CH 1 research method in health science

Jewish Chronic Disease Hospital Study

-performed at new yorks chronic disease hospital -researchers wanted to find out if the bodys inability to reject cancer cells was due to cancer or debilitation -live cancer cells were injected into hospitalized patients with chronic, debilitating disease -oral consent was obtained, but not documented, -patients were not told they were being injected with cancer cells -reason: researcher did not want to frighten them

scientific merit

-propose research topic meets the definition of research, -must be conducted by qualified researcher -study build on prior research, and -is systematic investigation that once the study has been concluded, new knowledge will be generated

beneficence

-requires that persons are treated in an ethical manner by: -protecting them from harm -maximizing benefits and minimizing risks

lack of respect

-s shown when - An individuals' considered judgments are rejected - An individuals' ability to act on their judgments is denied - Information needed by an individual to make athoughtful, considered judgment is withheld when is there no compelling reason to do so

QUAL

-small group of purposefully selected people that can best answer RQ -type- visual, verbal. narrative, artifact, image how- interview, written statement, old documents, diaries, observation, gather artifacts, picture -pattern/ theme

justice

-the process used to select subjects fair? -the inclusion and exclusion criteria fair?

comprehension

-time to ask questions -demonstrate they understand the information

9. Once a researcher has an idea for a new study, the first thing they should do is: a. Conduct a systematic review of the literature to see if the idea rises to the level of research. b. Collect and analyze data, as this is the only way to find out if the idea rises to the level of research. c. Consider whether the idea is from the positivism, constructivism, or pragmatism perspective. d. Submit the idea to the Institutional Review Board (IRB) to see if the idea is ethical.

A Conduct a systematic review of the literature to see if the idea rises to the level of research.

both quan and qual

Scientific merit, sampling , understand, research, paradigm, data collection, data analysis, rigor

An investigator planning to study behavioral changes during alcohol intoxication will pay participants $600 for six hours of testing that includes drinking a moderate level of alcohol and completing several written questionnaires. He plans to recruit people age 21 years and older (college students taking his course and people who are homeless in the local area). Considering this scenario, which of the following is the most important issue that the researcher needs to address before submitting the protocol to the university's Institutional Review Board? a. The reading level comprehension of the participants b. How to advertise this study to recruit participants c. The monetary compensation may be considered undue influence d. The most effective way to pay participants who are homeless

The monetary compensation may be considered undue influence

Common Rule

The policies for human subjects' protection in healthscience research can be found under the Departmentof Health and Human Services regulation's, 45 CFRPart 46. • This regulation has four subparts which include: - subpart A, also known as the Federal Policy or the"Common Rule" - subpart B, additional protections for pregnant women,human fetuses, and neonates - subpart C, additional protections for prisoners - subpart D, additional protections for children

vulnerable population are vulnerable to

When a person has limitations on either their capacity or voluntariness, they are considered vulnerable. -coercion -undue influence

IRB members are responsible for all of the following EXCEPT: a. determining if research findings are generalizable b. assessing whether participants are giving informed consent c. determining the risks and benefits to participants d. reviewing the manner in which data will be secured

a. determining if research findings are generalizable

exempt

administrative review by IRB staff only) • Only certain types of studies that are considered low risk and the identities of the subjects are not linked to the data

clinical research is

applied research conducted in the health care arena with primary focus of finding practical solutions to improve patient care/clinical outcomes

basic or applied A recent study has discovered that high-fat diets are associated with physical changes in the hypothalamus region of the brain, a region known for the regulation of body weight homeostasis and metabolism.

applied/clincal

Which of the following is not acceptable when conducting research with humans? a. Having the participant give informed consent b. Telling participants they must remain in the study until it is completed c. Keeping the identity of the participants confidential d. Informing participants they are free to withdraw from the study at any time

b Telling participants they must remain in the study until it is completed

IRB is an acronym for: a. Internal Review Board b. Institutional Review Board c. Internal Revision Board d. Institutional Responsibility Board

b. Institutional Review Board

A researcher obtains IRB approval to conduct a research study: a. before a plan is developed b. before data is collected c. after data is collected d. after data is analyzed

b. before data is collected

two types of research

basic and applied/clinical

constructivism

beliefs espouse that account of an event can be equally truth or false, the researcher does not need to find one truth but the whole truth gleaned from participants experiences

positivism

cause and effect relationship exist, the research must control for variable, and research can be free from bias

quantitative only

compare two groups, impact, scientific method, variables, predicting, internal validity

human subject

living individuals about whom an investigator conducting research obtain 1. data through intervention or interaction w/ individual or 2. identifiable private information

nazi war crimes

medical researcher in nazi germany conducted a wide range of dangerous and often fatal experiments on prisoners of concentration camps, without their consent

