. ROHP & LST: LST clear for all. ROHP is clear for only 3 out of 5. BUA Site Assessment: No problem. Recommendation: Approved Pending For: 19 Against: 0 Abstain: 0

8. rDNA Protocol 802 “Altered Regulation of the Dynein Motor Complex in the piRNA pathway mutant germ-line of Drosophila melanogaster” Primary Reviewer: Barbara Slack Secondary Reviewer: Bob Timmerman Biosafety Level: 1 (Drosophila) Animal Biosafety Level: N/A Campus: BUMC Layman’s Description: The goal of this project is to gain a better understanding of how molecules are placed at different locations within the cell. This work will shed light on how cells become different from one another and has broad implications in the study of diseases such as cancer and neurodegenerative disorders. Pre-Meeting Comments: Overview and Grant Funding Information: Please remove the text from the “summarize changes” box as this box is only for annual renewal and amendments. Personnel Information: Please complete the rDNA/Infectious agent/Select agent question. Research Laboratory Facility Information: Room E-315 is marked as BSL2 with BSL-3 practices. Is this correct? If not, change it to as appropriate for your protocol (BSL-1). Research Project Description: Q1- Layman's terms section is rather vague. Please add a few words about the experimental model to be used in the protocol. Q3- What is BDGP in the procedure section? Please add few more words to the statements of “standard protocol will be followed” for methods such as In situ hybridization probe preparation or RNA injections. PPE and SE: Q7- Separate solid wastes from Q7A and place them in Q7B. Q12- Please answer this question. Materials Used in Research: Check the Radiation and X-Ray box and a complete section G. Uncheck Live Animal box and mark N/A for highest ABSL level for your project.

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Meeting Comments: PI is interested in understanding the mechanism of directional migration of biomolecules inside cells during embryonic development using Drosophila melanogaster as a model organism. Such migrations define cell polarity, which ultimately dictates proper development of organs. In particular PI is interested to study how dynein protein regulates microtubule-based transportation of macromolecules. They also study how phosphorylation of a dynein-associated protein called Bicaudal D regulates cellular signaling involved in defining cell polarity. Description is succinct and most of the pre-meeting concerns have been addressed in the revised application. PI will not be using any radioactive material at this time and modified the protocol appropriately. Only minor administrative issues remain. The PI needs to: Research Laboratory Facility Information: Room E-315 is marked as BSL2 with BSL-3 practices. Please change it to as appropriate for your protocol (BSL-1). Materials Used in Research: Uncheck Live Animal box and mark N/A for highest ABSL level for your project. This section is typically for the use of vertebrate animals. However, please keep the information in rDNA section as it is now. ROHP & LST: All clear BUA Site Assessment: Lots of suggestion made to the PI and she seems to be very willing to be compliant. No issues. Recommendation: Approved Pending. For: 19 Against: 0 Abstain: 0

9. rDNA/Bhz Protocol 1424 “Lineage specific determinants of oncogenic KRAS addiction in human cancers Identifying a KRAS regulated microRNA signaling network” Primary Reviewer: Sajal Ghosh Secondary Reviewer: Jim Keeney Biosafety Level: 2 Animal Biosafety Level: N/A Campus: BUMC Layman’s Description: Kras is the most frequently mutated oncogene in solid tumors with highest frequencies seen in lung, pancreatic and colorectal cancers. I propose to generate gene expression signatures for lung, pancreatic and colorectal cancers in the hopes of identifying novel therapies for each of these cancers, which are very difficult to treat with current chemotherapeutics. Pre-Meeting Comments: Overview and Grant Funding Information: Please remove the comment from the “summarize changes” box. This is only for annual renewal and amendments. Investigator Contact Information: Please change Departmental Administrator’s contact information. Personnel Information: Please provide both the Title and descriptive role for all personnel in a format as suggested next to each box in RIMS. Answer the rDNA/Infectious Agents/Select Agents questions for all (select agent question’s answer should be “No” for all as you are not working with any select agent). Please update the question “State how many years experience, when and where” for the PI and answer for other members. William’s lab safety training and ROHP needs to be cleared. Research Laboratory Facility Information: Indicate the function of the room K719. Research Project Description: Q3- Please correct typos that are carried over from previous submissions. Indicate the source of lentivirus packaging vectors (Sigma/Addgene/Trono or other) PPE and SE: Q5- Please update the biosafety cabinet certification information. Q7- Please describe the liquid and solid waste disposal procedure separately in sections 7A and 7B. Q8- Add 70% ethanol also in this section.

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Q10- Also describe where stock of cell lines are stored. Q12- Please answer this question. Materials Used in Research: Please check the appropriate ABSL box for your study (should be N/A for your protocol). Hazardous Biological Agent: Please complete the “obtained from” box for lentiviruses. Recombinant DNA: NIH guidelines have been updated since 2011. The new version is November 2013. Please change the reference appropriately in question 19. The new guidelines may be obtained in the following link: http://osp.od.nih.gov/sites/default/files/NIH_Guidelines_0.pdf. Meeting Comments: PI previously identified that presence of oncogenic KRas is not only responsible for cancerous transformation of cells, but actually is required for the survival of some cancer cells. PI wants to explore this so called KRas addiction phenomenon of certain cancer cells to find out if inhibition of KRas or KRas-dependent signaling partners can have therapeutic potential. PI is particularly interested in analyzing the microRNA expression pattern of these KRAS-dependent cancer cells and to determine modulation of epithelial-mesenchymal transition (EMT) network in these cells. MicroRNA microarray and lentivirus-based short hairpin RNA expression system to knockdown KRAS expression will be used in this protocol along with other standard molecular biological assays. Simple protocol but has several minor issues. The PI needs to: Overview and Grant Funding Information: Please remove the comment from the “summarize changes” box. This is only for annual renewal and amendments. Investigator Contact Information: Please change Departmental Administrator’s contact information. Personnel Information: Please provide both the Title and descriptive role for all personnel in a format as suggested next to each box in RIMS. Answer the rDNA/Infectious Agents/Select Agents questions for all (select agent question’s answer should be “No” for all as you are not working with any select agent). Please update the question “State how many years experience, when and where” for the PI and answer for other members. William’s lab safety training and ROHP needs to be cleared. Research Laboratory Facility Information: Indicate the function of the room K719. Also the rooms K719A and K721 need to be included in your protocol. Research Project Description: Q3- Please correct typos that are carried over from previous submissions. Indicate the source of lentivirus packaging vectors (Sigma/Addgene/Trono or other) PPE and SE: Q5- Please update the biosafety cabinet certification information. It is currently valid until 11/30/14. You need to recertify the cabinet very soon. Q7- Please describe the liquid and solid waste disposal procedure separately in sections 7A and 7B. Q8- Add 70% ethanol also in this section. Q10- Also describe where stock of cell lines are stored. Q12- Please answer this question. Materials Used in Research: Please check the appropriate ABSL box for your study (should be N/A for your protocol). Hazardous Biological Agent: Please complete the “obtained from” box for lentiviruses. Recombinant DNA: NIH guidelines have been updated since 2011. The new version is November 2013. Please change the reference appropriately in question 19. The new guidelines may be obtained in the following link: http://osp.od.nih.gov/sites/default/files/NIH_Guidelines_0.pdf. Note: ROHP clearance for the PI and William is needed for the approval of this protocol. Please contact ROHP office directly for this matter (617-414-7647). ROHP & LST: LST clear for all but ROHP is not for the PI and William BUA Site Assessment: BSC certification is valid until 11/30/2014. Rooms 719, 719A and 721 needs to be included. Recommendation: Approved Pending For: 19 Against: 0

