The work in this paper is based on primary research on how to obtain informed consent to medical treatment and or procedure among patients;this study was carried out in Papua New Guinea in both urban and rural health ...The work in this paper is based on primary research on how to obtain informed consent to medical treatment and or procedure among patients;this study was carried out in Papua New Guinea in both urban and rural health settings across customs,cultures,and languages in two provinces,on the basis of qualitative interviews with healthcare professionals including doctors,nurses,other healthcare workers,patients,and traditional healers.We emphasize the views of consent with participants of customs,cultural,and languages regarding informed consent.There are factors between peoples of differing circumstances which can greatly alter how they view consent.Some groups would involve people in the decision-making process that may not traditionally be involved in the decision making of a medical decision.Other groups may dislike certain medical procedures as in Papua New Guinea(PNG).And certain people have different views on what should be disclosed of the patient’s condition.Customs,cultures,and languages are common phenomena which continue to affect the daily lives of many thousands of people.It is unclear in PNG about the characteristics of customs,culture,and language on health care because there is no published information on informed consent and issues that affect the making of informed consent.展开更多
BACKGROUND Brain-computer interface(BCI)technology is rapidly advancing in psychiatry.Informed consent competency(ICC)assessment among psychiatric patients is a pivotal concern in clinical research.AIM To analyze the ...BACKGROUND Brain-computer interface(BCI)technology is rapidly advancing in psychiatry.Informed consent competency(ICC)assessment among psychiatric patients is a pivotal concern in clinical research.AIM To analyze the assessment of ICC and form a framework with multi-dimensional elements involved in ICC of BCI clinical research among psychiatric disorders.METHODS A systematic review of studies regarding ICC assessments of BCI clinical research in patients with six kinds of psychiatric disorders was conducted.A systematic literature search was performed using PubMed,ScienceDirect,and Web of Science.Peer-reviewed articles and full-text studies were included in the analysis.There were no date restrictions,and all studies published up to February 27,2025,were included.RESULTS A total of 103 studies were selected for this review.Fifty-eight studies included ICC factors,and forty-five were classified in ICC related ethical issues of BCI research in six kinds of psychiatric disorders.Executive function impairment is widely recognized as the most significant factor impacting ICC,and processing speed deficits are observed in schizophrenia,mood disorders,and Alzheimer’s disease.Memory dysfunction,particularly episodic and working memory,contributes to compromised ICC.Five core ethical issues in BCI research should be addressed:BCI specificity,vulnerability,autonomy,dynamic ICC,comprehensiveness,and uncertainty.CONCLUSION A Five-Dimensional evaluative framework,including clinical,ethical,sociocultural,legal,and procedural dimensions,is constructed and proposed for future ICC research in BCI clinical research involving psychiatric disorders.展开更多
The major challenges militating against the proper practice of informed consent identified in our desk top review are related to cultural issues of the people.Many patients continue to value strongly their kinship tie...The major challenges militating against the proper practice of informed consent identified in our desk top review are related to cultural issues of the people.Many patients continue to value strongly their kinship ties with the past and believe in the traditional methods of healing sickness.The patients must be given some information about what the doctor proposes to do.The underlying spirit of informed consent is new in PNG,and it strives against the traditional attitudes of doctors that they know it best for the patients and the strong culture in customs and patients’misconceptions that affect their perceptions in making important health care decisions.Majority of the patients have some notion of informed consent,however not many people understand what it is.They still hang onto their traditional customs,beliefs and opinions that affect their health care decisions;they often look to their village elders,family and parents for advice in times of sickness or death in the family but where the law implies consent it is not often obtained.Summarization of current laws,reports of legal cases,and personal experiences were examined.Special requirements must be prescribed when patients are subjected to medical treatment.Documentation of a well-defined process,not only on paper,may not only protect the medical doctor from exposure to liability but increases the patient’s autonomy in decisions concerning health and encourages compliance with treatment;and advances the interests of both patient and doctor.Lack of informed consent can reinforce a claim of medical malpractice,and could well undermine relevant health care policy to protect patient autonomy.展开更多
