scispace - formally typeset
Search or ask a question

What are the ethical considerations in conducting randomized controlled trials (RCTs) in research? 

Observational study
Conceptualization
Randomized controlled trial
Clinical trial
Discontinuation
Best insight from top research papers

Ethical considerations in conducting randomized controlled trials (RCTs) encompass various aspects. RCTs in development economics often violate ethical principles, such as local law adherence and accountability for adverse events . In the field of human-animal interaction, unique considerations like ethical concerns, control groups, and transparent reporting are crucial for RCTs evaluating animal-assisted interventions . Ethical obligations bind counselors to implement RCTs for evidence-based interventions in child and adolescent counseling, emphasizing the importance of rigorous research methods . The ethical dilemma of leaving treatment choice to chance in RCTs is justified by the concept of 'clinical equipoise,' although new therapeutic modalities challenge this notion . Additionally, the incomplete publication of RCTs raises ethical and financial concerns, impacting patient safety and healthcare resource allocation .

Answers from top 5 papers

More filters
Papers (5)Insight
Open access•Journal Article•DOI
431 An Observational Analysis of Randomized Controlled Trials (RCTs) Discontinuation and Non-Publication in Spine Disease
Jakov Tiefenbach, Andreas K. Demetriades, Jay J. Park 
01 Apr 2023-Neurosurgery
Ethical considerations in RCTs include trial discontinuation, non-publication, and under-reporting, impacting patient safety, resource wastage, and evidence distortion, necessitating improved completion and publication rates.
Open access•Journal Article•DOI
The Randomised Controlled Trial at the Intersection of Research Ethics and Innovation
Torbjörn Callréus
25 Jul 2022-Pharmaceutical medicine
Ethical considerations in RCTs include the dilemma of randomization based on 'clinical equipoise,' ensuring no consensus on treatment superiority within the expert community, supporting the ethical grounds for conducting RCTs.
Journal Article•DOI
The Randomized Controlled Trial and Child Counseling Interventions: The Why and the How
Dee C. Ray
16 May 2023-Journal of child and adolescent counseling
Ethical considerations in RCTs involve counselors ensuring interventions are evidence-based, following rigorous research methods, and upholding ethical standards in child counseling research.
Open access•Journal Article•DOI
Complexities and considerations in conducting animal-assisted intervention research: A discussion of randomized controlled trials
Kerri E. Rodriguez, Freya L. L. Green, John-Tyler Binfet, L H Townsend, Nancy R. Gee 
17 Feb 2023
Ethical considerations in RCTs for animal-assisted interventions include ensuring participant welfare, informed consent, and minimizing biases to uphold research integrity and participant protection.
Journal Article•DOI
Some questions of ethics in randomized controlled trials
Reetika Khera
26 May 2023-Review of Development Economics
1 Citations
Ethical considerations in RCTs include adherence to Belmont principles, local laws, accountability for adverse events, and the disproportionate influence on research agendas and policy, with inadequate safeguards.

Related Questions

What are the ethical conciderations with rcts?5 answersEthical considerations in Randomized Controlled Trials (RCTs) encompass various aspects such as violations of local laws, inadequate frameworks like the Belmont Report, and issues like informed consent, data harms, and human costs to research participants and staff. Pragmatic RCTs present unique challenges related to usual care understanding, informed consent, and the need for newer consent models to enhance comprehension. Additionally, ethical and medical ethics issues in pragmatic RCTs involve research-practice distinction, vulnerable populations, oversight, regulatory frameworks, and conflicts of interest. These concerns highlight the critical need for robust ethical guidelines, improved consent processes, and a deeper understanding of the implications of RCTs on human subjects and policy decisions.
What are ethical considerations in research?5 answersEthical considerations in research involve adhering to a proper code of conduct to minimize harm to research participants and protect their rights. This includes obtaining informed consent from volunteers, maintaining confidentiality and anonymity, and protecting the well-being of vulnerable populations such as children and neurologically injured patients. Regulatory bodies like Institutional Review Boards play a critical role in reviewing and ensuring the ethical considerations of research protocols. In social change research, researchers have an obligation to obtain informed consent and maintain confidentiality, while also considering the potential risks and benefits to all stakeholders. Additionally, cultural, social, economic, and political contexts can complicate the application of ethical standards in research involving children, highlighting the importance of considering their opinions, involvement, and emotional well-being.
What are ethical considerations for research study?5 answersEthical considerations for research studies include obtaining informed consent from participants, ensuring confidentiality and anonymity, minimizing risks of harm, and protecting the rights of vulnerable populations.The principle of informed consent requires that participants have access to relevant information, make voluntary decisions, and have the capacity to consent.Confidentiality and anonymity are important to protect participants from potential harm or malfeasance.Vulnerable populations, such as children and neurologically injured patients, require special ethical considerations, including surrogate consent and waiver of informed consent.Additionally, the fair distribution of research harms and benefits is a key ethical principle, ensuring that research is socially valuable and does not exploit participants.Overall, ethical conduct in research involves upholding moral codes of conduct, minimizing risks, and protecting the rights and well-being of participants.
What are ethical considerations in research ?5 answersEthical considerations in research encompass obtaining informed consent, maintaining confidentiality, minimizing risks of harm to participants, and ensuring the safety and well-being of the subjects. These considerations are crucial in various types of research, including clinical trials, social change research, and studies involving children. Regulatory bodies and ethical principles play a critical role in protecting human participants and upholding ethical standards in research. Additionally, the interplay of cultural, social, economic, and political contexts can complicate adhering to ethical standards and protocols, especially when conducting research with vulnerable populations such as children.
What are the ethical considerations in clinical trials?5 answersEthical considerations in clinical trials include the protection of participants' rights, safety, and well-being, as well as the promotion of potential benefits of ethical research. Informed consent is a crucial requirement for ethical clinical research, but it is not the only one. Other specific requirements include social or scientific value, scientific validity, fair subject selection, favorable risk/benefit ratio, independent review, and respect for enrolled participants. Placebo use in clinical trials is a debated topic, especially when effective treatments already exist. The use of placebos in vaccine efficacy trials for pregnant women is ethically questionable due to the potential harm and the availability of effective vaccines. Additionally, the genetic analysis of samples collected in clinical trials should be restricted to the main objectives or well-justified goals to protect patients' privacy and prevent misuse of genetic information. Overall, research committees play a crucial role in ensuring ethical standards are met in clinical research.
What are some ethical considerations when conducting research?3 answersEthical considerations when conducting research include issues such as deception, coercion, self-determination, physical or mental stress, and maintaining confidentiality. Informed consent, confidentiality, and protecting the study participants are important principles to ensure ethical conduct in research. Researchers must also respect the autonomy and privacy of research participants, ensure benefits and minimize risks for participants, and be honest in disclosing results. When studying sensitive topics like stereotypes and stereotypical reasoning, researchers need to be aware of the potential harm to individuals or groups and weigh the purpose of the study against this harm. Additionally, the role of institutional review boards and codes of ethics are important in ensuring ethical research practices. Overall, researchers need to be conscious and responsible in applying ethical principles in their research.

