OO18 The organization's policies, procedures, charters, or bylaws (including Institutional Review Board) that protect the rights of participants in research.
Procedures
Protection of the rights of human subjects and their health information has the highest priority in the review and approval of all research projects within BHSF and Homestead Hospital. All persons who want to participate in research are required to complete the Collaborative Institutional Training Initiative Course (CITI). https://www.citiprogram.org/aboutus.asp?language=english. Additionally, members of the Evidence-based Practice and Research Council (EBPRC) are required to complete either a CITI training or an National Institute of Health (NIH) training on Protecting Human Research Participants https://phrp.nihtraining.com/users/login.php
Bylaws
The EBPRC charter is contained within the Homestead Hospital Shared Governance Bylaws. [OO18 01 Shared Governance Bylaws (highlighted)]
Policies
Policy Title |
Location |
Purpose |
Institutional Review Board (IRB) Meetings |
BHSF Intranet |
Describes frequency and steps for conducting IRB meetings. (OO18 02 BHSF-830.03 IRB Meetings) |
Vulnerable Subjects |
BHSF Intranet |
Delineates definition of vulnerable subjects and the IRB’s procedure aimed at providing additional protections for them (OO18 03 BHSF-200-5810-833.03 Vulnerable Subjects) |
General Requirement of Informed Consent |
BHSF Intranet |
Outlines BHSF’s IRB general requirements of an informed consent in accordance with applicable federal regulations pertaining to human subjects research, institutional policy, and Florida statutes (OO18 04 BHSF-833.01 General Requirement of Informed Consent) |
IRB Approval |
BHSF Intranet |
Describes standard procedure required for obtaining and maintaining IRB approval (OO18 05 BHSF-1340.01 IRB Approval) |
Informed Consent Procedure for Clinical Investigations |
BHSF Intranet |
Articulates the policy of seeking prospectively (except for emergency research) legally effective informed consent from each human subject of BHSF clinical research or the subject’s legally authorized representative (OO18 06 BHSF-1340.02 Informed Consent Procedure for Clinical Investigations; OO18 07 BHSF-1340.02 Informed Consent Process Documentation; OO18 08 BHSF-1340.02 Documentation of Enrollment/Consent Process) |
Research Staff Training |
BHSF Intranet |
Defines the procedures to be followed for initial and continuing training for investigators and research staff (OO18 09 BHSF-1340.05 Research Staff Training) |
Medicare Coverage Analysis (MCA) |
|
Outlines standards and processes for conducting MCA to determine which items and services provided by BHSF in the course of a clinical trial can be appropriately billed to Medicare (OO18 10 BHSF-1340.14 Medicare Coverage Analysis) |
Research Uses and Disclosures |
BHSF Intranet |
Describes policy and procedure in place to protect protected health information (PHI) in the conduct of research (OO18 11 BHSF-100-8085-401.00 Research Uses and Disclosures) |
The Role and Authority of BHSF IRB |
BHSF Intranet |
Explains the role and authority of BHSF IRB in reviewing research involving human subjects in order to protect the rights and welfare of potential study participants (OO18 12 BHSF-830.00 The Role and Authority of BHSF IRB) |
BHSF IRB Registration |
BHSF Intranet |
|
IRB Initial Review of Protocols |
BHSF Intranet |
Outlines procedures which the IRB will follow for conducting initial review of research protocols (OO18 14 BHSF-200-5810-831.00 IRB Initial Review of Protocols) |
IRB Audit Program |
BHSF Intranet |
Describes the BHSF audit program which includes random protocol audits (OO18 15 BHSF-834.01 IRB Audit Program) |
Quality Assurance and Monitoring |
BHSF Intranet |
Defines procedures and quality assurance and monitoring process at the Center for Research and Grants (CR&G) which calls for review of research protocols for compliance with relevant policies, and the protection of research subjects (OO18 16 BHSF-1340.06 Quality Assurance and Monitoring) |