IRB

must be at least 5 people- should be a diverse group of people with regard to race, gender, and cultural and professional backgrounds • as well as any other issues that would be relevant to the research interests of the institution - at least one person who is primarily involved in a scientific area - one person who is not primarily involved in a scientific area - one person who is not affiliated with the institution

paradigms

positivism, post positivism, constructivism, pragmatism

scientific method

principle and procedures for the systematic pursuit of knowledge involving the recognition and formulation of problem, the collection of data through observation and experiment, and the formulation and testing of hypothesis

research methodologies

quantitative, qualitative, mixed methods

systematic investigation

researcher must utilize approved sets of procedures, also referred to as design and methods, to conduct the research study

mixed methods research

researchers ask questions that cross quantitive and qualitative methodologies, often conducting two (qual/quan or quan/qual) studies within one larger study

three basic ethical principles

respect for persons, beneficence, justice

research methods

sampling, data collection, data analysis

methods

sampling- getting people into my study -data analysis

problem statement

study must clearly and concisely identify a problem that is worthy of being investigated and will generate new knowledge

example of basic research

study would explore how the human immunodeficiency virus (HIV) replicates in a human cell.

assent

that although the legal guardian is the one giving informed consent for the child to participate in the research study, the researcher has explained the study to the child, the child has agreed to take part in the study, and the researcher has documented they have the child's assent.

post positivism

truth exists in natural scientific laws but it might not be possible to control for every variable and while its important to control for bias total elimination might not be possible - found statistical proof of cause and effect relationship

dissemination (sharing)

writing a journal article to share results/ finding (new knowledge) with scientific community

diminished autonomy

• An individual who is not "... capable of deliberation and personal goals and of acting under the direction of such deliberation".

information

• purpose of the research, procedures involved, potential risks and anticipated benefits (if any), available alternative procedures (when therapy is involved) • a statement informing the potential research participant theycan withdraw from the research study at any time

undue influence

"occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance"

coercion

"occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance"

full review

(full IRB board) • Research subjects are from a vulnerable population or • Study involves more than minimal risk

expedited

(staff of the IRB and typically a few experts but not the full IRB board) • Study has no more than minimal risk

Willowbrook Hepatitis Study

- a study was conducted at an institution for mentally disabled children in staten island, New york, to determine: -the natural history of viral hepatitis -to test the effectiveness of gamma globulin as an agent for inoculating against hepatitis -children were deliberately infected with mild form of hepatitis

private information

- behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place - information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public(i.e., medical record)

nuremberg code

- combined hippocratic ethics and protection of human participants -called the most important document with regard to ethics in medical research - identifies 10 standards that must be adhered to when conducting experiments on human subjects -includes -voluntary informed consent -weighing risks against anticipated benefits -stipulation that experiments can only be conducted by scientifically qualified individuals

design planning

- submitting the research study proposal for IRB review -selecting the best research design and research methods (sampling, data collection, data analysis) that align with research questions

nuremburg doctors trial

-american military court considered the fate of 23 german physicians -trial lasted 140 days -85 witnesses testified -almost 1,500 documents were introduced -court could not convict on grounds of violating

analytic (analyzing)

-answering the research questions and simultaneously uncovering new avenues of inquiry -utilizing the best anaylsis strategies to yield

voluntariness

-conditions surrounding the consent are free of coercion and/or undue influence

tuskegee study of untreated syphilis

-document the natural disease progression of syphilis in black men. (poor and illiterate) -was conducted with the public health service, in conjuction with tuskegee institute -were told they were being trated for 'bad blood' which involved painful spinal taps

Belmont Report (1979)

-drafted by the national commission for the protection of human subjects of biomedical and behavioral research

thinking conceptual

-having an idea (research problem) -systematically reviewing the literature to verify the problem has the potential to generate new knowledge -writing a problem statement, a research purpose statement, and research questions