See what other people are reading

What are the benefits of budgeting when making family recipes?
5 answers
Budgeting plays a crucial role in enhancing family recipes by promoting financial planning and healthy eating habits. Financial planning, as highlighted in, aids in decision-making for families, ensuring better financial behavior and wealth building. Additionally, budgeting, as discussed inand, serves as a sustainable mechanism for effective cost management, enabling enterprises to make informed decisions and optimize resources. Moreover, adapting evidence-based healthy food budgeting programs, as mentioned in, can improve diet quality and cooking skills in underserved populations, such as American Indian communities. By incorporating budgeting principles into family recipes, individuals can not only manage their finances efficiently but also promote healthier eating habits, ultimately leading to improved overall well-being.Can music therapy go wrong for people with dementia?
5 answers
Music therapy has shown positive outcomes for individuals with dementia. However, it is essential to consider potential challenges. While music therapy is generally beneficial, there can be instances where it may not yield the desired results for individuals with dementia. Factors such as the appropriateness of music selection, the individual's response to the therapy, and the skill of the therapist can influence the effectiveness of the intervention. Additionally, the progression of dementia and individual preferences must be taken into account to ensure the therapy's success. Therefore, while music therapy is a valuable tool for enhancing the well-being of individuals with dementia, careful consideration of various factors is crucial to prevent any potential negative outcomes.How understand networking and complex systems can help achieved sustainability?
5 answers
Understanding networking and complex systems is crucial for achieving sustainability. By utilizing a network-based approach, such as constructing multiplex networks to analyze interactions among Sustainable Development Goals (SDGs), we can unveil new aspects of sustainability and develop decision support systems for SDG achievement strategies. Recognizing the interconnected nature of complex systems, like ecosystems and technological infrastructures, is essential for addressing sustainability challenges. Systems must regulate activities internally and externally to remain 'fit' and sustainable, requiring adaptivity, evolvability, and a hierarchical cybernetic governance subsystem. By supporting the activity of specific nodes in a network, unsustainable systems can be transformed into sustainable ones, emphasizing the importance of external interventions and network connectivity for sustainability.Theories about experiential learnings?
5 answers
Experiential learning theories, such as Kolb's Experiential Learning Theory (ELT), emphasize that knowledge is created through experiences and reflection. Kolb's model of ELT includes the concept of learning styles, where individuals have preferred styles for acquiring knowledge and problem-solving, which can be identified through assessments like the Learning Style Inventory. The learning process in ELT involves four stages: concrete experience, reflective observation, abstract conceptualization, and active experimentation, facilitating a holistic learning approach. This theory has been widely applied in various educational settings, including mathematics education in Cartesian coordinates and clinical education in medical colleges, enhancing students' ability to internalize, process, and apply new information effectively.What are the best group interventions to lose weight?
5 answers
Group interventions have shown to be more effective than individual approaches for weight loss. Studies indicate that group-based multi-component lifestyle interventions lead to greater weight loss outcomes compared to one-to-one interventions, with participants more likely to achieve ≥5% weight loss. Additionally, culturally tailored group interventions have demonstrated promising results in improving dietary behaviors among specific populations. Furthermore, group-based lifestyle programs have been effective in promoting ovulation, improving PCOS-related quality of life, and achieving clinically relevant weight loss in women with PCOS. In a South African study, facility-based therapeutic group interventions were more successful in reducing weight, enhancing physical activity, and advancing participants to the action stage of change compared to usual care.How do social media platforms contribute to the rise of cyberbullying among adolescents?
5 answers
