CITI Training - Research Study Design - All Modules
A researcher is conducting a written survey about people's attitudes toward walking as an exercise option at the local shopping mall that supports a walking program. The survey is anonymous (without codes, names, or other information) and subjects may complete the survey and place it in a box at the shopping mall exits. Which of the following is the most important issue that the researcher addressed in planning the research?
Confidentiality of the individual subject's responses
Which of the following would be appropriate during the process of acquiring excess blastocysts (embryos) for research purposes?
Consenting donors are informed that the embryo will be destroyed during the attempted derivation of embryonic stem cell lines
Deductive disclosure refers to which of the following?
Learning respondents' identities based on their responses to multiple questions.
Which of the following most accurately describes the risks associated with SBR?
Less predictable, more variable, and less treatable than physical harms
Outlier data in a distribution:
May be useful to the analysis and the researcher should consider whether to use it or not.
Which of the following is most likely to help the journal publication process mitigate reproducibility problems?
Moving away from a review process that favors the publication of positive results.
Which of the following do expert panel and focus group members have in common?
Both should have their feedback taken seriously.
Which of the following studies has the LEAST potential to create group harm?
A Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer.
An investigator obtains consent and HIPAA authorization from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with subject identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes:
A breach of confidentiality
Respondents will likely be least motivated to fill out an online survey for:
A car dealership where they took a test drive.
Embryonic stem cells (ESC) may be obtained from which of the following tissues:
A five day old blastocyst
What is the optimal sample size in qualitative research?
As many as needed to reach saturation
The results from research have been known to produce harms to members of the sampled population who do not actually participate in the research study. An example of the type of research that could result in group harms by stigmatizing members of the group (even for individuals who do not participate in the research) is:
A study of the types and prevalence of sexually transmitted infections (STIs) in small rural towns in a midwestern state.
When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:
All of the above:- The employer may encourage or deny participation of workers- Employees may experience pressure from management to participate in the study because the employer perceives the study to be advantageous to the organization.- Unions may encourage employees to participate with the expectation that "entitlements" may follow from study results- The research study's finding could affect an employee's pay, benefits or promotion potential.
Researcher access to confidential records adds to the vulnerability of workers who participate in workplace studies. Inappropriate release of identifiable private information could adversely affect a worker's retention of a job, insurance, or other employment related benefits. To avoid or minimize these risks, the study design must include adequate safeguards to protect the confidentiality of the information collected. A plan for the proper management of study data and records should clearly define:
All of the above:- Who will have access to the data.- If the study results, if any, will be included in the employee's personnel records- How the data will be collected and secured- If personal identifiers will be retained and used in the data analysis.
The FDA's regulations related to electronic records and electronic signatures (21 CFR Part 11) are intended to:
Allow the use of electronic documents and signatures in the regulatory process for drugs and devices.
An example of an institutional COI is:
An industry sponsor pays for the construction of a new research laboratory at the organization
If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue.
An investigator proposes a study to determine the clinical relevance of a new assay technique to measure minimal residual disease (MRD) in adolescent (age 14-16) cancer patients undergoing chemotherapy. The study requires that two additional bone marrow aspirates be performed during the course of chemotherapy. The subject's chemotherapy will not be altered based on the results of the assay technique measures. However, future patients with cancer would benefit from improved interventions based on study findings. The IRB determined that the activity was a minor increase over minimal risk. Which of the following statements best describes the IRB approval requirements for involving adolescent cancer patients in the research study?
Assent of the child and permission of both parents are required.
The purpose of a federally supported research study is to examine the effect of scheduled cell searches on gang violence among men confined to drug treatment facilities under court order. Which of the following best describes the IRB's duties when reviewing this research?
Because this research involves individual subjects who would be considered prisoners and examines the possible causes, effects, and processes of incarceration, the IRB should ensure that the additional requirements for prisoner research are met
Adult stem cells are found most commonly in:
Bone marrow
A researcher wants to invite therapists to participate in small focus groups to discuss their perceptions regarding "troubled" adolescent girls and the relationships they have with their parents. Specific clients of the therapists will not be discussed. Which of the following will be the most important issue for the researcher to consider when planning the research?
