2-day In-person Seminar on Advanced Course Human Subjects Research Seminar: Current Regulations under FDA and HIPAA

Summary: MentorHealth will hold a two-day, in-person seminar in Burlingame, CA on the topic, “Human Subjects Research Seminar: Current Regulations under FDA and HIPAA” on September 18th & 19th 2014 (Thursday and Friday). Sarah Fowler-Dixon, an Education Specialist and instructor with Washington University School of Medicine, will be the speaker at this two-day session.

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Venue, date and timings: The venue for this seminar is Hotel Courtyard Miami Downtown   200 SE Second Avenue - Miami, Florida 33131 USA. The seminar will be on September 18th & 19th 2014, from 8 AM to 5 PM.

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What the seminar is about:

This two-day seminar will provide the foundation for the application, concepts and theories of clinical research.

Protection of human subjects and everything relating to it is of paramount importance for those involved in or wanting to be involved in research dealing with human subjects or an individual's private identifiable information. For these individuals, professionals and companies, it is extremely important to understand that there are federal regulations that must be followed. There are also state statutes, institutional policies, federal guidance documents, and ethical codes that guide the conduct of the research. This is done to ensure that the research not only meets the regulatory requirements but also that it is conducted in an ethical manner containing adequate protections for the individuals who elect to enroll in the research or allow their information to be used for research.

However, the challenge that this position presents is that the guidelines –that also provide interpretation of the regulations –are not always as clear as they might appear upon first reading them.

This seminar will clarify on these regulations. The speaker will not only provide an introduction or refresher of the regulations; she will provide attendees with the opportunity to discuss and learn how these regulations, ethical codes and guidance documents get applied in different situations, as well. This information can then be used to help attendees in their day-to-day decision making when confronted with situations or questions regarding how to handle issues that do arise (e.g. a participant not showing for a scheduled appointment, an event that is unexpected occurs, someone who does not speak wishes to enroll in the study, a participate signed an outdated consent document, etc.) when conducting human subjects.

The learning acquired over these two days will help attendees learn about the historical evolution of research, and current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. This session will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements that apply to different study designs. It will also discuss a variety of research including genetic, drug, device, and studies that use off-site or community partners. Current examples will be used and the audience will be invited to share their experiences and information.

The following areas are covered at this seminar:

o   Department of Health and Human Services regulations, 45 CFR 46

o   Office for Human Research Protections Guidance

o   The FDA regulations, 21 CFR 50, 56, 312, 314, 812, 814

o   HIPAA and HITECH

o   ICH E6 Good Clinical Practices

o   Coercion vs. undue influence

o   Recruitment of Research Subjects

o   Vulnerable populations

o   Non-English speaking populations

o   Inclusion of Women and Minorities

o   Waivers of consent

o   Waivers of consent vs. waivers of authorization

o   Assent vs. consent

o   Wards of the State

o   Certificates of confidentiality

o   Levels of de-identification what they are and how they affect consent

o   Privacy vs. confidentiality

o   Study responsibilities: ICH vs. NIH

o   Drug/Device Accountability

o   Codes of Conduct

o   Conflicts of Interest

o   Reporting responsibilities

o   Monitoring

o   Investigator-sponsor responsibilities

o   Study types

o   Special concern studies

o   Standard operating procedures vs. protocol vs. IRB submission

o   Common compliance issues

o   Data safety monitoring

o   Adverse event monitoring and reporting including Serious adverse events and unanticipated problems

o   Investigational Drug and Device use in clinical trials

o   Assurances and Agreements (e.g. MOU)

o   Site Responsibilities

o   International Ethical Guidelines

o   Applying ICH to international sites

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About the Speaker:

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. Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.

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The agenda:

The seminar will have the following agenda:

Day 1 –Agenda

Lecture 1: The Evolution of Human Experimentation Regulation and Overview of Clinical Research and Ethics in Human Research

Lecture 2:  Current Federal Regulations and Agencies involved in Human Research

Lecture 3: Selection and Recruitment of Research Subjects

Lecture 4: Informed Consent in Clinical Trials

Lecture 5: Confidentiality of Clinical Trial Information

Lecture 6: The Investigator

Lecture 7: Research Protocols

Agenda –Day 2

Lecture 8: Multisite, Community and Collaborative Studies

Lecture 9: The Institutional Review Board

Lecture 10: Patient Safety in Clinical Trials Research

Lecture 11: Research under the Food, Drug & Cosmetic Act

Lecture 12:International Research

Lecture 13: Compliance and Human Research

Lecture 14: Accreditation and Risk Management in Clinical Trials

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For whom:

This seminar will benefit:

o   Principal Investigators/Sub-investigators

o   Clinical Research Scientists (PKs, Biostatisticians,)

o   Safety Nurses

o   Clinical Research Associates (CRAs) and Coordinators (CRCs)

o   Recruiting staff

o   QA/QC auditors and staff

o   Clinical Research Data managers

o   Human Research Protection professionals

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About MentorHealth:

MentorHealth is a specialized offering from NetZealous LLC, a Technology and Business Process Solutions and Services Company registered in Fremont, CA. MentorHealth is a comprehensive training source for healthcare professionals. It offers high-value, yet affordable trainings. MentorHealth is the right training solution for healthcare professionals. With MentorHealth, healthcare professionals can make use of the best benefits relating to their professional training.

Various aspects of healthcare, such as Meaningful Use, Patient Protection and Affordable Care Act of 2010, HIPAA, HITECH Act, Stark and Anti-Kickback Act, Valid Consent, Patient Safety and Process Improvement, Patient Safety and Quality Outcomes, Healthcare Information Technology Standards Panel (HITSP), Substance Abuse and Mental Health Records, Nursing Informatics, Healthcare Disclosure, Electronic Transactions Standards such as 5010 and ICD-10, Electronic Health Records, Stimulus Code, Healthcare Information Exchange, Healthcare Information Technology, Medical Necessity, Personal Health Records, Clinical Decision Support, Financial Management and ROI, Electronic Prescribing, Healthcare Information Systems, Clinical Informatics, Insurance Claim Appeals, Auto ID and Bar Coding, Integration and Interoperability, Risk Management in the Retention and Destruction of Medical Records and Medical Records Law, to name just a few, are covered.

These seminars are an extension of online trainings, at which MentorHealth has conducted around 500 webinars since inception on a variety of topics for these industries/verticals. More than 15,000 professionals have benefited from these trainings. MentorHealth’s trainings are focused, flexible and tailored to the client’s need.

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Price:

Register now and save $200. (Early Bird)

Until July 31, Early Bird Price: $1,295.00.

From August 01 to September 16, Regular Price: $1,495.00

Discounts are available for group participation in the following manner:

For two attendees: 10% discount

For three to six attendees: 20% discount

For seven to 10 attendees: 25% discount

For more than 10 attendees: 30% discount

To avail the above group discounts, all the participants should register by making a single payment.

Please note that the registration will be closed two days (48 hours) prior to the start date of the seminar.

Call our representative on 1800 447 9407 to have your seats confirmed.

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Contact Information:

Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884

Email: support@mentorhealth.com

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