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http://osp.od.nih.gov/sites/default/files/NIH_Guidelines_0.pdf

http://osp.od.nih.gov/sites/default/files/NIH_Guidelines_0.pdf


Abstain: 0

10. Bhz Protocol 1202 “Integrated, Point-of-care Diagnostics for low-resource settings” Primary Reviewer: Frank Gibson Secondary Reviewer: John Gonsalves Biosafety Level: 2 Animal Biosafety Level: N/A Campus: CRC Layman’s Description: Sputum (phlegm) is commonly used to diagnose respiratory disease such as Tuberculosis. When bacteria infects the lungs they can commonly be found in sputum. To diagnose diseases it is often necessary to extract the bacteria from the sputum, however this can be difficult due to the complex nature of sputum. The overall goal of the project is understand the physical properties of sputum. Pre-Meeting Comments: Reviewer 1: Few comments, but generally OK. PI page Is this an annual renewal or 3-year? III Personnel Lab safety and other trainings? ROHP clearance needed for 1 team member IV Research Laboratory Facility Information Little confusion about space. Sci library indicated as BSL-2 space for work? All other listed rooms are ID'ed as BSL-2, but have no descriptions for room function VII Research Project Will obtain de-identified sputum for collaborator, and this will be used to study physical characteristics of this type of sample, treatment approaches to decrease complexities of this specimen type, and will spike with M. smegmatis. All work with samples to be conducted with BSL-2 precautions. As the focus is Tb research, what are the safeguards of the study to ensure that sputum samples are free of Tb? Is there a possibility that these will come from suspected Tb individuals? Transporting samples - not sure of location, but indication is that "tupperware-type" transport is spill proof. If transporting outside, might want to consider something a bit more robust such as a sample transporter? Concern here is that the info on the sputum is not defined, and may harbor agents. "All waste" treated with 10% fresh bleach and disposed of in red bag waste. Please separate description of treatment approaches for liquid and solid waste streams. VIII PPE and Safety Equipment Q1 unclear if vortexing or other mixing will be needed during studies? Please confirm if needed? Q5 BSC recertification needed Q7 Biological waste management needs to be separated by type and description of management done accordingly. Solid, liquid. Also in waste management, sharps use indicated, but above Q6 (Sharps) sharps use indicted as no. Please modify to be consistent. Q11 Transport in personal vehicle. Is it OK to do so, suggested transport packaging? Training of team for shipping needed. Q12 Need to answer Q12 Section A Remove M. smegmatis from Section A. Uncheck Hazardous biological agents. Section B IRB: Unclear how IRB would want to handle something like this. I don't think IRB needed as de-identified, but as samples are clinical in nature, I'm a bit confused as to whether it beneficial to cite the IRB from the originating institution? Reviewer 2:

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The review approval date; the last was 11/29/11- is it the 3 year? Has the PI updated the PPE information? Layperson's Terms; adequate. Meeting Comments: The overall objective of this project is to improve devices used for point of care Tuberculosis diagnosis by improving sputum sample preparation methods. Extraction of bacteria from the sputum for the purpose of diagnosis could be difficult due to the complex nature of sputum. To understand the composition and physical properties of the sputum samples, PI will measure the fluidic properties of samples after subjecting them to different digesting and decontaminating agents. They will also analyze how these reagents will affect survival of pathogens in these clinical samples. This will be done by spiking samples with BSL1-level non-pathogenic bacteria that belongs to the same mycobacterium family. Although the protocol is not complicated, several minor concerns were voiced. This include requirement of shipping training, IRB issues, transportation container and others. The PI needs to: Overview and Grant Funding Information: Please change the submission type to 3-year re-submittal. Personnel Information: Please remove Erica Fong as we have been informed that she is no longer in the lab. Is PI the only person who does benchwork on this protocol? Please clarify. Also, shipping training is required for the operation of this protocol. Personnel listed in the protocol do not have this training. Again, clarification required. Research Laboratory Facility Information: Science Library room 306 is listed as a BSL-2 research space. Please correct or clarify. Functions of other listed rooms Eng 501, 509 and 623 needs to be described. Research Project Description: Q3- As the focus is Tb research, what are the safeguards of the study to ensure that sputum samples are free of Tb? Is there a possibility that these will come from suspected Tb individuals? Please provide additional statement to address these concerns. PPE and SE: Q5- Update the BSC certification date. Q7A- Please separate the solid waste and place them in Q7B. When sputum samples are being transported from outside, committee recommends PI to consider something a bit more robust sample transporter. Concern here is that the info on the sputum is not defined, and may harbor disease causing agents. Q12- Please answer this question. Materials Used in Research: Since Mycobacterium smegmatis is a BSL-1 organism there is no need for this Section A. Please delete. Other Potentially Infectious Material: Need IRB approval or relevant IRB information of the collaborator Sarah Fortunes at Harvard School of Public Health. ROHP & LST: Fong is not on protocol anymore. PI’s LST is clear, ROHP would be soon. BUA Site Assessment: Erica Fong is not in Boston anymore although still with BU. Who does all the work? Recommendation: Approved Pending. For: 18 Against: 0 Abstain: 0