Breach of confidentiality from the focus group subjects (therapists)
The publication of short methods sections:
Can contribute to reproducibility problems because important details about materials and procedures are likely to have been omitted.
The NBAC looks at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a:
Cognitive or communicative vulnerability
Which of the following practices can be effective in minimizing group harms?
Collaborative IRB review- Ongoing consultation- Planning disclosure of research results- Community consultation
Which of the following is true regarding data acquisition?
Data acquisition should follow a detailed collection plan that is set in advance.
A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:
Data that does not cross state lines when disclosed by the covered entity.
As of January 2015, the NIH expects investigators to obtain the informed (valid) consent of research participants in NIH -funded genetic research for broad research use of data and data sharing, even if the cell lines or specimens are:
De-Identified
Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects?
Determining that the study has a maximization of benefits and a minimization of risks.
HIPAA includes in its definition of "research," activities related to:
Development of generalizable knowledge.
During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should:
Disclose their potential COI and may answer questions, but recuse themselves from voting
A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of:
Economic vulnerability
The National Research Act of 1974
Established the National Commission.
Conducting numerous, separate statistical analyses increases the chance that one or more of the results appear to be statistically significant, but are actually attributable to random variation or measurement error. The problem is referred to as:
Family-wise inflation of error rate
How long is an investigator required to keep consent documents, IRB correspondence, and research records?
For a minimum of three years after completion of the study
Which choice is the best definition of "genetic determinism?"
Genes are primarily responsible for human traits, including health, behavior, and disease
A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on-going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?
Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.
A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). Your IRB has determined that assent of children age 8 and older is required for the study. A 10-year-old firmly declined to participate in the study described above. Which of the following procedures best describes the action to be taken by the investigator?
Honor the child's decision.
A general requirement for the informed consent form is that it may not include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?
I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
Which is true of inducements in research?
Inducements constitute an "undue influence" if they alter a potential subject's decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research.
Which of the following is considered a SBR data collection method?
Interviews
What is the appropriate method for calculating reliability for a coding category assessed on a continuous scale?
Intraclass correlation
A null hypothesis:
Is accepted if statistical analysis shows there is low probability that a difference between two groups occurred by chance.
Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ...
Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.
A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:
It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success
Which of the following is true about hypothesis-free research?
It should normally be disclosed because the practice can introduce bias into a study.
A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). According to 45 CFR 46, an IRB's risk assessment would likely conclude that this study involves:
No more than minimal risk to the child.
Investigator A has biological specimens that are coded and linked to identifiers of the source individuals. Investigator A provides the specimens to Investigator B but does not provide the individual identifiers. Investigator B agrees not to re-identify the source individuals. Is Investigator B's research using the biospecimens human subjects research according to the definition of human subjects research in the federal regulations?
No, because Investigator B cannot readily ascertain the identity of the source individual and Investigator B has agreed not to attempt re-identification.
IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:
Occur at least annually.
When reviewing federally supported research involving prisoners, an IRB must have which of the following, in addition to the standard requirements for IRBs to ensure that the prisoners' perspective is represented:
One member who is a prisoner or prisoner representative
The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that:
Persons with diminished autonomy are entitled to protection.
The use of prisoners in research is a concern under the Belmont principle of Justice because:
Prisoners may not be used to conduct research that only benefits the larger society
Little is known about what it is like for individuals to experience being laid off from their job after decades of employment. Which qualitative method is best suited to explore this question?
Phenomenological
According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four?
Physical control, coercion, undue influence, and manipulation
Due to past abuses, which of the following groups of potential research subjects has specific Department of Health and Human Services (HHS) regulations to ensure additional protections when this population is being considered for research.
Prisoners
Which of the following was the result of the Beecher article?
Realization that ethical abuses are not limited to the Nazi regime
A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?
Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.
When researchers plan to involve a prisoner population, which answer best describes the type of federally supported research that may be conducted?
Research that is relevant to prisoners and their conditions or situations
The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?
Researcher
Which of the following is true regarding data sharing and stewardship?
Researchers who receive federal funding may have to adhere to a data sharing requirement.
Informed consent is considered an application of which Belmont principle?
Respect for Persons
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice
A Type I error, or a false positive, refers to a situation when:
Results are found to be statistically significant, but they are actually due to chance.
