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Presentation at a workshop on Week I: Bioethics Module - CRC Program held at King Fahad Medical City via Zoom on 23 May 2021 at 9:00-10:00 am by Professor Omar Hasan Kasule MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Professor of Epidemiology and Bioethics, King Fahad Medical City
INTRODUCTION:
§ Presentation of each standard and its measurable elements
§ Presentation of CPP that addresses the elements?
§ Evidence to support compliance with the elements
§ Taskforce to prepare for accreditation: policies, documentation,
training/awareness
STANDARDS - 1:
§ HRP. 1: The organization’s leaders are accountable for the protection of human
research subjects.
§ HRP. 2: The organization’s leaders establish the scope of research activities.
§ HRP. 3: The organization’s leaders establish requirements for sponsors of research
to ensure their commitment to the conduct of ethical research.
§ HRP. 4: The organization’s leaders create or contract for a process to provide
the initial and ongoing review of all human subject research.
STANDARDS - 2:
§ HRP. 5: The organization identifies and manages conflicts of interest with research
conducted at the organization.
§ HRP. 6: The organization integrates the human subject research program into the
quality and patient safety programs of the organization.
§ HRP. 7: The organization establishes those policies and procedures necessary to
inform and protect patients during the selection process for research subjects
and during the research.
CFOs:
§ IRB CFO
§ Ethics Committee CFO
CPPs:
§ CPP 1430-27: Emergency Hazardous Materials Spill Management Code Yellow Phar
§ CPP 1432-431: Handling of investigational drugs (FMS)
§ CPP 1431-130: Job Performance Evaluation Policy (Admin)
§ CPP 1431-184: Workplace conduct and misconduct (CPD)
§ CPP 1432-31: Industry-Sponsored Research (?RC)
§ CPP 1432-35?: Requirement for Master Research Degree Application for Physician in the
Scholarship
§ CPP 1432-35: Faculty of Medicine Research Fund (FOM)
§ CPP 1432-85: Provision of Information to Patients and Families on Participation in
Clinical Research (IRB)
§ CPP 1432-91: Institutional Review Board (IRB)
§ CPP 1432-92: Guidelines and Procedures of Informed Consent for Clinical Research (IRB)
§ CPP 1432-101: Confidentiality Policy (MCI)
CPPs,
con’t. - 1…
§ CPP 1432-173: Eligibility as Principal Investigator Policy ((RC)
§ CPP 1432-86: Sending Human Tissue Abroad for Research Purposes (IRB)
§ CPP 1433-07: Intramural Research Funds (RC)
§ CPP 1433-08: Protected Health Information PHI for Research Subjects
§ CPP 1433-17: Payment of IRB Reviewers (IRB)
§ CPP 1433-20: Use of Research Laboratories Facilities (FMS)
§ CPP 1433-22: Publication Incentives (RC)
§ CPP 1433-51: Level of Sponsorship (ATA)
§ CPP 1435-07: Institutional Review Board Committee Operating Procedures (IRB)
§ CPP 1435-08: IRB Audit and Monitoring Processes for Approved Research Studies (IRB)
§ CPP 1435-09: IRB Auditing and Monitoring Follow-up Procedures (IRB)
§ CPP 1435-10: IRB Concern or Complaint Process (IRB)
CPPs,
con’t. - 2…
§ CPP 1435-14: IRB Intellectual Property at KFMC (IRB)
§ CPP 1435-15: IRB Informed Consent for Vulnerable Participants in Approved Research
Projects (IRB)
§ CPP 1435-16: IRB Monitoring the Informed Consent Process (IRB)
§ CPP 1435-17: The Use of Patient Medical Record Information in Research and
Recruitment of Research Participants (IRB)
§ CPP 1435-18: IRB Determination Regarding Research Versus Quality Improvement Projects
(IRB)
§ CPP 1435-19: IRB Patient Safety and Quality Program (IRB)
§ CPP 1435-20: Registration of Clinical Trials with the Saudi Food and Drug
Administration (IRB)
§ CPP 1435-21: Principal Investigators Taking a Leave of Absence, Sabbatical, or Moving
to another Institution (IRB)
§ CPP 1435-23: Conflict of Interest in IRB Approved (IRB)
