Speaker 1: Welcome back everyone. Today, we'll continue on our study. Guy.
We're gonna elaborate on the four core principles from the
Belmont Report, autonomy, beneficence, non maleficence, and justice, and we'll
detail a little bit of informed consent processes, protections for
vulnerable populations, confidentiality safeguards, and IRV functions. So we're gonna
start off with some of the definitions and examples of them.
As I mentioned, autonomy, beneficence, non maleficence, and justice are imbortant.
These are Belmont derived principles. Autonomies respect for persons of
self determining agents who possess the right to make informed,
voluntary decisions about research participation. So this includes full disclosure
of relevant information, absence of corrision, capacity assessment, and the
ongoing ability to withdraw at any time without penalty. So
a clinical example is a longitudinal study examining the long
term effects of childhood trauma on adult attachment patterns. The
researcher provides potential participants with a detailed information sheet covering
all procedures, risks such as emotional distress, benefits, and their
unconditional rights to discontinued participation. Midsession even after signing consent
while confirming understanding through teach back methods. So again, that's
the autonomy component right, respecting the for persons of self
determining agents who possess the right to make informed, voluntary
decisions about research participation, beneficence is the obligation to maximize
potential benefits, whether direct access to innovative treatment, for instance,
or indirect contributing to scientific knowledge that may help future
clients while actively promoting participant welfare and well being. An
example would be designing a randomized control try of a
novel mindfulness intervention for anxiety disorders in primary care settings.
Investigators incorporate participant feedback loops, monitor for positive outcomes, and
design the protocol to offer continued access to effective components
for the control group post study. Non Maleficence is the
ethical duty to avoid causing harm physically, emotionally, socially or
legally through proactive risk minimization, careful proparation for potential distress,
and establishment of clear referral pathways. So, in a study
exploring disassociative symptoms among survivors of IPv, researchers implement pre
screening for acute safety concerns, provide on site crisis counseling, availability,
trained staff, and trauma informed responses, and insuring media referrals
to community mental health resources. Another one is justice, the
principle requiring fair and equitable selection of participants along with
an equitable distribution of research burdens and benefits. This prohibits
exploiting vulnerable groups for convenience or systematically excluding marginalized populations.
A researcher investigating culturally tailored cognitive behavioral interventions for depression
deliberately recruits from diverse community health centers serving low income
and ethnic minority populations rather than limiting the sample to
readily available university students, ensuring that the burdens of participation
of potential benefits of new treatments are distributed more equitably.
Let's look at informed consent and ongoing relational process of
clear communication, in which participants receive and comprehend comprehensive information
about the studies, purpose, duration, procedures, or even the therapy involved.
Right clinical example, prior to initiating a study on family
communication patterns and households with a parent diagnosed with schizophrenia,
the investigator conducts A thorough consent discussion uses visual aids
and simplified summaries for participants with varying literacy levels, verifies
comprehension by asking participants to explain key elements in their
own words, and provides ongoing opportunities to ask questions or
withdrawal as esthetic progresses. Vulnerable populations. Remember, all these ethics
are for research groups requiring heightened protections due to diminished autonomy,
increase risk of coercion, or heightened vulnerability to exploitation. Common
examples include children, prisoners, cognitively implayed individuals, pregnant women, and
other marginalized groups. These often necessitate surrogate consent, additional safeguards
and IRB scrutiny. An examples and an indevelopmental study of
executive functioning and adolescents involved in the juvenile justice system,
researchers secure both parental and guardian consent and developmentally appropriate
adolescent assent design procedures to minimize coersion, give the participants
limited freedom, and ensure the research directly relates to improving
conditions for incarcerated youth. Confidentiality in privacy, it's the ethical
and legal obligation to protect participant identity and data integrity
through methods such as de identification and anonymous making them anonymoisation,
secure coding systems, encryption, and clear disclosure of any limits
of confidentiality. So an example would be a team studying
the psychological impact the workplace harassment employees, encrypted digital storage,
separate key coding systems, and explicit consent language and forming
participants the confidentiality where we breached only in cases of
eminent harm or court ordered subpoenas which also address group
level privacy risks. The IRB it's an independent, orb sized
body responsible for reviewing, approving, monitoring, and ensuring ethical compliance
in all human subjects research. IRBs evaluate participant protection, scientific merit,
and regulatory adherent to three main levels, exempt, expedited, and
full board. For example, a proposal for anonomous online survey
examining burnout among licensed psychologists qualifies for exempt review due
to minimal risk. In contrast, a clinical trial involving trauma,
exposed veterans and potential deception elements undergoes full board review
with requirements for detailed risk mitigation plans. Deception the intentional
withholding a misrepresentation of information about the study's true purpose
or procedures ethically permissible only when no feasible alternative exists
and risks or minimum minimal, and scientific or societal benefits
are substantial. Deception must never involved withholding information about risks
or participant rights. Clinical example could be in a controlled
lab investigation of implicit bias and helping behavior. Participants have
told the study concerns perceptual tasks deception regarding the true hypothesis,
but are fully debriefed afterward, offered the option to withdraw
their data, and provided with resources exploiting and explaining the
importance of the deception for valid measurement. Debriefing a prompt,
thorough and educational post participation session that explains the study's
true purpose, including any deception, clarifies withheld information, offers support
resources for any distress, answers questions, and reaffirms participants' rights,
such as data withdrawal. An example would be a study
that temporarily induce small performance anxiety to examine coping strategies.
The researcher conducts an immediate debriefing session, explain the methodology,
normalizes participant experiences, provides contact information for follow up counseling
and confirms that participants may request removal of their data
from the data set. Ethical frameworks and regulations requires informed
consent according to Standard H Standard eight requires informed consent,
safeguards for deception, data accuracy, transparent authorship, and prohibits plagiarism.
In fact, fabrication are unjustified withholding of data. Federal Regulation
forty five CFR forty six the Common Rule the prior
US law governing human subjects research. It defines minimal risk,
establishes IRB structures and consent standards, and includes subparts offering
special protections for pregnant women, prisoners, and children. RCR Responsible
conduct of Research encompasses ethical integrity integrity throughout the research
life cycle, including design, data collection, analysis and dissemination, while
addressing conflicts of interest, a cure, accurate reporting, and appropriate
acknowledgment of collaborators. So when evaluating research scenarios on the exam,
systematically apply the four core principles. Was autonomy respected, were
risks minimized and benefits maximized? Was participant selection just where confidentiality,
protections and IRB oversight appropriately implemented. So again, the four
keys for the Belmont is autonomy, beneficence, maleficence, and justice.
That's it for now, folks,