Strategies to minimize therapeutic misconception include
giving a clear description of the research procedures and goals
(e.g. explaining study design, treatment allocation and the possibility of receiving a placebo since the allocation is randomized) and having a comprehensive discussion, with the subject, about the …
What is an example of therapeutic misconception?
For example, questions based on the Scientific Purpose dimension, with agree–disagree or true–false responses, might include: “This study has been designed only to improve the
health
of the patients enrolled in it” and “If the experimental treatment is not effective, then the study is a failure.” Questions based on the …
How can therapeutic misconception be prevented?
In the context of hypothetical clinical trials in five medical domains, this study found that therapeutic misconception can be substantially reduced through
a non-burdensome scientific reframing intervention that augments existing informed consent practices
, without jeopardizing enrollment to a statistically …
What is the appropriate definition of therapeutic misconception?
Therapeutic misconception (TM), which occurs
when research subjects fail to appreciate the distinction between the imperatives of clinical research and ordinary treatment
, may undercut the process of obtaining meaningful consent to clinical research participation.
What is called as therapeutic misconception during a patient recruitment?
Therapeutic misconception occurs when “a research subject fails to appreciate the distinction between the imperatives of clinical research and of ordinary treatment, and therefore
inaccurately attributes therapeutic intent
to research procedures” (Lidz and Appelbaum, 2002). From: Handbook of Clinical Neurology, 2013.
Who signs the short form consent?
The short form will be signed by
the participant and the witness
. The written summary will be signed by the witness and the person actually obtaining consent.
What is the appropriate definition of therapeutic misconception quizlet?
therapeutic misconception is
when patients believe research projects will directly benefit
; meaningless brand names; avoid the word ‘experiment’; overstate benefits of the trial.
Is informed consent required?
Informed consent
is mandatory for all clinical trials involving human beings
. … Valid informed consent for research must include three major elements: (1) disclosure of information, (2) competency of the patient (or surrogate) to make a decision, and (3) voluntary nature of the decision.
What is the appropriate definition of clinical equipoise?
Clinical equipoise is
the assumption that there is not one ‘better’ intervention present (for either the control or experimental group) during the design of a
randomized controlled trial (RCT). … Clinical equipoise has also been called an honest null hypothesis and/or a state of uncertainty.
What is protocol deviation?
Protocol Deviation:
Accidental or unintentional changes to
, or non-compliance with the research protocol that does not increase risk or decrease benefit or; does not have a significant effect on the subject’s rights, safety or welfare; and/or on the integrity of the data.
What’s the meaning of beneficence?
Beneficence is defined as
an act of charity, mercy, and kindness with a strong connotation of doing good to others including moral obligation
. … In the context of the professional-client relationship, the professional is obligated to, always and without exception, favor the well-being and interest of the client.
What is an appropriate method for maintaining confidentiality of private information?
What is an appropriate method for maintaining confidentiality of private information obtained from human subjects?
Keeping data in a password-protected database
. Storing data in a secured cabinet. Coding data or specimens and keeping the key to the code in a separate location.
Which is a required element of the informed consent form?
The consent form must
contain information to allow the subject to make an informed decision about participation in a clinical investigation
(see section III, FDA Informed Consent Requirements and Discussion). (21 CFR 50.20 and 21 CFR 50.25.)
Is it ethical to use deceptive methods in research when the scientific goals of the project can be achieved by non deceptive methods?
It is ethical to use deceptive methods in research when the scientific goals of the project can be achieved by
non-deceptive methods
.
How long does it take to Unblind clinical trial?
The timing is
usually 15 calendar days
with the clock start the same as the clock start for the FDA report. So this is a bit nebulous; it suggests that all initial reports should be sent to all investigators though it is not explicit about unblinding.
Why is equipoise important in clinical trials?
Clinical equipoise
allows investigators to continue a trial until they have enough statistical evidence to convince other experts of the validity of their results
, without a loss of ethical integrity on the part of the investigators.