QUAN

-large sample from a population (random) -type- numerical how- tools/ instruments -ex; survey, scale, BF cuff, MRI -Stats

applied

is a type of research that seeks to study issues to have "immediate relevance to current practices, procedures and policies"

data anaylsis

is how the researcher performs the analysis on the data that has been collected

Which of the following is the correct way for a researcher to think or act? A researcher should: a. use the scientific method to test hypotheses b. realize that truth is relative; meaning an account can be both true and false at the same time c. be detached, neutral, and objective in order to strictly control all variables d. be active and engaged in the research, realizing that all research is value laden e. attempt to prove a cause-and-effect relationship f. seek a rich understanding of a phenomenon g. Any of the above

G

Empirical (Doing)

Obtaining IRB approval to conduct the study, recruiting/selecting the sample, obtaining informed consent from participants, collecting -recruiting/ selecting the sample, collecting the data

informed consent

Required for research with human beings and must include -information -comprehension -voluntariness

data collection

is the type of data that will be collected and the procedures/ processes a researchers uses to collect data

research questions

have question that when answered have potential to generate new knowledge

evaluative

how well is this working

sampling

is the way researcher recruit or selects individuals from population to be participants in the study

literature research

is used to determine if the research idea, when systematically studied, can lead to creation of new knowledge

deductive reasoning

hypothesis testing -question -generate hypothesis -collect data -analyze data -accept or reject hypothesis - if the hypothesis is rejected, generate new hypothesis to test

belmont principles- respect for person

individuals should be trated as autonomous agents

qualitative only

inductive reasoning

qualitative

involves the collection, analysis and interpretation of verbal, narrative and visual data in order to gain insights (pattern and themes) into particular phenomenon of interest

quantitative

involves the collection, analysis, and interpretation of numerical data to compare, explain, predict and/or control phenomenon of interest

ethical research

is a systematic investigation designed to develop or contribute to generalizable knowledge that conforms to accepted standards of conduct.

3. The in-depth interviews the researcher conducted is how the researcher a. sampled b. collected data c. analyzed the data d. achieved scientific merit

B. Collected data

basic research

is a type of research that seeks to enhance overall knowledge about the "physical, biological, psychology, or social world

Why do researchers ask themselves this question: Has this study been planned in such a way that the potential to generate new knowledge exists? a. This question is used to keep the concept of scientific merit in the researcher's mind as they conceptualize, plan, design, and conduct the study. b. This question is used solely to guide the researchers through the literature review process. c. This question is used to keep the concept of scientific method in the researcher's mind as they disseminate the findings (write the journal article). d. This question is used solely to guide the researcher through the process of identifying the paradigm the researcher holds.

A This question is used to keep the concept of scientific merit in the researcher's mind as they conceptualize, plan, design, and conduct the study.

IRB

A group that has been assembled for the primary purpose of reviewing research proposals to ensure that the rights and welfare of human subjects participating in research studies are protected. • Research involving human subjects that is funded or regulated by the federal government must be approved by an Institutional Review Board

An investigator is studying a new drug. There might be some foreseeable risks to taking the new drug, but he makes this clearly known to all participants he consents. He recruits participants into the control group (no drug) from the local college. He recruits participants from homeless shelters into the experimental group (drug) because he knows if the drug works that group will benefit most. Which of the following ethical principles did this study violate? a. Justice b. No ethical violation c. Beneficence d. Respect for persons

A. JUSTICE

An individual with diminished autonomy is entitled to protection. This state- ment demonstrates the principle of: a. Respect for persons b. Beneficence c. Justice d. Voluntariness

A. Respect for persons

7. Which methodology was used in this study? a. Mixed Methods b. Applied c. Quantitative d. Qualitativea. Basic b. Applied/clinical

A. mixed methods

common rule

Also know as the Federal Policy for the Protection ofHuman Subjects requires each of the 15 different agencies/departments to • Puts forth rules and procedures researchers must follow when conducting research• Includes, but is not limited to, the following - Development of an Institutional Review Board (IRB) - Level of IRB review the study must go through - Development of standards for information to be included in consent forms

A surgeon keeps a patient under anesthesia an extra 3 minutes to collect tissue samples after clinically required surgery. She only keeps demographic information such as age, race, and gender and removes all other identifying information from her data collection. Since there is no identifying information linked to the samples, she does not consent the participants. This is an example of: a. Lack of justice b. Lack of respect for autonomy c. Acceptable research procedures d. Coercion of participants

