RESEARCH DESIGN (WEEK 7)

KINDS OF DATA
1. EMPIRICAL REFERENCES - include documents, articles and reports on studies based
on actual experience or observation. These are references based on research (could
be a primary or secondary source)
2. NON -EMPIRICAL/ NON- RESEARCH REFERENCES aka. conceptual literature - not
based on actual research experience or investigation. Includes case reports, anecdotal
recordings, commentaries and opinion articles and clinical description (journals.
books, and magazines. - subjective

Research Designs
- The plans or research design form the structure and the researcher's method of
answering his questions and conducting studies
- Is is the blueprint of a study
- Research designs categorized according to the procedura that collect and
analyze data on the way information is collected
- Two basic research design
A. Qualitative
B. Quantitative

Common Research Designs in Nursing

● Historical Research - a systematic and critical inquiry of the whole truth of past
events using the critical method in understanding and the interpretation of
facts which are applicable to current issues and problems.
● Descriptive Research- the study focuses on the present condition and the
purpose is to describe and find new truth which includes case studies and
survey research.
● Comparative Research - the researcher examines carefully the relationships
(similarities or differences) among several variables.
● Experimental Research - seeks to answer question about causation; researchers
attribute the change in one variable to the effect of one or more variable
QUANTITATIVE RESEARCH
- Is a formal, objective, systematic process in which numerical data are used to
obtain information about the world.
- Is "hard science" it is perceived as rigorous (exact), systematic and objective
focusing on numerical data and using statistical analysis and controls in an
attempt to eliminate bias.

QUANTITATIVE RESEARCH
It is conducted to test theory by;
● Describing variables
● Examining relationship among variables
● Determine cause and effect interaction between variables.

TYPES OF QUANTITATIVE RESEARCH:

1. Descriptive - the study focuses on the present condition and the purpose is to
describe and find new truth which includes case studies and survey research.
 - explore new areas/describe situations.
2. Co-relational/ Comparative Research -the researcher examines carefully the
relationships (similarities or difference) among several variables.
3. Quasi-experimental- effectiveness of intervention.
4. Experimental - seeks to answer question about causation: researchers attribute the
change in one variable to the effect of one or more variable
- producing positive outcomes

RANDOMIZATION
- Participants being assigned to either receive (experimental group) or not
receive (control group), the treatment condition or intervention (IV).
MANIPULATION
- is the process of maneuvering the intervention, so that its effect on the
dependent variable (D.V) Can be observed/measured.
METHOD OF MANIPULATION
- Researcher gives intervention to the experimental group and withholds it to the
control group or administers some other treatment.
 - E.g. Gentle messages are effective as pain relief measures for elderly.
CONTROL
- for elimination of bias.
- Control group refers to a group of subjects, whose performance is used to
evaluate the performance of an experimental group on the same dependent
variable.
- Eg. Effect of nutrient diet on the weight of premature infants in two weeks.
Comparison of post intervention weight with pre-intervention weight
determines the effectiveness of nutrient diet.

QUALITATIVE RESEARCH
- Is a systematic, subjective approach used to describe life experiences and
situations and to give them meaning.
- "Mode of systematic inquiry concerned with understanding human beings and
the nature of their transaction with themselves and with their surroundings"
(Benoliel, 1984).
- Qualitative research is often described as holistic, that is, concerned with
humans and their environment in all their complexities. It is lived and as it is
defined by the actors themselves

TYPES OF QUALITATIVE RESEARCH

● Phenomenological
● Grounded theory
● Ethnographic
● Historical

PHENOMENOLOGICAL
- Rooted in a philosophical tradition
- Developed by Husserl and Heidegger
- Concerned with lived experiences of humans
 - It is an approach to thinking about what life experiences of people are like and
what they mean.
- O'Dell and Jacelon (2005) conducted in depth interviews to explore the
experiences of women who had undergone vaginal closure surgery to correct
severe vaginal prolapse

GROUNDED THEORY
- Was developed in the 1960s by two sociologists Glaser & Strauss
- Focus is on a developing social experience, social & psychological stages and
phases that characterize a particular event or episode.
- Formulate, test and refine a theory about a phenomena.
Eg. King et al (2006) conducted a series of grounded theory studies with men and
women from five ethnocultural groups in Canada who had been diagnosed with
Coronary Artery Disease risk. (CAD) The analysis of the process through which patients
met the challenge of managing Coronary Artery Disease risk.