BACKGROUND Hip fractures are the most common reason for inpatient orthopaedic trauma admission.Urgent surgical intervention for hip fractures has remained a clinical priority throughout the coronavirus disease 2019(CO...BACKGROUND Hip fractures are the most common reason for inpatient orthopaedic trauma admission.Urgent surgical intervention for hip fractures has remained a clinical priority throughout the coronavirus disease 2019(COVID-19)pandemic.Despite this,there is a paucity of clinical guidance addressing the informed consent process for hip fracture surgery in COVID-19 positive patients.This is of paramount medicolegal importance in a high-risk patient population.AIM To quantify the additional perioperative risks for COVID-19 positive patients undergoing hip fracture surgery and provide clinicians with an evidence-based framework to establish an informed consent process.METHODS Two hundred and fifty nine consecutive patients undergoing surgical intervention for hip fractures in four hospitals in the United Kingdom were recruited.51 patients were confirmed positive for COVID-19.Predefined outcomes were analyzed over a 30-d postoperative period.COVID-19 positive and COVID-19 negative patients were compared after adjustment for confounding factors.RESULTS COVID-19 positive patients had more intensive care admissions(27%vs 5%,P<0.001),longer inpatient stays(median 23 d vs 9 d,P<0.001)and a higher 30-d mortality(29%vs 10%,P=0.001)than COVID-19 negative patients.Postoperative complications were evident in 74.5%of COVID-19 positive patients.35.3%of COVID-19 positive patients suffered postoperative lower respiratory tract infections with 13.7%developing acute respiratory distress syndrome(ARDS)and 9.8%experiencing symptomatic thromboembolic events.CONCLUSION The COVID-19 pandemic has created uncertainty in the medical community worldwide and poses unique challenges in providing informed consent for surgery.COVID-19 positive patients undergoing hip fracture surgery should be consented for the additional risk of postoperative complications(including lower respiratory tract infection,ARDS,deep vein thrombosis and pulmonary embolism),increased requirement for intensive care admission,longer inpatient stay and higher risk of mortality.Further,clinicians must be transparent about the potential for unknown risks as research into the long-term surgical outcomes of COVID-19 positive patients continues to evolve.展开更多
Recent advancements in next generation sequencing have allowed for genetic information become more readily available in the clinical setting for those affected by cancer and by treating clinicians.Given the lack of ac...Recent advancements in next generation sequencing have allowed for genetic information become more readily available in the clinical setting for those affected by cancer and by treating clinicians.Given the lack of access to geneticists,medical oncologists and other treating physicians have begun ordering and interpreting genetic tests for individuals with cancer through the process of"mainstreaming".While this process has allowed for quicker access to genetic tests,the process of"mainstreaming"has also brought several challenges including the dissemination of variants of unknown significance results,ordering of appropriate tests,and accurate interpretation of genetic results with appropriate followup testing and interventions.In this editorial,we seek to explore the process of informed consent of individuals before obtaining genetic testing and offer potential solutions to optimize the informed consent process including categorization of results as well as a layered consent model.展开更多
Biological residual materials can be obtained from surgical activities or from pathological waste material collected for analysis and stored in formalin. This material can be stored in biobanks with the purpose of fut...Biological residual materials can be obtained from surgical activities or from pathological waste material collected for analysis and stored in formalin. This material can be stored in biobanks with the purpose of future research. Formalin-fixed tissue and also formalin-fixed paraffin embedded tissues are not suitable for all kinds of genetic studies on DNA or RNA, as formalin solution is well known for damaging nucleic acids. Therefore, for the purpose of conducting genetic studies, samples should be frozen in order to maintain a good quality of DNA/RNA over time Biobanks, in which waste samples are frozen, are undoubtedly expensive to maintain; however, it could be useful and important to consider their possible implication in particular research, regarding for example the tumor cells growth process, or when the procurement of samples is difficult. Regarding the relationship between informed consent and tissue collection, storage and research, two choices are possible： irreversible or reversible sample anonymization. These procedures involve different approaches and possible solutions that we will seek to define. Also, an important ethical aspect in regard to the role of biobanks is encouraging sample donation. For donors, seeing human sample being kept rather than discarded and seeing them become useful for research highlight the importance of the human body and improve the attitude towards donation. This process might also facilitate the giving of informed consent more trustfully and willingly.展开更多
