OO19 The organization's policies, procedures, charters, or bylaws designating that at least one nurse must be a voting member of the governing body responsible for the protection of human research participants, and that at least one nurse votes on nursing-related protocols.
Provide evidence (policy/procedure, charter OR bylaws) that validates that a nurse votes on nursing-related protocols and is a voting member of the governing body responsible for the protection of human research participants.
OR
Provide a letter signed and dated by the chair of the governing body responsible for the protection of human research participants that attests to this requirement. A template for the letter is available at http://www. nursecredentialing.org/Magnet/Magnet-FormsTemplates.
Homestead Hospital has structures and processes in place to ensure protection of human research participants. The Evidence-based Practice and Research Council (EBPRC) reviews research projects and Institutional Review Board (IRB) application for completeness and scientific integrity. (OO19 01 Shared Governance Council Bylaws: EBPRC highlighted): The members are trained on either National Institute of Health’s (NIH) “Protecting Human Research Participants” module or the Collaborative Institutional Training Initiative (CITI) Human Subjects training program. The council is composed of nurses from across all levels and various nursing departments. The names of EBPRC RN members are listed in Exhibit OO19a.
Exhibit OO19a: Evidence-based Practice and Research Council (EBPRC) RN Members
Name and Credentials |
Job Title |
Department |
Alicia Brown-Rowe, BSN,RN |
Special Projects Coordinator |
ICU |
Ana Cabrera, DNP, ARNP, ACNP-BC, CCRN |
Assistant Vice President of Nursing |
Nursing Administration |
Ann Marie Allen, MSN, MS/HSA, RN |
Assistant Vice President of Nursing |
Nursing Administration |
Beatriz Taboada, RN |
Clinical Nurse |
3 South |
Gail Gordon, MSN, RN, NEA-BC |
Vice President, Chief Nursing Officer |
Nursing Administration |
Jean McJilton, RN |
Research Participant Specialist |
Center for Research and Grants |
Jill White, RN, CPHQ |
Director |
Performance Improvement, Case Management |
Joan Baker, RN, MSN, CCPC, CCRN, CNRN |
Chest Pain Center Coordinator |
Emergency Department |
Jose Nazario, MSN, RN, CGRN |
Clinical Nurse Educator |
Surgical Services |
Joyce Jones, BSN, RN, CMSRN |
Clinical Nurse |
MS5 |
Julie David, MSN, ARNP, ANP-BC |
Magnet Project Director |
Magnet Designation |
Karen Anding, BSN,RN |
Patient Care Supervisor |
Staffing Office |
Kathy Dumas, MSN, RN, CPHM |
Appeal and Denials Coordinator |
Case Management |
Margaret Barnes, BSN, RN |
Clinical Nurse, Relief Charge |
ICU |
Maria Gonzalez, BSN, RN |
Clinical Nurse, Relief Charge |
Emergency Department |
Maria Ojeda, DNP, PhD-c, MPH, ARNP, NP-C |
Nurse Scientist |
Nursing and Health Sciences Research |
Mileivy Armas Rivero, RN |
Clinical Nurse |
MS4 |
Rosemary Lee, DNP, ARNP, ACNP-BC,CCNS, CCRN |
Clinical Nurse Specialist |
ICU/PCU |
Sandra Jones, BSN, RN, CMSRN |
Clinical Nurse Educator |
3 South |
Tiffany Llera-Lora |
EBP Research Fellowship Coordinator |
Center for Research and Grants – Research Operations |
Tina Wolfcale, BSN,RN |
Clinical Nurse |
3 South |
Melinda Watson, RN, CMSRN |
Clinical Nurse |
Surgical Services |
After EBPRC approval is obtained by majority vote of standing RN members, the chief nursing officer (CNO) signs-off on the IRB application. The application is then forwarded to the corporate IRB, which oversees research activities involving human subjects in Homestead Hospital. There are 2 RN voting members in the IRB, namely: Rose Allen, BSN, MSM/HM, RN, CHPN and Flor Amor Aguirre, MSN, RN, ONC CNL. (OO19 02 BHSF-830.02 IRB Membership policy; OO19 O3 List of RN IRB Members, highlighted at the bottom of the document) During the initial review process, the IRB chair or designee determines if the protocol qualifies for full, exempt, or expedited reviews. Those that meet the criteria for full review (including nursing protocols) will be reviewed at a convened meeting during which RN IRB members vote. Majority of nursing-related protocols qualify for either exempt (OO19 04 BHSF-831.04 Exemptions from IRB Reviews) or expedited (OO19 05 BHSF-831.03 Expedited Review Procedures) reviews which are approved by the IRB Chair or designee and not reviewed by the convened IRB. However, the IRB will be notified of an exempt or expedited approval during the assembled meeting. The IRB has the prerogative to ask for Additional Documentation or suspend approval for any exempt or expedited-approved protocols during the convened meeting. (OO19 06 BHSF-831.00 IRB Initial Review of Protocols Policy)
Summary of Attachments/Hyperlinks/Evidences:
Exhibit OO19a: Evidence-based Practice and Research Council (EBPRC) RN Members
OO19 01 Shared Governance Council Bylaws: EBPRC highlighted
OO19 02 BHSF-830.02 IRB Membership policy
OO19 O3 List of RN IRB Members, highlighted at the bottom of the document
OO19 04 BHSF-831.04 Exemptions from IRB Reviews
OO19 05 BHSF-831.03 Expedited Review Procedures
OO19 06 BHSF-831.00 IRB Initial Review of Protocols Policy