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ForwardInstitutional Review Board: Investigator Responsibilities When Conducting Human Subjects Research
This booklet is designed to help investigators better meet their obligations for conducting human subject research by clarifying their responsibility (1) to supervise a clinical study in which some study tasks are delegated to employees or colleagues of the investigator or other third parties, and (2) to protect the rights, safety and welfare of study subjects.
Original Release Date: January 2016
Review Date: May 2022; December 2022; June 2023
Target Audience
All investigators responsible for human subject research.
Learning Objectives
- Describe the history and importance of human subjects protection.
- Explain why additional protections are needed for vulnerable populations.
- Delineate the appropriate procedures for recruiting research participants.
- Implement the requirements and process for obtain informed consent following national evidence-based guidelines and Baptist Health IRB policies and procedures.
- Recognize the importance of study design in the protection of research participants.
- Explain the responsibilities of a principal investigator.
Mark Hauser, M.D., and Amanda Coltes-Rojas, content contributors and reviewers of this educational activity, have no relevant financial relationships with ineligible companies* to disclose, and have indicated that the content will not include off-label or unapproved product usage.
Non-faculty contributors and others involved in the planning, development, and editing/review of the content have no relevant financial relationships to disclose with ineligible companies*.
*Ineligible companies - Companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.
Baptist Health South Florida is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Baptist Health South Florida designates this enduring material for a maximum of 1.50 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Available Credit
- 1.50 AMA PRA Category 1 Credit™
- 1.50 General certificate of attendance
- 1.50 Nurse Practitioners
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