11. rDNA/Bhz Protocol 1461 “1) Neural Substrates of Cognitive Decline in Aging 2) Neurobiological Consequences of Hypertension &Aging 3) Memory/Executive Function in Prefrontal & Temporal Lobe Cortex 4) Non-human Primate Model for Assessing Motor Recovery after Stroke 5) iPSC infusion as a treatment for ischemic stroke in the non-human primate” Primary Reviewer: Debbie Stearns-Kurosawa Secondary Reviewer: Jim Levin Biosafety Level: 2 Animal Biosafety Level: 2

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Campus: BUMC Layman’s Description: Studies focus on understanding the how the brain functions in learning and memory. To do this, studies use the rhesus monkey as this animal has both mental capacities and brain organization most similar to humans. The goal is to determine how normal aging, brain damage similar to stroke and the effects of high blood pressure impair brain function. All monkeys are tested on tasks designed to measure their mental or brain functions and then the brains are studied to identify the changes and mechanisms responsible for the impairments produced by normal aging, stroke and high blood pressure. Recently, studies have focused on the use of induced Pluripotent Stem cells (iPSC), which are stem cells derived from a persons own skin cells. These cells have potential as treatment for a variety of diseases. The cells can differentiate into a wide variety of cell types, including brain cells. The purpose of the present study is to assess the feasibility of injecting iPSC developed from human skin cells into the brains of rhesus monkeys as a possible treatment from stroke. The retrovirus we will inject has been widely used over the past decade to label adult born neurons. Pre-Meeting Comments: Overview and Grant Funding Information: Please remove comments in the “summarize changes” box as this is specific for annual renewal and amendments. Personnel Information: Please provide brief descriptive role for all personnel (as suggested in personnel page). Answer rDNA/infectious agent/Select agent question for Maalavika Ragunathan Please answer the question “State how many years experience, when and where” for Mary Kate, John Bladon, Eustathia Giannaris and Margee Kyada. Research Laboratory Facility Information: Is BSL2 with BSL3 practice designation for rooms X-313, 315 and 317 correct? Either change them to BSL2 or provide explanation. Also provide ABSL designation for X-315 and 317, as animal experiments are being proposed in those two rooms. In Personnel, Eustathia Giannaris is listed as Asst profess at U Mass, Worcester. Will any work for this protocol be done at this off-site location? If so, please provide relevant information. Research Project Description: Q2- As Dr. Rushmore has already submitted his own IBC protocol on designer drug receptor inactivation study, please remove the last paragraph of this section. Also remove relevant comments about his study in your front page comments. Also if the use of AAV was entirely for Dr. Rushmore’s work, it should be removed from this section and from Materials used in research, Section A. Please provide a brief description and IBC protocol number for Dr. Abraham’s work which is not described in detail here (Biochemical and Molecular Studies). Please make correction in “Tissue Freezing and Storage” section “—brain is frozen at -75°C”. PPE and SE: Q1- Please check animal handling, cage changing Q5- Biosafety Cabinet certification is expiring on 11/4/14, Please have it recertified before the expiration date. Q6- In sharps section, please change description to say the sharps container will be closed and taped when about ¾ full before disposal. Materials Used in Research: Please uncheck human embryonic stem cells. The J&J cells are umbilical cells, not directly from human embryos, which is what this box is intended to declare. And the iPSC are adult cells. There is no need for Section C on HESC. Please check highest animal biosafety level box for this protocol (ABSL-2). Hazardous Biological Agent: Section A Hazardous Biol Agents- please include source of human umbilical stem cells (J&J or industry sponsor). Remove AAV if it is there only for Dr. Rushmore’s study. The protocol injects human cells from a clinical trial but do not list an IRB approval number. It is not clear if these cells are a pharmaceutical clinical trial material or a human therapy that should be approved under an IRB. PI indicated that they are FDA approved but then qualifies it as a clinical trial approval. The use of FDA approved is misleading since an FDA approval is for marketing and sale of a drug or biologic. The use of a material in a clinical trial is not 'approved' by the FDA and this is an inappropriate use of this terminology. Please clarify this issue. High hazard chemical: Please provide more information on safe handling of osmium tetroxide.

