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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, 1001)

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 the significant risks involved and

alternatives available. Aside from the protection it serves, patients exercised their

autonomy independently.

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


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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. 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). In the Philippines, medical

malpractice issue is a battle of idea and perception. Fortunately, the whole medical

community is vigilant to educate our countrymen regarding the ill effects of medical

malpractice legislations (P. Bisnar, 2008). 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.


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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

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

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.


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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

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 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.

And, done poorly, it contributes to a climate of public mistrust in healthcare

professionals. (Aveyard, 2008)

Consent may be express or implied. Express consent is an oral or written authority by the

patient to render the proposed treatment. Consent may be implied by the patient in a

particular case - a patient who voluntarily submits to treatment under circumstances that

indicate awareness of planned treatment without the express consent - for instance, when

the patient signs for admission into the hospital. Consent for routine blood work and x-

rays are considered implied. Informed consent provides a cause of action if a patient is

not adequately informed of the nature and consequences of a particular medical

procedure, process, or treatment prior to giving consent to that treatment

Aveyard, 2008 (The Requirement for Informed Consent Prior to Nursing Care

Procedures) also said 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.


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According to Potter and Perry (2009), 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.

Local Literature

Hayt and Hayt (Professional Nursing in the Philippines, 2010) 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.

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


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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.

Local Study

The study was conducted by De Castro et.al (2009), on Filipino who donated

transplant organs for material consideration in medical institutions in the Philippines.

Specifically, the study sought to find out where organ donors came from, were recruited,

how much information they were given about the procedure and its possible

consequences, the medical care they received, the manner in which they were treated, and

the outcome of the experience for them in terms of self- assessed social and economic

indicators. The donors were asked to report their own perception and assessment of their

situation. They were not provided an objective scale for assessment.

Molina et.al (Applying a Sociolinguistic Model to the Analysis of Informed

Consent Documents, 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.


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Foreign Studies

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.

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.

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.

Smith et.al, 2012 (Injury; Sep2012,) 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


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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.

Moreover, Oosthuizen et.al, 2012 (The changing face of informed surgical

consent. Journal of Laryngology & Otology; Mar2012,) cited that the introduction of

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

failings of 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.

According to Erlen, 2009 (ETHICS: Informed Consent: Revisiting the Issues

informed), 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


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form. It also continues to be a source of malpractice liability, because the legal

requirements continue to lack complete clarity.

Synthesis

The similarity of this study from the related literature and studies 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 and studies emphasis is

more on level of awareness, in terms of patient satisfaction in informed consent

process, provision of written information improves trauma patients recall of the risks

associated with their surgery and improving patients knowledge after informed consent.

The researchers study focused on the Assessment of Informed Consent 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. The objective of this study

is to assess the extent of implementation of the informed consent process in UPHDMC.

The result of this study will serve as a basis for Program Development.

Theoretical framework

Faden and Beauchamp's 1986 work A History and Theory of Informed

Consent is 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,


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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

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).


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Conceptual Framework

Input Process Output

Figure 1.1

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

Demographic profile

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

economic

status

Informed consent

dimensions

a.) legalityb.) ethical

obligationc.)perceptiond.) extent of

implementati

on

Assess Level of

Awareness and

Extent of

Implementation

a) Data gatheringb) Data processing

such as encoding

and data analysis

includes

frequency, and

weighted mean,

one way

ANOVA.

Propose InformedConsent

Development

Program.


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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 extent of implementation of Inform Consent in UPHDMC.

Specifically, it aims to answer the following questions:

1. What is the demographic data of respondents in terms of:a. Age;b. Civil Status;c. Diagnosis;d. Gender;e. Socio-economic status?

2. What is the level of awareness of the respondents about Inform Consent Processin terms of:

a. Ethical obligations;b. Perception; andc.

Terms of legality?

3. What is the extent of implementation of Inform Consent Process?4. Is there a significant difference on the level of awareness of the respondents about

informed consent process in terms of:


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a. Ethical Obligation;b. Perception; andc. Terms of legality

5. Is there any significant difference on the extent of implementation of InformConsent Process in the respondents when they are grouped base on their

demographic data:

a. Age;b. Civil Status;c.

Diagnosis;

d. Gender; ande. Socio-economic status

Hypothesis

1. There is no significant difference on the level of awareness of the respondentsabout informed consent process in terms of:

a) Ethical obligation;b) Perception: andc) Terms of legality

2. There is no significant difference on the extent of implementation of therespondents on informed consent process in terms of:

a) Age;b) Civil Status;c) Diagnosis;d) Gender; and


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e) Socio-economic statusScope 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 the 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.

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 or medical

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.

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


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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 fiel d. 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.


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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.

Age. In this study, it refers to the number of years of our respondents has lived since

birth.

Civil Status. It refers to the position or standing of a person in relation to marriage or the

married state.

Diagnosis. It connotes to the identified condition, or disease, of our respondents by

systematic analysis of the history, examination of the signs or symptoms, evaluation of

the research or test results, and investigation of the assumed or probable causes.

