Research Guidelines - National Kidney and Transplant Institute

CLINICAL TRIAL AND RESEARCH UNIT
National Kidney and Transplant Institute
GUIDELINES:
a. No outside research studies will be conducted in this Institute if no NKTI staff member is one of the
lead investigators.
b. Non-NKTI personnel cannot conduct research in this institute.
c. The following research protocol require submission to the Institutional Review Board (IRB) for
approval:
1. All interventional research
2. All pharmaceutical-funded or industry-initiated research such as post-marketing surveillance
(PMS)
3. All multicenter research
4. All off-label studies
5. All researches requesting for funding from the Institute
6. All research requiring direct patient contact such as interviews, surveys, questionnaires, home
visits, laboratory tests
d. Researches composed solely of chart review will not need IRB review but should be registered to
CTRU prior to commencing the research.
e. All other research not corresponding to the above will require registration with the CTRU since the
Research Committee needs to be aware of all researches being performed in the Institute. It will be
the responsibility of the Department Chairman to ensure that such researches are registered with the
Research Committee prior to commencing the research. Indicate sponsor/s or agency/ies involved.
f. For collaborative/multicenter research studies:
1. Identify all the collaborating institutions to the research project.
2. Identify the consultants from all collaborating institutions to the research project. The
consultant from NKTI must be one of the principal investigators in the project.
3. Assign liaison officers from each collaborating agency who can be contacted at any time with
regards the status of the study. Liaison officers may be persons other than the principal
investigators. Include their contact numbers and update this information yearly as may apply.
4. State the duties and responsibilities of the collaborating consultants.
5. Based on the responsibilities of the collaborating parties, establish from the start the
authorship criteria, which agency/investigator will have the rights to the paper (i.e. to what
publication the completed paper will be submitted to), and acknowledgments.
g. Submit the research protocol in ten (10) hard copies and electronic form to CTRU. Pay attention to
the FORMAT for research protocol attached to this guideline. It is the sole responsibility of the
primary investigator to ensure that they comply with the proper format. Non-compliance will result in
delay in the review of their protocol.
h. Submission of research protocol should be 10 working days before the scheduled IRB review.
i. For pharmaceutical-funded or industry-initiated research, the following fees are required:
1. Technical Review Board (TRB) Fee - P 15,000.00
2. Research Ethics Review (REC) Fee - P15,000.00
3. Administrative Fee – 10% of the total research budget.
For Post Marketing Surveillance Studies
a. <30 Patients
b. 31-50 Patients
c. 51-70 Patients
d. >70 Patients
P5,000.00
P8,000.00
P9,000.00
P10,000.00
Room rental fee if applicable – Php 400.00/hr with minimum monthly rate of Php 6,000.00
j.
k.
l.
Payment of the Technical Review Board fee and Research Ethics Review fee should be made prior to
calendaring the protocol for review.
Once the research protocol has been approved the administrative fee, should be paid according to
the portion of the budget of the study performed at the NKTI.
Submit a copy of the budget of your study for patients to be enrolled at the NKTI, excluding
investigator’s fees. This will be used to compute the administrative fees to be charged to the
sponsoring agency/pharmaceutical company.
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m. Non-compliant with rules and regulations governing the conduct of the research at the NKTI will be
penalized by paying in addition to the administrative fee, a penalty of 30% of the total budget of the
NKTI portion of the study.
n. Once the research protocol has been approved, if the laboratory procedures/examinations will be
performed at the NKTI, the pharmaceutical company sponsoring the study should check one of the
following options as applicable:
Expenses for laboratory exam will be deducted from a revolving fund to be deposited at
the NKTI Cashier in the amount equivalent to 10 % of the total budget. This fund is to be
replenished once it is consumed and no laboratory examination will be performed once this
fund is consumed.
Expenses for laboratory exams will be paid by the sponsoring agency/pharmaceutical
company on a per patient basis for every laboratory procedure performed.
o. Once the research proposal has been approved the CTRU will assign to the study a Research Code.
Use this in all your transactions in relation to this study.
p. For amendment to original protocol, you must attach the original protocol to the amendment in 9
copies. You must submit one week prior to scheduled REC meeting. Failure to submit on time will
cause a delay to the review.
q. For further information, please contact CTRU at 981-0400 local 4408/4407 or visit our website at
http://www.nkti.gov.ph/research.do
I have read completely the guidelines and understand that the research protocol will not commence until
all of the above procedures have been complied with and the research protocol has been approved by the
TRB and REC.
_______________________________________ _______________________
Name of Principal Investigator
Signature
____________
Date
_______________________________________ _______________________
Name of Representative of
Signature
Sponsoring Agency/Pharmaceutical
Company
____________
Date
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