Flagler Hospital, Inc. Human Subjects Research Training: Based on Flagler Hospital, Inc. IRB Policy (PRE-009) with Revised 2018 Common Rule Regulations

Activity Release: 05/30/2019 Activity Expiration:05/29/2021

ACTIVITY NEED/PURPOSE:

This CME activity was designed to educate researchers and Flagler Hospital, Inc. Institutional Review Board members about the ethical protection of human research subjects as required by the Flagler Hospital, Inc. Institutional Review Board Policy (PRE-009).

AUDIENCE:

This CME activity is designed for prospective researchers (physicians, APRNs, PAs, Flagler Hospital, Inc. employees) and Flagler Hospital, Inc. IRB members.

OBJECTIVES:

At the conclusion of this CME activity, participants will be able to:

1. Identify one historical key triggering event that led to the establishment of ethics in research.

2. Explain the purpose of an Institutional Review Board (IRB).

3. Define key changes incorporated in the Revised Common Rule.

4. Describe the importance of informed consent.

DISCLOSURES:

* No Commercial Interest

* No relevant financial interest by authors, reviewers, or CME Committee Planners.

* No investigational products/products not labeled for use is mentioned within the enduring CME activity.

DISCLAIMER:

In no event will Flagler Hospital be liable for any decision made or action taken in reliance upon the information provided through this CME activity.

TECHNICAL REQUIREMENTS

Adobe reader to access power point slides or appropriate software to view You Tube video(s).

DIRECTIONS AND HOW TO OBTAIN CREDIT:

1. Review CME adobe pdf presentation slides and accompanying Belmont Report Video

2. After completion of CME activity (including presentation slides and Belmont Report video), pass the post-test (with a grade of 80% or higher) and complete the CME evaluation.

3. Earned credit will be reported to CE Broker by CME Office personnel once post-test has been processed. CME certificate is available upon request to CME office personnel.

ACCREDITATION/CREDIT STATEMENT:

Flagler Hospital is accredited by the Florida Medical Association to provide continuing medical education for physicians.

Flagler Hospital designates this educational activity for a maximum of one 1.00 AMA PRA Category 1 Credit(s) TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Flagler Hospital is accredited for Florida Board of Clinical Social Work and Mental Health Counseling, Florida Board of Nursing, Florida Pharmacy Board 50-664 for continuing education units. This activity is approved by the above boards for continuing education.