Ethical Obligations. It refers to the moral duties that health care providers are bound to

do to protect their patients. An ethical obligation in informed consent includes the

disclosure of the nature of the treatment plan (risk/benefits), the rights of patients and to

establish goals of care with the patient.

Gender. It refers to the socially constructed roles, behaviors, activities, and attributes that

a given society considers appropriate for men and women.

Implementation. In this study, this refers in how informed consent process is being

applied to the patient. It includes the participation of patient in their health care treatment.

Informed consent. It is referred to the patients autonomous decision about whether to

undergo a surgical procedure. The ethical purpose of the consent is seeking to respect

patient autonomy by ensuring that treatment is directed toward the ends desired and is


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chosen by the patient. The further obligation for physicians is to disclose all the details

about treatment to help the patient to make decision. The patient personally signs it of

legal age and mentally capable.

Perception. It refers to the organization and interpretation of thoughts in order to

represent and understand the environment. It involves the cognitive processes required to

process information. In this study, it refers to the respondents level of understanding in

the context of informed consent.

Socio-economic status. It is the respondents economic and sociological combined total

measure of his/her work experience and of their familys economic and social position in

relation to others, based on income, education, and occupation.

Terms of legality. This refers to the extent of the agreement in the informed consent

process. The legal standards that apply to obtaining informed consent vary across

jurisdictions, and their interpretation continues to evolve.
http://en.wikipedia.org/wiki/Incomehttp://en.wikipedia.org/wiki/Educationhttp://en.wikipedia.org/wiki/Educationhttp://en.wikipedia.org/wiki/Income


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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.

This type of research is to describe the data and characteristics about what is

being studied. The idea behind this type of research is to study frequencies, averages, and

other statistical calculations. Although this research is highly accurate, it does not gather

the causes behind a situation. Descriptive research is mainly done when a researcher

wants to gain a better understanding of a specific topic. Forty-five respondents will be the

target population; these respondents are going to be assessing through the use of survey

questionnaires. The purpose of this study is to assess the extent of implementation of

informed consent in UPHDMC.


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Respondents of the Study

The respondents will be the selected Surgical Patients/ Guardian/ Parent 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, the

respondents sample size will be forty-five (45). The respondents will be chosen

regardless of age, sex and educational level.

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) The size of a

sample varies inversely as the size of the population. A larger proportion is required of a

smaller population and a smaller population may do for a bigger population. For a

population of five thousand a sample of 10% may do but for a population of 500, a

proportion of 30% may be required. (Calderon et.al, 2008) furthermore UPHDMC has

150 working bed capacity and the 30% of this is forty-five. There is no particular division

of hospital that is for surgical or for medical area.


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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. Using the Likert Scale 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?

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.


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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.

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

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

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

respondents.


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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% = %

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

and extent of implementation will be treated with weighted mean. It will be

interpreted using the Likert Scale.


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Mean:

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

Weighted mean:

X=

LIKERT SCALE

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 and significant difference on the level of

awareness, the researchers will be using the T-test, and analysis of variance

(ANOVA).

a. Sum of squares componentsSSt = SSa + SSx1A


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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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Bibliography

Books

Potter, P. and Perry, A. (2009). Fundamentals of Nursing: 7th Edition (pg. 333).Publisher Mosley 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: I s 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.
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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,

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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

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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, Ralp Andrew

Rivera, Romalyn


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Part I: Demographic Profile

Age:

Diagnosis:

Gender:

Civil Status:

Socio-economic Status: Monthly Income

a. 5,00015, 000 c. 26,00035,000 e. Others: _________b. 16,00025, 000 d. 36,00050, 000

Part 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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Perception

Strong

Agree

5

Agree

4

Uncertain

3

Disagree

2

Strongly

Disagree

1

1. I know that I am required to sign

the Informed consent.

2. The information I received prior

to the surgery was helpful.

3. I feel that I am fully involved in

decision- making with regards to the

procedure.

4. I understand all the procedures to

be done especially the importance of

the signed inform consent.

5. I understand the explanation of

the staff nurse about informed

consent.

6. I am satisfied with the present

consent form.

7. I always know what they I am

signing for.


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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


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consent.

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



Father : Ubaldo Baltar

Mother : Rosalinda Baltar


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



Father : Enrique Carreon Sr.

Mother : Ma. Vilma O. Carreon


Elementary : Dona Mauela Elementary School

Secondary : RESPSCI



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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



Father : Ernesto L. Ednaco Jr.

Mother : Rodelina L. Ednaco


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



Father : Maurice B. Garcia

Mother : Nell Ann Q. Garcia


Elementary : Mary Immaculate Parish Special School

Secondary : Mary Immaculate Parish Special School



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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



Father : Raul B. Palces

Mother : Ma. Theresa B. Palces


Elementary : Elizabeth Seton School

Secondary : Legazpi Hope Christian School



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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



Father : Rodrigo Rivera

Mother : Marilyn Rivera


Elementary : Masville Elementary School

Secondary : Dr. Arcadio Santos National High School

Tertiary : University Of perpetual Help System DALTA


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Final Checked Nres for Printing

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