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Recombinant DNA: Please complete the animal experiments part of this rDNA section (indicate animal species in 1st column, vectors in the 2nd column (viral packaging vectors) and names and source of the cloned genes in 3rd column. Meeting Comments: Layman’s description very nicely summarizes the activities involved in this protocol. Essentially the PI and large number of associate investigators analyze function of the brain of rhesus monkeys as the animals age or encounter physiological stress situation. In all studies monkeys are behaviorally tested using food rewards, receive MRI scans and in some studies undergo sterile surgery to inject microliter quantities of neuroanatomical tracer molecules, inducible pluripotent stem cells (iPS cells), or retro-, lenti- or adenovirus vectors into the brain. Brain samples are harvested from deeply anesthetized animals before exsanguinations and are subjected to identification of features related to cognitive function, neurophysiological analysis while under perfusion or histological staining. In some monkeys iPS cells are infused into the brain as a method of treatment for ischemic stroke. The laboratory procedure description is quite elaborate and addresses all potential biohazard aspects of the protocol appropriately. PI addressed most of the concerns indicated in the pre-meeting comments. He also provided explanation of his responses in separate word document provided to the committee. However, the protocol enlists 5 co-investigators and number of faculty level investigator without describing who is in charge of which section of the work. Few other minor issues as listed below need to be addressed. The PI needs to: Personnel Information: Please answer the question “State how many years experience, when and where” for Mary Kate, John Bladon and Margee Kyada. If you are having trouble in completing this in RIMS, let us know – we can help. Research Project Description: Q3- The committee expressed concerns on the lack of information that the PI should provide about what his collaborators are doing with monkey tissue samples or other materials generated in this study. Committee recommends that PI needs to provide brief statement (a line or two) about the work of individual co-investigators and senior faculty members (listed in the protocol) as appropriate for this protocol. For example, a statement of Dr. Abraham’s work written below would be sufficient. Co-investigators do not have to have separate IBC protocol. Please provide a brief description and IBC protocol number for Dr. Abraham’s work, which is not described in detail here (Biochemical and Molecular Studies). Dr. Abraham’s IBC protocol number is 13-108 where she uses monkey brain tissues to analyze relationship of Klotho protein expression and aging by immunohistochemistry. Please make correction in “Tissue Freezing and Storage” section “—brain is frozen at -75°C”. This is in the very first line of the section that starts with “Tissue Freezing and Storage: After perfusion the brain is removed from the skull, weighed, volumes taken, photographs taken and then immediately frozen at 75 degrees C or taken……..” (in research project description question 3, right below the reference to Dr. Abraham’s K312 lab work). Please review the IBC updated policy on laboratory use of certain toxins including tetrodotoxin in Appendix H in the BU Biosafety manual available on the IBC web site: http://www.bu.edu/orc/policies-procedures/environmental-health-safety/ibc-policies-procedures/ Please add this statement that when tetrodotoxin is manipulated in powder form, this will be done in a certified biosafety cabinet. A toxin that is in powder form should be dissolved in solution, through the septum, without opening the container. PPE and SE: Q5- Biosafety Cabinet certification has expired on 11/4/14, Please have it recertified immediately. Mention in “Make” line that this BSC is ‘in LSAC space –recertification scheduled.’ Q7A- Please remove duplication of solid waste disposal procedure from this section (Q7B is the place for solid waste). Instead, please write how you dispose of liquid wastes generated in your protocol in Q7A. Q11- EHS noted that at times transportation is done in personal vehicle. Please indicate that DOT regulations for transportation will be followed during all transportations of biological materials. ROHP & LST: 26 out of 30 are clear for ROHP. LST is clear for all.

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BUA Site Assessment: Liquid waste disposal needs to be corrected. DOT regulations for transportation must be followed even when things are being transported in personal vehicle. Recommendation: Approved Pending. For: 18 Against: 0 Abstain: 0

12. Bhz Protocol 1798 “PROJECT 1: The energetic cost of immune function in bats; PROJECT 2: Effects of White-Nose Syndrome on Little Brown Myotis in New England; PROJECT 3: AIRFOILS: Animal Inspired Robust Flight with Outer and Inner Loop Strategies” Primary Reviewer: Frank Gibson Secondary Reviewer: Jim Levin Biosafety Level: 2 Animal Biosafety Level: 2 Campus: CRC Layman’s Description: The ecological welfare of several North American bat species is affected by the complex interplay between factors such as social bat behavior, environmental conditions, colony seasonal dynamics, energy expenditure, and immune function. The ultimate goal of this research is to inform methods of surveillance and control strategies for fungal pathogens of bat species. Bats are critical to the ecological system in North America and additionally provide continued inspiration for studies of flight mechanisms and patterns and other unique bat behaviors. Pre-Meeting Comments: Reviewer 1: Few items noted below, but nothing major. III Personnel Title info would help to understand the level of each researcher. ROHP indicates cleared, but 1 individual has > 1year from last ROHP date - is this needed for the 1 person? Maneuvers: Will bat guano be harvested from roosts or other? Inhalation risk? Handling animals in the lab, are these alive, or dead animals. If alive, please indicate that bite-resistant gloves will be used (similar to that for field studies). Bat plasma added to E. coli to determine bactericidal activity. Please add strain info on E. coli to clarify if BSL-1 or BSL-2 bacteria used. Need for liquid N2 flash freezing, vs. dry ice. If dry ice acceptable, may be preferred (lessen transport hazard?) What type of Immunological endpoint assays will be performed? Please elaborate. VIII PPE and Safety Equipment Q1 Pipetting infectious liquid is checked off. Unclear what this material is. Are these the samples obtained from bats - possible rabies risk? The E. coli? Other? Q2 No BSC indicated. Unclear if needed, based on answer above to Q "pipetting infectious liquid" Q4 Some indication of cave work inconsistency. Need for hard hats / rubber boots indicated here, but also stated in same paragraph that cave studies completed. Please clarify. Q7 Unclear if there will be liquid waste generated. I anticipate so based on studies. Please ensure that liquid waste treatment is in agreement with BU Waste Water Policy Section B Please separate E. coli from bat samples. Depending on E. coli strain, may or may not be BSL-2. Please clarify Section E Not clear from Experimental procedures that rabies will be investigated? Unclear what this then means, and how to be studied. Please clarify. BPHC

