Ethical Issues in Human Subjects Research

Summary: MentorHealth, a leading provider of online training for the healthcare industry, is organizing a webinar on May 7 on the topic, "Ethical Issues in Human Subjects Research" It will be presented by Sarah Fowler-Dixon, an Education Specialist and instructor with Washington University School of Medicine.

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Description:

The most important aspect for investigators is keeping in mind regulatory criteria when designing a study. While the current trend of conducting research in private physician offices and other community venues makes research more accessible to potential participants, it also calls for another set of regulations and requirements, complicating matters further.

Several questions arise in relation to the consent document and process. Researchers have to consider questions such as what can and cannot be used and why, what is allowable, and what are the risks and benefits and how those are viewed and accessed. All these are certainly confusing, to say the least.

Knowledge of what to consider and what the possible stumbling blocks could be, goes a long way in easing getting an approval to conduct human subject's research. This webinar equips participants with just this knowledge. The speaker will not only give participants a working knowledge of the areas that create the most confusion; she will also offer an understanding that will help them avoid or work through these areas faster.

This webinar is a compilation of information in areas that generate the most questions for human subject's researchers when conducting research internationally. It will discuss 45 CFR 46.111 (a) (2), an important section of this regulation.

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 speaker will familiarize participants with this.

She will also consider Federalwide Assurance, a written assurance filed with the Office for Human Research Protections (OHRP) required for NIH funded studies.

This webinar will cover the following areas:

• 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?
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When: May 7, 10:00 AM PDT | 01:00 PM EDT

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By whom:

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, and submission and reviewer forms often working with state and federal authorities.

She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she led a task force in the development of the Community Engaged Research Program at Washington University.

Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook.

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For whom:

The webinar will benefit those in:

• 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
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Duration: 60 minutes

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To enroll for this webinar, contact

webinars@mentorhealth.com

Ph: 800-385-1607

Fax: 302-288-6884

http://bit.ly/1pM4cgK

MentorHealth is a comprehensive training source for healthcare professionals. Our trainings are high on value, but not on cost. MentorHealth is the right training solution for healthcare professionals.