Full Answer
Is everyone who applies for a clinical trial accepted?
Therefore, not everyone who applies for a clinical trial will be accepted. It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people, because different people may respond differently to treatments.
When must deception be debriefed before consenting participants are informed?
a. Individuals must be informed that deception is involved before they consent to participate. b. Individuals must be debriefed about the deception within six weeks after the data have been analyzed. c. The deception can only be something a "reasonable person" would consider acceptable. d.
What should researchers not assume in the scientific method?
c. Researchers should not assume that a relationship exists between two entities or actions. d. Researchers should not assume that a relationship exists between two entities or actions. The scientific method assumes something does not exist unless it is proven to exist.
Do participants know whether they are in an experimental or control group?
Participants do not know whether they are in an experimental or a control group. Double-blind procedure Neither the participant nor the researcher interacting with the participants knows which participants are in the experimental or control groups. Standardized instructions and procedures.
What are the participants in a research study who do not receive treatment called?
The treatment group (also called the experimental group) receives the treatment whose effect the researcher is interested in. The control group receives either no treatment, a standard treatment whose effect is already known, or a placebo (a fake treatment).
When subject do not know if they are receiving the experiment treatment they are said to be?
A double-blind study is one in which neither the participants nor the experimenters know who is receiving a particular treatment. This procedure is utilized to prevent bias in research results.
What is an experiment in which the experimental unit or subject does not know which treatment he or she is receiving called?
In a single-blind experiment, the subject does not know which treatment is received. In a double-blind experiment, neither the subject nor the researcher in contact with the subject knows which treatment is received.
What is an extraneous variable?
In an experiment, an extraneous variable is any variable that you're not investigating that can potentially affect the outcomes of your research study. If left uncontrolled, extraneous variables can lead to inaccurate conclusions about the relationship between independent and dependent variables. Research question.
What is a blind study in psychology?
A blind or blinded experiment is a scientific experiment where some of the people involved are prevented from knowing certain information that might lead to conscious or subconscious bias on their part, thus invalidating the results.
What does bias mean in an experiment?
In research, an experimenter bias, also known as research bias, occurs when a researcher unconsciously affects results, data, or a participant in an experiment due to subjective influence. It is difficult for humans to be entirely objective which is not being influenced by personal emotions, desires, or biases.
What is confounding variable in research?
Confounding variables are the stowaways in a research study that can result in misleading findings about the relationship between the independent variable (IV), the input in the study, and the dependent variable (DV), the results of the study.
What is a confounding variable in psychology?
Confounding variables are factors other than the independent variable that may cause a result. In your caffeine study, for example, it is possible that the students who received caffeine also had more sleep than the control group. Or, the experimental group may have spent more time overall preparing for the exam.
What is a concomitant variable?
A concomitant variable, or covariate, is a variable which we observe during the course of our research or statistical analysis, but we cannot control it and it is not the focus of our analysis.
What is a protocol in clinical research?
Protocol: a written plan for carrying out a clinical study. A protocol includes what will be done, when, and how. Randomization: Mixing up the types of participants in enrolled into an experimental group or a control group, so that it will be fair to compare the two groups.
What is blinded study?
Blinded study: a study done in such a way that the study participants do not know whether they are getting a placebo (an inactive substance) or a drug, but the study team does know. If the study is comparing two different doses or two different medications, then the human participants do not know which they are getting.
What is a human subject?
Human subject: a participant who volunteers to be in a clinical study. Informed consent: a patient’s written consent to participate in a clinical study after fully discussing with the researchers all the relevant health-related facts and the risks involved.
What is an investigational drug?
Investigational drug/device: a new medical drug and/or device that has been tested in a laboratory but has not yet been approved by the Food and Drug Administration (FDA) to be legally sold and used by health care providers and/or patients. Investigators: These are researchers.
What is clinical investigation?
Clinical investigation or ‘clinical research’ or ‘clinical study’ or ‘clinical trial’: research that either directly involves human participants or uses materials of human origin (for example, blood) to test the safety and/or effectiveness of drugs, medical devices, procedures, or preventions.
What is the FDA?
FDA (Food and Drug Administration): an agency of the United States federal government that approves or disapproves new drugs and devices. Human subject: a participant who volunteers to be in a clinical study.
What is an adverse event in clinical research?
Adverse event: any unexpected change in health or any side effect that occurs in a person while they are still under the effect of a treatment in a clinical trial. All adverse events must be reported to an institutional review board, whether they are serious or minor.
How to avoid subject bias?
There are several ways that experimenters can attempt to avoid subject bias: A single-blind control study: Researchers and experimenters refrain from telling subjects the purpose of the experiment. A double- blind control study: Researchers hire research assistants to conduct the study/experiment but don't tell them the purpose of the study.
Why is subject bias bad?
Unfortunately, subject bias is bad for experiments because it compromises the external validity of the experiment. An experiment's results are externally valid if the results (the dependent variable) are truly due to influence by the independent variables instead of other causal factors.
Is a placebo biased?
Therefore, they are not biased, nor are the actual subjects of the experiment. A placebo/control group: The subjects are divided into a placebo group (they get no treatment) and an experimental group (they get the treatment). In this way, the subjects don't know if they are receiving the treatment or not.
Do subjects know if they are receiving treatment?
In this way, the subjects don't know if they are receiving the treatment or not. Or, all of them think they are receiving the treatment, but only half are actually receiving it. Therefore, even if all of the participants know the purpose of the study, any subject bias will be universal across all subjects. Lesson Summary.
Can subject bias be prevented?
Subject bias can possibly be prevented with a single-blind control study, a double-blind control study, or with use of a placebo/control group. To unlock this lesson you must be a Study.com Member. Create your account.
Who put strict rules on clinical studies?
Strict rules for clinical studies have been put in place by National Institutes of Health and the FDA. Some studies involve promising new treatments that may directly benefit participants. Others do not directly benefit participants, but may help scientists learn better ways to help people.
Who sponsors clinical trials?
Clinical trials can be sponsored by organizations (such as a pharmaceutical company), Federal offices and agencies (such as the National Institutes of Health or the U.S. Department of Veterans Affairs), or individuals (such as doctors or health care providers).
How does the FDA work?
FDA works to protect participants in clinical trials and to ensure that people have reliable information before deciding whether to join a clinical trial. The Federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks.
What to do before joining a clinical trial?
Before joining a clinical trial, it is important to learn as much as possible. Discuss your questions and concerns with members of the health care team conducting the trial. Also, discuss the trial with your health care provider to determine whether or not the trial is a good option based on your current treatment.
What does the FDA do?
FDA seeks to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials. Learn more about FDA’s efforts to increase diversity in clinical trials.
Why is confidentiality important in clinical research?
Confidentiality is an important part of clinical research and ensures that personal information is seen only by those authorized to have access. It also means that the personal identity and all medical information of clinical trial participants is known only to the individual patient and researchers.
What are the criteria for clinical trials?
All clinical trials have guidelines, called eligibility criteria, about who can participate. The criteria are based on such factors as age, sex, type and stage of disease, previous treatment history, and other medical conditions.