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No evidence of rDNA work being performed. qPCR and sequencing of isolated DNA not rDNA, unless cloning, or moving genes/sequences. If no rDNA work, then all info in BPHC registration should be removed. Reviewer 2: My only comment is to ask the PI to clarify if all of these procedures are still in use. It's my understanding that the lab has given everything away and they have shut down the lab. It seems to me that if they are done performing any of the hazardous procedures, they should be removed from this application which would lower the risk assumption of the approval. Maybe the PI can clarify what is still active and required, and then remove what is not. Meeting Comments: There is indication that many of the procedures described in this protocol will not be done anymore. It was also brought to the attention that PI wants to keep the protocol in order so that if there be a need, the group can go to the wild and work with the animals. Please specify which part of the protocol is not active anymore. Also somebody needs to be in charge of coordinating the personal safety issues and be responsible for it. That assurance from the PI must be there in the protocol. The PI needs to: Overview and Grant Funding Information: Please remove comments in the “summarize changes” box as this is specific for annual renewal and amendments. Personnel Information: Please provide both the Title and descriptive role for all personnel in a format as suggested next to each box in RIMS. This is to understand their role in the project and their professional level. Research Laboratory Facility Information: Please add room Physics- Bio Research 537. Research Project Description: Please clarify the overall status of the protocol in question 3 (that this is slowly winding down). Especially which part of the protocol is not active anymore and what is active. Committee also wants to know why the non-active portions of the protocol are still there. Please provide a statement that addresses these issues. Committee was concerned that if students/fellows need to do more field studies or other studies with live bats and if there be any personal safety issues, how will they be taken care of? Committee wants some sort of assurance from the PI in this regard. There are few other minor issues on the lab procedure section. Is there any inhalation risk while collecting guano from the roosts? Not clear what type of immunological assays will be carried out to determine immune function of the bats. What kind of E. coli is being used for assessing the strength of innate immune response? Is it non-pathogenic variety or BSL-2 type? Does pipetting infectious liquid (indicated in PPE question 1) relates to handling of bacterial culture? PPE and SE: Q1- If you are pipetting infectious liquid, you may need to use Biosafety Cabinet depending on the nature of the infectious liquid. Please clarify in question 7A. If BSC is used, please complete question 5. Q7A- Please also indicate what is your liquid waste. Materials Used in Research: If any BSL-2 level bacteria is being used in the protocol check the Hazardous Biological Agent box and complete the section A form. Section B: Other Potentially Infectious Material: Please remove E.coli from this list. It should go to section A (if BSL-2 level organism; if it is BSL-1 level bacteria, there is no need to complete this section.) Boston Public Health Commission Form: Since there is no evidence of rDNA work being performed (unless cloning or moving genes/sequences, qPCR and sequencing of isolated DNA are not rDNA work), delete the content of the BPHC registration form. ROHP & LST: LST and ROHP are clear for all. BUA Site Assessment: Add room 537. Otherwise all good Recommendation: Conditional Approval For: 0 Against: 0 Abstain: 0

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13. rDNA/Bhz Protocol 784

“Studies of neurodegeneration” Primary Reviewer: Elke Muhlberger Secondary Reviewer: Jim Levin Biosafety Level: 2 Animal Biosafety Level: 2 Campus: BUMC Layman’s Description: We study neurodegenerative diseases, such as amyotrophic lateral sclerosis, Parkinsons disease and Alzheimers disease. These diseases are thought to result from the accumulation of abnormal forms of particular proteins, such as Synuclein, TDP-43, tau, TIA-1, beta-amyloid and LRRK2. The abnormal aspect of these proteins is that they are clumped (aggregated). The accumulation of these clumped proteins appears to kill nerve cells. The goal of the experiments described in this application/protocol is to figure out how to reproduce the disease process in the laboratory, and then develop ways to prevent the disease process (protein clumping/aggregation) from occurring. Pre-Meeting Comments: Reviewer 1 Overview and grant funding information Please remove outdated amendment description from box. VII.3 laboratory procedures Please indicate if the used feline leukemia retroviral vector is replication-incompetent. Is AAV exclusively used without helper virus? Please add brief description of experimental procedures used to analyze cultured cells, sacrificed animals and nematodes. Generation of iPSCs: Please add Dr. Murphy’s IBC protocol number covering this part of the work. Which vectors are used to induce pluripotency? Since culture stirrers and colony plating are checked in the PPE section, it is assumed that bacterial work will be done in the lab to amplify plasmid DNA. If this is correct, please add the bacterial work to laboratory procedure section. VIII, PPE Ad 5: Please update BSC certification date. Ad 6: Please describe the safety precautions for handling sharps. Ad 11: Please describe how the cell lines will be transported from Dr. Murphy’s lab to the PI’s lab. Section A, Hazardous Biological Agents Please add HIV-based lentiviral vector system (virapower). Section B, Other Potentially Infectious Material Please provide IRB number for human tissue. Section H, recombinant DNA Please add AVV and feline leukemia retroviral vector to vector packaging system box. Reviewer 2: 1)The ABSL level in table IX was not checked. 2) Perhaps I missed it, but I couldn't find the evidence that the various viruses were confirmed as replication incompetent. If you found this information, then please ignore this comment. 3) I couldn't find IRB numbers for the human source materials from patients. 4) He should uncheck disposable scrubs. 5) On page 19, he lists two IACUC protocols. One is approved but the one listed as pending is not in the IACUC system. I suspect this is old and should be removed from this application. Meeting Comments: The PI is investigating the pathophysiology of neurodegenerative diseases focusing on genes linked to the disease, including the genes/proteins alpha synuclein, Tau, TIA-1, TDP-43, Matrin-3 and LRRK2. They will investigate genes/proteins and chemicals that modify toxicity associated with these proteins using animal and cellular models of each disease. The chemicals that we will be studying include chemicals that reduce protein aggregation, the major cause of neurodegenerative diseases. They will also investigate cellular pathways that are responsible for

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carrying out toxic effects of synuclein or LRRK2 proteins. Cell culture work as well as animal model studies with C. elegans and transgenic mice expressing synuclein and/or LRRK2 will be used in this protocol. The protocol is written well but some details are missing. The PI needs to: Overview and Grant Funding Information: Please remove comments in the “summarize changes” box as this is specific for annual renewal and amendments. Personnel Information: Please provide the Title of Allison and yourself. Complete the rDNA/Infectious Agents/Select Agents question for all personnel. Core Facilities: Please indicate whether primary hippocampal or cortical neurons and cell lines are live or fixed. Also indicate their source (mice, human or nematode). Research Project Description: Q3- Please indicate if the used feline leukemia retroviral vector is replication-incompetent. Is AAV exclusively used without helper virus? Please add brief description of experimental procedures used to analyze cultured cells, sacrificed animals and nematodes. Committee did not approve homogenization of human brain samples in regular fume hood. Use of biosafety cabinet has been strongly recommened. Generation of iPSCs: Please add Dr. Murphy’s IBC protocol number covering this part of the work. Which vectors are used to induce pluripotency? (George Murphy’s protocol number is 13-011). Since culture stirrers and colony plating are checked in the PPE section, it is assumed that bacterial work will be done in the lab to amplify plasmid DNA. If this is correct, please add the bacterial work to laboratory procedure section. PPE and SE: Q5- Please update the BSC certification date (should be done annually) - Your new certification date is 6/17/14. Q7- Please separate the solid waste statement from section 7A to section 7B. Q8- Please indicate that the bleach is “freshly made 10% bleach”. Q12- Please answer this question. Materials Used in Research: Check highest ABSL-2 level of your work. Hazardous Biological Agent: Please add lentivirus vector system (Virapower) also. Your IACUC protocol listed as “pending” could not be located in INSPIR system. Please clarify. Other Potentially Infectious Material, Section B: IRB approval number is required for approval of this IBC protocol. You have a pending IRB application on this topic (H-32855). Let us know as soon as it is approved. rDNA: Please add AAV and feline leukemia retroviral vector to vector packaging system box. ROHP & LST: Both clear for all BUA Site Assessment: There are more personnel in the project which have not added because PI could not complete that in RIMS. Recommendation: Approved Pending. For: 18 Against: 0 Abstain: 0