Introduction: Informed consent is a process that enshrines respect for patients’ autonomy, their dignity, and their rights to determine what happens to their own bodies. We set out to describe the surgical informed c...Introduction: Informed consent is a process that enshrines respect for patients’ autonomy, their dignity, and their rights to determine what happens to their own bodies. We set out to describe the surgical informed consent process and evaluate its quality in patients undergoing elective gynaecological surgeries in two University Teaching Hospitals in Yaounde, Cameroon. Methods: This was a cross-sectional, prospective study over 9 month period, from October 1<sup>st</sup>, 2018, to June 30<sup>th</sup>, 2019 at the Yaounde Gynaeco-Obstetric and Paediatric Hospital (YGOPH) and the Yaounde Central Hospital (YCH). By administering a modified Brezis questionnaire 48 hours after surgery, we obtained data which enabled us to evaluate and score the informed consent process and obtained written reports of patients’ appreciation of key aspects of the informed consent process prior to surgery. We then called each participant 6 months after their surgery date to obtain information on the occurrence or not of post-operative complications. Results: We recruited 72 patients aged 24 to 68 years old (61 at YGOPH, 11 at YCH). The operating gynaecologist sought patient consent in 65.3% (49/72) of cases, while 61.1% (44/72) of the subjects would have loved to have more information on surgical risks;69.4% (50/72) were satisfied with the consent process;and 56.9% (41/72) could recall and repeat the information they received prior to surgery. While 37.5% (27/72) had poor quality (non-valid consent), 40.3% had good quality consent (valid). Consent administered by the gynaecologist (OR = 0.172;95% CI = 0.060 - 0.049) was a strong determinant of valid consent. Also, patients with non-valid consent significantly reported more complications (OR = 4.469;95% CI = 1.412 - 14.147) than those with valid consent. Conclusion: Informed consent prior to elective gynaecological surgeries in our study was poor. The timing of the consent process, as well as the person involved in the process affect the validity of the consent.展开更多
In this study,we are discussing the rationale behind informed consent in clinical trials in developing countries.It elaborates how informed consent has remained an ethical and practical issue.Poverty,endemic diseases,...In this study,we are discussing the rationale behind informed consent in clinical trials in developing countries.It elaborates how informed consent has remained an ethical and practical issue.Poverty,endemic diseases,and a lack of investment in healthcare systems influence the ease of conducting and selecting trials that can benefit the people of developing countries.Differences in cultural perspectives,religious beliefs,a lack of formal training for clinical staff,children,time zone difference,literacy,vulnerable population,and language barriers for subject enrollment,protection,and informed are also challenges.This report doesn’t only highlight the right the wrongs of the past or reiterate cases where clinical trials have hurt subjects in developing countries.The current study investigates the conditions of human research in developing countries to make them more ethically sound.The extends proposals to investigators,scientists,governments,sponsors,and other groups who are interested where appropriate.展开更多
The “informed consent principle” in human clinical trials is the product of the extension of the concept of human rights in the field of human trials and a reflection of the progress of human civilization in biomedi...The “informed consent principle” in human clinical trials is the product of the extension of the concept of human rights in the field of human trials and a reflection of the progress of human civilization in biomedical research. In recent years, the legal protection of the right to informed consent for research subjects has been gradually improved in China. The right to informed consent for research subjects has been improved from an ethical norm to a legal norm. The legal status of legal norms has also been gradually improved. Based on the public law regulations, private law relief has been added to the legal relief system for the infringement of the right to informed consent for research subjects. As a result, the protection of rights has been enhanced. The domestic informed consent protection system is partially in line with international norms. The protection of the right to informed consent depends on the perfection of the legal system and the social consensus to respect human rights and the right to self-determination.展开更多
Guan Qiqian, a 42-year-old journalist in Yongqing of southeast China＇s Fujian Province, never expected his search for medical treatment of his psoriasis in 2000 ended up in hepatitis and uremia.