ETHNOGRAPHY
- Primary research, tradition with in anthropology
- Provides a framework for studying the patterns, life ways, and experiences of a
cultural group in a holistic fashion.
- Aim of ethnographers is to learn from members of a cultural group, to
understand their world view as they perceive & live it to describe their customs
& norms
investigates cultures in depth.
Eg. Schoenfeld and Juarbe (2005) conducted ethnographic fieldwork in two rural
Ecuadorian communities and studied the burdens of women's roles, the women's
perceived health needs, and their health care resources.
HISTORICAL
- a systematic and critical inquiry of the whole truth of past events using the critical
method in understanding and the interpretation of facts which are applicable to
current issues and problems.

Definition of Terms
● Conceptual definition - usually taken from the dictionary
● Operational definition- expresses the meaning of terms as used in the
particular field of the study
● Guidelines:
1. Define those terms which may have a special meaning or are differently
Used
2. Define those terms or languages created by some discipline
3. Define only what is absolutely necessary

Plagiarism
- To steal or pass off the ideas or words of another as one's own
- To use another's production without crediting the source
- To commit literary theft
- To present a new and original idea or product derived from an existing source
- In short, it is an act of fraud.
- It involves both stealing someone else's work and lying about it afterward
All of the following are considered plagiarism
● Turning in someone else's work as your own
● Copying words or ideas from someone else without giving credit
● Filing to put a quotation in quotation marks
● Giving incorrect information about the source of a quotation
● Changing words but copying the sentence structure of a source without giving
credit
● Copying so many words from a source that it makes up the majority of your
work whether you give credit or not
Locale and Population of the Study
- A brief description of the place where participants or respondents are to be
obtained
- REMEMBER: TITLE DEFENSE = all tenses is in future tense
FINAL DEFENSE = past tense
3.2 Research Locale
•The study was conducted in a highly urbanized most populous area. According to the
last census, the total population of Quezon City is 29 Million, estimated in March
2018. Furthermore, Quezon City has one of the high prevalence of Hypertension and
Diabetes an estimated 9.37 were responded to by the CDRRMO from 2018. This area
was selected in this study to know the Socio-Demographic profiles and behavioral
factors of the respondents. The participants in this area have been surveyed through
an online platform in the comfort of their home, and this study will be implemented
on the patients with diagnosed Hypertension.

RESEARCH METHOD
● SAMPLING
● LOCALE
● TOOL
● ANALYSIS

POPULATION
- the larger group from which individuals are selected to participate in a study

TARGET POPULATION
- A set of elements larger than or different from the population sampled and to
which the researcher would like to generalize study findings.
SAMPLE
- A sample is "a smaller (but hopefully representative) collection of units from a
population used to determine truths about that population" (Field, 2005)

SAMPLING
- The process of selecting a number of individuals for a study in such a way that
the individuals represent the larger group from which they were selected

REASONS OF SAMPLING
1. ECONOMY- saves fire.resources and effort
2. PRACTICALITY-impossible to involve the whole population if it is too large for
every element to be measured
3. NECESSITY- ex, a researcher needs only a small quantity of blood from the
human body to test for the presence of a rare disease
4. ETHICALITY - ex, infesting the effects of a certain medication, it is unethical to
test the effect of the drug on the whole population

SYSTEMATIC SAMPLING
- The sampling interval can be determined by dividing the size of the population
by the size of the sample to be chosen
- For example, if we wish to draw 32 names out of the list of 320 names, the
sampling interval will be 10.

