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ETHICS
refers to the rules of conduct recognized in certain associations or departments of human life ( Simpson, 2004). these are moral principles that govern a person’s behavior.
RESEARCH ETHICS
refers to the rules of conduct recognized in certain associations or departments of human life ( Simpson, 2004)
Research Ethics
concerned with the responsibility of the researchers to be honest and respectful to all individuals who are involved in research study the conduct of research should NOT inflict harm on researcher as well as research subjects
Ethical guidelines
developed consistent with the rules and norms of human behavior based on Christian Morality and Ethics.
The Universal Declaration of Human Rights
no one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment.
NUREMBERG CODE
was developed in 1949 borne out of the Nuremberg trials. done primarily due to sadistic treatment of subjects by Nazi experimenters. rules were formulated to guide investigators in their conduct of research
NUREMBERG CODE
1949
DECLARATION OF HELSINKI
adopted by the World Medical Association in 1964 main contribution was the introduction of the distinction between therapeutic and non therapeutic research.
DECLARATION OF HELSINKI
1964
CIOMS GUIDELINES ( Council for International Organization in Medical Science)
formally known as the International Ethical Guidelines for Biomedical Research Involving Human Subjects it is a set of 21 ethical principles and guidelines regarding human experimentation created in 1933 it address the issues on informed consent, external review, recruitment of participants
CIOMS GUIDELINES
1933
CIOMS GUIDELINES
a set of 21 principles
BELMONT REPORT
July 12, 1974, National Research Act was signed into law thereby creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
BELMONT REPORT
July 12, 1974
National Research Act
was signed into law thereby creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
BELMONT REPORT CONSIDERATIONS
boundaries between biomedical & behavioral research assessment of risk benefit criteria for the respondents guidelines in selection of human subjects informed consent
CODE OF ETHICS FOR NURSES
the code served as the standard for nurses’ performance worldwide since it was first adopted in 1953
CODE OF ETHICS FOR NURSES
1953
INFORMED CONSENT
participants must be fully informed about the nature of research, its purpose and potential risks and benefits. must have the power of free choice to voluntary consent or decline in case of children, an assent form should be obtained.
BENEFICENCE AND NONMALEFICENCE
this means “to do good” and “to do no harm”
Beneficence and non maleficence
CONSIDERATIONS: freedom from any physical & psychological harm freedom from exploitation
RESPECT FOR HUMAN DIGNITY
rights of all involved in the study must be protected and respected. it includes: right to self-determination right to full disclosure right to remain anonymous or right to confidentiality of personal information
JUSTICE AND FAIRNESS
participants deserve fair and equitable treatment before, during, and after the study period. CONSIDERATIONS: right to fair treatment anonymity and confidentiality right to intellectual property
Nazi Experiments
~ World War II (1939–1945), Nazi doctors and scientists conducted inhumane medical experiments in Germany.
~ 23 Nazi physicians and administrators were indicted at the Nuremberg Doctors’ Trial (1946–1947, Germany)
~focused on survival, military advantage, and racial ideologies, immense suffering, permanent injuries, and death
~ Led to the creation of the Nuremberg Code (1949), the basis of modern medical ethics and human research protections
Tuskegee syphilis study
notorious and unethical medical experiment conducted by
the U.S. Public Health Service between 1932–1972
~Involved 600 Black men (399 with syphilis, 201 without) from Macon County, Alabama.
Henderson Act (1943)
requiring syphilis treatment
Monster study
a speech experiment conducted in 1939 at the University of Iowa
It involved 22 orphan children, divided into groups receiving either positive or negative speech therapy
NAZI EXPERIMENTS
1946–1947
23
Nazi physicians and administrators
TUSKEGEE STUDY
600 Black men (399 with syphilis, 201 without)
TUSKEGEE STUDY
1932–1972
MONSTER STUDY
1939
Nuremberg code
Nazi experiment contributed to the development of
Tuskegee study
ended almost a decade after the Declaration of Helsinki and prompted the passage of the National Research Act
Tuskegee study
directly led to the creation of the Belmont Report in 1979
POPULATION
refers to a collection of individuals who share one or more noteworthy traits that are of interest to the researcher. it is the entire group that you want to draw conclusion about
SAMPLE
a small portion of the population selected for observation and analysis. it is the specific group that will collect data from
SAMPLING
procedure of getting a small portion of the population for research.
TARGET POPULATION
group of individuals or objects which is of interest to the researcher and about which speculative information is derived.
SUBJECTS OR RESPONDENTS
a group of individuals or objects chosen to provide actual data and information needed in a research.
STRATUM
term describes a mutually exclusive segment of the population, distinguished by one or more traits or qualifications.
INCLUSION CRITERIA
criteria or characteristics specified in the population to be included in the study.
