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    Chapter 1

    THE PROBLEM AND REVIEW OF RELATED LITERATURE

    AND STUDIES

    Introduction

    Personal autonomy encompasses, at a minimum, self-rule that is free from

    both controlling interference by others and from certain limitations such as an

    inadequate understanding that prevents meaningful choice.

    (Beauchamp and Childress 2008)

    Informed consent is more than simply getting a patient to sign a written consent

    form. It is the process by which a fully informed patient can participate in choices about

    his health care. It originates from the legal and ethical right the patient has to direct what

    happens to his body and from the ethical duty of the physician to involve the patient in

    his health care (K. Edwards, 2008). Comprehension on the part of the patient is equally as

    important as the information provided. The informed consent doctrine has become a

    foundational precept in medical ethics and health law. Although it was practiced, it rarely

    achieves the whole contexts of the informed consent process. It has been implemented

    worldwide. And an optimal establishment of an informed consent requires adaptation to

    cultural or other individual factors of the patient. Legally, simple consent protects

    patients against assault and battery in the form of unwanted medical interventions

    (CMAJ, 2012). The patient must have been given an adequate explanation about the

    nature of the proposed investigation or treatment and its anticipated outcome as well as

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    the significant risks involved and alternatives available. Aside from the protection it

    serves, patients exercised their autonomy independently.

    Worldwide, twenty-five hundred years of Western medicine, starting with

    Hippocrates, have been built on the preferred conception that physicians should protect

    their patients from information about their diseases or treatment options. The Patient

    Self-Determination Act (PSDA) was passed in 1990 and went into effect in December

    1991. The essence of this legislation is to empower the public with the right to be fully

    informed and fully self-determining regarding end-of-life decisions. However, since its

    implementation there is little evidence of national acceptance by the health care industry.

    The law applies to all health care facilities that receive any federal reimbursement for

    services, and includes hospitals, nursing homes, home health agencies, and clinics. The

    PSDA requires a health care mechanism for disseminating information about advance

    directives with patients (R. Pear, 2010). The time honored relationship between Filipino

    physicians, their patients and the community has undergone significant changes in recent

    times. A law has been passed on July 01, 2004 declaring the rights and obligations of

    patients and establishing a grievance mechanism for violations thereof and for other

    purposes. House Bill 261, Title III: Declaration of Rights presents all the right of patients

    in health care treatment.

    Questions continue to arise regarding the process of informed consent so the

    researchers chosen this study in order to know whether the persons right to self-

    determine was actually upheld. It does so by examining the development of indigenous

    peoples rights of participation, consultation, and consent in undergoing a specific

    medical intervention. The fundamental idea of this study is that patients should be able to

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    tailor the disclosure process to their own values and informational needs. The researchers

    aimed to study on the clinical practice of informed consent in UPHDMC are being done.

    Generally, the purpose of this study is to assess the extent of implementation of informed

    consent in UPHDMC.

    Review of Related Literature

    Foreign Literature

    CMS and informed consent: Is your institution getting it right?

    Bryant et.al (2008), stated hospitals must establish processes to assure that each

    patient or his/her representative is given information on the patient's health status,

    diagnosis, and prognosis. Hospitals must utilize an informed consent process that assures

    patients are given the information and disclosures needed to make an informed decision

    about whether to consent to a procedure, intervention, or type of care that requires

    consent. Informed decisions related to care planning also extend to discharge planning.

    Hospitals must establish policies and procedures that assure a patient's right to request or

    refuse treatment, and how this right will be exercised. Include the patient's right to

    delegate to a representative. Address the patient's right to have information on his

    medical status, diagnosis and prognosis and how patients will receive this information.

    How the patient will be involved in his/her care planning and treatment. The facility's

    informed consent policy should describe: Who may obtain the patient's informed consent.

    Which procedures require informed consent? The circumstances under which surgery is

    considered an emergency, and may be undertaken without informed consent. The

    circumstances when a patient's representative may give informed consent. The process

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    used to obtain informed consent, including how it is to be documented in the record. How

    the consent forms obtained outside the hospital will be incorporated in the patient's chart.

