Student in Medical Lab with her reflection in the hood-glass.

Leadership at THRIV
Membership at THRIV
Community at THRIV

 

Upcoming Events

Apr
3
Mon
Methodology, Ethics, and Regulations of Research Involving Human Subjects @ C1 Auditorium
Apr 3 @ 12:00 pm – 1:00 pm

Methodology, Ethics, and Regulations of Research Involving Human Subjects

Course Meetings: Mondays 12:00-1:00, Spring Semester 2017, C1 Auditorium                            

Course Leader: Jean Eby, ScD (Email: jmg5b@virginia.edu)

Tentative Schedule of Course Topics/Speakers (Spring 2017):

 

1/23 An Overview of Methodological, Ethical, and Regulatory Issues in Research Involving Human Subjects
(Jean Eby, ScD, Assistant Professor, Public Health Sciences and Director of Human Subjects Research Education, Office of the Vice-President for Research)

 

1/30 Evolving Protections for Human Research Subjects:

History, Ethical Principles, and Current Challenges
(Susie Hoffman, RN, BSN, CIP, Director IRB-HSR)

 

2/6 The Responsible Conduct of Research
(David Hudson, PhD, Associate Vice-President for Research)

 

2/13 Data Security
(Susie Hoffman, RN, BSN, CIP, Director IRB-HSR)
(Tim Tolson, PhD, Director IT Policy and Compliance, ISPRO)

 

2/20 Assessing Risks and Benefits in Research: A Biostatistician’s Perspective
(Gina Petroni, PhD, Professor, Public Health Sciences)

 

2/27 Clinical Research: What NOT to do

(Linda Duska, MD, Professor of Obstetrics and Gynecology and Associate Dean for Clinical Research)

 

3/13 Informed Consent in Research
(Lois Shepherd, JD, Professor, Public Health Sciences)

 

3/20 Comparative Effectiveness Research; Cluster Randomized Trials

(Jean Eby, ScD, Assistant Professor, Public Health Sciences and Director of Human Subjects Research Education, Office of the Vice-President for Research)

 

3/27 Management of Conflicts of Interest
(Steven Wasserman, PhD, Assistant Dean for Research, Director Office for Research, School of Medicine)

 

4/10 FDA Research
(Lori Elder, RN, BSN, CCRA, Director, Clinical Trials, SOM Clinical Trials Office)

 

4/17 Global Health Research

(Liz Rogawski, PhD, WHIL Innovations Postdoctoral Fellow, Center for Global Health)

 

4/24 Respectful Research with Vulnerable Communities

(Jeanita Richardson, PhD, MEd, Associate Professor, Public Health Sciences)

 

5/1 The Ethics of Big Data

(Bob Meyer, MD, Director of the Virginia Center for Translational and Regulatory

Sciences and Associate Professor of Public Health Sciences)

 

 

Apr
10
Mon
Methodology, Ethics, and Regulations of Research Involving Human Subjects @ C1 Auditorium
Apr 10 @ 12:00 pm – 1:00 pm

Methodology, Ethics, and Regulations of Research Involving Human Subjects

Course Meetings: Mondays 12:00-1:00, Spring Semester 2017, C1 Auditorium                            

Course Leader: Jean Eby, ScD (Email: jmg5b@virginia.edu)

Tentative Schedule of Course Topics/Speakers (Spring 2017):

 

1/23 An Overview of Methodological, Ethical, and Regulatory Issues in Research Involving Human Subjects
(Jean Eby, ScD, Assistant Professor, Public Health Sciences and Director of Human Subjects Research Education, Office of the Vice-President for Research)

 

1/30 Evolving Protections for Human Research Subjects:

History, Ethical Principles, and Current Challenges
(Susie Hoffman, RN, BSN, CIP, Director IRB-HSR)

 

2/6 The Responsible Conduct of Research
(David Hudson, PhD, Associate Vice-President for Research)

 

2/13 Data Security
(Susie Hoffman, RN, BSN, CIP, Director IRB-HSR)
(Tim Tolson, PhD, Director IT Policy and Compliance, ISPRO)

 

2/20 Assessing Risks and Benefits in Research: A Biostatistician’s Perspective
(Gina Petroni, PhD, Professor, Public Health Sciences)

 

2/27 Clinical Research: What NOT to do

(Linda Duska, MD, Professor of Obstetrics and Gynecology and Associate Dean for Clinical Research)

 

3/13 Informed Consent in Research
(Lois Shepherd, JD, Professor, Public Health Sciences)

 

3/20 Comparative Effectiveness Research; Cluster Randomized Trials

(Jean Eby, ScD, Assistant Professor, Public Health Sciences and Director of Human Subjects Research Education, Office of the Vice-President for Research)

 

3/27 Management of Conflicts of Interest
(Steven Wasserman, PhD, Assistant Dean for Research, Director Office for Research, School of Medicine)

 

4/10 FDA Research
(Lori Elder, RN, BSN, CCRA, Director, Clinical Trials, SOM Clinical Trials Office)

 

4/17 Global Health Research

(Liz Rogawski, PhD, WHIL Innovations Postdoctoral Fellow, Center for Global Health)

 

4/24 Respectful Research with Vulnerable Communities

(Jeanita Richardson, PhD, MEd, Associate Professor, Public Health Sciences)

 

5/1 The Ethics of Big Data

(Bob Meyer, MD, Director of the Virginia Center for Translational and Regulatory

Sciences and Associate Professor of Public Health Sciences)

 

 

Apr
12
Wed
Advanced SBIR/STTR Strategies — Building Business from SBIR/STTR Funding @ Virginia Biotechnology Research Park
Apr 12 @ 8:30 am – 4:30 pm

This workshop presents a short intro to the core goals of the SBIR/STTR programs, followed by tips to help move from Phase I to Phase II, overview of key commercialization requirements of SBIR/STTR, legislation that provides advantages to SBIR/STTR companies, how to build business from your SBIR/STTR technologies, state programs designed to foster commercialization success for SBIR/STTR recipients, and how to use the sole source contracting provisions available to SBIR/STTR recipients.