STRATIFIED RANDOM SAMPLING

- A common method is to arrange or classify by sex, age, ethnicity and similar
ways. Splitting subjects into mutually exclusive groups and then using simple
random sampling to choose members from groups.
- Members in each of these groups should be distinct so that every member of all
groups get equal opportunity to be selected using simple probability. This
sampling method is also called "random quota sampling"
 - The population is divided into two or more groups called STRATA, according to
some criterion, such as geographic location, grade level, age, or income, and
subsamples are randomly selected from each strata

STRATIFIED RANDOM SAMPLING

ADVANTAGES
● More accurate sample
● Can be used for both proportional and non- proportional samples
● Representation of subgroups in the sample
DISADVANTAGES
● Identification of all members of the population can be difficult
● Identifying members of all subgroups can be difficult

CLUSTER OR AREA RANDOM SAMPLING

- A sampling method where multiple clusters of people are created from a
population where they are indicative of homogeneous characteristics and have
an equal chance of being a part of the sample. In this sampling method, a
simple random sample is created from the different clusters in the population.
For example,
a. if a researcher wants to conduct a study to judge the performance of sophomore's
in business education across the US, it is impossible to conduct a research study thot
involves a sophomore in every university in the US.
b. by using cluster sampling, the researcher can club the universities from each city
into one cluster.
c. These clusters then define all the sophomore student population in the US.
d. either using simple random sampling or systematic random sampling, some clusters
can be picked for the research study.
e. sophomore's from each of these selected clusters can be picked on whom to
conduct the research study.
MULTI-STAGE SAMPLING
- Combination of all the methods described above.
- Involves selecting a sample in at least two stages
e.g: i. Stage 1: Stratified Sampling
Stage 2: Systematic Sampling
e.g: ii. Stage 1: Cluster Sampling
Stage 2: Stratified Sampling
Stage 3: Simple Random Sampling

NON-PROBABILITY SAMPLING
- refers to the sampling process in which the samples are selected for a specific
purpose with a pre-determined basis of selection.
- The sample is not a proportion of the population and there is no system in
selecting the sample. The selection depends upon the situation.
- No assurance is given that each item has a chance of being included as a
sample
- There is an assumption that there is an even distribution of characteristics
within the population, believing that any sample would be representative.
- Unequal chance of being included in the sample (non-random)

TYPES OF NON-PROBABILITY SAMPLING

1. Judgment or purposive or deliberate sampling
2. Convenience sampling
3. Quota sampling
4. Snow Ball sampling

EXAMPLE
- Suppose 100 boys are to be selected from a college with 1000 boys.
- If nothing is known about the students in this college, then the investigator
may visit the college and choose the first 100 boys he meets.
- Or he may select 100 boys all belonging to III Year.
 - Or he might select 25 boys from Commerce courses, 25 from Science courses,
25 boys from Arts courses and 25 from Fine arts courses. Hence, when only the
sample size is known, the investigator uses his discretion and selects the
sample.

CONVENIENCE SAMPLING
- commonly known as unsystematic, accidental or opportunistic sampling.
- a sample is selected according to the convenience of the investigator.
- In this method of sampling the choice of sample items depends primarily on the
judgment of the researcher. In other words, the researcher determines and
includes those items in the sample which he thinks are most typical of the
universe with regard to the characteristics of the research project.
A convenience sampling may be used in the following cases:
a. When universe is not well defined,
b. When sampling unit is not clear, and
c. When a complete list of the source is not available.

QUOTA SAMPLING
- The sample size is determined first and then quota is fixed for various
categories of population, which is followed while selecting the sample.
Example:
Suppose we want to select 100 students, then we might say that the sample
should be according to the quota given below: Boys 50%, Girls 50% Then among
the boys, 20% college students, 40% plus two students, 30% high school students
and 10% elementary school students. A different or the same quota may be
fixed for the girls.

SNOWBALL SAMPLING
- It refers to Identifying someone who meets the criteria for inclusion in the
study.
 - Selection of additional respondents is based on referrals from the initial
respondents.

