Department of Science and Technology Philippine Council for Health Research and Development

ZAMBOANGA CONSORTIUM FOR HEALTH RESEARCH AND DEVELOPMENT
DOST- IX Compound, Capt. F. Marcos St. cor. Gen. Alvarez St. Pettit Barracks, Zamboanga City 7000

DETAILED RESEARCH PROPOSAL
Part I Procedural Documents: these include individual pages containing the cover sheet, Standard Application Form for Ethics Review (SAFER), clearances, endorsement from the agency head, and the curriculum vitae. There should be no pagination on these documents as they are meant to stand-alone. Cover sheet – Please use a separate sheet. This contains the following information: 1. 2. 3. 4. Revision date and number Title of the study Study number – (to be provided by PCHRD) Signatures and dates: a. Author(s) / Contact numbers b. Implementing agency / Contact numbers(This refers to the agency/ies implementing the research proposal) c. Cooperating agency / Contact numbers (This refers to the agency/ies, which is/are expected to cooperate/contribute to the research work.)

A.

Standard Application Form for Ethics Review (SAFER) – Please use a separate sheet. This contains the following information: (For Ethics Review Committee use only) 1. 2. Reference Number– (to be provided by ZCHRD) Contact details of Program/Project leader (This indicates the name of the program and/or project leader, his/her designation or title in his/her agency, field of specialization and his/her mailing address, telephone and fax numbers. Indicate percentage time to be devoted to his/her research. A program leader is one who directly plans, organizes, supervises the over-all activities of an R and D, and is directly responsible for the conduct of one of the projects of said program. A project leader is one who directly plans, organizes and supervises, and conducts the implementation of a basic unit of investigation of a specific R and D problem.)

B.

3.

a. Name b. Position/Academic Rank c. Address d. Telephone / Fax / Mobile / e-mail Program/Project Title (The title is the distinctive name given to the research proposal (program/project), which describes the work

4. 5. 6.

scope in specific, clear, and concise terms. A program is a group of inter-related R and D projects requiring an interdisciplinary or multidisciplinary approach to meet established goal(s) within a specific period. A project on the other hand is a basic unit in the investigation of a specific R and D problem to accomplish predetermined objectives within a specific period.)

Planned date of start Project duration Summary of Ethical concerns (This should contain the risk-benefit analysis in detail)

Clearances – Technical Review Board Clearance – should come from the implementing agency’s Research Center. In the absence of an Institutional Research Center, a letter of endorsement from the Institutional head/College Dean/Immediate head is required. C. Ethical/biosafety clearance – Ethical clearance from the agency’s Institutional/College-level Ethics Review Committee (IERC/CERC) accredited by ZCHRD-ERC is required for researches involving the use of human subjects. In the absence of the IERC, the implementing agency may send a letter seeking for ethical clearance enclosed with their research proposal for ethical review to ZCHRD. A technical/ethical clearance is required prior to review of the proposal by the funding agencies. Likewise, biosafety clearance is required to ensure that all studies dealing with genetic engineering and pathogenic organisms in the Philippines are conducted under reasonably safe conditions. If the implementing agency has no built-in Institutional Biosafety Committee, then the proposal could be submitted for review by the DOST’s National Committee on Biosafety of the Philippines. Endorsement from the agency head – This is indicative of the support of the implementing agency to the research project in terms of use of facilities and equipment, and assistance in undertaking the project. Curriculum vitae – This portion provides relevant information regarding the author(s) research capability.

D. E.

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Backgrounder: This includes the table of contents, research abstract (Introduction), objectives, significance of the proposal, end-users/target beneficiaries, expected output/s, program/project duration, conceptual design, variables to be investigated. This is in the light of a thorough literature review and intended to explain the proposal in brief. Margins: Font style: Font Size: Font size within Tables and text boxes: Spacing: Alignment: Indentation 1” on all sides Arial, Arial Narrow 12

Part II

10 1.15 within and between paragraphs JUSTIFIED 0.5” Include line numbers (see Detailed guide in writing research proposals) This setting is to be used in the entire proposal. Subheadings should be indented 0.5 from the heading and in bold for emphasis subheadings of a previous subheading should no longer be in bold, it should be indented by 0.5” A. Table of contents – This section contains a complete table of contents including a listing of all appendices Research Abstract (Introduction) – This section contains a 300-word summary (excluding direct citations and references ie. Apolinario, 2012) of the background information relevant to the study design and protocol methodology. Sufficient information includes description of disease/condition of interest and present knowledge of the subject matter of the research. This information is necessary in order to understand the rationale for the study. Objectives – Enumerate the goals that the program/project attempts to achieve. Delineate the general from the specific objectives. Research objectives should be Specific, Measurable, Attainable, Relevant, and Time-bounded. Indicate the program/general objectives as well as specific project objectives if the proposal is a program. Significance of the proposal – This is the rationale of the research. It answers the question, “what is the study for?” End-users/target beneficiaries – This refers to the probable end-users or beneficiaries of the research output and the number and locality of beneficiaries, if applicable. Expected Output/s – This refers to the end results (e.g. production technology or knowledge) expected upon completion of the research. The output (s) needs to be identified to highlight impact/importance of the research. Program/project duration – This refers to the planned start date, completion date, and duration expressed in months. Literature Review – This section discusses literature relevant and specific to the topic and locale of the research proposal. It is complete and concise to convince the reader that the research proposal is based on sound information base, address current health priorities, and will help improve health research in the country. Conceptual Design – This should be presented in a diagram/figure, should contain a brief discussion, and should not contain line numbers. Variables to be investigated – dependent/outcome and independent variables are presented in a diagram/figure, it should contain a brief discussion, and should not contain line numbers.