14. rDNA/Bhz Protocol 936 “Early diagnostics and therapeutics for Neurodegenerative diseases” Primary Reviewer: Andy Henderson Secondary Reviewer: Jim Keeney Biosafety Level: 2 Animal Biosafety Level: N/A Campus: BUMC Layman’s Description: Amyloid-beta and alpha-synuclein are proteins that tend to form clumps. In the brains of people who have Alzheimer's and Parkinson's disease, these clumps build up and become toxic resulting in death of brain cells. The goal of this project is to develop a method for producing these clumps in tissues maintained in the laboratory. Once we can generate these clumps, we can search for molecules that can prevent formation of these clumps. We hope that these molecules can be used to treat patients with Alzheimer's and Parkinson's disease and delay the progression of the illness. Pre-Meeting Comments:

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Personnel Information: Please provide the Title and descriptive role for all personnel (suggested descriptive roles are indicated at the bottom of those boxes). Research Laboratory Facility Information: Biosquare III 424 is marked as BSL2 w/BSL3 practices. If this is incorrect, change it appropriately. In section IX, highest BSL is marked as BSL-2. Materials Used in Research: Check highest animal biosafety level for your work (should be N/A) Reviewer 2: It is non hospital-based, BSL-2 study with the goal of developing early diagnostics for neurodegenerative diseases. Training of investigators appears up to date as does the certification of the BSL to be used and transport procedures. The study uses replication-defective genes. In conclusion, I have no objections to the study based upon it’s safety to the community. Meeting Comments: PI is interested to understand how amyloid clumps are formed in the brain which causes neurological diseases such as Alzheimer’s disease or Parkinson’s disease. PI wants to extensively utilize rDNA technology to manipulate expression of various genes known to be associated with these diseases. Rat or mouse brain slices, rat or mouse primary neurons, C. elegans, neuroblastoma cell lines will be used for the expression manipulation studies. PI wants to reproduce amyloid clump formation so that he can test various chemical that would inhibit such clump formation. The science behind the project and the laboratory procedures are described nicely in the protocol. The protocol is quite heavy on rDNA manipulations but except the PI no other personnel seems to be experienced with the rDNA work. The PI needs to: Personnel Information: Please provide the Title and descriptive role for all personnel. Research Laboratory Facility Information: Biosquare III 424 is marked as BSL2 w/BSL3 practices. If this is incorrect, change it appropriately. In section IX, highest BSL is marked as BSL-2. Research Project Description: Since nobody other than the PI is reported to have experience with rDNA work, committee expressed concern over who actually is doing the rDNA and all other works listed in the protocol. Committee asks the PI to specify the responsibility of each listed personnel in the protocol (write in Section III, the Personnel Information page). Materials Used in Research: Transgenic mice are being used in the protocol, so please check the “live animal use” checkbox. Also please check the highest animal biosafety level for your work (as appropriate). Recombinant DNA: Since transgenic mice are used as animal model for Alzheimer’s disease, your response to the question 17 in rDNA section should be “Yes”. Please modify your response. ROHP & LST: All clear BUA Site Assessment: Lab is clean. Recommendation: PI indicated that he is not going to do any work under this protocol until a new person is hired to do the rDNA work but does not want to close the protocol. This is so that he can start the work as soon as he finds someone suitable. Because IBC does not have a ‘On hold’ type status, it was decided that the committee chair and primary reviewer will review the situation with the PI and a formal decision will be made after the meeting. Therefore, even though the protocol was reviewed, discussed at the meeting and was open to the committee members for comments, no formal voting was initiated. For: 0 Against: 0 Abstain: 0

15. rDNA/Bhz Protocol 641 “Quantitative Analysis of RET Receptor Activation and Signaling Macrocyclic Inhibitors of the NEMO/IKKbeta Protein-Protein Interaction” Primary Reviewer: Sajal Ghosh Secondary Reviewer: Elke Muhlberger Biosafety Level: 2 Animal Biosafety Level: N/A Campus: BUMC