Translation of recent advances in stem cell research into clinical trials for restorative therapies for human disease is accelerating dramatically,with a strong focus upon neurodegenerative disorders such as Parkinson...Translation of recent advances in stem cell research into clinical trials for restorative therapies for human disease is accelerating dramatically,with a strong focus upon neurodegenerative disorders such as Parkinson’s disease（PD）,Huntington’s disease（HD）,and amyotrophic lateral sclerosis（ALS）.展开更多
Background:Informed consent has medicolegal implications and is imperative in presentday medical practice.Aims and Objectives:The objectives of this study were to estimate the awareness regarding informed consent in i...Background:Informed consent has medicolegal implications and is imperative in presentday medical practice.Aims and Objectives:The objectives of this study were to estimate the awareness regarding informed consent in interns and to determine the effectiveness of sessions in interns’orientation programs about informed consent.Materials and Methods:Pretest-Posttest study was conducted with a validated questionnaire distributed through Google Forms to interns attending the orientation program at our institute.Responses were recorded on the Likert scale(−2 to+2).Paired t-test was used to compare the mean pretest and posttest scores.The number of interns with a positive score(+1,+2)for every question in pretest and posttest were also compared.Results:One hundred and seventyone out of 232 interns who attended the program submitted both pretest and posttest responses.In the pretest,12 interns scored<50%and 46 interns scored more than 75%.A significant increase in posttest responses was seen in the mean score(P<0.001)and questions related to consent in research,radiological investigations,regarding the need for consent in the additional nonlifesaving procedure.There was an increase in the number of interns having a positive score(+1,+2)for all the questions in posttest as compared to pretest,but a statistically significant increase was seen in questions related to consent in ultrasound and need for consent in the additional nonlifesaving procedure.Conclusion:A wellstructured interns’orientation program is effective in improving awareness regarding consent.Certain gaps in knowledge regarding various aspects of consent need to be emphasized.展开更多
Background: With the development of globalization, the rising cost of clinical trials in Europe and the United States, and the huge drug consumption market in developing countries, multinational pharmaceutical giants ...Background: With the development of globalization, the rising cost of clinical trials in Europe and the United States, and the huge drug consumption market in developing countries, multinational pharmaceutical giants have set their sights on emerging developing countries. As a leader in developing countries, China has unparalleled advantages, so more and more clinical trials are registered and carried out in China. Objective: The objective of the study is to understand the current practice of informed consent in clinical trials in public hospitals in Xuzhou. Methods: In this study, a 15-question questionnaire was distributed to 369 subjects in the affiliated hospital of Xuzhou medical university. Each question was graded on a 3-point scale (1 = no, 2 = unsure, 3 = yes). The sum of the scores for the 15 questions represented the level of awareness of clinical trials. Results: Valid questionnaires were received from 300 subjects. A considerable number of subjects still had insufficient understanding of clinical trials, especially concerning the nature of clinical trials, understanding of informed consent forms, contact with researchers, and ethics committee. (The “yes” rate was around or below 50%). Factors associated with responses to the survey include education, occupation, and source of medical expenses. Conclusion: Overall, this study showed that the implementation of informed consent in China remained room for improvement. Legislators, ethics officers, and researchers should work together to protect the interests of subjects.展开更多
The legal and moral permissibility of clinical research entails that researchers must secure the voluntary,informed consent of prospective research participants before enrolling them in studies.In seeking the consent ...The legal and moral permissibility of clinical research entails that researchers must secure the voluntary,informed consent of prospective research participants before enrolling them in studies.In seeking the consent of potential participants,researchers are also allowed to incentivise the recruitment process because many studies would fail to meet enrollment goals without a financial incentive for participation.Some philosophers and bioethicists contend that the use of incentives to secure consent from research subjects is problematic because it constitutes undue inducement and a coercive offer.Some