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WHAT'S NEW
Web notes  
August 2007
HUMAN SUBJECTS RESEARCH - Back

New Additions to IRB Website (http://irb.jhmi.edu)

Faculty requested clarification about how to report events to the IRBs, as there are several different regulatory requirements and sponsor requirements that do not match. To address questions about when to report information to the IRB and the appropriate report form to use, the following new material has been posted:

-Organization Policy on Reports of Unanticipated Problems Involving Risks to Participants and Others, a flow diagram, and a revised report form R.F. 1: Unanticipated Problem/Event Report Form.

-Organization Policy on Reporting Death of a JHM Research Participant, Guidance on Reporting Death of a JHM Research Participant, and a new report form, R.F. 2: Report of Death of a JHM Research Participant

-Guidance on Reporting Protocol Deviations, a flow diagram, and a new deviation log form R.F. 4: Protocol Deviation Summary Sheet

-Guidance on Reporting IND Safety Reports, a flow diagram, and a new IND Safety Report Transmission Form R.F.5: IND Safety Report Transmission Report (for Paper Studies Only).

These documents can be found at http://irb.jhmi.edu/Guidelines/reportingrequirements.
html.

If you have any questions about the new material, please contact a member of the OHSR Compliance team for assistance (5-3008).

Return to top of Human Subjects Research
 
   
August 2007 articles:
HUMAN SUBJECTS RESEARCH
- New Additions to IRB Website (http://irb.jhmi.edu)
   
ANIMAL RESEARCH
- Seminar Series
   
FUNDING OPPORTUNITIES
- Sol Goldman Pancreatic Cancer Research Center Grants
- NIH RFA-NR-08-001 NINR Nursing Science Research on Interventions in Chronic Illness (P01)
- Talecris Biotherapeutics' Talents Program Accepting Applications for Research Grant Awards
- J.P. McCarthy Fund Developmental Grant Award Program
- Sturge-Weber Syndrome Research Funding
- Pew Latin American Fellows Program in the Biomedical Sciences 2008
   
GRANT AND CONTRACT PROCEDURES
- JHU SOM ESCRO Online Educational Training Module
- COEUS Training in August

PUBLICATIONS
- This Month's Departmental Listings

PRIZE OPPORTUNITIES
- Upcoming Deadlines for August, September and October
       

 

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