DETERMINING SAMPLE SIZE

EXAMPLE
n = sample size
N = population size
1 = constant
e= margin of error
Suppose a researcher has a population of 6,000 nurses and the margin of error is
5%,the sample size is computed as follows
n = 6000/ 1 + (6,000) (.05) (.05)
= 6,000/16
= 375 nurses
*MDAS
MARGIN OF ERROR
- A higher margin of error in statistics indicates less likelihood of relying on the
results of a survey or poll, i.e. the confidence on the respits will be lower to
represent a population
- Lower margin of error indicates higher confidence levels in the produced
results.

WEEK 9
INDEPENDENT VARIABLE
- Variable that is presumed to influence other variable
- It is the presumed cause, influence or affect outcomes of a problem
- Affects the value of the dependent condition that produces the outcome
- What the researcher manipulates or varies .
- Also called the treatment, manipulated or predictor variables.
Example: The researcher examined the effect of tactile stimulation on weight gain in
premature infants
IV: effect of tactile stimulation
Example: A study examining the effect of nurse's contraceptive counseling on
unwanted births
IV: nurse's contraceptive counseling

DEPENDENT VARIABLE
- Variable affected by the independent variable
- It responds to the independent variable.
- Variable that being measured or Outcome Variable
- Also called the criterion, outcome, effect and response variables.
- Outcome of the process or "assume Effect" or the result of influence of the
independent variable.
Example: The researcher examined the effect of tactile stimulation on weight gain in
premature infants
DV: weight gain in premature infants
- Example: A study examining the effect of nurse's contraceptive counseling on
unwanted births
DV: unwanted births

Example 1
You are interested in "How stress affects the mental state of human beings?"
INDEPENDENT VARIABLE - Stress
DEPENDENT VARIABLE --- mental state of human beings
You can directly manipulate stress levels in your human subjects and measure how
those stress levels change mental state.

Example 2
Promotion affects employees' motivation
Independent variable ----Promotion
Dependent variable ---Employees motivation

INTERVENING/MEDIATING VARIABLE
- a variable whose existence is inferred but it cannot be measured.
Example 1
Higher education typically leads to higher income
Higher education- (independent variable)
Higher income- (dependent variable)
Better occupation--- intervening variable
It is causally affected by education and itself affects income.

MODERATING VARIABLE
- one that has a strong contingent effect on the Independent & Dependent
variable relationship.
- Considered as the presence of third variable
CONTROLLED VARIABLE
- the factor that is kept CONSTANT (UNCHANGED) all throughout the experiment
in order to test the relative relationship of the Interdependent and dependent
variables.
For example: If we are testing to see how the amount of light received affects plant
growth:
1. In plant growth experiments, water and fertilizer levels are constant.

SAMPLE RESEARCH QUESTIONS

What are the causes of poverty in the philippines?
1.poor education
2. rising living costs
3. low pa
4. lack of work
Are corruption in government and overpopulation associated with the increasing
poverty rate in the philippines?
How did the political policies and economic programs of former prime minister Lee
Kua Yu transform Singapore into a modern and rich south east asian country?

What are the causes of poverty in the philippines?

● is not well formulated
● very broad
● does not indicate the specific relationship among the variables.

Are corruption in government and over population associated with the increasing
poverty rate in the philippines?
Presents 3 variable which are:
1. corruption in government
2. overpopulation
3. increasing poverty rate in the philippines

How did the political policies and economic programs of former prime minister Lee
Kua Yu transform Singapore into a modern and rich south east asian country?
Presents 3 variables which are:
1. how the political policies
2. economic programs
3. for prime minister led to the transformation of singapore in to a modernize and
reach south east asian country

RESEARCH SIMULACRUM (WEEK 10)

Research Simulacrum/Research Paradigm
- Serves as a model and guide which describes and illustrates how the variables
are treated in the study.
- It is a figure that represents the interplay of the variables.
SYMBOLS USED
● BOX - it contains the variables. Normally, it answers a question in the SOP
which needs descriptive analysis.
● ONE-HEADED ARROW - illustrates influence on one variable on the other.
● TWO-HEADED ARROW - it represents association or relationships between
variables.
● CONNECTOR LINE - connects one variable with another but does not necessarily
mean that the variables will be subjected to a statistical procedure.