§ CPP 1435-68: Re-Consenting in IRB Approved Research Studies (IRB)
§ CPP 1435-25: Outsourcing Research Services
(RC)
DPPs
AND IPP:
§ DPP 11251-008-32: Biological Hazardous Shipment Guidelines (PCLMA)
§ DPP 30501-111-30: NS Confidentiality of Patient Information (MCI)
§ DPP 050007-02-33: Incentives for the Research Scientific Committee (RC)
§ DPP 050007-01-33: Payment of Intramural Research Fund IRF Reviewers (RC)
§ DPP 050007-02-33: Incentives for the Research Scientific Committee (RC)
§ Admin IPP 040005-008-35: Handling of Hazardous/Contaminated Medical Equipment (Admin)
HOSPITAL
LEADERSHIP IS ACCOUNTABLE FOR THE PROTECTION OF HUMAN RESEARCH SUBJECTS:
|
MEASURABLE ELEMENTS |
POLICIES |
|
1. Hospital leadership establishes and promotes a code of ethical
professional behavior. |
CPP 1431-184, Ethical framework
statement |
|
2. Hospital leadership, verbally and in writing, communicates within the
hospital their commitment to protect human subjects and research participants and
support the code of ethical professional behavior. |
Quality Council No. 20-4-32-3, Research
Council 421-32-1, Risk Management Policy Apr 2014 |
|
3. Hospital leadership identifies the official(s) responsible for
maintaining the development of and compliance with all human subjects research
policies and procedures. |
CFO IRB No. CE4-00-35-03, CFO
Ethics Committee No. 01-01-01-35-05, Risk Management Policy Apr. 2014. |
|
4. Hospital Leadership assumes responsibility for patient protection
irrespective of the sponsor of the research. |
IRB CPP 1432-91, Quality Council
No. 204-32-3, Research Council No. 421-32-1, Risk Management Policy Apr 2014. |
HOSPITAL
LEADERSHIP ESTABLISHES THE SCOPE OF RESEARCH ACTIVITIES:
|
MEASURABLE ELEMENTS |
POLICIES |
|
5. Hospital leadership identifies the program scope in terms of drugs,
medical devices, testing, and other potential research topics and
methodologies. |
IRC CPP 1432-91 Art 5.2, IRB CPP
1435-18. |
|
6. Hospital leadership identifies s those facilities that will be included
in the research function. |
Facility Mgmt CPP 1433-20, RC CPP
1433-07, FOM CPP 1435-80, RC DPP 050007-02-33, RC CPP 1433-22 |
|
7. Hospital leadership identifies the qualifications of staff permitted to
participate in the research program as principal investigators or other
members of the research team. |
RC CPP 1432-173, 1432-35 |
|
8. There is documentation of the qualifications of staff permitted to
participate in the research program |
IRB CPP 1432-91 ART 6.1.3 |
|
9. Hospital leadership identifies those circumstances in which staff can
serve as research subjects. |
IRB CPP 1435-15 |
HOSPITAL
LEADERSHIP ESTABLISHES REQUIREMENTS FOR SPONSORS OF RESEARCH TO ENSURE THEIR
COMMITMENT TO THE CONDUCT OF ETHICAL RESEARCH:
|
MEASURABLE ELEMENTS |
POLICIES |
|
10. The requirements include the sponsor's compliance with the hospital’s
policies and processes for monitoring and evaluating the quality, safety, and
ethics of the research. |
SFDA guidelines, GCP Guidelines,
IRB CPP 1435-20, RC CPP 1432-31 |
|
11. The requirements include that sponsors use research teams that are
trained and qualified to conduct the research. |
SFDA guidelines, GCP Guidelines, RC
CPP 1432-31 |
|
12. The requirements include that
sponsors protect the privacy and confidentiality of subject data (Also see
PFR.1.3 and MOI.2). |
SFDA guidelines, GCP Guidelines,
Hlth Info. CPP 1433-08, RC CPP 1432-86, MCI DPP 30501-111-30 NS, MCI CPP
1432-101 |
|
13. The requirements include that sponsors ensure that the research data
are reliable and valid and that the results and reporting are statistically
accurate, ethical, and unbiased. |
SFDA guidelines, GCP Guidelines. RC
CPP 1432-31 |
|
14. The requirements include that sponsors do not permit patient or
researcher incentives that would compromise the integrity of the research. |
SFDA guidelines, GCP Guidelines, RC
CPP 1432-31 |
HOSPITAL
