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UREC Form 10 Research Study Protocol2

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Izza Cael
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171 views

UREC Form 10 Research Study Protocol2

Uploaded by

Izza Cael
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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PUP-UNIVERSITY RESEARCH ETHICS CENTER

UREC Form 10
Study Protocol / No.
Research Protocol Version No. 1

(1) Program / Project Title


The identification of the program and/or the component projects.
Program – consists of interrelated R&D projects requiring a multi-disciplinary approach to meet
established goals within a specific time frame.
Project – basic unit in the investigation to meet pre-determined objective within a specific time frame.
(2) Program/Project Proponent
Program Leader – the overall in charge of the R&D program
Project Leader – the one to take the lead in the implementation of a research project
Must be either a permanent full-time faculty member of the University without administrative
designation or permanent administrative employee of the University

*Please attach curriculum vitae


(3) Program/Project Co-proponent and Research Assistant/s
Those who are not qualified as program/project proponent may qualify as co-proponent/s and research
assistants. However, research assistants are limited to bona fide students and/or administrative
employees.
(4) Program/Project Proponent’s Department/College/Office
Department/College/Office that will spearhead the implementation of the research proposal
(5) Background and Significance
Justification or rationale for doing the research. This will include a brief introduction, the problem/need
being addressed, the historical basis for R&D, utilization of the expected output, socioeconomic
benefits, and the possible impact on health / allied health science, the users, beneficiaries, and the
country.

(6) Objectives and Research Questions


Statement of general and specific objectives of the study. You may include the research problems

(7) Materials and Methods


A. Study Design
 Definitions
 Prospective/retrospective
 # of centers, randomized?
 Blinded, placebo, etc.
 Period of enrollment or chart review covers? Informed consent?
 Study Drugs, Device, or Intervention
 Randomization/Sampling (If appropriate)
 Instruments: Standardized Surveys, etc. (provide a description of each)
 Endpoints: the main thing that you are looking at

B. Study Population
 Who? Age, Sex, Race, Diagnoses if appropriate.
 Inclusion/Exclusion criteria
 Experimental group vs. Control group

S423, 4th Floor South Wing, PUP A. Mabini Campus, Anonas Street, Sta. Mesa, Manila 1016
Trunk Line: 335-1787 or 335-1777 local 235/357
Website: www.pup.edu.ph | Email: [email protected]

THE COUNTRY’S 1st POLYTECHNICU


PUP-UNIVERSITY RESEARCH ETHICS CENTER
UREC Form 10
Study Protocol / No.
Research Protocol Version No. 1

C. Assessment of Resources
Indicate how investigator will ensure that the study:
 Has sufficient access to the study population
 Has sufficient time to conduct and complete the study
 Has adequate qualified staff members to conduct the study
 Facility is adequate to conduct the study
 Staff has been adequately trained on the protocol and their specific research related duties

D. Study Procedures
Include a description of the study procedures (as they relate to the subject). Be sure to include (as
applicable):

Plans for Recruitment


 The number and estimated length of each study visit
 Procedures and/or interventions that will be performed for each visit (a chart may be helpful)
 If a drug study, include instructions for administering drugs, handling instructions, and storage
and disposal instructions
 For biological samples, explain how the samples will be collected, as well as storage, testing,
and disposal methods
 For behavioral studies, identify the instruments being used and who will be administering the
instrument (including their qualifications
 If a survey study, include who created the survey, whether survey has been standardized, how
survey will be distributed and returned, and how confidentiality will be maintained
 If chart review, indicate whether or not the materials will be obtained prospectively, or if the
materials will come from previously existing specimens, records, or data. Explain what
information will be used to identify potential human subjects for inclusion in research.

E. Data Collection
 How and what data will be collected (i.e. demographics, comorbidities, standardized tools etc).
 Reliability and validity of the research instrument

F. Data Analysis

 Sample Size Considerations


 Power analysis based on previous studies or exploratory study?
 Justifying the sampling procedure

 Statistical Methodology
 Comparisons to be made and statistical tests to be used for the comparisons.

(8) Safety and Monitoring Plan


Describe any provision for monitoring the data for safety. Cite steps/ways how the collected data will be
stored. Who will have access to the collected data? For how long the collected data will be stored? How
will the researchers destroy the collected data?

(9) Limitations
This refers to the potential limitations of procedures. Enumerate characteristics of design or
methodology that might influence the interpretation of the findings of the study.

