The Department of Research and Development (R&D) oversees all research projects at the Lung Center of the Philippines (LCP). It receives, evaluates and coordinates all research activities. It establishes policies and guidelines for the development, writing presentation and approval of research proposal and budget. Thru its Technical Review Board, it provides guidance and technical expertise on protocol development, including sample size estimation and statistical analysis plan. It conducts workshops on Research Methods and Protocol Writing. It spearheads institutional researches as well as coordinates research collaboration with other national and international agencies. The R&D runs the TB Research Team at the LCP’s National Center for Pulmonary Research that performs the observational study A Natural History of Tuberculosis in the Philippines: Molecular Characteristics of Mycobacterium tuberculosis, now on its second phase. It spearheads the Lung Cancer Registry to gather and collate the most comprehensive local data on lung cancer. The R&D organizes and conducts the hospital-wide Annual Research Forum as a venue to present the latest completed institutional researches and to train fellows and other hospital staff in oral presentation of scientific papers.
The R&D publishes the Scientific Proceedings, the official journal of the LCP, to share local relevant educational material in the field of respiratory medicine. The Scientific Proceedings publishes original clinical investigations, epidemiological studies, case reports, review articles, evaluation of diagnostic and surgical techniques, and latest updates on management guidelines.
The R&D is in charge of the Medical Library, which provides reading materials, both print and online, and learning opportunities for all hospital staff, as well as medical and allied medical students from outside institutions and the general public. As a training institution, the Medical library furnishes learning materials particularly to training fellows and consultants and other staff alike on patient care, training and research activities.
The R&D is also in charge of the Medical Records Section (MRS). As the repository of all patients’ records, the MRS provides data to the hospital staff directly responsible in patient care management as well as information to decision makers that serves as management tool for sensible planning and evidence based decision making. It is also a source of information for local data gathering in research.
The R&D has developed disease specific hospital programs from which physicians and patients have benefited. Among these are the Home Oxygen Program, COPD Support Group, Asthma School Program, Asthma Clinic Workshop, Asthma Training Center, Tuberculosis Workshop, and Multi-Drug Resistant TB Program. Among the new programs being initiated and developed are the Office for Science Diplomacy, Air Pollution Toxicology, Cancer Genomics, and Artificial Trachea Project.
Sullian Sy Naval, MD Department Manager
Norberto A. Francisco, MD Overall Research Coordinator
Ma. Jonas C. Cervas Stenographer II/ Secretary
RESEARCH TEAM (National Center for Pulmonary Research)
Sullian Sy Naval, MD Principal Investigator
Louise Ann D. Sanchez, RN Patient Care Administration
Michelle M. Cabanatan, RMT Research Medical Technologist
Kenneth A. Bongulto Molecular Biologist
APPENDIX A - GENERAL POLICY IN REQUESTS FOR APPROVAL OF RESEARCH PROTOCOLS
All researches to be conducted by the LCP personnel and or with LCP premises should have prior endorsement by the Department of Research and Development and final approval of the Executive Director. Approval of protocols will be done quarterly, which includes processing by the Technical Review Board (TRB) and Ethics Review Committee (ERC) as well as Budget/Research Funding.
Each department has a staff member who also functions as a Research Officer. The Research Officer supervises the respective staff in all their research requirements
Lourdes S. Badion, MD Department of Radiology
Dominador P. San Andres Jr., MD Section of Anesthesia
Camilo C. Pada, MD Department of Surgery
Ma. Teresa A. Barzaga, MD. Department of Pathology
Daphne D. Bate, MD. Department of Pulmonary Medicine
Glenda L. Picardal, RN, MAN, MPA, Ph.D Nursing Department
APPENDIX B - TECHNICAL REVIEW BOARD (TRB)
The members of the Technical Review Board (TRB) are all appointed by the Executive Director. The TRB is responsible for evaluating the substance, and importance of the research proposals. It may recommend such proposals to the Executive Director and recommends which proposals to be conducted with funding, monitors the conduct and administration of research protocols or programs and evaluates the outputs and outcomes of research projects within the hospital or in cooperation with other hospitals or groups or institutions.
With regards to research studies originating from the pharmaceutical industries, the study shall be submitted to the Department of Research and Development for proper documentation before being submitted to the TRB for a short review to determine if it is in line with the provisions of the ICH-GCP guideline. Once approved and signed by the TRB Chairman, the study is immediately submitted to the Institutional Ethics Review Board.
Requirements in Submitting Protocols for evaluation by the Technical Review Board
A. INSTITUTIONAL RESEARCHES (Initiated by LCP Personnel )
Four (4) copies of the research protocol
Four (4) copies of the Informed Consent
A letter of request for approval from the principal investigator
Certification from the Department /Unit of the principal investigator
Budget proposal with or without request of funds
• Same requirements are submitted to the Institutional Ethics Review Board
B. RESEARCHES INITIATED BY EXTERNAL GROUPS (Pharma Industries, etc)
Four (4) copies of the research protocol
Four (4) copies of the Informed Consent
Letter of request for approval from the principal investigator
Fully accomplished Study Information Sheet
• Same requirements are submitted to the Institutional Ethics Review Board
ALL RESEARCHES SENT TO THE INSTITUTIONAL ETHICS REVIEW BOARD FOR EVALUATION MUST HAVE A PRIOR APPROVAL BY THE TECHNICAL REVIEW BOARD (TRB)
DATES FOR SUBMISSION OF RESEARCH PROTOCOLS
Approval of research protocols will be done every first and third Mondays of the month unless otherwise changed by its Chairman with the approval of the majority of the members. However, the Chairman may also call for a review at any day and time depending on the number of protocols submitted to be evaluated to facilitate submission for ethics review.