Apr
17
Mon
Methodology, Ethics, and Regulations of Research Involving Human Subjects @ C1 Auditorium
Apr 17 @ 12:00 pm – 1:00 pm

Methodology, Ethics, and Regulations of Research Involving Human Subjects

Course Meetings: Mondays 12:00-1:00, Spring Semester 2017, C1 Auditorium                            

Course Leader: Jean Eby, ScD (Email: jmg5b@virginia.edu)

Tentative Schedule of Course Topics/Speakers (Spring 2017):

 

1/23 An Overview of Methodological, Ethical, and Regulatory Issues in Research Involving Human Subjects
(Jean Eby, ScD, Assistant Professor, Public Health Sciences and Director of Human Subjects Research Education, Office of the Vice-President for Research)

 

1/30 Evolving Protections for Human Research Subjects:

History, Ethical Principles, and Current Challenges
(Susie Hoffman, RN, BSN, CIP, Director IRB-HSR)

 

2/6 The Responsible Conduct of Research
(David Hudson, PhD, Associate Vice-President for Research)

 

2/13 Data Security
(Susie Hoffman, RN, BSN, CIP, Director IRB-HSR)
(Tim Tolson, PhD, Director IT Policy and Compliance, ISPRO)

 

2/20 Assessing Risks and Benefits in Research: A Biostatistician’s Perspective
(Gina Petroni, PhD, Professor, Public Health Sciences)

 

2/27 Clinical Research: What NOT to do

(Linda Duska, MD, Professor of Obstetrics and Gynecology and Associate Dean for Clinical Research)

 

3/13 Informed Consent in Research
(Lois Shepherd, JD, Professor, Public Health Sciences)

 

3/20 Comparative Effectiveness Research; Cluster Randomized Trials

(Jean Eby, ScD, Assistant Professor, Public Health Sciences and Director of Human Subjects Research Education, Office of the Vice-President for Research)

 

3/27 Management of Conflicts of Interest
(Steven Wasserman, PhD, Assistant Dean for Research, Director Office for Research, School of Medicine)

 

4/10 FDA Research
(Lori Elder, RN, BSN, CCRA, Director, Clinical Trials, SOM Clinical Trials Office)

 

4/17 Global Health Research

(Liz Rogawski, PhD, WHIL Innovations Postdoctoral Fellow, Center for Global Health)

 

4/24 Respectful Research with Vulnerable Communities

(Jeanita Richardson, PhD, MEd, Associate Professor, Public Health Sciences)

 

5/1 The Ethics of Big Data

(Bob Meyer, MD, Director of the Virginia Center for Translational and Regulatory

Sciences and Associate Professor of Public Health Sciences)

 

 

Apr
18
Tue
IRB-HSR 101 Part II: Pre-Approval Issues @ IRB-HSR Offices
Apr 18 @ 8:30 am – 12:00 pm

IRB-HSR 101 Part II: Pre-Approval Issues
Date: 4/18/17
Time: 8:30 AM-12 noon
Location: Morton 4th floor conference room
Time Topic Speaker
8:30 Informed Consent & Case Study Jean Gaare Eby
9:00 Modifications Medard Ng
9:30 Advertisements and Recruitment Tara Gaucher
10:00 Continuations & Closures Tara Gaucher
10:30 Break
10:45 Adverse Events, Protocol Violations, Amy
Blackman
Unanticipated Problems, Data Breaches
12:00 Conclude
______________________________________________________
Speakers:
Jean Gaare Eby, ScD Director of Human Subjects
Research Education
Medard Ng, PhD, CIP IRB-HSR Compliance Coordinator
Tara Gaucher, BA IRB-HSR Compliance Coordinator
Amy Blackman,MSN, CCRC IRB-HSR Compliance Coordinator

Learning Objectives:
-To describe how to conduct research more responsibly
-To describe how to better protect human participants
in research

Disclosures:
Speakers: Amy Blackman, MSN, CCRC; Jean Eby, ScD;
Tara Gaucher, BA; Susie Hoffman, RN, BSN, CIP; Dave
Hudson, PhD; Medard Ng, PhD, CIP; Eileen Sembrowich,
BS, BA, CCRP, CIP do not have any personal or
professional financial relationships with a
commercial entity producing healthcare goods and/or
services.

Planning Committee: Ruth Bernheim, JD, MPH; Jean Eby,
ScD; Susie Hoffman, RN, BSN, CIP do not have any
personal or professional financial relationships with
commercial entities producing healthcare goods and/or
services.

For each 8:30-noon class:
The University of Virginia School of Medicine is
accredited by the ACCME to provide continuing medical
education for physicians.
The University of Virginia School of Medicine
designates this live activity for a maximum of 3.25
AMA PRA Category 1 Credit(s)™. Physicians should
claim only the credit commensurate with the extent of
their participation in the activity.
The University of Virginia School of Medicine awards
3.25 hours of participation (equivalent to AMA PRA
Category 1 Credit(s)™) to each non-physician
participant who successfully completes this
educational activity. The University of Virginia
School of Medicine maintains a record of
participation for six (6) years.
To obtain a copy of your continuing education
transcript please go to www.cmevillage.com and click
on Transcripts and follow the instructions.

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