A Type II error, or a false negative, refers to a situation when:
Results are not found to be statistically significant, but a significant effect is actually present.
An elderly gentleman, whose wife is his legally authorized representative (LAR) since his strokes several years ago, was recently diagnosed with lung cancer. He is eligible for a clinical trial using a new investigational drug that aims to treat lung cancer. He is able to express interest, shows a basic understanding of the nature of the trial, and gives his assent to participation. The subject's wife is out of town on a business trip. Which of the following is the most appropriate action to take for the investigator?
Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back.
A sponsor proposes research to evaluate reengineering a commercially available pacemaker. It is hoped that the new pacemaker will pose fewer risks to individuals when compared to the current commercially available product. How should this device be classified?
Significant risk device
In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:
Situational cognitive vulnerability
New techniques to produce cells with the characteristics of embryonic stem cells include:
Somatic cell nuclear transfer (SCNT), Retroviral transduction of transcription factor genes into adult skin cells (iPS), and Parthenogenesis.
Which of the following are true:
Some states have legislation that is directly or indirectly tied to the federal policy
An investigator proposes to study a marketed product sold to treat high blood pressure in individuals over age 12 using a liquid formulation for children under age 12. The drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in younger children. Which of the following is the investigator's most appropriate course of action?
Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research
A basic characteristic of stem cells is:
The ability to divide and make two stem cells (self-renew)
Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:
The changes must be immediately implemented for the health and well-being of the subject.
An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual's LAR and no alternative method or recognized therapy is available. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator:
The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later.
An academic medical center is selecting a new database system for clinical research. The system needs to be "Part 11 compliant" in order to allow:
The medical center to replace the use of paper records with electronic records for its research.
A research project is designed to evaluate a new experimental type of fetal surgery to correct diaphragmatic hernia in the fetus (a potentially life-threatening condition for the baby) prior to delivery. This research is directed toward the fetus as subject to meet the health needs of the fetus. The pregnant woman is otherwise healthy. The investigator must obtain consent from whom?
The pregnant woman and the father of the fetus.
Investigators wish to evaluate a new treatment for eclampsia (a life-threatening condition in pregnant women) in women 30 - 50 years of age. The research is intended to directly benefit the pregnant woman who is otherwise healthy and competent. The investigator must obtain consent from whom?
The pregnant woman only.
In order to grant a waiver or alteration of the requirements of informed consent, an IRB must find which of the following:
The research could not practicably be carried out without the waiver of consent.
According to current NIH Guidelines, which of the following is adequate justification for exclusion of women from NIH-funded research?
There is compelling evidence that inclusion would be inappropriate with respect to the health of the subjects.
A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects. Which of the following considerations was relevant to the IRB's determination that this activity does not constitute research with human subjects?
The researcher will not be interacting/intervening with subjects and the data has no identifiers.
According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations
The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:
There may be bias by the peer reviewer as to the area of research
The HIPAA "minimum necessary" standard applies...
To all human subjects research that uses PHI without an authorization from the data subject.
The purpose of informed consent is:
To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research.
An adult with attention deficit hyperactivity disorder (ADHD) presents to a physician. To date, no behavioral or drug interventions have proven useful. The physician has just read several reports about a drug that is approved and marketed for another indication, but has shown some benefit for ADHD. The physician wants to prescribe this drug, in the labeled marketed dose, for the individual patient. Which of the following would be the most appropriate course of action?
Treat the patient with the drug based on physician's best medical judgment
When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject.
True
Issued in 1974, 45 CFR 46 raised to regulatory status:
US Public Health Service Policy
Which of the following statements is accurate in determining subject risk involved in a genetic study:
Understanding the purpose and context of a specific study is critical in determining the risk involved
Dr. Davis wants to study gang members in a major U.S. city. What is the best sampling strategy for him to use?
Use gang members to help recruit other gang members to participate in the study.
Vulnerable persons are those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46, Subpart A) has specific requirements for the following vulnerable populations, except:
Workers
Investigator A conducts research on emphysema using biospecimens from human subjects. The consent form indicates that the research will focus exclusively on emphysema. Investigator B wishes to use the biospecimens for research on lung cancer. Can Investigator B use the specimens for cancer research without re-consent if the specimens are de-identified?
Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research.
In which of these ways can researchers find out whether data are missing not at random?
There is no way to determine whether data are missing not at random.
Which of the following is correct regarding statistical analyses that delete cases with missing data?
Are appropriate only if data are missing completely at random.
What is the primary advantage of convenience samples?
Are inexpensive and easy to obtain.
Why are semantic differential scales similar to both Likert-type and ipsative response scales?
Ask respondents to choose between opposing adjectives
Which of the following research scenarios is likely to produce the largest amount of missing data?
Asking college students how much money their parents earn.
A hypothesis serves as:
A proposed mechanism by which key factors relevant to a research question interact with one another
In statistics, sensitivity refers to:
A test with a true positive rate
Why may telephone surveys using random digit dialing be less effective now? Check all that apply.
ALL THE ABOVE: - Caller-ID devices allow people to see who is calling them. - Many people no longer have home telephone numbers. - Some people do not have telephone access at all.
Because it is unethical to utilize a placebo-controlled design in cases where not offering study subjects an intervention would subject them to undue harm, and where an efficacious or effective intervention that exists is available, the best design option for a study involving such a situation would be:
Active comparator
Sampling weights are used to do which of the following?
Adjust for overrepresentation of some groups in the sample.
A subject is enrolled in a placebo-controlled study of an investigational drug for diabetic neuropathy. At the beginning of the study, the subject's pain scores are at ten out of a possible ten. After four weeks in the study, the subject's pain scores are consistently down to three. In their review of the study conduct, the researchers found that the lack of blinding of the researchers had an effect. Because researchers knew to which groups subjects were randomized, they were more eager to influence favorable responses from the subjects randomized to receive the study drug than those in the placebo group. This is an example of:
Bias
Researchers decide to find one customer who is willing to speak to them about their donut consumption. Apparently, this customer only started patronizing a certain café chain two months ago. Around the same time, she began experiencing migraine headaches. The researchers decide to do an in-depth analysis of this one case. What type of study is this?
Case Study
If the source data document or file is found to contain an out-of-range response to a question, how should this error be corrected?
Change the erroneous value to a missing value.
A successful literature review will depend on how relevant and comprehensive the chosen database is to the topics of interest, the search parameters, and which of the following?
Chosen search terms
Which of the following is true regarding the reporting of research results?
Clear specification of the methods and procedures used is essential.
A list of contact persons is most likely to be required for which of the following?
College students followed from their freshman to senior year.
Focus group members should:
Come from the target population
What are the three main goals of data lifecycle management (DLM)?
Confidentiality, availability, and integrity
The normal distribution (bell curve) results from collecting:
Continuous data
A group of researchers find that very few café customers are willing to talk to them. So, they now decide to look at public records available online at the Centers for Disease Control and Prevention (CDC). They intend to access diabetes prevalence data in each state. They are then going to examine the number of café franchises in each state. Finally, they will look for a relationship between the number of café franchises and diabetes prevalence. What type of study is this?
Correlational
Researchers are testing an experimental drug believed to be effective for controlling mild symptoms of arthritis. They are concerned that this population is older, likely to have additional health problems, and taking additional medications. Therefore, there is the possibility that there could be many confounding variables when comparing two different groups. The researchers decide to conduct a "before-after" type trial where they will compare the same test group's experiences for a period when they receive the test drug versus their experiences when they do not receive the test drug. What type of design is this?
Cross-over
Which of the following is true regarding data analysis?
Data analysis methods should usually be specified in advance before a study begins.
A group of researchers want to examine the age, gender, and socioeconomic status of patrons of a local café chain. What research design is this?
Descriptive Research
The objectives of descriptive epidemiology are to address who, what, where, when, and how much of a variable under study is occurring. Which area would be most appropriate for a descriptive research design?
Determine the prevalence of teenage pregnancies
Dr. Jones wants to study nurses' attitudes toward end-stage cancer patients. He is primarily interested in collecting information that will be used as preliminary data for a grant application. Which one of the following is most accurate?
Dr. Jones can use a convenience sample for his study.
Which of the following statements is true concerning data selection?