CONCEPTUAL FRAMEWORK AS PARADIGM:

COMMON MODELS
- IPO - Input-process-output model
- IV-DV - independent variables - dependent variables model
- CP - (criterion-predictor) model
- P model stands for an additional box.
- POM (proposed original model)

INPUT-PROCESS-OUTPUT MODEL
- Largely used when the research studies attempt to isolate the factor or major
variable that causes the problem, subject, or phenomenon under investigation.
ETHICAL ASPECTS IN RESEARCH ETHICS (WEEK 11)
BACKGROUND
- Human research is done in pursuit of generalizable scientific knowledge.

ETHICS
ETHICAL PRINCIPLES
- Provided basis on which specific guidelines may be formulated, criticized and
interpreted.
ETHICAL GUIDELINES:
- For the protection of human subjects in research
- To assess that research is conducted in accordance with basic ethical
principles.

ETHICS
● a declaration of right or wrong: reflects the "should" of human behavior.
● a science of ideals - guides our judgment concerning morality of human acts.
 ● moral principles that govern a person's behavior or the conducting of an
activity

There are several reasons why it is important to adhere to ethical norms in research.
1. Norms promote the aims of research, such as knowledge, truth, and
avoidance of error.
2. Research often involves a great deal of cooperation and coordination among many
different people in different disciplines and institutions, ethical standards promote
the values that are essential to collaborative work, such as trust, accountability,
mutual respect, and fairness.
3. Many of the ethical norms help to ensure that researchers can be held accountable
to the public.
4. Ethical norms in research also help to build public support for research. There are
research problems in which participants" rights and study demands are put in direct
conflict, posing ethical dilemmas for researchers

FUNDAMENTAL OF ETHICAL PRINCIPLES FOR RESEARCH

● Respect for Persons
● Benéficence and Non-maleficence
● Justice

RESEARCH ETHICS GUIDELINES

Belmont Report - April 18, 1979
- Identified 3 basic principles, among those generally accepted in our cultural
tradition, that are particularly relevant to ethical research involving human
subjects.

Council for International Organizations of Medical Sciences (CIOMS)

Guidelines
- Used to guide the preparations of scientific proposals
- May be expressed differently and given different moral weight
 - Their application may lead to different decisions or courses of action

National Ethical Guidelines

- The research protocol should adequately address the identified ethical
principles
- It is mandated to ensure that all
phases of health research shall adhere to universal ethical principles
that value the protection and promotion of dignity of health research
participants." PHREB

Philippine Health Research Ethics Board (PHREB)

- is the national policy making body in health research ethics in the country,
created under DOST Special Order No. 091 s. 2006, which ensures adherence to
the universal ethical principles for the protection and promotion of the dignity
of health research participants.

RESPECT TO PERSONS
Respect for Autonomy
- Act in such a way to respect the patient in his right to responsibility decide
whether to accept or refuse a suggested treatment
● Participants should be given the opportunity to choose what shall or shall not
happen to them
● Respect for personal dignity and cultural values
● Pátient confidentiality

Unethical Research Dilemmas in conducting Research

● Laud Humphreys was a Ph.D. student sociologist in 1960's at Washington
University
● Subject of Research: the act of FELLATIO (oral stimulation of a man's
penis.between two anonymous men in public restroom)
 ● Observation was done by pretending to be lookout for these men. Copied plate
numbers to get the addresses, interviewed the men by pretending to be market
researcher.

RESPECT TO PERSONS
● Best exemplified by the informed consent process
● Three Elements of the informed Consent
- Information
- Comprehension
- Voluntariness

INFORMED CONSENT
- Each potential subject must be adequately informed of the aims, methods,
sources of funding, any possible conflicts of interest, institutional affiliations of
the researcher, the anticipated benefits and potential risks of the study and the
discomfort it may entail, and any other relevant aspects of the
study.(Declaration of Helsinki)

DECLARATION OF HELSINKI - ETHICAL PRINCIPLES FOR MEDICAL RESEARCH

INVOLVING
HUMAN SUBJECTS
- It means that participants have adequate information regarding the research,
are capable of comprehending the information, and have the power of free
choice, enabling them to consent for or decline participation voluntarily.