B Lack of respect for autonomy

The purpose of this study was to create an integrated care manual for health care providers using the perspectives of patients who are homeless and living with chronic illnesses. The manual was developed from both the results of quantitative survey data and the analysis of in-depth interviews. The combined results identified 14 areas that can enhance provider competency when working with individuals that are homeless. This manual will assist the health care team in providing higher-quality health care to people who are homeless (adapted from the Colorado Coalition for the Homeless, 2013). Answer questions 6 and 7. 6. What type of research was performed? a. Basic b. Applied/clinical

B. applied/ clinical

4. Reading and rereading the data looking for themes is how the researcher a. sampled b. collected data c. analyzed the data d. achieved scientific merit

C. analyzed the data

The purpose of this study was to measure the physiological stress responses of radiologic technology students during their initial clinical rotations. Specifically, the first rotation where the students took images (X-rays) of patients in a familiar setting (radiology department where they had their lab classes) versus an unfamiliar setting (first time taking portable X-rays in the emergency department). Cortisol is a hormone that is related to stress. In this study stress responses were measured using a lab test that measured the levels of cortisol in the students' saliva (adapted from Pottier et al., 2011). Answer question 8. 8. Which methodology would be used in this study? a. Mixed Methods b. Applied c. Quantitative d. Qualitative

C. quantitative

2 .The purpose of this study was to explore the experiences women who self-identify as les- bian had with the health care system as their partners prepared to give birth. The researcher purposefully selected 20 women with whom to conduct in-depth interviews. The researcher read and reread transcripts of the verbal interview data to identify common themes among the experiences. The researcher found that being acknowledged as a co-mother to the new-born was the most important finding (adapted from Dahl, Fylkesnes, Sorlie, & Malterud, 2013). Answer questions 2-4. Which methodology did this study use? a. Mixed Methods b. Applied c. Quantitative d. Qualitative

D. QUAL

Studies have documented that Pre-Exposure Prophylaxis (PrEP) can reduce the risk of HIV infection in people who are at high risk by more than 90% (CDC, 2016). As such, this drug treatment is strongly recommended for people who are HIV-negative and at very high risk for HIV infection. However, insufficient studies have been conducted that explore and describe the experiences of those taking PrEP daily. Further exploration must be conducted to understand the meaning this drug has in the lives of those who are at ongoing risk of HIV infection. Answer question 5 Which methodology would be used in this study? a. Mixed Methods b. Applied c. Quantitative d. Qualitative

D. qualitative

Which of the following is acceptable when conducting research involving human participants? a. Saliva and blood samples are taken from a group of high school students compar- ing DNA and giftedness. Volunteers gave proper informed consent for the study. b. A group of people in a cancer support group are asked to participate in a study in which painful tissue biopsies (10 times over a two-year time period) must be collected to serve as a control group in a national cancer study. Participation in the study is voluntary, and the participants give proper informed consent. c. A professor makes an announcement in a psychology class that student volun- teers are being sought for a behavioral psychology study. The class is informed that extra credit will be given if the students participate. Students who don't participate can receive extra credit by doing an alternative assignment. d. All are acceptable.

d. All are acceptable.

Which of the following need(s) to be obtained when doing research with children? a. Informed consent from the parent or guardian b. Assent from the child if he or she is capable c. Informed consent from the child d. both a and b

d. both a and b

descriptive

describe problem (who, what, where, and when)

explanatory

determine a cause and effect relationship

Institutional Review Board (IRB)

ensure that in researchers zeal for new knowledge human subjects are being treated ethically

National Research Act of 1974

established the national commission for the protection of human subjects of biomedical and behavioral research

purpose of research

exploratory, explanatory, descriptive, evaluative

exploratory

explore or investigation to determine scope of issue or to understand a problem that has not been clearly defined

inductive reasoning

few observations build general understanding of an issue -findings from these observations are not tested simply offered as an explanation of what is occurring or why something is occurring

pragmatism

generate deeper and broader insights, to develop important. claims that respect a wider ranger of interest and perspective

research =

generation of new knowledge

purpose statement

have a clear purpose or what the study will accomplish in relation to the problem