    Informed Consent Prior to Nursing Care Procedures

    Informed Consent is still an issue on the healthcare agenda. Consent is a process,

    not a form. It also continues to be a source of malpractice liability, because the legal

    requirements continue to lack complete clarity. And, done poorly, it contributes to a

    climate of public mistrust in healthcare professionals. Aveyard also stated that the

    principles of informed consent should underpin our approach to nursing care procedures,

    which should not be mechanistic but determined by the needs of individual patients.

    (Aveyard, 2008)

    Informed Consent

    When nurses provide consent forms for clients to sign, nurses must ask the clients

    if they understand the procedure for which they are giving consent. If clients deny

    understanding or you suspect they do not understand, notify the physician, health care

    provider, or nursing supervisor. Health care providers must inform a client refusing

    surgery or other medical treatment about any harmful consequences of refusal. If the

    patient persists in refusing the treatment, this rejection needs to be written, signed and

    witnessed. It is important to note that nursing students cannot be and should be not be

    responsible for or asked to witness consent forms due to legal nature of documents.

    (Potter et.al, 2009)

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    Local Literature

    Hayt and Hayt stated that it is established principle of law that every human

    being of adult years and sound mind has right to determine what shall be done with his

    own body. He may choose whether to be treated or not and to what extent, no matter how

    necessary the medical care, or how imminent the danger to his life or health if he fails to

    submit to the treatment. The essential elements of informed consent include (1) the

    diagnosis and explanation of the condition; (2) a fair explanation of the procedures to be

    done and used and the consequences; (3) a description of alternative treatments or

    procedures; (4) a description of the benefits to be expected; (5) material rights if any; and

    (6) the prognosis, if the recommended care, procedure, is refused.

    Informed Consent

    According to Udan (2008) informed consent is an agreement by a client to accept

    a course of treatment or procedure after complete information, including the risks of

    treatment and facts relating to it, has been provided by the physician. The patient has the

    right to receive from his doctor information necessary to give informed consent prior to

    start of any procedure or treatment, the medically significant risks involved and the

    probable duration of incapacitation. Where medically significant alternatives for care or

    treatment exist, or when the patient requests information concerning medical alternatives,

    the patient has the right to such information. The patient has the right to know the name

    of the person responsible for the procedure or treatment.

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    Local Study

    Applying a Sociolinguistic Model to the Analysis of Informed Consent Documents

    Molina et.al (2009) also stated that Informed consent is important because it

    promotes individual autonomy and offers security that patients will not be forced or

    misled into making decisions. It must therefore be designed to allow patients to have

    control over most of the information received and the chance to withdraw their own

    previous consent.

    Foreign Studies

    Evaluation of informed consent in health research: a questionnaire survey.

    According to Lnsimies-Antikainen (2010) Informed consent is ethically and

    legally required for all biomedical and health research involving human participants. This

    study analyses the realization of informed consent in health research from the point of

    view of healthy, voluntary adult participants. Empirical studies from this point of view

    are still rare.

    Factors associated with Quality of Informed Consent in Patients Admitted for

    Surgery: An Iranian Study.

    According to Sheikhtaheri, (2010) Informed consent is regarded as a pillar of

    medical ethics. The purpose of this study was to evaluate perceptions of the informed

    consent process prior to surgery. Most of the participants (88.7%) reported that they had

    requested to be informed about the complications of the surgical procedures, including

    severe complications such as death, but most of them did not receive this information.

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    The most important factors associated with the perceived quality of informed consent

    were the patient's level of education and type of surgery. In conclusion, practices

    consistent with the principles of informed consent have not been adequately implemented

    in the surgical departments of these hospitals in Kashan.

    Injury

    Smith et.al, (2012) stated that Informed consent is vital to good surgical practice.

