Web notes  

July 2020
BIOSAFETY - Back

Health, Safety, and Environment

Visit the Health, Safety, & Environment website.

Sponsored Training Opportunities
HSE sponsors a variety of instructor-led and online training course options and dates.
(http://www.hopkinsmedicine.org/hse/training/#Instructor)

Welcome back everyone!

The Division of Health, Safety, and Environment (HSE) is here to help support the phased returning to Johns Hopkins campuses. As we wear required face masks/coverings and practice social distancing, please know that HSE staff are walking the campuses and are often just a stroll, an email (HSEInfo@jhmi.edu ), or a phone call (410-955-5918) away. We are here and ready to help the Johns Hopkins community maintain a safe and healthy environment.

Research Labs Reopening
Annual Research Safety Surveys will resume as laboratories reopen. To prepare for Research Safety Surveys, you can do the following:

  1. Biosafety Information Sheets- A new form must be completed annually by each Principal Investigator. Once updated, please send the sheet to the attention of Mr. Jack Barrett via fax at 410-955-5929 or as an email attachment to jbarret1@jhmi.edu.
  2. Updated Departmental Contact Information- It is important that any changes to laboratory contacts, phone numbers, laboratory relocations, departures, and new arrivals be communicated to the HSE Research Safety Specialists. Please send any changes in Principal Investigator status, building, room changes, etc., to the attention of Mr. Jack Barrett via email at jbarret1@jhmi.edu.
  3. Research Registrations- Ensure that you are in compliance with required Research Registrations. All independent investigators must hold Institutional Biosafety Committee (IBC) approved research registrations for using or possessing material involving Recombinant or Synthetic Nucleic Acid Molecules, Potentially Infectious Agents/Pathogens, Biological Toxins, and/or Human Tissues at Johns Hopkins. Questions regarding a registration's approval status may be addressed by phone (410-955-5918) or email (ibc@jhu.edu).

Research Involving SARS-CoV-2/COVID-19 Related Materials
Please note that work with SARS-CoV-2 virus, derivatives thereof, and material derived from COVID-19 patients all need to be registered with the Biosafety Office and approved by the Institutional Biosafety Committee before obtaining these materials and commencing research.

Considering COVID-19 Animal Model Research? Contact the CAM (COVID19 Animal Models) at JHU team. Submit your project details on this site.

Considering COVID-19 Clinical Research? Contact the COVID-19 Johns Hopkins Clinical Research Coordinating Committee

BioRAFT Chemical Registry
Principal Investigators, please remember to complete the initial lab registration in BioRAFT. BioRAFT is an online, 24/7 accessible, software package that is being deployed to serve as the chemical registry for laboratory spaces located on the campuses of Johns Hopkins. Completion of the lab registration in BioRAFT will be reviewed as part of the annual departmental safety survey.

To access BioRAFT, please go to: https://jhu.bioraft.com. After logging in using your JHED, the General Setup Wizard will guide you through the lab set-up. We greatly appreciate your assistance with this project.

Dual Use Research of Concern (DURC) policies:
The United States Government's Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC) went into effect on September 24, 2015. DURC is defined by the federal government as:

"life research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security."

In the federal policy's current form, there are 15 agents (microbial entities and toxins) that fall under institutional DURC oversight. The current list of 15 agents as well as a list of 7 categories of experiments or experimental effects that would constitute DURC may be found at this website: http://www.hopkinsmedicine.org/hse/ire/regulations.html. Questions regarding DURC should be directed to the Biosafety Office at biosafety@jhu.edu or ire@jhu.edu.


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July 2020 articles:
Essential Information for Human Subjects Research Teams Related to COVID-19
Coronavirus Research Billing Notices and FAQ
Managing Investigational Product Returns from Research Participants
Update to Organization Policy on Registration of Clinical Trials
Changes in HSR Recertification
Update on Insurance and Research Participant Financial Responsibility Information Sheet: Signature No Longer Required
Change in JHM IRB Review Fees for Commercially-Funded Studies
Data and Safety Monitoring Board Training Manual Now Available
Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Fee Schedule Adjustment for Hospital Services Charged to Clinical Trial Budgets
Changes to NIH-funded Human Subjects Research
Free Resources for Longitudinal Clinical Research Studies
JHM IRB Reliance Requests
Sharing Partnership for Innovative Research in Translation
Johns Hopkins Institute for Clinical and Translational Research
Johns Hopkins Clinical Research Network
 
Visit Animal Care and Use Committee Website
Current Classes
"Interinstitutional Assurance" Agreement
Health, Safety, and Environment (HSE) presents: Safety in Research Updates
COVID-19 Funding Opportunities
Searle Scholars Program
Michael J. Fox Foundation (MJFF) Challenge
Updated Guidance from NIH on COVID-19 Flexibilities for Applicants and Recipients
COVID-19 and Research Updates
Townhall Thursdays - Providing a Pulse on What's Happening in Research at JHU
New System to Request Outgoing Subawards
Point of Contact for NIH Loan Repayment Program
JHU SOM Update on NIH Policy on Foreign Involvement
Disclosure of Payments from Foreign Educational Institutions and Government Agencies
Institutional Letter of Support Required for Institutional Training Grant Applications
Notice to the Johns Hopkins Community Regarding the National Science Foundation Grant Reporting Requirement for Harassment Findings and Actions
Prohibited Mention of Prior Review for New Replacement Applications
NIH Policy on Foreign Component Involvement
NIH Policy: Foreign Components Added to a Grant to a Domestic or Foreign Organization
Why Project Outcomes Matter in your Interim and Final Research Performance Progress Report (RPPR)
NIH Matchmaker, A Tool For Finding Similar NIH Projects
NIH Video Tutorials on How to Apply for Grants

This Month's Departmental Listings

Upcoming Deadlines for July and September

Updates and Events at the Genetics Research Core Facilities
       

 

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