EXCLUSION CRITERIA
characteristics or the population that are not specified in the study and are therefore disqualified to participate in the study.
SAMPLING UNIT
refers to a specific area or place which can be used during the sampling process.
SAMPLING FRAME
comprises a complete list of sampling units from which sample is drawn Example: If there are a total of 10 clinical areas in the hospital, only 2 or 3 areas are sampled.
SAMPLING DESIGN
the scheme that specifies the number of samples drawn from the population, the inclusion and exclusion criteria for the choice, and the sampling technique used ( purposive, random sampling, stratified, convenience sampling).
SAMPLE SIZE
the total number of samples who will participate in the study after the sampling design was completed
BIAS
the results of the sample do not represent the population.
SAMPLING BIAS
when data is influenced by external factors so that the data no longer represents the entire population.
SAMPLING ERROR
it is when the researcher selects a sample that is not representative of the population being studied.
Probability Sampling
-Every member of the population has a probability of being selected or included in the sample
-it involves random selection, allowing you to make strong statistical inferences about the whole group.
SIMPLE RANDOM SAMPLING
All members of the population have an equal chance at being chosen as part of the sample
STRATIFIED RANDOM SAMPLING
The population is split into different sub groups or strata. People from each group will be randomly chosen to represent the whole population.
SYSTEMATIC OR SEQUENTIAL
RANDOM SAMPLING
The sample is drawn by randomly selecting a starting number and then selecting every nth unit in arbitrary order until the desired sample size is reached.
CLUSTER/MULTI- STAGE SAMPLING
sub groups of the population are used in the sampling unit, rather than individuals. population is divided into subgroups ( clusters) which are randomly selected to be included in the study
Non-Probability Sampling
respondents are selected in a non random way the researcher desires to use available subjects at his convenience anytime during the period of the study
A research instrument
is a tool used to collect, measure, and analyze data related to your research.
ACCIDENTAL OR CONVENIENCE SAMPLING
Participants are chosen for their convenience and availability, rather than through a random or systematic selection process they are also called as volunteer samples
QUOTA SAMPLING
are selected based on pre defined quotas to represent specific characteristics or subgroups often used by market researchers researchers are given a quota of subjects of a specified type to recruit
PURPOSIVE SAMPLING
Participants are handpicked to be included in the sampling frame based on certain qualities for the purposes of the study subjects are viewed as “typical cases” or “experts” that provide enough data to answer the research questions.
SNOWBALL SAMPLING
Participants are chosen based on referrals or recommendations from existing participants this is used to gain access to people who are difficult to identify
Data gathering instruments for “qualitative research”
means open- ended questionnaires, interviews, observation, or any other forms which are used to collect information.
STANDARDIZED RESEARCH INSTRUMENT
-It is an instrument used in previous studies. developed and tested by experts and the results of using them may be compared with the results of the other studies.
-no need for validation
-Ask permission from the owner to use the instrument
RESEARCHER - MADE INSTRUMENT
-created by the researcher
-items are based on the specific questions as shown in the SOP the researcher needs to conduct a validation process and should be done by at least 3 experts in the field or issue being investigated a pilot testing is also required before using the instrument.
MODIFIED STANDARDIZED INSTRUMENT
ADAPTING - the researcher follows the general
design of another instrument but adds items,
removes items, and/or substantially changes the
content of each item. (Korb, 2012)
QUESTIONNAIRE
It is a self-directing instrument structured with
questions and indicators for the respondents to react measures information levels, opinions, attitudes, beliefs, feelings, and perceptual assessment of the respondents regarding the variables of the study. may also contain the demographic data of the respondents
INTERVIEW
the researcher, in a one-on-one dialogue with the
respondents, asks or reads the questions to elicit
answers from the latter.
the researcher may use video camera and tape
recorder.
Semi structured interview
the interviewer uses a set of predetermined questions and the respondent answer in their own words.
Unstructured interviews
-the interviewer has no specific guidelines, restrictions, predetermined questions , or list of options. the interviewer asks a few broad questions to engage the respondent in an open, informal and spontaneous discussion
-it is useful for getting stories behind respondents’ experiences or when there is little information about a topic.
focus group discussions
involves gathering people from similar backgrounds or experiences together to. discuss a specific topic of interest.It is a form of qualitative research where questions are asked about their perceptions attitudes, beliefs, opinion or ideas.
OBSERVATION
it is a systematic data-collecting technique that
involves watching individuals in their natural
environment or a naturally occurring situation.
provide highly detailed information about natural
processes. data collection is laborious and time consuming and may have to be repeated to ensure reliability.
DIRECT OBSERVATION
an observation made by
using your senses.
INDIRECT OBSERVATION
- results of an interaction, process or behavior are observed.