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Ethical Issues in Human Subjects Research Webinar By MentorHealth
5/7/2014 10:00 AM - 11:00 AM
online event Fremont, California United States
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Overview: This webinar is a compilation of information in areas that generate the most questions for human subject's researchers when conducting research internationally. Discussed in this webinar will be: 45 CFR 46.111 (a)(2) which states, "In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research)." So what is risk assessment and how does that affect you? The Criteria for Approval found in both the FDA and HHS regulations stipulates what will be looked at during the approval process yet many do not know how, under which conditions, their study is reviewed and therefore do not anticipate possible questions in their study design.

The Federalwide Assurance is required for NIH funded studies. It is a written assurance filed with the Office for Human Research Protections (OHRP) that outlines under which terms a study will be reviewed, approved, and conducted. Even if the study is not NIH funded the principles in the Federalwide Assurance apply. Because of this assurance, additional criteria get applied to studies. When does that happen? Why? Can it be avoided? These questions and more will be answered by learning the information presented in this webinar.

Why should you attend: All researchers want their studies be reviewed and approved quickly. Most investigators do not think about regulatory criteria when designing a study. Complicating matters is the current trend to conduct research in private physician offices and other community venues. Although this makes research more accessible to potential participants, it also invokes another set of regulations and requirements.

The consent document and process are always areas that generate questions. What can and cannot be used? Why? What is allowable? Risks, benefits and how those are viewed and accessed also confound and befuddle individuals working in this field. Knowing what to consider and what the possible stumbling blocks could be, make getting an approval to conduct human subject's research easier. Attendance at this webinar will do just that. It will not only give you a working knowledge of the areas that create the most confusion, it will also give you an understanding that will help you avoid or work through these areas faster and be of assistance to those around you.

Areas Covered in the Session:

Assurances: What are these? What do they stipulate? How they affect you as a researcher

Criteria for review. What to think about and consider when developing or conducting your study

Consent and assent. What is required? What choices do you have?

Community research. What is involved when you ask a private physician to conduct your study or to recruit from his/her clinic?

Risk/Benefit Assessment. What is it? Who makes the determination? What does that determination mean with regards to additional requirements? What is allowable?

Who Will Benefit:

Principal Investigators / Sub-investigators

Clinical Research Scientists (PKs, Biostatisticians,)

Safety Nurses

Clinical Research Associates (CRAs) and Coordinators (CRCs)

Recruiting Staff

QA / QC auditors and Staff

Clinical Research Data Managers

Human Research Protection Professionals

Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities.


Phone No: 800-385-1607

FaX: 302-288-6884

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Eseed Entrepreneurship Training
2/24/2014 1:00 AM - 5/19/2014 4:00 AM
FVTC Waupaca Regional Center Waupaca, Wisconsin United States
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E-seed™ assists start-up, early-stage entrepreneurs and experienced small business owners in developing management and planning tools for their businesses.

Eseed Entrepreneurship Training
5/13/2014 6:00 PM - 8/12/2014 9:00 PM
D.J. Bordini Center Appleton, Wisconsin United States
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Thinking of starting a business? Need help? E-seed™ assists start-up, early-stage entrepreneurs and experienced small business owners in developing management and planning tools for their businesses.

Entrepreneurship Sessions with Sameer Shalaby
4/28/2014 2:00 PM - 4:00 PM
ThinkLab at the University of Mary Washington Fredericksburg, Virginia United States
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The iCenter is a startup incubator that was founded, by Sameer Shalaby, in October 2013 to help entrepreneurs, and members of the Fredericksburg community formulate their business ideas to incubate and take them from a successful launch successful to funding to ultimate exits.

Energizing Health 2014 San Francisco
12/5/2014 8:00 AM - 5:00 PM
TBD San Francisco, California United States
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Energizing Health 2014 Pittsburgh
7/14/2014 8:00 AM - 5:00 PM
TBD Pittsburgh, Pennsylvania United States
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Energizing Health 2014 New York City
9/9/2014 8:00 AM - 5:00 PM
TBD New York, New York United States
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Energizing Health 2014 Kansas City
11/7/2014 8:00 AM - 5:00 PM
Kauffman Foundation Conference Center Kansas City, Missouri United States
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Energizing Health 2014 Houston
10/10/2014 8:00 AM - 5:00 PM
TBD Houston, Texas United States
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Effective Portfolio Management Webinar By EITAGlobal
5/13/2014 10:00 AM - 11:30 AM
Online Event(World wide) Fremont, California United States
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This webinar is about Effective Portfolio Management. The objective is to help insure that you prioritize and select the right project for your strategic objective so you can manage this portfolio with agility and flexibility in order to adapt to "real life" while delivering the results as required. Are you funding the right projects? Is your staff working on the right task? Are you getting maximum value with the investments you have? Effective Portfolio Management is about getting the highest value of your investments while delivering the best value in accordance with the vision, principles and organization priorities.

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