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Layman’s Description: This project will provide a deeper understanding of how cells sense and respond to specific cues in their surrounding environment. These cues, and a cell's "machinery" for interpreting them, ultimately tell a cell to respond to its environment in a certain way, such as to live or die. Understanding what causes these responses can thus allow for better approaches to treating diseases, such as cancer. The NEMO work will help us develop novel methods for discovering small molecule inhibitors of protein-protein interactions. Pre-Meeting Comments: Reviewer 1: Personnel Information: Please provide the Title and descriptive role for all personnel (like the way you wrote it for Tadafumi, Mikayla and Mekesilika). Complete the rDNA/Infectious Agents/Select Agents question for rest of the personnel. Please answer the question “State how many years experience, when and where” for Simone. Lab safety training is expiring for Richard (11/16/14) and ROHP clearance is not available for yourself and Tadafumi, Mikayla and Mekesilika. Research Laboratory Facility Information: Please provide functions of all the rooms listed in section IV. Research Project Description: Please expand abbreviations (like NEMO, RET, GDNF) at their first use. The statement “the NEMO work will help us …….” is inappropriate for layman’s description. Please simplify. Q3-typo disposal/disposable. Name the lentivirus expression system and their source in this section also. PPE and SE: Q7A- Indicate exposure time with wescodyne before disposal down the sink. Materials Used in Research: Please uncheck the “Other Potentially Infectious Materials” section as nothing that you are using in your work fits in this category. Check the “Synthetically derived nucleic acid molecules” box since you have completed the associated questionnaire in the rDNA section. Hazardous Biological Agent: Lentivirus should be attenuated (in box 2) Other Potentially Infectious Material: Remove the contents of this page and delete the section. Reviewer 2: Do not have anything to add. It is straight forward, very clear and nicely written. Meeting Comments: The overall objective of this protocol is to understand how cells sense and respond to environmental stimuli. PI wants to do a thorough study of ligand binding, cell surface receptor stimulation, intracellular signaling and ultimately the cellular response following receptor-ligand interaction. They want to use a receptor tyrosine kinase family member (RET receptor) and GDNF ligand (Glial cell line derived neurotrophic factor) as the model system for their study. They will investigate how RET phosphorylation depends on the extent of RET expression on the cell surface. Also want to study the receptor activation by growth factors. Finally, they study the role of a modulatory protein called NEMO in NFkB signaling – which they do by developing small molecule inhibitors. Nicely written protocol, especially the detail description of management of biohazard material at each step is commandable. Only minor issues described below are to be taken care of. The PI needs to: Personnel Information: Please provide the Title and descriptive role for all personnel (like the way you wrote it for Tadafumi, Mikayla and Mekesilika). Complete the rDNA/Infectious Agents/Select Agents question for rest of the personnel. Please answer the question “State how many years experience, when and where” for Simone. Lab safety training is expiring for Richard (11/16/14) and ROHP clearance is not available for yourself and Tadafumi, Mikayla and Mekesilika. Research Laboratory Facility Information: Please provide functions of all the rooms listed in section IV. Research Project Description: Please expand abbreviations (like NEMO, RET, GDNF) at their first use.

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The statement “the NEMO work will help us …….” is inappropriate for layman’s description. Please simplify. Q3-typo disposal/disposable. Name the lentivirus expression system and their source in this section also. PPE and SE: Q7A- Indicate exposure time with wescodyne before disposal down the sink. Materials Used in Research: Please uncheck the “Other Potentially Infectious Materials” section as nothing that you are using in your work fits in this category. Check the “Synthetically derived nucleic acid molecules” box since you have completed the associated questionnaire in the rDNA section. Hazardous Biological Agent: Lentivirus should be attenuated (in box 2) Other Potentially Infectious Material: Remove the contents of this page and delete the section. ROHP & LST: LST and ROHP are clear for all. BUA Site Assessment: All good Recommendation: Approved Pending For: 17 Against: 0 Abstain: 0

16. rDNA/Bhz Protocol 1984 “Deactivation of cerebral cortex using AAV” Primary Reviewer: Andy Henderson Secondary Reviewer: Jim Levine Biosafety Level: 1 Animal Biosafety Level: 1 Campus: BUMC Layman’s Description: The goal of the experiment is to inject specific Adeno Associated Viruses (AAV) into a specific brain area. The animal recovers to allow the virus to infect the neurons around the injection. When a specific drug is administered, the infected cells will either turn off or turn on, depending on the type of virus. We will then use electrophysiological methods to determine the effects of removing this region on processing in other parts of the brain. Pre-Meeting Comments: Reviewer 2: No real concern but this application seems light in regards to details. 1) No animal handling PPE was checked 2) There is no BSC listed so I am not clear where and how virus stocks will be handled and loaded into the Hamilton syringes. It also sounds like a virus dilution step will take place in the procedure section but later it says there are no manipulations to virus stocks. 3) He says virus will be stored in his lab but no details provided. 4) he says virus is coming from a remote lab, but no details on transportation or receipt provided. 5) There is no associated IACUC protocol to compare to. This means I must rely on detail sin this IBC application and they seem to be missing. 6) It is not clear to me if the viruses are replication incompetent or remain active. If incompetent, no confirmation information was provided. If they remain active, then he should include procedures for safe handling of the animals. Meeting Comments: In this protocol the PI is interested to understand how function of specific region of brain is affected by molecular signaling. Specifically the PI is interested in identifying the function of a signaling molecule called citrine in the brain. PI wants to introduce inhibitory or excitatory variety of this citrine by adeno-associated virus mediated inducible expression system into the cerebral cortex region of rat brain. Expression of these recombinant virus vectors and their effect in brain function will be evaluated on anesthetized rat brain. Although not much detail has been described, the protocol seems to be a simple one. Some minor issues need to be addressed. The PI needs to: Personnel Information: Please provide the Title and descriptive role for all personnel. Also, please click “import training dates” for all personnel to make the most recent training and ROHP dates

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visible. Please answer the rDNA/Infectious Agents/Select Agents question and the “State how many years experience, when and where” question for yourself. Research Project Description: Q1- Simplify layman’s description and avoid scientific jargons. Q3- Indicate that by virus you mean viral vectors that expresses additional genes of your choice. Describe whether you prepare these viruses yourself or get them from other sources. If it is the latter, provide details. PPE and SE: Q1- Please check a) animal handling and cage changing and 2) animal inoculations boxes. Q4- No animal handling PPE was checked. Q6- Not clear if the syringe/needles are going to be re-used. If so, how are they being sterilized? Please clarify. Q8- Bleach should be “10% fresh bleach”. Q10- Indicate room number Q11- Indicate shipping standards for your protocol with emphasis on the primary and secondary containment. Please indicate from the source of these viruses for your study. Hazardous Biological Agent: IACUC application and its approval would be necessary before the actual work can be initiated. ROHP & LST: Both clear BUA Site Assessment: In good shape Recommendation: Approved pending For:17 Against: 0 Abstain: 0

IV. Approved Expedited Amendments & Annual Renewals

1. Protocol 1362 “Establishment of mouse models for Escherichia coli infection and Shiga toxin type-2 challenge for studies that address systemic Shiga toxin distribution and organ damage in vivo” Biosafety Level: BSL2 Animal Biosafety Level: ABSL2 Type: Expedited Amendment Modification: To add hamster and personnel

2. Protocol 1362 “Establishment of mouse models for Escherichia coli infection and Shiga toxin type-2 challenge for studies that address systemic Shiga toxin distribution and organ damage in vivo” Biosafety Level: BSL2 Animal Biosafety Level: ABSL2 Type: Expedited Amedment Modification: To add hamster and delete personnel