Establishing a data selection strategy prior to collecting data decreases the chance of a biased outcome.
Which of the following designs is most likely to have the quantitative component carried out first, with the qualitative component both subsequent to and dependent upon the quantitative?
Explanatory design
Which of the following designs is most likely to have the qualitative component conducted first, followed by the quantitative component?
Exploratory design
Which of the following is an acceptable method for assessing the validity of a coding system?
External auditor
When conducting survey research with children, which method of administration must be used?
Face-to-face interview
Researchers are testing the effects of a new weight loss method. Subjects will be randomly assigned to groups. One group will follow the new method and the other group will not. All subjects will be randomized a second time to watch a nutritional information video and the other group will receive a motivational speech. This will result in four different groups as follows: Weight Loss Method + Motivational Speech Weight Loss Method + Informational Video No Weight Loss Method + Motivational Speech No Weight Loss Method + Informational Video What type of design is this?
Factorial
Which of the following is not a potential disadvantage of Likert-type scales?
Forcing respondents to choose between two options
A researcher wants to understand the process of how college students decide whether or not to seek treatment for alcohol use. In the researcher's opinion, the existing models are limited and do not have sufficient explanatory power. Which qualitative method would be most appropriate for this research questions?
Grounded Theory
In order to be considered mixed methods research, a study must:
Have both quantitative and qualitative data, analysis, interpretation, or inclusion in the research program
Which of the following questions is least likely to elicit a socially desirable response?
How do you think other people in your church feel about same-sex marriage?
The U.S. National Institutes of Health (NIH) is seeking to increase research reproducibility by
Implementing a grant review process that evaluates various factors such as the rigor of the research premise and study design.
Dr. Cheng wants to examine beliefs about post-surgical recovery among a population-based sample of cardiac surgeons. She wants to include cross-ethnic comparisons in her analyses. However, she discovers that some ethnic groups represent less than five percent of the total population of cardiac surgeons. Which of the following should Dr. Cheng do?
Include more surgeons from these ethnic groups than would be indicated based on the representation of these ethnic groups within the population of surgeons
Which of the following is not one of the functions of a codebook?
Indicate what statistical analyses should be used with the data.
A Type I error:
Is one where the researcher rejects a true null hypothesis.
Which of the following most accurately describes the "reproducibility crisis?"
It is a problem that can potentially affect any research field.
Which of the following is not correct regarding a power analysis?
It is essential for calculating a confidence interval.
Which of the following most accurately describes data lifecycle management (DLM)?
It refers to the tools and processes for handling data during a research study and after it concludes.
The interquartile range is useful to researchers because:
It shows the researchers how much dispersion there is in the middle range of the distribution.
Which of the following represents the average, and is calculated by taking the sum of all the values in the data set divided by the number of values?
Mean
Measures of central tendency are statistics that summarize a distribution of scores by reporting the most typical or representative distribution value. The most commonly used measures of central tendency are:
Mean, median, and mode.
A research team collects both quantitative and qualitative data. They code the qualitative data and examine how variations in the themes are related to the quantitative data. What type of mixing is this?
Mixing in the analysis
When the same researcher uses quantitative and qualitative approaches on the same topic, but not necessarily in the same study, this is called:
Mixing in the program of research
Which of the following objective measures would be least appropriate to use?
Mother reports to complement child reports of depression
Which of the following methods is most appropriate for understanding an individual's life history and how they have made meaning of their experiences?
Narrative
A researcher is studying political attitudes among homeless adolescents. After completing an interview, the researcher asks the interviewee to help recruit her friends to participate in the study. What type of sampling strategy is the researcher using?
Network sampling
Which methodology best describes observational research designs?
No manipulation of study variables and no randomization of subjects
The alternative hypothesis states that the connection between key factors of interest and any observed connection is most likely:
Not due to chance
Which of the following is not true about dropout from longitudinal studies?
Once someone drops out of a longitudinal study, they do not come back.
Researchers are testing a drug that they believe to be effective in treating Disease X. Disease X causes symptoms that could be categorized as annoying but does not seriously affect an individual's health. There are no currently known treatments for Disease X. The researchers are concerned that people's belief that the drug will help them might affect their assessment of the drug's ability to improve their symptoms. What is the best design for this study?
