Research Exam 1

Why is research important?

1. Foundation of our profession and our knowledge base 2. Stakeholders expect us to provide nutrition services that are based on scientific fact/research 3. Research is the basis of educations 4. Research is important for supporting public policy

Every entry level dietitian should:

1. Keep up to date on nutrition science (read the literature) 2. Demonstrate ability to interpret research and basic statistics accurately and thoroughly 3. Have a basic knowledge about research methodologies, needs assessments, and outcomes research 4. correct misinformation

Standards for Professional Practice

1. Locate and review research for application within an area of practice 2. Base practice on sound scientific principles, research, and theory 3. Promote research 4. Contribute to the development of knowledge through research 5. Collect measurable data and documents outcomes within practice settings

Why do we research?

1. Recognizing the unexpected: scurvy 2. Extending existing information: Glycemic index and glycemic load 3. Changing the focus - point to counterpoint: Functional foods 4. Responding to the socioeconomic and political environment: Growing obesity epidemic

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB must occur within:

12 months of the approval date.

Federal Policy - National Research Act of 1974

1978 Created the National Commission for the for the Protection of Human Subjects of Biomedical and Behavioral Research

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors.

If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful:

Obtain a waiver of documentation of informed consent.

According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or:

Obtains, uses, studies, analyzes, or generates identifiable private information.

Additional safeguards that may be included in a social and behavioral study may include:

Remove all direct identifiers from the data as soon as possible.

Epidemiologic research

Research that relies on studying variables as they naturally occur. Ex: The study of the distribution and determination of disease frequency.

Power

The probability of correctly rejecting the null hypothesis.

P value

The probability that the observed result is due to chance alone.

Informed consent

The process by which potential research participants are provided with all of the information necessary to allow them to make a reasonable decision concerning their participation.

According to the federal regulations, research is eligible for exemption, if:

The research falls into one of eight categories of research activity described in the regulations.

According to Subpart D, research with children may be eligible for exemption under Category 2 when:

The research involves the use of educational tests

A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission?

The research must pose no more than minimal risk.

One of your subjects is half way through a study of an investigational antidepressant that is injected weekly. The drug requires a taper-down regimen, that is, it should not be stopped abruptly. You learn that the subject will be admitted to prison next week prior to the next scheduled injection. What is the appropriate response for the researcher?

The researcher should contact prison authorities about the medical issue , and report the events to the IRB of record.

Dependent variable

The variable that is believed to be influenced by the independent variable

Independent variable

The variable that is controlled and/or manipulated to see what effect it has on the dependent (outcome) variable.

The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?

"Tastes, Ties, and Time (T3)" study (2006-2009)

Some studies from the early and mid 1900s that led to legal standards for research include

-Nuremberg War Tribunal (1947) -Thalidomide use in pregnancy (1950's) -Radiation experiments (1940-60's) -Tuskegee Syphillis Study (1932

What is the International review board (IRB)?

A committee that has been formally designated to approve, monitor, and review research that involves human subjects.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression.

What Is an example of both a breach of confidentiality and a violation of subjects' privacy?

A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.

Experimental design

A manipulation of the independent variable occurs, with the intent of assessing if the independent variable causes a change in the dependent variable.

Reliability

A measure of consistency of data collected using the same instrument on different occasions and/or by different individuals.

Validity

A property of research in which measures and concepts accurately measure or describe what they really represent.

Pilot Study

A small-scale version of a research project that allows the researcher to practice or test the procedures to be used in the full-scale project.

Correlation

A statistical procedure used to estimate the extent to which changes in one variable are associated with changes in another

A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent:

A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.

Research

A systematic investigation (i.e. the gathering and analysis of information) designed to develop or contribute to generalizable knowledge.

Hypothesis

A testable statement of how two or more variables are expected to be related to one another

Common Rule

Additional protection for vulnerable research subjects; Requires that institutions conducting research have a institutional review board (IRB)

Per federal regulations, which elements must be included in an informed consent document?

All foreseeable risks and discomforts.

Case-control study

An observational (epidemiological), retrospective, study design in which participants are identified as having a disease or specific outcome (case) or not having the disease or specific outcome (control) and then the history of the cases and controls are examined to determine if a risk factor is more commonly present in the cases, histories as compared to the controls, histories.

Identify the example of when situation and time are key to assessing risk of harm in a research study:

Asking women if they have had an abortion

How can faculty researchers avoid undue influence of student subjects?

Avoid using their own students in their research

Justice

Benefits and risks of research must be distributed fairly

A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by:

Both the magnitude (or severity) and the probability (or likelihood) of harm.

Double Blind

Both the participant and the investigator are unaware of the intervention the participant is receiving.

Descriptive research

Describes data and characteristics about the population being studied. It cannot determine what caused a situation (non-experimental).

How can the principle of beneficence be applied to a study employing human subjects?

Determining that the study has a maximization of benefits and a minimization of risks.

Beneficence

Do no harm; Maximize possible benefits and minimize potential harms

Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?

Ensuring that risks are reasonable in relationship to anticipated benefits

Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?

Exempt

Where could student researchers and/or student subjects find additional resources regarding the IRB approval process?