    This study aims to assess whether provision of written information improves trauma

    patients recall of the risks associated with their surgery. 121 consecutive trauma patients

    were randomised to receive structured verbal information or structured verbal

    information with the addition of supplementary written information at the time of

    obtaining consent for their surgery. Patients were followed up post-operatively (mean 3.2

    days) with a questionnaire to assess recall of risks discussed during the consent interview

    and satisfaction with the consent process. Recall of risks discussed in the consent

    interview was found to be significantly improved in the group receiving written and

    verbal information compared to verbal information alone (mean questionnaire score 41%

    vs. 64%), p =0.0014 using the MannWhitney U test. Patient satisfaction with the

    consent process was improved in the group receiving written and verbal information and

    90% of patients in both groups expressed a preference for both written and verbal

    information compared to verbal information alone.

    The changing face of informed surgical consent

    Moreover, Oosthuizen et.al, (2012) cited that the introduction of procedure-

    specific brochures improved patients' pre-operative knowledge. Although the failings of

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    current consenting practice are clear, the Request for Treatment consenting process

    would not appear to be a viable alternative because of the large number of patients unable

    to accurately recall the nature of the proposed surgery or potential complications,

    following consent counselling.

    ETHICS: Informed Consent: Revisiting the Issues

    According to Erlen, (2009), this article reports on a qualitative study examining

    the way in which nurses obtain such informed consent. Data were collected through focus

    group discussion and by using a critical incident technique in order to explore the way in

    which nurses approach consent prior to nursing care procedures. An analysis of the data

    provides evidence that consent was often not obtained by those who participated in the

    study and that refusals of care were often ignored. In addition, participants were often

    uncertain how to proceed with care when the patient was unable to consent. Consent is

    still an issue on the healthcare agenda. It appears we are still not doing it properly.

    Consent is a process, not a form. It also continues to be a source of malpractice liability,

    because the legal requirements continue to lack complete clarity.

    Synthesis

    The similarity of the study of the researchers from the related literature is that

    both agrees that inform consent process involves the following dimensions such as

    legality, ethical obligations, perception and extent of implementation.

    The differences however, the review of related literature emphasis is more on

    level of awareness, in terms of legality, ethical obligations and perception.

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    The researchers study focusedon the Assessment of Informed Consent Process

    in UPHDMC: Basis for Program Development. Aside from demographic profile of the

    respondents, the researchers also included the following dimensions such as, legality,

    ethical obligations, perception and extent of implementation.

    Theoretical framework

    Faden and Beauchamp's 1986 workA History and Theory of Informed

    Consentis a primary source for informed consent theory within the legal and medical

    fields. It explores two foundations in moral theory for informed consent: one describing

    an autonomous authorization action by a subject, incorporating the concepts of

    understanding, no control (voluntariness), and intention; and the other, effective consent,

    decided within a set of rules in public policy, with such concepts as disclosure and

    competence. These general concepts of understanding, no control, disclosure, and

    competence have been, as we have seen, readily incorporated into the general ethical

    theory literature in medical and legal fields, and other related fields such as behavioral

    sciences. It serves as the basis for the examination of informed consent theory is

    grounded in the fact that almost all of the literature on informed consent in information

    technology refers back to Faden and Beauchamp for the theory used in developing

    informed consent practice.

    Faden and Beauchamp's theory of informed consent does not only form the basis

    for most of the literature in informed consent theory and practice, but the effective

    consent model is closest to that actually used in information technology procedures

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    Faden and Beauchamp begin by first exploring the idea of autonomy and how it

    underpins the idea of informed consent; they then discuss the main ethical concepts:

    intention, understanding, and no control. These concepts are tied together to form the

    autonomous action part of the authorization, and it is this act that constitutes their ``first

    sense'' of informed consent, that of informed consent as an autonomous authorization

    action (Flick, C. 2010).

    Conceptual Framework

    Input Process Output

    FEEDBACK

    Figure 1

    Demographic profile

    a.) Ageb.) Sexc.) Civil statusd.) Socio economic

    status

    Informed consent

    dimensions

    a.) legalityb.) ethical obligationc.)perceptiond.) extent of

    implementation

    a) Data gatheringb) Data processing

    such as encoding

    and data analysis.

    Propose Informed

    ConsentEnhancement

    Program.