Information
● Sufficient information
● complete disclosure
- Necessary
- Minimal risk
 - Debriefing

Comprehension
- Consider level of understanding
Voluntariness
- Free of coercion/undue influence

Elements of Informed Consent

1. Participant status. Prospective participants need to understand clearly the
distinction between research and treatment. They should be told which health care
activities are routine and which are implemented specifically for the study. They also
should be informed that data they provide will be used for research purposes.
2. Study goals. The overall goals of the research should be stated, in lay rather than
technical terms. The use to which the data will be put should be described.
3. Type of data. Prospective participants should be told the type of data that will be
collected.
4. Procedures. Prospective participants should be given a description of the data
collection procedures, and of the procedures to be used in any innovative treatment.
5. Nature of the commitment. Information should be provided regarding participants"
estimated time commitment at each point of contact, and the number of contacts
within specified timeframes.
6. Sponsorship. Information on who is sponsoring or funding the study should be
noted: if the research is part of an academic requirement, this information should be
shared.
7. Participant selection. Researchers should explain how prospective participants
were selected for recruitment, and how many people will be participating.
8. Potential risks. Prospective participants should be informed of any foreseeable risks
(physical, psychological, social, or economic) or discomforts that might be incurred as
a result of participation, and any efforts that will be taken to minimize risks. The
possibility of unforeseeable risks should also be discussed, - if appropriate. If.injury or
damage is possible. treatments that will be made available to participants should be
described. When risks are more than minimal, prospective participants should be
encouraged to seek the advice of others before consenting.
9. Potential benefits. Specific benefits to participants, if any, should be described, as
well as information on possible benefits to others.
10. Alternatives. If appropriate, researchers should provide information about
alternative procedures or treatments that might be advantageous to participants.
11. Compensation. If stipends or reimbursements are to be paid (or if treatments are
offered without fee), these arrangements should be discussed.
12. Confidentiality pledge. Prospective participants should be assured that their
privacy will at all times be protected. If anonymity can be guaranteed, this should be
noted

RESPECT TO PERSON
● Includes protection of persons with diminished autonomy (vulnerable
population)
● Consider legal representative
● Situational factors
● Relational factors

VULNERABLE POPULATION
➔ Children
➔ Mentally challenge
➔ Illiterate
➔ Senile (Dementia)
➔ Poor participants
➔ Patients
➔ Prisoners
➔ Military
➔ Minority groups
➔ Victims
Unethical Research Dilemmas in conducting Research
Nazi Medical Experiments
- were conducted on prisoners of war and racially "valueless" people who were
confined to concentration camps by the Third Reich.
- From 1933- 1945, the programs of the Nazi regime included sterilization,
euthanasia and medical experimentation for the purpose of producing a
population of „racially pure" Germans who were destined to rule the world.
- The medical experiments were conducted on prisoners of war and person
considered to be racially valueless such as Jews who were confirmed in
concentration camps.

1932-1972: ALABAMA, USA TUSKEGEE SYPHILIS EXPERIMENT

- The Tuskegee Syphilis Study begins. 200 black men diagnosed with syphilis are
never told of their illness, are denied treatment, and instead are used as
human guinea pigs in order to follow the progression and symptoms of the
disease. They all subsequently die from syphilis, their families never told that
they could have been treated

1932-1972: ALABAMA, USA TUSKEGEE SYPHILIS EXPERIMENT

● 1945 Penicillin accepted as treatment of choice for syphilis.
● 1972 First news articles condemn studies. Study ends.
● 1997 On May 16th President Clinton apologizes on behalf of the Nation

- 1974 A $10 million out-of-court settlement is reached and theU.S. government

promised to give lifetime medical benefits and burial services to all living
participants. The Tuskegee Health Benefit Program (THBP) was established to
provide these