B.

C. D. E. F. G. H.

I. J.

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Research Methodology: is a complete description of the intended research, through the full proposal, the proponent needs to convincingly explain and defend the study. The proponent should convince the panel how the research Part III proposal will contribute in solving or mitigating public health issue or problem and improve universal health care. This documentary record of the research undertaking should adequately address the four ethical principles: respect for persons, beneficence, non-malfeasance, and justice. Methodology – this section should detail how the welfare of the participants shall be protected during recruitment including advertisement, information regarding funding sponsors, institutional affiliations other potential conflict of interest and compensation for the subjects or participants. Demonstrates the appropriateness of the proposed methods for testing the stated hypothesis. All procedures whether invasive or not should be satisfactorily described in detail. Describes anticipated risks with corresponding measures on how these are minimized. Demonstrates that potential benefits outweigh risks (Potential/risk analysis). Study design: this section indicates how the study objectives will be achieved. It includes a description of the type of study design eg. Cross sectional, case control, cohort, etc. Study population: this is required for studies involving animals and humans. This section states the number of study subjects required to complete the study. A brief definition on the study subject is in this section. Inclusion criteria: this section describes the criteria each study subject must satisfy to be included in the study. These criteria may include, but are not limited to the following: age, sex, race, and diagnosis/condition. Exclusion criteria: this section details the criteria that would eliminate a study subject from participation in the study. This section should not focus however on the opposite of the inclusion but should include the factors that merit its exclusion from the study eg. Sore nipples, IPs in urban areas, etc. Sample size computation: this section describes the type of sampling design and the assumptions used to compute the sample size. Site of the study: it should detail the location where the R and D are to be conducted. Study plan: it should explain the plan of action, procedures, and methods used during the study. It should present a detailed methodology path for laboratory, diagnostic, interviews, and manner of data collection. Special instrumentation is presented in subsections (data collection tools, special equipment, etc.) Indicating how confidentiality of data and privacy of participants will be protected (implementation phase until disposal of data gathering tools/ manuscripts; shows respect for study participants and proactively minimizes emotional risks by carefully attending to the nature of the interactions with them. Utilizes appropriate strategies; e.g. debriefing sessions after data collection is comleted to permit participants to ask questions, to air complaints. Debriefing is especially important when the data collection has been stressful or when ethical guidelines had to “bent” like use of euphemisms in explaining the study. Case Report Form (CRF): It is a paper or electronic questionnaire tool specifically used by sponsors in clinical trials to collect data from each participating site. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events. Participant Information: Assent, and Informed Consent Form: Information shall be provided to the participants and such will be the basis for the assent and informed consent. This shall include the objectives, significance, and benefits of the research; the nature of participation; their rights, privileges, and obligations including payment of research-related expenses; safety information (e.g., the risks involved, safety precautions, contact persons in emergency situations or adverse events, contact telephone numbers). Aside from the project title, sponsor, and the investigator, it should contain the following: Purpose and conduct of study: Why is the study being done? What has been done previously? How will the present study be conducted? What is the nature and extent of involvement of research participants? Risks and inconveniences: Describe the possible discomforts/risks that will arise clearly. Explain the possible discomforts/risks that will arise comprehensively. Describe other effects that will arise during the conduct of the study that the participants need to know in order to make a decision? Possible benefits for the participants: What benefits can the participants expect? Compensation: Will there be re-imbursement of travel expenses? Compensation for loss of income? Meal expenses? Are there other financial considerations? Provision for psychological trauma, injury, or related illness? Will the participants be given free treatment in case of injury or illness incurred because of participating in the study? What are the provisions to prevent or alleviate psychological trauma?

A.

B.

