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Speaker 1: Welcome back everyone. Today, we'll continue on our study. Guy.

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We're gonna elaborate on the four core principles from the

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Belmont Report, autonomy, beneficence, non maleficence, and justice, and we'll

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detail a little bit of informed consent processes, protections for

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vulnerable populations, confidentiality safeguards, and IRV functions. So we're gonna

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start off with some of the definitions and examples of them.

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As I mentioned, autonomy, beneficence, non maleficence, and justice are imbortant.

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These are Belmont derived principles. Autonomies respect for persons of

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self determining agents who possess the right to make informed,

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voluntary decisions about research participation. So this includes full disclosure

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of relevant information, absence of corrision, capacity assessment, and the

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ongoing ability to withdraw at any time without penalty. So

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a clinical example is a longitudinal study examining the long

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term effects of childhood trauma on adult attachment patterns. The

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researcher provides potential participants with a detailed information sheet covering

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all procedures, risks such as emotional distress, benefits, and their

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unconditional rights to discontinued participation. Midsession even after signing consent

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while confirming understanding through teach back methods. So again, that's

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the autonomy component right, respecting the for persons of self

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determining agents who possess the right to make informed, voluntary

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decisions about research participation, beneficence is the obligation to maximize

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potential benefits, whether direct access to innovative treatment, for instance,

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or indirect contributing to scientific knowledge that may help future

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clients while actively promoting participant welfare and well being. An

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example would be designing a randomized control try of a

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novel mindfulness intervention for anxiety disorders in primary care settings.

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Investigators incorporate participant feedback loops, monitor for positive outcomes, and

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design the protocol to offer continued access to effective components

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for the control group post study. Non Maleficence is the

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ethical duty to avoid causing harm physically, emotionally, socially or

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legally through proactive risk minimization, careful proparation for potential distress,

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and establishment of clear referral pathways. So, in a study

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exploring disassociative symptoms among survivors of IPv, researchers implement pre

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screening for acute safety concerns, provide on site crisis counseling, availability,

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trained staff, and trauma informed responses, and insuring media referrals

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to community mental health resources. Another one is justice, the

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principle requiring fair and equitable selection of participants along with

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an equitable distribution of research burdens and benefits. This prohibits

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exploiting vulnerable groups for convenience or systematically excluding marginalized populations.

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A researcher investigating culturally tailored cognitive behavioral interventions for depression

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deliberately recruits from diverse community health centers serving low income

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and ethnic minority populations rather than limiting the sample to

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readily available university students, ensuring that the burdens of participation

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of potential benefits of new treatments are distributed more equitably.

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Let's look at informed consent and ongoing relational process of

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clear communication, in which participants receive and comprehend comprehensive information

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about the studies, purpose, duration, procedures, or even the therapy involved.

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Right clinical example, prior to initiating a study on family

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communication patterns and households with a parent diagnosed with schizophrenia,

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the investigator conducts A thorough consent discussion uses visual aids

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and simplified summaries for participants with varying literacy levels, verifies

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comprehension by asking participants to explain key elements in their

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own words, and provides ongoing opportunities to ask questions or

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withdrawal as esthetic progresses. Vulnerable populations. Remember, all these ethics

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are for research groups requiring heightened protections due to diminished autonomy,

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increase risk of coercion, or heightened vulnerability to exploitation. Common

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examples include children, prisoners, cognitively implayed individuals, pregnant women, and

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other marginalized groups. These often necessitate surrogate consent, additional safeguards

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and IRB scrutiny. An examples and an indevelopmental study of

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executive functioning and adolescents involved in the juvenile justice system,

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researchers secure both parental and guardian consent and developmentally appropriate

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adolescent assent design procedures to minimize coersion, give the participants

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limited freedom, and ensure the research directly relates to improving

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conditions for incarcerated youth. Confidentiality in privacy, it's the ethical

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and legal obligation to protect participant identity and data integrity

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through methods such as de identification and anonymous making them anonymoisation,

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secure coding systems, encryption, and clear disclosure of any limits

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of confidentiality. So an example would be a team studying

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the psychological impact the workplace harassment employees, encrypted digital storage,

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separate key coding systems, and explicit consent language and forming

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participants the confidentiality where we breached only in cases of

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eminent harm or court ordered subpoenas which also address group

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level privacy risks. The IRB it's an independent, orb sized

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body responsible for reviewing, approving, monitoring, and ensuring ethical compliance

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in all human subjects research. IRBs evaluate participant protection, scientific merit,

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and regulatory adherent to three main levels, exempt, expedited, and

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full board. For example, a proposal for anonomous online survey

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examining burnout among licensed psychologists qualifies for exempt review due

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to minimal risk. In contrast, a clinical trial involving trauma,

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exposed veterans and potential deception elements undergoes full board review

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with requirements for detailed risk mitigation plans. Deception the intentional

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withholding a misrepresentation of information about the study's true purpose

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or procedures ethically permissible only when no feasible alternative exists

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and risks or minimum minimal, and scientific or societal benefits

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are substantial. Deception must never involved withholding information about risks

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or participant rights. Clinical example could be in a controlled

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lab investigation of implicit bias and helping behavior. Participants have

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told the study concerns perceptual tasks deception regarding the true hypothesis,

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but are fully debriefed afterward, offered the option to withdraw

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their data, and provided with resources exploiting and explaining the

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importance of the deception for valid measurement. Debriefing a prompt,

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thorough and educational post participation session that explains the study's

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true purpose, including any deception, clarifies withheld information, offers support

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resources for any distress, answers questions, and reaffirms participants' rights,

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such as data withdrawal. An example would be a study

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that temporarily induce small performance anxiety to examine coping strategies.

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The researcher conducts an immediate debriefing session, explain the methodology,

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normalizes participant experiences, provides contact information for follow up counseling

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and confirms that participants may request removal of their data

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from the data set. Ethical frameworks and regulations requires informed

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consent according to Standard H Standard eight requires informed consent,

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safeguards for deception, data accuracy, transparent authorship, and prohibits plagiarism.

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In fact, fabrication are unjustified withholding of data. Federal Regulation

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forty five CFR forty six the Common Rule the prior

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US law governing human subjects research. It defines minimal risk,

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establishes IRB structures and consent standards, and includes subparts offering

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special protections for pregnant women, prisoners, and children. RCR Responsible

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conduct of Research encompasses ethical integrity integrity throughout the research

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life cycle, including design, data collection, analysis and dissemination, while

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addressing conflicts of interest, a cure, accurate reporting, and appropriate

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acknowledgment of collaborators. So when evaluating research scenarios on the exam,

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systematically apply the four core principles. Was autonomy respected, were

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risks minimized and benefits maximized? Was participant selection just where confidentiality,

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protections and IRB oversight appropriately implemented. So again, the four

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keys for the Belmont is autonomy, beneficence, maleficence, and justice.

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That's it for now, folks,