MEMBERS OF THE TECHNICAL REVIEW BOARD (TRB) 2015
• Sergio N. Andres Jr., MD - Chairman
• Angela C. Cruz, MD, Ph.D - Co-Chairman
Ma. Lourdes S. Badion, MD.
Daphne D. Bate, MD
Noemi R. Buensuceso, MD
Glynna A. Ong-Cabrera
Anjanette R. de Leon, MD
Ramoncito S. Habaluyas, MS, MD
Francisco M. Heralde III, RN, Ph.D
Red Earl Juanico, Ph.D
Zenaida M. Mariano, MD, MHA
Jopeth Ramis, R.Ch.E; MS
Armand Gregorio G. Sarmiento, MD
APPENDIX C - GENERAL PRINCIPLES AND GUIDELINES ON RESEARCH
All researches done in the Lung Center of the Philippines or using resources and facilities of the institution shall be under the supervision of the Department of Research and Development.
- Studies involving human subjects utilizing intervention methods currently not acceoted as standard indications shall be due to ethical review.
- The Ethics Review Committee will be compose of the medical research staff and the 5 officers of the different training programs.
- The Ethical Review Committee shall be composed of members of the community as specified by the Declaration of Helsinki and shall each serve a term of 3 years, subject to reappointment.
Types of Research Activities:
Training requirements – These studies are conducted by training fellow(s), residents, rotators and other paramedical personnel as a completion of requirement for their training.
- Institutional research - These studies are conducted by the hospital as an activity of an individual, a section, a department or the hospital.
- Research grants - These are studies conducted using institutional resources but externally supported fully or partially by other funding agencies, private group and/or companies.
Training staff under the different departments have respective requirements to accomplish before they are cleared or certified as having completed their training.
- All papers shall have an adviser(s) from among the consultant staff.
- Papers shall be read in a Research Forum set annually by the Department or it’s equivalent venue in a recognized specialty organization.
- All scientific papers submitted or presented shall be subject to review and revision by a technical working group before the final draft shall be published in a scientific journal of the institution.
- Assistance for several projects may be requested by writing to the Research Committee with submission of the research proposal and budget. Review and approval of the requested assistance shall be done by the Research Committee.
- All research papers submitted shall be considered properties of the institution.
Projects initiated by members of the staff may be funded by the institution after a review and approved by the technical working group formed by the department. Proposals shall include the protocol and proposed budget.
- Research subjects may include medical, paramedical and/or non-medical concerns related to the realization of the mission and vision of the institution.
- A final draft shall be submitted to the department before the results, conclusions and recommendations are released for publication, presentation or submission to other fora/venues.
Studies funded by outside sources shall be coordinated with the department. Proposals shall be submitted for review before initiation of the research.
Researches requiring the approval of the Ethics Review Committee shall be requested to submit seven (7) copies of the proposed study for dissemination to the Committee Members.
Institutional fee shall be charged for projects which shall identify the institution as the main study areas or as a participant in a joint venture. The rate shall determined by the department preferably at least 10% of the total proposed budget.
The institution reserves the right to withdraw its participation in projects which may be found to be inimical to the interest of the Lung Center of the Philippines.
Honoraria for study grant investigators handling charity patients shall go to the research fund.
APPENDIX D - STANDARD OPERATING PROCEDURES ON RESEARCH
A. COMPLETION OF TRAINING REQUIREMENTS
Trainees should submit a research question to his/her clinical adviser and research adviser for approval.
Upon approval of a particular topic or study, the researcher should prepare a final proposal for approval by the research technical working group. (Research Committee)
If there is a need for funding assistance , the researcher should submit a letter of request to the Department of Research and Development stating the amount /budget needed. Specific indications for the procedure(s), test(s), service(s), drug(s) and /or equipment should be explained. (see guidelines for Budget Proposal)
Preliminary report should be submitted to the research adviser before a final draft is prepared for publication or presentation.
Final Draft/Report of research study should be handed in two (2) weeks before the scheduled Research Forum . Five (5) copies of the manuscripts should be submitted to the secretary of the department before 5;00 p.m. of the set date.
All research papers should be presented in a Research Forum scheduled every December. An independent Board of Judges should rate the paper based on the submitted manuscript (Pre-judgement criteria 90%) and on the oral presentation (10% research forum proper).
All certificates of completion of training should be cleared with the department before they could issued to graduates of training programs
B. INSTITUTIONAL RESEARCHES AND RESEARCH GRANTS
Research proposals ( approved by the Department and Research Committee) should first be submitted to the Department of Research and Development for review by the technical group.