LEADERSHIP CREATES OR CONTRACTS FOR A PROCESS TO PROVIDE INITIAL AND ONGOING
REVIEW OF HUMAN SUBJECT RESEARCH:
|
MEASURABLE ELEMENTS |
POLICIES |
|
15. Hospital leadership identifies and supports the structure and
operational requirements of the research review function. |
IRB CFO, IRB CPP 1432-91, IRB CPP
1435-07, IRB CPP 1435-08, IRB CPP 1435-08 |
|
16. The research review function complies with applicable laws and
regulations. |
IRB CPP 1432-91, IRB CPP 1435-07,
IRB CPP 1435-08, IRB CPP 1435-08 |
|
17. Hospital leadership specifies the requirements of entities outside of the
hospital that provides all or a portion of the research review function, such
as a contract research organization. |
RC CPP 1435-25 |
|
18. Hospital leadership clearly identifies research that is exempt from the
research review process. |
IRB CPP 1432-91, IRB CPP 1435-07 |
THE
HOSPITAL IDENTIFIES AND MANAGES CONFLICTS OF INTEREST WITH RESEARCH CONDUCTED AT
THE HOSPITAL:
|
MEASURABLE ELEMENTS |
POLICIES |
|
21. The hospital specifies the requirements for managing conflicts of
interest, both financial and non-financial. |
IRB CPP 1435-23, RC DPP
050007-01-33, RC DPP 050007-02-33, KFMC Ethical framework, CPP Workplace
conduct |
|
22. The hospital specifies the individuals, committees, and others to whom
the requirements apply. |
IRB CPP 1435-23, RC DPP
050007-01-33, RC DPP 050007-02-33, KFMC Ethical framework, CPP Workplace
conduct |
|
23. The hospital has an ongoing education and monitoring process to ensure
compliance with the requirements. |
RC CPP NEEDED |
THE
HOSPITAL INTEGRATES HUMAN SUBJECT RESEARCH PROGRAM INTO THE QUALITY AND PATIENT
SAFETY PROGRAM OF THE HOSPITAL:
|
MEASURABLE ELEMENTS |
POLICIES |
|
24. The research program is a component of the hospital’s processes to
report and act on sentinel events, adverse events of other types, and the
processes to learn from near misses. (Also see MMU.7.1, QPS. 7, QPS. 8, and
QPS. 9). |
IRB Chair members of Quality
Council, receive DATIX reports, Adverse effects reported to the DATIX system
by IRB Chair, IRB CPP 1435-10, IRB CPP 1435-19 |
|
25. The research program is included in the hospital’s programs for
hazardous material management, medical technology management, and medication
management. (Also see FMS.5, FMS. 8, and MMU. 1) |
RC CPP NEEDED, Pharmacy CPP
1432-431, PCLMA IPP 11251-PCLM-078-35, Admin IPP 040005-008-35, Pharmacy CPP
1432-231, PCLMA DPP 11251-PCLM-008-32, FMS CPP 1430-27 |
|
26. The evaluation of staff participating in the research program is
incorporated into the ongoing monitoring processes of professional
performance. (Also see SqE.11) |
Admin CPP 1431-130 |
THE
HOSPITAL ESTABLISHES AND IMPLEMENTS AN INFORMED CONSENT PROCESS:
|
MEASURABLE ELEMENTS |
POLICIES |
|
27. Patients asked to participate are informed about the research, and duration of the patient’s participation. |
IRB CPP 1432-92, IRB CPP 1435-07,
IRB CPP 1435-15, IRB CPP 1435-16, IRB CPP 1435-68 |
|
28. Patients asked to participate are informed about the expected benefits,
potential risks, and alternative treatments and procedures that might also
help them. |
IRB CPP 1432-92, IRB CPP 1435-07,
IRB CPP 1435-15, IRB CPP 1435-16, IRB CPP 1435-68 |
|
29. Patients asked to participate are informed about the extent to which
confidentiality of records will be maintained. |
IRB CPP 1432-92, IRB CPP 1435-07,
IRB CPP 1435-15, IRB CPP 1435-16, IRB CPP 1435-17, IRB CPP 1435-68 |
|
30. Patients asked to participate are informed about the compensation or
medical treatments available if injury occurs. |
IRB CPP 1432-92, IRB CPP 1435-07,
IRB CPP 1435-15, IRB CPP 1435-16, IRB CPP 1435-68 |
|
31. Patients asked to participate are assured that participation is
voluntary and refusal to participate or withdrawal at any time will not
compromise care or access to hospital services. |
IRB CPP 1432-92, IRB CPP 1435-07,
IRB CPP 1435-15, IRB CPP 1435-16, IRB CPP 1435-68 |