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    The research paradigm represents the variables that comprise the study about the

    Assessment Informed Consent Process in UPHDMC: Basis for Program Development.

    An input-process-output diagram includes all of the materials and information required

    for the process, details of the process itself, and descriptions of all products and by-

    products resulting from the process. The input box contains demographic profile of the

    respondents gender, age, civil status, socio-economic status and the informed consent

    dimensions such as ethical obligations, legality and perception. While the process box

    contains the level of awareness and extent of implementation, data gathering and data

    processing such as encoding and data analysis includes frequency and weighted mean.

    And the last is the output box which contains the propose informed consent Development

    Program.

    Statement of the Problem:

    The study will assess the level of awareness of selected medical-surgical patients at

    UPHDMC, Las Pias on Informed Consent. Specifically, it aims to answer the following

    questions:

    1. What is the demographic data of respondents in terms of:1.1 Age;

    1.2 Civil Status;

    1.3 Educational Attainment

    1.4 Gender;

    1.5 Religion

    1.6 Socio-economic status?

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    2. What is the level of awareness of the respondents about informed consent processin terms of:

    2.1 Ethico-moral-legal aspect;

    2.2 Extent of implementation?

    3. Is there a significant difference on the extent of implementation of informedconsent process in the respondents when they are grouped based on their

    demographic profile?

    4. Based on the results of the study, what can be the proposed enhancementprogram?

    Hypothesis

    o There is no significant difference on the level of awareness of the respondentsabout informed consent process when they are grouped based on their

    demographic profile.

    Significance of the Study

    To the Patients at the University of Perpetual Help Dalta Medical Center

    (UPHDMC):

    They will be given the chance to improve their knowledge about the relevance of

    informed consent especially in their part as patients prior to nursing intervention to be

    done.

    To the Researchers: This study will enable the researchers to apply the theories learned

    in nursing research thus helping them to improve their knowledge and skills.

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    To the Nursing Students: They will be given more knowledge on the importance of

    Informed Consent to the Medical profession, the physician- nurse and especially the

    patient itself. They will be able to learn some alternative techniques or actions on how to

    emphasize the relevance and perform it as ethical issue is concerned. They will be

    competent and be effective nurses someday.

    To the Clinical Instructors: This study will give them knowledge and improve their

    learnings about Informed consent as they are in related to medical field. The clinical

    instructors then will be able justify and guide nursing students on their research.

    To the Future Researchers: This study will serve as guide and source of information to

    the future researchers thus make them finish their paper easier and faster.

    Scope and Limitation of the Study

    The respondents will be the forty five (45) selected Surgical Patients/ Guardian/

    Parent who have signed the informed consent in University of Perpetual Help Dalta

    Medical Center (UPHDMC) they will be chosen by convenience and quota sampling.

    The researchers will conduct a study on First Semester of school year 2013-2014.

    The emphasis of the study is on the assessment of the extent of implementation of the

    informed consent process in UPHDMC: Basis for Program Development. .The actual

    study will be conducted on June to July 2013.

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    Definition of Terms

    The following terms are operationally defined for better understanding of the

    context in which the concepts are used in the study.

    Ethico-moral-legal aspect.

    Extent of implementation.

    Informed consent.

    Enhancement Program.

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    CHAPTER 2

    METHODOLOGY

    This chapter presents the research design, population and sampling, participants

    of the study, the research instrument used and its description and validation, data

    gathering procedure and the statistical treatment utilized in analyzing and interpreting the

    data.

    Research Design

    The study used the descriptive method of research. Descriptive research refers to

    research studies that have as their main objective the accurate portrayal of the

    characteristics of person, situations or groups. This approach is used to describe variables

    rather than to test a predicted relationship between variables, since the study aims to

    determine the extent of implementation of informed consent in UPHDMC.

