Human Subjects Research Seminar: Current Regulations under FDA and HIPAA

OVERVIEW
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an event that is unexpected occurs, someone who does not speak wishes to enroll in the study, a participate signed an outdated consent document, etc) when conducting human subjects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:

1. Department of Health and Human Services regulations, 45 CFR 46
2. Office for Human Research Protections Guidance
3. The FDA regulations, 21 CFR 50, 56, 312, 314, 812, 814
4. HIPAA and HI-Tech
5. ICH E6 Good Clinical Practices
6. Coercion vs. undue influence
7. Recruitment of Research Subjects
8. Vulnerable populations
9. Non-English speaking populations
10. Inclusion of Women and Minorities
11. Waivers of consent
12. Waivers of consent vs. waivers of authorization
13. Assent vs. consent
14. Wards of the State
15. Certificates of confidentiality
16. Levels of de-identification what they are and how they affect consent
17. Privacy vs. confidentiality
18. Study responsibilities: ICH vs. NIH
19. Drug/Device Accountability
20. Codes of Conduct
21. Conflicts of Interest
22. Reporting responsibilities
23. Monitoring
24. Investigator-sponsor responsibilities
25. Study types
26. Special concern studies
27. Standard operating procedures vs. protocol vs. IRB submission
28. Common compliance issues
29. Data safety monitoring
30. Adverse event monitoring and reporting including Serious adverse events and unanticipated problems
31. Investigational Drug and Device use in clinical trials
32. Assurances and Agreements (e.g. MOU)
33. Site Responsibilities
34. International Ethical Guidelines
35. Applying ICH to international sites

SEMINAR SCHEDULE

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

Others Details

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