Willow brook Study

- involved deliberately infecting children with the hepatitis virus.
 - From the mid-1950s to the early 1970s, Dr. Saul Krugman conducted research
on hepatitis at Willowbrook, an institution for the mentally retarded in Saten
Island, New York (Rotman, 1982).
- The subjects were children who were deliberately infected with the hepatitis
virus.
- During the 20-year study. Willowbrook closed its doors to new inmates because
of overcrowded conditions. However, the research ward continued to admit
new inmates and parents had to give permission for their child to be in the
study to gain admission to the institution (Levine, 1986)

BENEFICENCE - research must be something that will be helpful to the majority of

people.
NONMALEFICENCE - research should not purposely cause harm.
Researcher's responsibility to minimize risk & maximize benefits to participants

JUSTICE
- People ought to be treated fairly
- Protection of participants from incompetence and access to research
treatments are expectations of the justice principle
- Random selection of participants avoids potential bias and unfairness in sample
selection

JUSTICE
● Distributive Justice
● Compensatory Justice
● Reciprocal Justice

DISTRIBUTIVE JUSTICE
- Fair distribution of the benefits and burdens of research
- Involvement of different population groups
 - Standard of care
- Differences in distribution of burdens and benefits are justifiable only if they
are based on morally relevant distinctions, such as vulnerability (CIOMS 2002)

COMPENSATORY JUSTICE
- Insurance during research
- Monetary compensation
- Research should be responsive to the health needs and priorities of the
population where the research is conducted

RECIPROCAL JUSTICE
- What should be given to participants after the end of the study.
- It is unjust for research subjects to be made worse off Afterwards than they
were during the research.
- It is ethically unacceptable for external sponsors to conduct research in
developing Countries and leave nothing behind when research is over.
INDIVIDUAL BENEFITS
● Who will benefit from the research?
● Which groups?
COMMUNITY BENEFITS

FUNDAMENTAL OF ETHICAL PRINCIPLES FOR RESEARCH

● Right to Self-Determination - Humans should be treated as autonomous agents,
capable of controlling their own activities. The principle of self-determination
means that prospective participants have the right to decide voluntarily
whether to participate in a study, without risking any penalty or prejudicial
treatment.
● Right to Full Disclosure - It means that prospective participants have the right
to know the details of treatment.
 ● Anonymity - The guarantee that the information the research subjects provided
cannot be linked to their individual responses even by the research
● Confidentiality - Is the keeping of another person or entity's information
private. It is the protection of personal information. - It ensures that the
identity of the research subject will not be linked with data or information he
provides, and it will not be divulged into public
● Non- Maleficence - An ethical principle in research which states that
researchers do not cause direct harm nor inflict unnecessary pain to the
subjects of the study, although unanticipated harm may occur during its course.
- It means non-harming or inflicting the least harm possible to reach a
beneficial outcome. The principle of nonmaleficence holds that there is an
obligation not to inflict harm on others. It is closely associated with the maxim
primum non nocere (first do no harm).
● Right to Privacy and Dignity - Privacy refers to freedom from intrusion and
relates to all information and practice that is personal or sensitive in nature to
an individual. Dignity is being worthy of respect.

MAJOR POTENTIAL BENEFITS TO PARTICIPANTS

1. Access to an intervention that might otherwise be unavailable to them
2. Comfort in being able to discuss their situation or problem with a friendly,
objective person
3. Increased knowledge about themselves or their conditions, either through
opportunity for introspection and self-reflection or through direct interaction with
researchers
4. Escape from normal routine, excitement of being part of a study
5. Satisfaction that information they provide may help others with. similar problems
or conditions
6. Direct monetary or material gains through stipends or other incentives

MAJOR POTENTIAL RISKS TO PARTICIPANTS

- Physical harm, including unanticipated side effects
- Physical discomfort, fatigue, or boredom
- Psychological or emotional distress resulting from self-disclosure,
introspection, fear of the unknown, discomfort with strangers, fear of eventual
repercussions, anger or embarrassment at the type of questions being asked.
- Social risks, such as the risk of stigma, adverse effects on personal
relationships, loss of status
- Loss of privacy
- Loss of time
- Monetary costs (e.g., for transportation, child care, time lost from work)