    Population Sampling

    The researchers will be utilizing the non-probability type of sampling specifically

    the Convenience Sampling and the Quota Sampling. Convenience Sampling is obtained

    when the researcher selects whatever sampling units are conveniently available. (Zulueta,

    2010) Quota sampling on the other hand is the method wherein the researchers will be

    determining the sampling size which should be filled up. It may also be specified unto

    how many will be included according to some criteria such as surgical patients admitted

    at the surgical ward who signed the informed consent. (Zulueta, 2010)

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    Respondents of the Study

    The respondents will be the patients or guardians of the patients that will undergo

    surgical or laboratory test and who have signed the informed consent. The UPHDMC has

    one hundred fifty (150) working bed capacity. Using the 30% of the total population size

    the sample size of this study will be forty-five (45). The respondents will be chosen

    regardless of age, sex and educational level.

    Research Instruments

    The questionnaire method specifically the guidance response type will be used in

    collecting data. It was a self-made instrument developed out of reading and consulting

    sample questionnaires used on previous similar studies and from the review of related

    literature. The questionnaires have 4 parts and each part is composed of 7 questions. The

    first part is the Perception, the second part is the Implementation, the third part is the

    Ethics and the last part is the Legality. The questions will be answer by (5) strongly

    agree, (4) agree, (3) uncertain, (2) disagree and (1) strongly disagree by just putting a

    check part on the desired answer of the respondent.

    Validation of Research Instruments

    After drafting the questionnaire, it will be submitted to the experts such as

    surgeons and nurses for correction and approval. Specialists in the content will measure

    the instrument and are asked to judge the appropriateness of the items on the instrument.

    Do they cover the breath of the content area (does the instrument contains a

    representative sample of the content being assessed)? Are they in a format that is

    appropriate for those using the instrument?

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    The experts will be requested to rate each item in the questionnaire as to whether

    the items measured the variables under study. They will be ask if the questionnaire

    provides the respondent with an easy method of indicating his/her answer, if questions

    will be worded simply and clearly and if questionnaire is uncluttered and easy to

    complete and if the questionnaire helps directly achieve the research objectives.

    After they had filled them out, the researchers will retrieve the questionnaires and

    will note the feedbacks of the validators.

    Pilot of the Study

    After the retrieval of the questionnaire from the experts the researchers will make

    necessary revisions as suggested. A pilot study will be conducted at Jonelta Ward to test

    aspects of the research design and to allow the necessary adjustment before the final

    administration of the questionnaire. This will involve testing the feasibility in practice or

    improving the methodological quality of parts of the study.

    Data Gathering Procedure

    Interviews will be conducted one-on-one or with a small group (the smaller the

    better so that everyone has a chance to contribute fully). Interviews will be use

    throughout the data gathering process, but they are perhaps most useful during the

    performance analysis stage.

    Direct observation of work performance will be used in gathering data because it

    is done in conjunction with another data gathering method that is used to fill in the gaps

    and answer questions.

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    With the permission of Dean Ma. Imelda O. Javier, the Dean of the College of

    Nursing and Mrs. Amelia Mendoza RN MAN, the Nursing Head Officer of UPHDMC,

    the copies of the questionnaire will distributed personally by the researchers to the

    respondents.

    The respondents will be given adequate time to fill out the questionnaire. The

    questionnaires will be collected back from the respondents and will be carefully checked

    for completeness.

    Statistical Treatment

    The following statistical treatments will be using by the researchers to analyze the

    data and interpret the results:

    1. To determine the demographic profile of the respondents in terms of Age;Gender; Civil Status; Socio-economic status; and Diagnosis will be treated

    with frequency and percentage in tabular distribution.

    Frequency:

    Fi =

    =

    Percentage:

    X 100% = %

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    2. The extent of the level of awareness of the respondents about InformedConsent Process in terms of Terms of Legality; Ethical Obligations; and

    Perception will be treated with weighted mean.

    Mean:

    (n+n+n+n+n..) numbers of n = mean

    Weighted mean:

    X=

    Value Weighted Mean Interpretation

    5 4.51-5 Fullest Implementation

    4 3.51-4.5 Full Implementation

    3 2.51-3.5 Moderate

    Implementation

    2 1.51-2.5 Least Implementation

    1 1-1.5 No Implementation

    Table 1

    3. In order to reject or accept if there any significant difference on the extent ofimplementation of Inform Consent in the respondents when they are grouped

    base on their demographic profile, the researchers will be using the T-test, and

    analysis of variance (ANOVA).