Faculty Advisor/Research Mentor; IRB Office

Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research?

Federal regulations do not require the documentation of minors' assent.

Case study

Intensive study of a single participant over an extended period of time.

According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:

Justice

According to federal regulations, the expedited review process may be used when the study procedures pose:

No more than minimal risk and the research activities fall within regulatory categories identified as eligible.

A master's degree candidate needs to conduct a research project for her master's thesis. She is interested in the types of junk food available to the public. She plans on going to the local convenience stores and asking the owners what types of junk food the store normally stocks and which are the biggest sellers. Identifiers will not be collected. This study would fall under which of the following?

Not Human Subjects

A researcher is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children's first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are:

Not an excessive incentive.

A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should:

Not approve this project because the prisoners are merely a population of convenience for the student.

The history of ethical regulations in human subjects research began with the

Nuremberg Code

Randomization

Participants are non-systematically assigned to groups, so that groups are equivalent to each other in important characteristics

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 Belmont principle of beneficence requires that:

Potential benefits justify the risks of harm.

In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?

Prisoners

A medical record is an example of:

Private information

What is the Institutional Review Board (IRB) charged with? (There may be more than one correct answer. Please be sure to select all correct answers.)

Protecting the rights and welfare of human subjects; Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed; Reviewing subject recruitment materials and strategies.

As part of the consent process, the federal regulations require researchers to:

Provide potential subjects with information at the appropriate reading comprehension level.

Census data (the final report as published by the Census Bureau) is an example of:

Public information

Control group

Receives no treatment or a standard treatment with which new treatments are compared

Which of the following statements about prison research is true?

Researchers may study the effects of privilege upgrades awarded by the prison.

Which three principles are discussed in the Belmont Report?

Respect for Persons, Beneficence, Justice

Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:

Respect for persons

Which confidentiality procedures would protect against compelled disclosure of individually identifiable information?

Securing a Certificate of Confidentiality

A general requirement for informed consent is that no informed consent may 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?

Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.

The Academy's Philosophy on Research

The Academy believes that research is the foundation of the profession providing the basis for practice, education, and policy

Generalizability

The ability to apply the results of a specific study to groups or situations beyond those actually studied.

Alternative hypothesis

The hypothesis that sample observations are influenced by some non-random cause; (H1) Example: Candidates sitting for the RD exam who graduated with a GPA of 3.5 or higher will pass the exam at a significantly higher rate than those who graduate with a GPA of less than 3.5.

A waiver of the requirement for documentation of informed consent may be granted when:

The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct?

The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.

A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?

There was neither a violation of privacy nor a breach of confidentiality.

A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate?

Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.

Null Hypothesis

Usually the hypothesis that sample observations result purely from chance; (H0) Example: There will be no difference in the passing rate on the R.D. exam in candidates who graduated with a GPA of 3.5 or higher and those who graduated with a GPA of less than 3.5.

Confounders

Variables that are not controlled in an experiment but that have a systematic affect on the dependent variable

Underreporting

Very common in self-reported dietary data, in which individuals report consuming less food than they actually do consume.

Attrition

When participants in a research study drop out of participating in the study so that follow-up cannot be achieved

Statistical significance

When the null hypothesis can be rejected due to an outcome having a low probability of occurring by chance; A p of <0.05 is believed to have statistical significance; Unlikely to have occurred by chance

A sociologist wants to study a culture that occurs in some women's prisons: "state families," in which individual prisoners take on certain roles within a group of like-minded prisoners. There is previous evidence that younger prisoners will use older inmates who play the roles of grandparents as a resource before they will turn to staff for help and advice. The lieutenant in charge of a dorm of long-term prisoners offers to gather volunteers to speak to the researcher and also offers to vouch for the integrity of the researcher. The use of this staff is:

Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners.

Children sign an ______ form and parents would sign a ____ form.

assent; consent

How must recommendations be made?

based on science

How can you make data anonymous?

by destroying all identifiers connected to the data.

You must go through the IRB when any research involves

humans who are living— includes surveys, medical record reviews, etc.

Respect fo persons

individuals should be treated as autonomous agents; Individuals with diminished autonomy are entitled to additional protections

The informed consent process should include these three things:

information, comprehension, voluntariness

Research in the early and mid 1900's led to

legal standards for the design and conduct of research

RDN's must correct

misinformation as the expert in the field of nutrition

When was the Belmont Report?

one of the leading works concerning ethics and health care research; Its primary purpose is to protect subjects and participants in clinical trials or research studies; 3 principles - beneficence, justice, and respect for persons; commissioned in 1978

An institution may ____ an IRB approval

overrule

Purpose of the International review board (IRB)?

protect the rights and welfare of research subjects

Secondary Source

reports or summarizes research done by others or the author

Primary Source

reports original research

Standard for research

the gold standard

Breach of confidentiality

the research data have been disclosed, counter to the agreement between researcher and subjects

Right to privacy

the right of the individuals to be protected against intrusion into their personal lives or affairs

Risks are specific to what?

time, situation, and culture.

When a focus group deals with a potentially sensitive topic, a researcher cannot control

what participants repeat about others outside the group.