Social media platforms significantly contribute to the escalation of cyberbullying among adolescents. The widespread use of social media exposes adolescents to increased risks of cyberbullying victimization. The emergence of new media violence, including cyberbullying, has negatively impacted the credibility of the media industry. Studies have shown that cyberbullying statistics for 2022 reveal a disturbingly high incidence of harassment, with victims being more prone to self-harm and suicidal thoughts as coping mechanisms. Adolescents often face cyberbullying on platforms like Facebook and Twitter, leading to anxiety, sadness, stress, and depression. Efforts to address cyberbullying involve collaborative strategies among parents, teachers, and students, emphasizing the need for a supportive environment and psychological adjustment programs.How does bed positioning affect the severity of obstructive sleep apnea (OSA)?
5 answers
Bed positioning plays a crucial role in affecting the severity of obstructive sleep apnea (OSA). Studies have shown that positional obstructive sleep apnea (POSA) is prevalent in both adultsand children. Positional therapy (PT) in non-supine sleeping positions has been found to significantly reduce OSA severity, making it a viable low-cost and non-invasive intervention. Additionally, the use of intelligent sleep apnea beds (ISABel) has been explored, showing that tilting beds can potentially reduce supine AHI and prolong the time to the next apnea/hypopnea event. Furthermore, in severe cases of positional obstructive sleep apnea syndrome (POSAS), mandibular advancement devices (MADs) have been effective in reducing AHI and improving quality of life, serving as an alternative to CPAP therapy.How address forms are used with elders in Australia?
5 answers
Address forms used with elders in Australia are influenced by status and solidarity dimensions of talk, as discussed in the research papers. In Australian tribes, strict conventions govern the use of personal names, with limitations on when they can be used, indicating a complex system of addressing and referring to individuals. The analysis of geropsychological research in Australia highlights the growing need for quality research to inform psychological practice, emphasizing the importance of psychologists' training including a stronger focus on aging. Paid newspaper advertisements have been found to generate the best response, showcasing the effectiveness of certain communication methods in reaching out to older populations.What is inference based therapy?
5 answers
Inference-Based Therapy (IBT) is a specialized psychological treatment approach that focuses on strengthening reality-based reasoning and correcting dysfunctional reasoning underlying symptoms like obsessive-compulsive disorder (OCD). IBT aims to reduce symptoms by addressing doubts and ego-syntonic values, such as in hoarding disorder, through exposure to the self-sabotaging nature of the hoarding-self. This therapy involves a computational process guided by the therapist, which helps render hidden causes of behavior conscious and facilitates memory re-consolidation to resolve symptoms. IBT has shown effectiveness in reducing OCD symptoms across various subtypes, even in treatment-resistant cases, with significant improvements in overvalued ideation and general OCD severity. Additionally, IBT has been adapted for self-help administration, showing promising results in reducing obsessions and compulsions in OCD patients.How is inference based therapy different from other therapies?
5 answers
Inference-Based Therapy (IBT) stands out from other therapies due to its focus on strengthening reality-based reasoning and correcting dysfunctional reasoning that gives rise to symptoms. IBT is an empirically derived experiential psychotherapy based on Psychological Constructivism, viewing symptoms as outputs from implicit models of the world. It involves therapist-guided Active Inference to render hidden causes of behavior conscious, aiding in memory re-consolidation and symptom resolution. IBT has shown effectiveness across various obsessive-compulsive disorder (OCD) subtypes and treatment-resistant cases, with significant reductions in symptom severity and overvalued ideation. Additionally, IBT has been adapted for self-help administration, demonstrating modest but significant symptom decline in OCD patients. This therapy's unique approach and positive outcomes make it a valuable alternative for individuals with OCD and potentially other conditions requiring cognitive restructuring and reality-based reasoning.What are the potential health effects of heatwaves on the fetus in the first trimester of pregnancy?
5 answers
Exposure to heatwaves during the first trimester of pregnancy can lead to adverse health effects on the fetus. Studies have shown that high ambient temperatures can increase the risk of adverse pregnancy outcomes such as preterm birth, stillbirth, low birth weight, and congenital abnormalities. The physiological mechanisms underlying these associations include reduced placental blood flow, dehydration, and inflammatory responses that may trigger preterm birth. Heat stress caused by elevated temperatures can disrupt hormonal regulation and impact the endocrine system, potentially affecting successful pregnancy progression and fetal development. Gestational heat exposure is considered a teratogen, with evidence suggesting that human pregnancies are vulnerable to extreme heat, particularly in the context of climate change.