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    a. Sum of squares componentsSSt = SSa + SSx1A

    SSA= n (.-..)2

    SSna= (Yy -) 2

    b. Degree of FreedomDfa= a-1, dfna= a(n-1) = N-a

    Dft = an-1 = n-1

    c. Mean squares and FF=

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    REFERENCES

    Books

    Potter, P. and Perry, A. (2009).Fundamentals of Nursing: 7th Edition (pg. 333). PublisherMosley Elsevier (Elsevier, Inc.)

    Udan, J. (2009). Fundamentals of Nursing: Concept and Clinical Applications: 3rd

    Edition (pg. 468). Giuani Print House.

    Venzon, L. and Venzon, R. (2010).Professional Nursing in the Philippines: 11th

    Edition

    (pg. 175).C & E Publishing, Inc.

    J ournals

    Aveyard, H. (2008). Informed Consent Prior to Nursing Care Procedures. American

    Society of Registered Nurses (ASRN.ORG)

    Beauchamp, Tom L., and James F. Childress. (2008).Principles of Biomedical Ethics.

    6th ed. Oxford: Oxford University Press.

    Bisnar, P. (2008) History of Medical Malpractice in the Philippines (Part II.) Filipino

    Physician Blog. http://doktorko.com

    Bryant, S & Sagin, T. (2008). CMS and informed consent: Is your institution getting it

    right? American Society of Registered Nurses.

    De Castro, L. (2009). Failure of Informed Consent in Compensated Non-Related Kidney

    Donation in the Philippines. Asian Bioethics Review/June 2009 Volume 1,

    Issue2. http://muse.jhu.edu

    Edwards, K. (2008). Informed Consent. Ethics in Medicine of University of Washington

    School of Medicine, April 11, 2008 at

    http://depts.washington.edu/bioethx/topics/consent.html.

    Erlen, J. (2009). ETHICS: Informed Consent: Revisiting the Issues. Bio Info Bank

    Library. http://lib.bioinfo.pl/pmid:20664467.

    Flick, C. (2010).Informed Consent Theory. February 3, 2012 atwww.liedra.net.

    http://depts.washington.edu/bioethx/topics/consent.htmlhttp://depts.washington.edu/bioethx/topics/consent.html
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    Hall, D., Prochazka, A., Fink, A. (2012) Informed Consent for Clinical Treatment.

    Canadian Medical Association Journal.

    Lnsimies-Antikainen, H. et.al. (2010). Evaluation of informed consent in health

    research: a questionnaire survey. Scandinavian Journal of Caring Sciences/

    March 2010, Vol. 24 Issue 1. www.ebscohost.com.

    Molina, J. (2009).Applying a Sociolinguistic Model to the Analysis of Informed Consent

    Documents.Nursing Ethics. www.ebscohost.com

    Oosthuizen, JC et.al. (2012). The changing face of informed surgical consent. Journal of

    Laryngology & Otology/March 2012, Vol. 126 Issue 3. www.ebscohost.com.

    Pear, R. (2010). "Obama Returns to End-of-Life Plan That Caused Stir". December 25,

    2010 at The New York Times.

    Sheikhtaheri, A. and Farzandipour, M. (2010). Factors associated with Quality of

    Informed Consent in Patients Admitted for Surgery: An Iranian Study. AJOB

    Primary Research; October 2010, Vol. 1 Issue4. www.bioethics.net

    Smith, H. et.al, (2012).Injury. September 2012 at www.sciencedirect.com. Vol. 43 Issue

    9, p1534-1538, 5p

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    APPENDIX A

    UNIVERSITY OF PERPETUAL HELP SYSTEM DALTA

    AlabangZapote Road,Las Pinas City

    COLLEGE OF NURSING

    Dear Respondents,

    We are the nursing students in the University of Perpetual Help System DALTA,

    Las Pias Campus, BSN 3A. We would like to seek your cooperation in accomplishing

    the questionnaire of our study Assessment of Informed Consent Process in UPHMC:

    Basis for Program Development.

