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.

RESEARCH OFFICERS

     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.

Members:

ETHICS REVIEW COMMITTEE

The Ethics Review Committee (ERC) of the Lung Center of the Philippines is an independent body whose sole purpose is to review and approved/disapprove all research proposals dealing with human subjects.

Chairperson:
Sergio Andres, M.D.

Members:
Jaime Mendoza, M.D.
Daphne Bate, M.D.
Justice Rizalina Vera
Prof. Bernadette Nepomuceno
Fr. Efren Balistoy, OSC
Mrs. Cecilia del Rosario

GENERAL PRINCIPLES AND GUIDELINES ON RESEARCH

General Principles:

1. 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.
   
2. Studies involving human subjects utilizing intervention methods currently not accepted as standard indications shall be due for ethical review.
   
3. The Ethics Review Committee will be composed of the medical research staff and the 5 officers of the different training programs.
   
4. 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.

1. Training requirements – These studies are conducted by training fellow(s), residents, rotators and other paramedical personnel as a completion of requirement for their training.
   
2. Institutional research – These studies are conducted by the hospital as and activity of an individual, a section, a department or the hospital.
   
3. Research grants – These are studies conducted using institutional resources but externally supported fully or partially by other funding agencies, private group and/or companies.

1. Training staff under the different departments have respective requirements to accomplish before they are cleared or certified as having completed their training.
   
2. All papers shall have an adviser(s) from among the consultant staff.
   
3. Papers shall be read in a Research Forum set annually by the Department or its equivalent venue in a recognized specialty organization.
   
4. All scientific papers submitted and 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.
   
5. 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.
   
6. All research papers submitted shall be considered properties of the institution.

1. Projects initiated by members of the staff may be funded by the institution after a review and approved by a technical working group formed by the department. Proposals shall include the protocol and proposed budget.
   
2. Research subjects may include medical, paramedical and/or non-medical concerns related to the realization of the mission and vison of the institution.
   
3. 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.

1. Studies funded by outside sources shall be coordinated with the department. Proposals shall be submitted for review before initiation of the research.
   
2. 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.
   
3. 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.
   
4. 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.
   
5. Honoraria for study grant investigators handling charity patients shall go to the research fund.

1. Trainees should submit a research question to his/her clinical adviser and research adviser for approval.
   
2. 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)
   
3. If there is a need for funding assistance, the research 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)
   
4. Preliminary report should be submitted to the research adviser before a final draft is prepared for publication or presentation.
   
5. 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.
   
6. All research papers should be presented in a Research Forum scheduled every December/ An independend Board of Judges should rate the paper based on the submitted manuscript (Pre – judgment criteria 90%) and on the oral presentation (10% research forum proper).
   
7. All certificates of completion of training should be cleared with the department before they could issued to graduates of training programs.

1. 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.
   
2. 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 Thursday to assess and discuss proposals.
   
3. Studies requiring resolution of ethical issues should be submitted to the Ethics Review Committee after being received and endorsed by the technical working group.
   
4. Copies of the research proposals should be provided each member of the Ethics Review Committee for their individual evaluation. After two (2) weeks they should meet as a committee to approve or disapprove a particular study proposal. The meeting should be presided by a chairman appointed from among themselves. A member of the technical working group may be called in to provide information the committee may need to know.
   
5. Only upon approval by a majority of the committee should any proposal proceed.
   
6. 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 P10,000.00)
   
7. Study grant investigators should forfeit their honoraria in favor of the Educational Training and Research fund if the subjects involved are charity patients or when the research investigation is done by trainees.
   
8. 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. These shall be categorized as:

a) full assistance = 100% of the budget requested
b) partial assistance = up to 50% of the budget

9. Quarterly reporting of expenses should be submitted to the department for filing.
   

10. Final draft of all research studies should be submitted to the department for filing.
    
11. Publication or presentation of the findings and recommendations of the research should be the first option of the author. The department should however recommend possible venues for the study venues for the study results.
    
12. 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.

REQUIREMENTS IN SUBMITTING RESEARCH PROTOCOLS

• Requirements for evaluation of the research protocol by the Technical Review Board:
  

INSTITUTIONAL RESEARCHES (INITIATED BY LCP PERSONNEL)

1. Copies of research protocol = #4
2. Copies of Informed Consent Form = #4
3. Letter of request for approval from the principal investigator
4. Certification from Department/Unit of the principal investigator
5. Budget proposal, with or without request of funds

RESEARCHES INITIATED BY EXTERNAL GROUPS (INCLUDING DRUG COMPANIES)

1. Copies of research protocol = #4
2. Copies of Informed Consent Form = #4
3. Letter of request for approval from the principal investigator
4. Fully accomplished Study Information Sheet
5. Budget proposal

• Requirements for evaluation of the research protocol by the Ethics Review Committee.