Placebo-controlled
Researchers are interested in examining whether a rigorous exercise program may prevent the development of cardiovascular disease. The subjects are healthy individuals, but considered at risk of developing cardiovascular disease. How should this study be broadly categorized?
Preventive
A group of researchers want to examine the effects of "Boston cream" donuts versus "glazed" donuts. They observe a group of people who only eat Boston cream donuts and another group that only eats glazed donuts. The groups are going to be followed for ten years and the occurrence of diabetes will be compared amongst the two groups. What type of study is this
Prospective Cohort
Dr. Wong randomly assigns respondents to complete an attitude measure with either a five-point Likert-type scale or a ten-point Likert-type scale. Compared to respondents using the five-point scale, those using the ten-point scale would be expected to:
Provide more responses near the scale endpoints
Which of the following sampling methods uses subject characteristics to determine the sample?
Purposeful sampling
A researcher conducts a series of interviews and codes the data for three main themes. These themes are then analyzed for variations by age and gender using statistical procedures. What type of approach is this?
Quantized qualitative research
A researcher is planning a study to test the safety and efficacy of a drug to treat asthma. The study will be conducted amongst adult patients with asthma who do not have other major pulmonary diseases. Which best describes all patients with asthma?
Reference Population
In statistics, the term outliers:
Refers to items in a statistical sample that lie well above or below the mean in a normal distribution.
The listening guide method of assessing reliability includes all of the following, except:
Reliability coefficient (for example, Kappa)
Which of these is the first step in specifying the direction that research will take?
Research question
What does the Institutional Review Board (IRB) do?
Reviews proposed research in order to assess that the research is in keeping with ethical guidelines and regulatory requirements in order to protect human subjects.
If focus group members express concerns about a survey item, what should the researchers do?
Revise the item or delete the item
Surveys with data all reported by the same person may be somewhat biased because of which of the following reasons?
Socially desirable responding and shared method variance
What is common to all qualitative methods?
Textual data
When a researcher says that distribution is "skewed," the researcher means that:
The distribution is heavily to one side or the other of the mean.
A researcher conducts a written survey to determine the opinion of subjects regarding their opinion of the favorability of a certain hospital. What does a large standard deviation on all the answers tell the researcher about the research sample?
There is little agreement among the survey respondents.
A researcher conducts an experiment and sets the alpha value at ≤ .05. After conducting the statistical analysis, the researcher finds that the actual p-value is .19. The researcher should make the following interpretation:
The odds that the experimental result was caused by chance/error are too large to reject the null hypothesis
Which of the following is most likely to own the data resulting from a research project?
The organization that receives federal funding for a project.
If data are collected via paper and pencil in a classroom, the source data are which of the following?
The paper forms on which students wrote their answers.
In the case of interventional research, the research question should specify which of the following?
The population of individuals that researchers are interested in examining
The choice of which methods (quantitative or qualitative) to use in a mixed methods study should always be determined primarily by:
The research question
If a respondent skipped some of the questions on a subscale, which of the following should occur?
The subscale score should be a weighted sum of the item responses provided, as long as no more than 25 percent of item responses are missing
Which of the following is true regarding missing data?
The type of statistical analyses chosen must match the type of missing data present.
In general, which of the following qualitative approaches is the method of choice for a mixed methods study?
Thematic analysis
Disadvantages of ipsative response scales include all but which of the following?
There are too many response choices.
Which statement is true about confidence intervals?
There is a close relationship between confidence intervals and p-values.
Which of the following is an example of a well-focused survey purpose?
To ascertain what people know about HIV/AIDS.
What is the primary responsibility of oversight bodies (such as an IRB or IACUC)?
To determine compliance with regulatory requirements, including those relating to protecting research subjects.
Researchers develop hypotheses:
To offer explanations for phenomena they observe.
Dr. Baker wants to study cancer survivors' satisfaction with online cancer support groups. Respondents come from many different U.S. states and foreign countries, so the survey will need to be administered online. Which of the following is the best course of action for Dr. Baker to follow?
Use open-ended questions to ask about a range of experiences.
In the research context, the term validity most commonly refers to:
Whether operationalized terms actually measure what they purport to measure.