3. Protocol 1688 “Culturing Human Cells for Three-dimensional Bioprinting” Biosafety Level: BSL2 Animal Biosafety Level: N/A Type: Expedited Amedment Modification: Change in personnel and minor modification of protocol

4. Protocol 1234 “Project 1: NB-CVOT: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Occurrence of Major Adverse Cardiovascular

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Events (MACE) in Overweight and Obese Subjects With Cardiovascular Risk Factors Receiving Naltrexone SR/Bupropion SR Project 2: Pivotal Aspiration Therapy with Adjusted Lifestyle (PATHWAY) Study Project 3: A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Metformin and/or Sulfonylurea Anti-Diabetes Agents (ENDO Trial) Project 4: H-33390 A Mechanistic Examination of Dietary Composition on Metabolic Fuels Availability: BMC Substudy” Biosafety Level: BSL2 Animal Biosafety Level: N/A Type: Expedited Amedment Modification: To add IRB protocol and to add rooms

5. Protocol 1403 “1. Interaction of vitamin D and fish oil on the prevention and treatment of cancers 2. Analysis of biomarkers in IRB approved clinical study specimen” Biosafety Level: BSL2 Animal Biosafety Level: N/A Type: Expedited Amedment Modification: To change lab rooms

6. Protocol 1573 “The Somatic Genetics of the Humoral Response to Anthrax Vaccine Adsorbed (AVA) in Humans” Biosafety Level: BSL2 Animal Biosafety Level: N/A Type: Expedited Amedment Modification: Revison-To add minor rDNA component

7. Protocol 898 “Protective and Pathogenic B Cell Epitopes in Infectious Diseases” Biosafety Level: BSL2 Animal Biosafety Level: ABSL2 Type: Expedited Amedment Modification: Change of lab safety coordinator, correction of personnel experience check box

8. Protocol 1827 “Cellular and stem cell therapy in mouse wounds” Biosafety Level: BSL2 Animal Biosafety Level: ABSL2 Type: Expedited Amedment Modification: To add personnel

9. Protocol 1173 “Vaginal/Cervical tissue models: endocrine effects and susceptibility to infection” Biosafety Level: BSL2 with BSL3 practices Animal Biosafety Level: N/A Type: Expedited Amedment Modification: To add 2 and delete 3 personnel

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10. Protocol 848 “Uncoupling obesity from breast cancer in African American women; Mechanisms of Brd2 immunoprotection from insulin resistance; B cell proliferation regulated through BRD2 signaling” Biosafety Level: BSL2 Animal Biosafety Level: ABSL1 Type: Expedited Amedment Modification: To add two personnel

11. Protocol 633 “Role of Cytokines in Sepsis and Trauma Immunopathology in a murine model of pulmonary infection following traumatic brain injury” Biosafety Level: BSL2 Animal Biosafety Level: ABSL2 Type: Expedited Amedment Modification: To add personnel

12. Protocol 901 “Effect of interstitial pressure on epithelial invasion from human mammary ducts” Biosafety Level: BSL2 Animal Biosafety Level: N/A Type: Annual Renewal Modification: No Change

13. Protocol 725 “Gene expression and cell analyses in systemic sclerosis” Biosafety Level: BSL2 Animal Biosafety Level: N/A Type: Annual Renewal Modification: No Change

14. Protocol 1539 “Use of kidney specimens to identify endogenous antigens in membranous nephropathy” Biosafety Level: BSL2 Animal Biosafety Level: N/A Type: Annual Renewal Modification: No Change

15. Protocol 1820 “NIH R01 EB00262 Local regulation of angiogenesis by microenvironmental cues NIH R01 GM074048 Mesenchymal stem cells and the microenvironment NIH R01 EB008396 Engineering Multicellular Tissue Structure, Function, and Vascularization NIH R01 HL73305 Stiffness, Cadherins, Integrins, and Mechanochemical Signaling NIH UH2 EB017103 Integrated Heart-Liver-Vascular Systems for Drug Testing in Human Health and Disease” Biosafety Level: BSL2 Animal Biosafety Level: N/A Type: Annual Renewal Modification: Change in personnel and modification of PPE information

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16. Protocol 1811 “Neural Function in Embodied Active Sensing” Biosafety Level: BSL1 Animal Biosafety Level: ABSL1 Type: Annual Renewal Modification: To add personnel

17. Protocol 898 “Protective and Pathogenic B Cell Epitopes in Infectious Diseases” Biosafety Level: BSL2 Animal Biosafety Level: ABSL2 Type: Annual Renewal Modification: No Change

18. Protocol 989 “Innate Immune Responses to Neisseria and Chlamydia Grant numbers: Role of the Innate Immune System in Pathogen Induced Chronic Inflammation P01 AI078894” Biosafety Level: BSL2 with BSL3 practices Animal Biosafety Level: ABSL2 Type: Annual Renewal Modification: Just to change submission type

19. Protocol 1049 “The Mechanism of Cancer Cell Growth, Migration and Metastasis” Biosafety Level: BSL2 Animal Biosafety Level: ABSL2 Type: Annual Renewal Modification: No Change

20. Protocol 801 “Structure and assemble of apoB lipoproteins” Biosafety Level: BSL1 Animal Biosafety Level: N/A Type: Annual Renewal Modification: To delete toxin use and delete personnel

21. Protocol 231 “Collaborative Study of Head and Neck Diseases; Measuring Human Exposure to PBDE's; Pilot Study: Measuring Human Exposure to PBDE's in the Office Environment; Greater Boston PBDE Bosy Burden Project; Epigenetic Changes Following Exposure to Tetrachloroethylene; Biomarkers of Exposure and Kidney Damage among Sugarcane Workers in Nicaragua; Gymnast Exposure to Flame Retardants; Pathways From Stress to Metabolic Syndrome and Health Decline in Aged Caregivers; Prospective Study of Endocrine Disrupting Chemicals and Time to Pregnancy” Biosafety Level: BSL2 Animal Biosafety Level: N/A Type: Annual Renewal Modification: Change in personnel and addition of IRB protocol

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ibc meeting minutes boston university i. review of october

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