Web notes  

April 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)

Have a New Research Interest including Biological Materials? Don't Forget to Register Your Research!
The Biosafety Office assists the Johns Hopkins community in maintaining a safe work environment that is compliant with federal, state and community regulations. Our goal is to serve as a technical knowledgebase and training resource for biological safety issues on campus.

Contact Biosafety in the department of Health, Safety, and Environment (HSE) and get help from the experts about how to set up your lab, maintain compliance with required procedures, and so much more.

Biosafety at Johns Hopkins is overseen and reviewed by the Institutional Biosafety Committee (IBC). The goals of the IBC are:

  1. To ensure that reasonable and proper precautions and procedures are used and facilities free of hazards are available for research activities involving biological agents.
  2. Prevent potential threats to the safety of JH personnel from biological hazards.
  3. Assist and advise Johns Hopkins Principal Investigators and research personnel to become knowledgeable about and comply with appropriate international, federal, state, and local biosafety regulations or guidelines associated with research.

The IBC operates in close association with Biological Safety Officer (BSO) and his or her staff with regard to compliance with federal, state, and local biosafety regulations.

In order for the IBC and the division of Biological Safety to serve as helpful resources in your research efforts, it is imperative that you work closely with your Laboratory Director/ Principal Investigator to ensure that all applicable biological materials are registered with the IBC.

  1. Principal Investigators must register the use or possession of Recombinant or Synthetic Nucleic Acid Molecules, Infectious Agents/Pathogens, Biological Toxins, and Human Tissues on the Homewood, East Baltimore, Bayview, Montgomery County, All Children's Hospital, and JH Community Hospital campuses with the Biosafety Office of the Johns Hopkins Institutions. Investigators are responsible for registering the above-listed research material and describing the protocols in which they will be used. This rule applies to all independent investigators. Collaborators may not "piggy-back" on each other's registrations. Postdoctoral fellows, graduate students, and research associates are covered by the registrations of their Principal Investigator. The Principal Investigator is ultimately responsible for the registration, training, and safe handling of research materials used by their personnel.
  2. Registration and IBC approval must occur prior to the use or possession of these materials. Registration forms may be found at http://www.hopkinsmedicine.org/hse/forms/forms.html.
  3. Registrations are approved for a one-year term. Registrations may be renewed by completion and return of the registration update form, which is sent to the investigator by the Biosafety Office prior to the registration expiration date.
  4. Registrations are necessary for IACUC approval. Investigators must hold current registrations for Recombinant or Synthetic Nucleic Acid Molecules, Infectious Agents/Pathogens, Biological Toxins and/or Human Tissue if their projects involve the use of these materials in animals.

For more information regarding the policy on Institutional Biosafety Committee objectives and requirements from the department of Health Safety and Environment please visit: https://hpo.johnshopkins.edu/hse/?event=section&sectionid=1004 and select policy HSE500.


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.


Johns Hopkins 2019-20 Flu Campaign

Flu vaccine for Johns Hopkins employees is here! The inactivated influenza vaccine (injectable) will be administered to Hopkins employees beginning October 7th, 2019. (Please see locations & schedules below)

The Johns Hopkins Institutions require health care providers to have annual influenza vaccination or possess an approved qualified exception. If vaccinated outside of Johns Hopkins, a proof of immunization must be provided to Occupational Health Services to receive credit for the vaccination. Please review the Mandatory Seasonal Influenza Vaccination Policy (HSE048) for more information.

The Influenza vaccine will be administered to Physicians, Faculty, Staff, Employees, Students and Volunteers by Occupational Health Services as listed below.

Have questions about the mandatory flu vaccination policy? Read these FAQs.

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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Apri 2020 articles:
Essential Information for Human Subjects Research Teams Related to COVID-19
Coronavirus Research Billing Notices and FAQ
Research Billing Buzz eNewsletter
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
William T. Grant Scholars Program
Pew Biomedical Scholars Program
Michael J. Fox Foundation (MJFF) Challenge
COVID-19 and Research Updates
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 April, May and June

Temporary Closures and Updates at the Genetics Research Core Facilities
       

 

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