    Please answer all questions honestly without leaving any items unanswered. Rest

    assured that your responses will be treated with utmost confidentiality.

    Thank you very much for your cooperation.

    The researchers:

    Angeles, Cathleen Joy

    Baltar, Michelle

    Carreon, Ma. Ericka

    Ednaco, Kenneth Jay

    Garcia, Patrick Angelo

    Palces, Ralph Andrew

    Rivera, Romalyn

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    I. Demographic Profile

    Direction: Please put a check mark on the boxes that correspond your answer.

    A. Age:Above 45 yrs. old 1830 yrs. old

    3145 yrs. old Below 18 yrs. old

    B. Civil Status:Single Married

    C. Diagnosis:________________________________________D. Gender:

    Female Male

    E. Socio-economic Status: Monthly IncomePhp 31,000 and above Php 15,000 and below

    Php 16,00030,000

    II. Direction: The questionnaire contains questions that will assess the extent of

    implementation of informed consent process in UPHDMC. Kindly, put a check on the

    answer of your choice in the space provided.

    Value Interpretation

    5 Fullest Implementation

    4 Full Implementation

    3 Moderate

    Implementation

    2 Least Implementation

    1 No Implementation

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    Implementation

    Strong

    Agree

    5

    Agree

    4

    Uncertain

    3

    Disagree

    2

    Strongly

    Disagree

    1

    1. The doctor/ staff spent enough

    time in explaining procedure.

    2. They always asked me if I

    understand the procedure.

    3. The staff used visual aids in

    explaining the procedure.

    4. My doctor was always available

    to answer my questions

    5. I was completely informed by the

    doctor of all the procedures,

    treatments, surgery obtain, etc.

    6. I was very satisfied with the

    amount of involvement offered to

    my family with regards the

    procedure

    7. The doctor/ staff explained very

    well the informed consent and they

    give some alternatives/ options?

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    Ethics

    Strong

    Agree

    5

    Agree

    4

    Uncertain

    3

    Disagree

    2

    Strongly

    Disagree

    1

    1. I signed the informed consent

    voluntarily.

    2. The physician- staff nurses give

    you enough time before deciding.

    3. I think that the informed consent

    is ethically right?

    4. The physician- staff nurses

    obtained the inform consent in a

    right manner?

    5. The physician- staff nurses give

    ample time for you to decide to sign

    for the inform consent?

    6. I have no choice but to sign

    7. The staff nurses hurt your feelings

    when she/ he explained/ gave to you

    about informed consent.

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    Legality

    Strong

    Agree

    5

    Agree

    4

    Uncertain

    3

    Disagree

    2

    Strongly

    Disagree

    1

    1. The inform consent form is

    specific for each procedure.

    2. I was given a copy of the

    informed consent form.

    3. I understand that the doctor/ staff

    nurses/ hospital administrators are

    not liable if the surgery fails prior to

    the expected outcome.

    4. A legally authorized

    representative can signed on behalf

    of an adult with diminished

    decision- making capacity.

    5. I consider that in a case to case

    basis aside from the scheduled

    surgery, another surgery be done as

    needed.

    6. There is a significance of

    guardian in the context of obtaining

    consent.

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    7. There is a basis why I need to sign

    in the informed consent.

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    Curriculum Vitae

    Name : Cathleen Joy V. Angeles

    Address : #37 Amelita St., BF HOMES,

    Almanza II, Las Pinas City

    Gender : Female

    Date of Birth : April 28, 1994

    Place of Birth : Las Pias City

    Civil Status : Single

    Religion : Roman Catholic

    Father : Rolly A. Angeles

    Mother : Ma. Rosabel T. Villones

    EDUCATIONAL BACKGROUND

    Elementary : Almaza Elementary School

    Secondary : Las Pias East National High School, Talon Village Annex

    Tertiary : University of Perpetual Help System DALTA

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    Curriculum Vitae

    Name : Michelle Capate Baltar

    Address : 179 P. Diego Cerra St.