(10) Ethical Considerations

S423, 4th Floor South Wing, PUP A. Mabini Campus, Anonas Street, Sta. Mesa, Manila 1016
Trunk Line: 335-1787 or 335-1777 local 235/357
Website: www.pup.edu.ph | Email: [email protected]

THE COUNTRY’S 1st POLYTECHNICU


PUP-UNIVERSITY RESEARCH ETHICS CENTER
UREC Form 10
Study Protocol / No.
Research Protocol Version No. 1

A. Informed Consent (Applies to studies using human subjects)


1. Provide a description of the Informed Consent Process, including:
a) Circumstances under which consent will be obtained
b) How Consent will be documented
c) Special Provisions for Vulnerable Populations
d) Steps taken to minimize coercion
e) Who will be involved in obtaining consent
f) When will subject be approached
g) Method used to ensure that subject fully understands study procedures
2. If requesting waiver or alteration of consent, explain why it is needed to complete the study

B. Risks and Side Effects (Applies to studies using human subjects)


1. Potential Risks (include medical, psychological, legal, financial, social)
a) Assess for severity and likelihood
b) Procedures for protecting against or minimizing risks
i.e. Alternative treatment or procedures
c) Unforeseen risks
d) Time to be spent by the participants in answering survey questionnaires or attending interviews/
focus group discussion
2. Adverse events (please define)
a) Provisions for medical and professional intervention
b) Reporting adverse events
3. Compensation for Injuries
a) Where and from whom medical therapy may be obtained
b) Who will pay for the therapy
c) Whom to contact in case of injury

C. Benefits to Subjects (Applies to studies using human subjects)


 Explain the expected benefits in relation to the subjects (example: Improvement of oneself).
Explain the benefit to general science or others if applicable.

D. Costs to Subject (Applies to studies using human subjects)


1. Clearly describe the financial costs (ex. internet load) that the subject may incur (if there are none,
state as much).
a) Justify any costs that the subject will incur as a result of participating in the study.

E. Compensation to Subject (Applies to studies using human subjects)


 Describe any compensation that is received by the subjects, whether monetary or otherwise.
When determining compensation, keep in mind what is reasonable based on the time and effort
required of the subject. The use of benefits to offset the burden due to participation in the
research should be incremental and not based on study completion.
a) Discuss schedule of payments based on their completion or partial completion.
b) Please state if the researchers will not provide compensation to subjects/participants

F. Provisions for vulnerable subjects (Applies to studies using human subjects)


 Indicate whether there will be vulnerable subjects in the study (i.e. PWD, Senior Citizen, Minors,
Indigenous people). State if there are no vulnerable participants.
 Describe additional protections provided to these subjects to protect their rights and welfare

S423, 4th Floor South Wing, PUP A. Mabini Campus, Anonas Street, Sta. Mesa, Manila 1016
Trunk Line: 335-1787 or 335-1777 local 235/357
Website: www.pup.edu.ph | Email: [email protected]

THE COUNTRY’S 1st POLYTECHNICU


PUP-UNIVERSITY RESEARCH ETHICS CENTER
UREC Form 10
Study Protocol / No.
Research Protocol Version No. 1

G. Subject Privacy and Data Confidentiality (Applies to studies using human subjects)
1. Privacy of Participants
a) Describe appropriate provisions to protect the privacy of the subjects.
2. Confidentiality of Data
a) Provide a clear description of how the data will be disseminated. Outline the sharing of data with
others outside of the institution, and include provisions for maintaining confidentiality. Additionally,
describe how the results of the data will be used (i.e. presentations at professional organizations,
submission to professional journals).
i. Will data be identified?
ii. How will Data be kept Secure (where will data be stored)
iii. Who will have access to the data?
3. Plan for Record Retention and Disposal
4. Limits to Confidentiality

(11) Plan for Dissemination of Findings


This refers to the explanation of your dissemination plans (Defense/Paper Presentation/Publication).

(12) References
Please use the latest APA edition.

(13) Appendices
This refers to research instruments, rating scales, consent forms, etc.

(14) Prepared by (15) Endorsed by


Signature

Name of proponent

Designation/position (Immediate Supervisor)

Date

S423, 4th Floor South Wing, PUP A. Mabini Campus, Anonas Street, Sta. Mesa, Manila 1016
Trunk Line: 335-1787 or 335-1777 local 235/357
Website: www.pup.edu.ph | Email: [email protected]

THE COUNTRY’S 1st POLYTECHNICU

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