The Department secretary should prepare and distribute copies for members of the Technical committee to read through one (1) week before the scheduled en-banc meeting for approval. The research technical group should meet every Monday to assess and discuss proposals.
- Only upon approval by a majority of the committee should any proposal proceed.
- Research studies funded from outside sources should have a budget proposal submitted. An institutional fee should then be determined ten (10%) based on the total amount expected to be incurred in the conduct of the study in the institution (minimum of PHP10,000.00)
- Proposals seeking funding assistance from the institution should be reviewed by the technical working group and awarded the degree of assistance, subject to the availability of funds.
- Quarterly reporting of expenses should be submitted to the department for filing.
- Final draft of all research studies should be submitted to the department for filing.
- Publication or presentation of the findings and recommendations of the research should be the option of the author. The department should however recommend possible venues for the study venues for the study results.
- Prizes and awards for research works should be given to the investigators unless full funding assistance was extended by the institution, in which case Awards and Incentive Committee should decide ownership of the awards upon the recommendation of the department.
APPENDIX E - TRAINING WORKSHOPS
Program for Research Methodology & Protocol Writing
Formulation of Research Question & Objectives
Study Population & Sampling
Variables in Research & Outcome Measures
Methodological Issues in Research
Statistical Issues in Research (Sample Size)
Statistical Issues in Research (Statistical Analysis)
Ethics & Budgeting
Program for Data Management Workshop
Review of Research Process
Overview of Data Management
Sample Questionnaire and Preparation of Coding Manual
Workshop on Coding Manual
Demo and workshop on Data Entry using Excel
Demo and workshop on File Conversion from Excel to Epi Information
Demo and workshop on Data Editing and Data Analysis using Epi Info
APPENDIX F - RESEARCH PROTOCOL OUTLINE
I. Research Question/Hypothesis
Significance of the Study
III. Research Design
IV. Study Population
Control (if any)
V. Materials and Methods
VI. Study Endpoints
VII. Statistical Issues
Sample Size Calculation
Levels of significance
RESEARCH PROPOSAL FORMAT
Define the hypothesis to be tested or the question to fulfill the following:
(a) one sentence in the form of a question
(b) the question can be answered with a phrased terms of clinical significance/administrative importance
(c) the population is defined
(d) the exposure or intervention is specified
(e) the endpoint of interest is specified in quantifiable terms
i. Explain why the study is good
ii. Review of literature
Demonstrate that you know the field and are up to date
Demonstrate that you are aware of any previous attempts to test the hypothesis being studied
Identify whether the objective is primarily one of identification of need, efficacy, effectiveness, efficiency or quality of care. If it is either efficiency or quality of care, then effectiveness/efficacy is a pre requisite and the evidence for this should be indicated.
e.g. Descriptive study, case control, cohort, randomized concurrent trial
(major issues- Reproducibility and Generalizability)
Define target population
Define how sample is selected – e.g. Random selection; and inclusion and exclusion criteria
Identification of proportion who agree to participate
Sample size specification
Minimization of sampling bias
Materials and Method
Description of Experimental Maneuver
I. Specify how allocation will occur if an experiment and how code breaking will be avoided
II. Specify how experimental and control group differ and direction of intervention
• the maneuver must be defined sufficiently and precisely for it to be reproducible by others (i.e. Who does, what, to whom, when, why, and how)
• if an innovative, therapeutic maneuver or method of delivering health care is involved, this is even more crucial
I. Specify who, if anyone will be blinded
II. Specify how co-intervention and contamination will be avoided
III. Specify how compliance, if applicable, will be assessed
IV. Specify how you will minimize bias in administering the maneuver
Description of Outcome Measurement
I. Specify the outcome attribute(s) being measured :
• consider which of the following should be measured:
Symptoms; Death; Physical Functions; Patient Satisfaction; Family function
II. Specify methods(s) instrument(s) questionnaire to be used to measure the attribute(s)
III. Specify the evidence for, or the plans for pretesting that will ensure the following:
• The credibility and sensitivity of the instrument/questionnaire to change in the attribute and any other components of validity felt to be relevant
Specify whether assessment will be “blind”
Specify how harmful side-effect will be detected
Specify how you will minimize bias in measuring exposures and outcomes
Justification of Sample Size
Expected frequency of endpoint events in control/non-exposed groups
Clinical/Administrative significance of interest
Type I and II error used in the calculation
The source of estimate of the Standard Deviation where applicable
•Specification of pre-testing (if necessary) formulation
•identification of eligible subjects
• estimation of sample size
• development of outcome measures
• overall feasibility and logistics of study
Time Schedule and Duties of Research Personnel
Good outweighing harm
Free Informed Consent
Freedom from Assault
Budget and Budget Specification
Data Handling Costs (e.g. Computers)
Material and Supplies
Letter of Agreement to Collaborate
Unpublished data on methods
Department of Research and Development
Rm. 4005, Lung Center of the Philippines
Quezon Ave. Extension, Quezon City 1100
Telephone No: 924-6101 locals 235 / 411