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Part III Research Methodology continued… Contact Person: Who is the person knowledgeable about research and rights of the participant? Voluntariness of Participation: Is the participant free of any coercion in participating? Is there an assurance that the participant can withdraw anytime without affecting treatment care due him/her for the injuries that will possibly be incurred during the conduct of the research? Is there provision for obtaining the informed consent from the legal representative in case of minors, the mentally handicapped, or the incapacitated? Note: Please refer to Annex A for Parental authority and Guardianship of ward Confidentiality: Is there a statement that describes the measures that will be taken to keep and ensure the confidentiality of the participant’s records? ASSENT / CONSENT FORM
(This should be included in the appendices section but discussions pertaining to is made here)

I have read and understood the above information and had been given the opportunity to consider and ask questions on the Information regarding the involvement in this study. I have spoken directly to the investigator who has answered to my satisfaction all my questions. I have received a copy of this Participant Information and Informed Consent Form. I voluntarily agree to participate. Participant’s Signature: (Name of Participant) (Signature of Participant ) (Date)

Witness or Legal Guardian’s Signature: (Name of Witness/Legal Guardian) Investigator’s Signature: I, the undersigned certify that to the best of my knowledge, the participant signing this consent form has read the above information sheet fully, that this has been carefully explained to him/her, and that he/she clearly understands the nature, risks, and benefits of his/her participation in this study. (Name of Investigator) (Signature of Investigator) (Date) (Signature of Witness/Guardian) (Date)

Part IV Data presentation, analysis, and interpretation A. Plans for data processing and analysis – This includes computer facilities to be used, software packages; statistical tools/tests to be used; dummy tables Work plan schedule – This is brief description in chronological order of each activity to be undertaken. The plan of work of a project should reflect the schedule of the study components. For the program, individual schedules of each of the projects are to be supplied. A Gantt chart of activities is included. This chart will indicate the relative period and schedule of the major activities of the proposal, including plans for research utilization. It is feasible to complete the proposed study within the specified time and with the resources that are available. Agreements on the time schedule for publication of research findings and authorship are specified. Plan/s of sharing the research results to the respondents before it is published / reported. Research utilization – This section should indicate the strategies to be used in disseminating and ensuring utilization of the expected research results. For product-based researches, proposal should include the prospective technology user, as well as, plans for technology transfer.

B.

C.

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Part V Financial Requirement Estimated budgetary requirements – Indicate the annual budget of the proposal according to source of funds. For the first year, specify the budget for major expense items. For succeeding years, only the total annual budget is required initially (only for long-term researches). The detailed breakdown of financial assistance requested should be in accordance with the New Government Accounting System (NGAS); the counterpart funding of the implementing agency must be reflected as well as other agencies cooperating in the project. Details of the financial requirements per expense item and source of funds are illustrated at the end page. Under the Personnel Services (PS), segregate the number and positions of those who will be receiving salaries from those who will be entitled to honoraria. Salaried personnel will consist of those who will work full time for the project. Part-time staff to be hired for the research will be entitled to honoraria. Likewise, the Project Leader and the consultants will be recipients of honoraria. Indicate the recommended salaries/honoraria rates per position and the coverage of their service periods. A. For Maintenance and Other Operating Expenses (MOOE), the traveling expenses of transportation of one’s personal and essential baggage, per diems while in route or away from permanent station and items necessarily incidental thereto in connections with the research work. The item on supplies and materials will include expenses on consumable and semi-expendable field/laboratory/office supplies and materials needed in the course of the study. Budget for sundry will consist of expenses on communications, repairs and maintenance, estimated cost for research utilization (RU) component, computerization, and miscellaneous expenses. Details for each line item should be provided. The Capital Outlay (CO) details the budgetary requirement of the research for equipment items needed for the project. Indicate the quantity, unit cost, and total amount. An administrative cost equivalent to 7.5% of total costs under PS and MOOE can be included as part of the budget. This item corresponds to the overhead expenses (PS and MOOE) incurred by the implementing agency in managing, evaluating and monitoring the program/project. Line Item Budget (LIB)
Particulars I. Personal Services (PS) a. Salaries b. Honoraria Sub-total for PS II. Maintenance and Other Operating Expenses (MOOE) a. Traveling expenses b. Supplies and materials expenses Sub-total for MOOE III. Capital Outlay Sub-total for Capital Outlay Grand Total Sources of Funds and Amount (PHL pesos) PCHRD Assistance Agency Counterpart Other Sources

B.

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References & Appendices – Resources should be cited here. Use only Harvard style of referencing or the Vancouver style of referencing. Researchers who are not adept with the mentioned citation styles may continue using the American Psychological Association (APA) citation style for as long as they maintain consistency Part VI in citing their references. Researchers may secure a copy of the preferred referencing styles through the consortium secretariat. A. B. References – contains an alphabetical and/or numerical list or referencing of sources, relevant information or literature that the researcher read and may have or may have not cited all throughout the proposal as used in referred medical journals or other international journals. Appendices – is an auxiliary material at the end of a manuscript usually of an explanatory, statistical, or bibliographical in nature.