1. Copies of research protocol = #4
2. Copies of Informed Consent Form = #4
3. Letter of request for approval from the principal investigator
4. Fully accomplished Study Information Sheet
5. Budget proposal

All researches sent to the Ethics Review Committee for evaluation must have prior approval by the Technical Review Board.

CUT-OFF DATES FOR SUBMISSION OF RESEARCH PROTOCOLS

Approval of protocols will be done quarterly, i.e., protocols should be submitted not later than the 30^th of the months of January, April, July and October. Final approval (including TRB, ERB and Budget/Research Fund) for protocols received on or before 30 January is expected to be released not later than 30 March (30 June, 30 September, 30 December as the case may be).

TRAINING WORKSHOPS

Program for Research Methodology & Protocol Writing

Formulation of Research Question & Objectives
Study Population & Sampling
Variables iin Research & Outcome Measures
Methodological Issues in Research
Statistical Issues in Research (Sample Size)
Statistical Issues in Research (Statistical Analysis)
Ethics & Budgeting
Workshops

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
Basic Statistics
Demo and workshop on Data Editing and Data Analysis using Epi Info
Summary of Statistics

RESEARCH PROTOCOL OUTLINE

1. Research Question/Hypothesis

2. Introduction
   Significance of the Study
   Literature Search/Overview
   Objectives (General/Specific

3. Research Design

4. Study Population

Cases
        Inclusion Criteria
        Exclusion Criteria

Control (if any)
        Selection Procedure

5. Materials and Methods

Procedure/Maneuver
Randomization
Treatment Allocation
Blinding
Matching/Stratification

6. Study Endpoints

Variables: independent/dependent
Dummy Tables

7. Statistical Issues

Sample Size Calculation
Data Analysis:
Statistical tests
Levels of significance

8. Ethics

9. Budget

RESEARCH PROPOSAL FORMAT

Research Question/Hypothesis

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 number phrased in 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

Introduction

1. Explain why the study is good

2. 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

3. Objectives

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 effectivenss/efficacy is a prerequisite and the evidence for this should be indicated.

Research Design

e.g. Descriptive study, case control, cohort, randomized concurrent trial

Study Population

(major issues – Reproducibility and Generalizability)

1. Define target population
2. Define how sample is selected – e.g. Random selection; and inclusion and exclusion criteria
3. Demographic Data
4. Identification of proportion who agree to participate
5. Sample size specification
6. Minimization of sampling bias

Description of Experimental Maneuver

1. Specify how allocation will occur if an experiment and how codebreaking will be avoided
2. 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

1. Specify who, if anyone, will be blinded
2. Specify how co-intervention and contamination will be avoided
3. Specify how compliance, if applicable, will be assessed
4. Specify how you will minimize bias in administering the maneuver

1. Specify the outcome attribute(s) being measured

• consider which of the following should be measured: Symptoms; Death; Physical Functions; Patient Satisfaction; Family Function

1. Specify method(s)/instrument(s)/questionnaire to be used to measure the attribute(s)
2. 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
• Precision
• Feasibility

1. Specify whether assessment will be "blind"
2. Specify how harmful side-effects will be detected

3. Specify how you will minimize bias in measuring exposures and outcomes

Justification of Sample Size

1. Expected frequency of endpoint events in control/non-exposed groups
2. Clinical/Administrative significance of interest
3. Type I and II error used in the calculation
4. The source of estimate of the Standard Deviation where applicable

1. Criteria for substantive and statistical success
2. Reproducible details of statistical strategy to be used
3. Specifications of data handling and collation and computer use

Specification of pretesting (if necessary) formulation

• identification of eligible subjects
• estimation of sample size
• development of outcome measures
• overall feasibility and logistics of study

Ethics

1. Good outweighing harm
2. Free Informed Consent
3. Freedom from Assault
4. Confidentiality

1. Personnel
2. Data Handling Costs (e.g. Computers)
3. Travel
4. Equipment
5. Material and Supplies

1. Letters of Agreement to Collaborate
2. Questionnaires
3. Unpublished data on methods

Head Office    :  Department of Research and Development
Telephone No. : 924-6101 to 20 locals 235 • 411
E-mail Address:  research@lcp.gov.ph