    Las Pinas City

    Gender : Female

    Date of Birth : May 18, 1993

    Place of Birth : Brgy. Astorga Tunga, Leyte

    Civil Status : Single

    Religion : Roman Catholic

    Father : Ubaldo Baltar

    Mother : Rosalinda Baltar

    EDUCATIONAL BACKGROUND

    Elementary : Astorga Elementary School Tunga, Leyte

    Secondary : Gregorio C. Catenza National High School

    Tertiary : University of Perpetual Help System- DALTA

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    Curriculum Vitae

    Name : Ma. Ericka Beatriz O. Carreon

    Address : #4 Faith St, Veraville 1,

    Moonwalk Village, Las Pinas

    City

    Gender : Female

    Date of Birth : March 12, 1993

    Place of Birth : Manila

    Civil Status : Single

    Religion : Roman Catholic

    Father : Enrique Carreon Sr.

    Mother : Ma. Vilma O. Carreon

    EDUCATIONAL BACKGROUND

    Elementary : Dona Mauela Elementary School

    Secondary : RESPSCI

    Tertiary : University of Perpetual Help System DALTA

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    Curriculum Vitae

    Name : Kenneth Jay I. Ednaco

    Address : Blk 15 Lot 2 Faith St., Veraville 1,

    Moonwalk Village, Las Pinas City

    Gender : Male

    Date of Birth : August 23, 1993

    Place of Birth : Madonna Medical Hospital, Balayan, Batangas

    Civil Status : Single

    Religion : Roman Catholic

    Father : Ernesto L. Ednaco Jr.

    Mother : Rodelina L. Ednaco

    EDUCATIONAL BACKGROUND

    Elementary : Lian Central School

    Secondary : Lian Institute

    Tertiary : Batangas State University

    University of Perpetual Help System DALTA

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    Curriculum Vitae

    Name : Patrick Angelo Q. Garcia

    Address : 24 Skynet St. Moonwalk

    Village Talon V Las Pias City

    Gender : Male

    Date of Birth : August 13, 1993

    Place of Birth : Sampaloc, Manila

    Civil Status : Single

    Religion : Roman Catholic

    Father : Maurice B. Garcia

    Mother : Nell Ann Q. Garcia

    EDUCATIONAL BACKGROUND

    Elementary : Mary Immaculate Parish Special School

    Secondary : Mary Immaculate Parish Special School

    Tertiary : University of Perpetual Help System DALTA

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    Curriculum Vitae

    Name : Ralph Andrew B. Palces

    Address : Courtyard II Portofino

    Heights, Daang-Hari,

    Muntinlupa City

    Gender : Male

    Date of Birth : June, 05, 1992

    Place of Birth : Quezon City

    Civil Status : Single

    Religion : Roman Catholic

    Father : Raul B. Palces

    Mother : Ma. Theresa B. Palces

    EDUCATIONAL BACKGROUND

    Elementary : Elizabeth Seton School

    Secondary : Legazpi Hope Christian School

    Tertiary : University of Perpetual Help System DALTA

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    Curriculum Vitae

    Name : Romalyn C. Rivera

    Address : 9021 km 23 West Service Road

    Alabang Muntinlupa City

    Gender : Female

    Date of Birth : June 30, 1987

    Place of Birth : La Medella Baao Camarines Sur

    Civil Status : Single

    Religion : Roman Catholic

    Father : Rodrigo Rivera

    Mother : Marilyn Rivera

    EDUCATIONAL BACKGROUND

    Elementary : Masville Elementary School

    Secondary : Dr. Arcadio Santos National High School

    Tertiary : University Of perpetual Help System DALTA

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    Theoretical Framework

    A History and Theory

    of Informed Consent

    (Faden and Beauchamp's

    1986 work)

    Autonomous

    Authorization

    Effective

    Consent

    Understanding No control

    (voluntariness)

    Intention

    Disclosure Competence