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Human Subjects Research Seminar: Current Regulations under FDA and HIPAA

By John Robinson

Netzealous LLC - GlobalCompliancepanel



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This two day seminar will provide the foundation for the application, concepts and theories of clinical research. Within the two days, attendees will learn about the historical evolution of research, current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. We 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. We will 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.

Why should you attend?

For those involved in or wanting to be involved in research dealing with human subjects or an individual's private identifiable information, protection of human subjects and all that this topic encompasses is imperative to know as there federal regulations that must be followed. In addition to federal regulations, there are state statues, institutional policies, federal guidance documents, and ethical codes that guide the conduct of the research so that it not only meets the regulatory requirements but so that the study 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. Guidelines also provide interpretation of the regulations which are not always as clear as they might appear upon first reading them. Attendance at this two day session will not only provide an introduction or refresher of the regulations, it will also provide attendees with the opportunity to discuss and learn how these regulations, ethical codes and guidance documents get applied in different situations. 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an event that is unexpected occurs, someone who does not speak wishes to enroll in the study, a participate signed an outdated consent document, etc) when conducting human subjects

Areas Covered in the Session:

  • Department of Health and Human Services regulations, 45 CFR 46
  • Office for Human Research Protections Guidance
  • The FDA regulations, 21 CFR 50, 56, 312, 314, 812, 814
  • HIPAA and HI-Tech
  • ICH E6 Good Clinical Practices
  • Coercion vs. undue influence
  • Recruitment of Research Subjects
  • Vulnerable populations
  • Non-English speaking populations
  • Inclusion of Women and Minorities
  • Waivers of consent
  • Waivers of consent vs. waivers of authorization
  • Assent vs. consent
  • Wards of the State
  • Certificates of confidentiality
  • Levels of de-identification what they are and how they affect consent
  • Privacy vs. confidentiality
  • Study responsibilities: ICH vs. NIH


  • Drug/Device Accountability
  • Codes of Conduct
  • Conflicts of Interest
  • Reporting responsibilities
  • Monitoring
  • Investigator-sponsor responsibilities
  • Study types
  • Special concern studies
  • Standard operating procedures vs. protocol vs. IRB submission
  • Common compliance issues
  • Data safety monitoring
  • Adverse event monitoring and reporting including Serious adverse events and unanticipated problems
  • Investigational Drug and Device use in clinical trials
  • Assurances and Agreements (e.g. MOU)
  • Site Responsibilities
  • International Ethical Guidelines
  • Applying ICH to international sites

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


Day 1 Schedule

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

Day 2 Schedule

Lecture 1: Multisite, Community and Collaborative Studies

Lecture 2: The Institutional Review Board

Lecture 3: Patient Safety in Clinical Trials Research

Lecture 4: Research under the Food, Drug & Cosmetic Act

Lecture 5: International Research

Lecture 6: Compliance and Human Research

Lecture 7: Accreditation and Risk Management in Clinical Trials


Sarah Fowler-Dixon

Education Specialist and instructor, Washington University

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. 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 lead 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.

Location: Atlanta, GA Date: November 3rd & 4th, 2016 and Time: 09:00 AM to 06:00 PM


Venue: DoubleTree by Hilton Hotel Atlanta Airport

Address: 3400 Norman Berry Drive, Atlanta, Georgia, 30344, USA



Register now and save $200. (Early Bird)


Price: $1,295.00 (Seminar for one delegate)


Until September 25, Early Bird Price: $1,295.00 from September 26 to November 1, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*


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Cite this work

Researchers should cite this work as follows:

  • John Robinson (2017), "Human Subjects Research Seminar: Current Regulations under FDA and HIPAA,"

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