Approval and Hospital Permit for

Conducting Research in JEC Eye Hospital

Riset dan Pendidikan

Presented in:
Rapat …
Nov … , 2018
 Approval and Hospital Permit
Faculty of Medicine
(FK UGM, FKUI, FK UnHas, etc) JEC Eye Hospital

- Ethical Clearance - Ethical Clearance

- Hospital Permit
 Documents to Prepare
 Application letter (completed and signed)
 Research proposal
 Previous ethical board review approval (FK UGM, FKUI, etc)
 Informed consent form for research subjects
o (in plain language which enable common, average people to understand fully)
o Included, but not limited to: explanation to research protocol, procedure, benefit,
risk, alternatives, refusal, protection (insurance, compensation), contact person &
number
 Member of the research team, institution, contact number
 Research budget allocation and source of funds:
o Personal
o Sponsored
o Help / partial funding request from JEC
 Softcopy design of poster / standing banner
 Process and Output

• Submit the necessary documents

• Wait for the ethical board review and hospital permit
• Revisions and further explanation (if requested)
• Endpoint:
– Ethical review board approval / ethical clearance
– Hospital permit
– Special sticker / sign for subjects of ongoing clinical trials (completed/
previous clinical trial?)
JEC EYE HOSPITAL
Special Considerations with Regards to JCI Accreditation
 Our Hospital – JCI Accredited
• In compliance with JCI’s
Standards for Academic Medical
Center Hospital
• Chapter: Human Subjects
Research Programs (HRP)
Human Subjects Research Programs (HRP)

• Standard HRP.2
• Hospital leadership establishes the scope of
research activities
• In our hospital, studies which are not included
in the scope (cannot be conducted in JEC):
– Animal study
– Phase 1, phase 2 clinical trial (?)
Human Subjects Research Programs (HRP)

• Standard HRP.3
• Hospital leadership establishes requirements
for sponsors of research to ensure their
commitment to the conduct of ethical
research.
Human Subjects Research Programs (HRP)
• Clinical trials involving sponsors must be informed to
Risdik (along with existing or potential contracts
between sponsors and research team and/or JEC)
• Sponsor’s qualification:
• Highly qualified team to conduct study
• Obligation to maintain secrecy and confidentiality of
study subjects
• Research sponsors actively participate in ensuring
reliable, valid study results data and reports are
statistically accurate, ethical and unbiased.
• Incentives to patients or researchers are reviewed, to
maintain the integrity of study.
Human Subjects Research Programs (HRP)

• Standard HRP.3.1
• When one or more of the research-related
duties and functions of the sponsor are
provided through an outside commercial or
academic contract research organization, the
accountabilities of the outside contract
research organization are clearly defined.
Human Subjects Research Programs (HRP)

• Standard HRP.5
• The hospital identifies and manages conflicts
of interest with research conducted at the
hospital.
 Human Subjects Research Programs (HRP)
Standard HRP.5
Full disclosure

• Financial support • For non financial support:

– Research grant, travel grant,
compensation
– Key Opinion Leader or member
of Advisory Board from sponsor
• Ethical review board will
monitor any conflict of
interests
– No form of cash / financial
support
– Accommodation
– Flight / travel support
– Non financial support can’t
be given to family members
of the research team
Human Subjects Research Programs (HRP)

• Standard HRP.6
• The hospital integrates the human subjects
research program into the quality and patient
safety program of the hospital.
Human Subjects Research Programs (HRP)

• Standard HRP.6
• Report:
– Adverse event : whom to report in JEC?
– Management of biomedical waste
– Medical equipment and device: user manual,
storage, maintenance
Human Subjects Research Programs (HRP)

• Standard HRP.7
• The hospital establishes and implements an
informed consent process that enables
patients to make informed and voluntary
decisions about participating in clinical
research, clinical investigations, or clinical
trials.
 Human Subjects Research Programs (HRP)
• Standard HRP.7
• Potential study subjects must be informed (written and oral):
– Procedures / drugs used in the clinical trial
– Study and follow up duration
– Potential benefit, risk, alternatives of procedure / drugs used in the
trial
– Maintain of confidentiality and medical record
– Compensation and/or therapy for any injury
– Name and number of contact person
• Participation in the trial must be voluntary
• Refusal will not interfere with the patient's service or access
to services in the hospital
Human Subjects Research Programs (HRP)

• Standard HRP.7.1
• The hospital informs patients and families about how
to gain access to clinical research, clinical
investigations, or clinical trials and includes
protections for vulnerable populations to minimize
potential coercion or undue influence.

• The needs of poster/ banner (along with contact

number)
THANK YOU