Fairplay Consultants, Inc. - Human Research Protection Workshop

Human Research Protection Workshop

Description:

The Least of My Brothers ethics course, online format combined with conference workshop.

Course Level:

Intermediate

Overview:

This course combines a phenomenal one-month on-line learning experience with a conference workshop learning experience to ensure a greater understanding of clinical trial team responsibities related to clinical research involving human subjects. Paramount to the conduct of all clinical research professionals delegated to perform services during clinical trial conduct; this course fills a critical training objective. This course was developed by Indiana University Poynter Center with the help of a NIH grant.

Who Should Attend:

ANYONE conducting clinical trial research or involved in research using human subjects, including: Investigators Research nurses Sponsor project team members CRO employees Site staff IRB members Industry vendors Sponsor sales team Industry consultants Patients/subjects

Objectives:

To facilitate discussions on ethics and encourage interaction between investigators, sponsors, research teams, and clinical research professionals

To encourage appropriate and adequate understanding of responsibilities related to ethical conduct during clinical trial conduct

Agenda:

Historical perspectives on human subject research Ethical and moral justification for human subject research Conflict of interest and disclosure Participant Recruitment and Retention in Clinical Trials Informed Consent Process The Belmont Report Reporting of Adverse Events and Serious Adverse Events Discussion of current regulations related to protection of the human subject Roles and responsibilities of institutions and independent sites Roles and responsibilities of investigators and study staff Role of the Institutional Review Board (IRB) Role of the Data Safety Monitoring Committee (DSMC) Role of the regulatory agencies The therapeutic obligation in medical research

Please note:

If you would like to see this course offered in your area, please contact us for scheduling opportunities and fees.