proponents of this view are Ruth Macklin(1981,1989)and Joan McGregor(2005).Macklin claims that it is ethically inappropriate to pay research subjects.The payment is likely to coerce the research subject,thereby violating the ethical requirement on the voluntariness of research participation.Also,such offers can prompt subjects to lie,deceive or conceal information that,if known,would disqualify them as participants.For McGregor,incentives could be undue and coercive because they make offerees better off relative to their baseline as well as constrain them to accept the offer of incentives as the only eligible choice or option.I argue that coercive offers are distinct from undue inducement.Coercive offers are essentially morally objectionable because by making people accept an offer through threats for the sake of some interests or ends,the offeror vitiates the offeree’s capacity to make informed,voluntary,and rational decisions and choices.I further claim that the quantity of an incentive does not render an inducement undue.I contend that the only condition under which incentives are regarded as an undue inducement and as such vitiates an agent’s voluntary consent is if they are offered through deceptive or manipulative means.展开更多
This article explores the ethical considerations surrounding the reporting of offlabel and experimental treatments in medical case reports,with a focus on fields such as oncology,psychiatry,and pediatrics.It emphasize...This article explores the ethical considerations surrounding the reporting of offlabel and experimental treatments in medical case reports,with a focus on fields such as oncology,psychiatry,and pediatrics.It emphasizes the balance between innovation and evidence-based medicine,highlighting the critical role of case reports in disseminating clinical experiences and advancing medical knowledge.The discussion delves into the ethical framework guiding case reporting,including principles of patient autonomy,informed consent,non-maleficence,beneficence,justice,and transparency.Challenges such as negative outcome reporting,commercial interests,and the balance between innovation and caution are examined.Recommendations for ethical vigilance,the development of comprehensive guidelines,and the role of regulatory bodies are proposed to ensure patient safety and uphold scientific integrity.The article concludes by underscoring the importance of a collaborative effort among clinicians,researchers,ethicists,and regulatory bodies to foster the responsible advancement of medical science while adhering to the highest ethical standards.展开更多
The Swiss-Ghana Amendments to the Basel Convention mark a significant milestone in global e-waste(electronic waste)management,requiring Prior Informed Consent(PIC)for all transboundary movements of Waste Electrical an...The Swiss-Ghana Amendments to the Basel Convention mark a significant milestone in global e-waste(electronic waste)management,requiring Prior Informed Consent(PIC)for all transboundary movements of Waste Electrical and Electronic Equipment(WEEE),regardless of their hazard classification.However,developing nations encounter substantial challenges in adhering to these amendments due to regulatory gaps,limited infrastructure,and an increasing influx of illicit e-waste imports.This study uses Malaysia as a case study to evaluate the readiness of developing nations to implement amendments,highlighting transferable solutions and recommendations.This study employs a mixedmethods approach that combines qualitative thematic analysis and bibliometric mapping to analyze academic literature,official reports,and international case studies.The findings reveal that while Malaysia has foundational policies in place,significant challenges remain in addressing informal recycling practices,improving enforcement mechanisms,and building the institutional capacity to implement PIC procedures effectively.This study identifies key areas for improvement,including regulatory reforms,infrastructure development,and enhanced monitoring systems.To address these issues,this study proposes a six-key Integrated Decision Framework that emphasizes legislative and regulatory updates,infrastructure development,international cooperation,capacity building and training,public awareness and engagement,and robust monitoring and enforcement mechanisms.Although tailored to Malaysia,the framework offers transferable solutions to align e-waste management systems with the Swiss-Ghana Amendments,providing a pathway for developing nations to strengthen regulatory readiness,mitigate environmental risks,and contribute to global sustainability.展开更多
The World Medical Association’s Declaration of Helsinki(DoH)serves as a key document of ethical guidance advocating principles of medical research involving human participants.Since its inception in 1964,the DoH has ...The World Medical Association’s Declaration of Helsinki(DoH)serves as a key document of ethical guidance advocating principles of medical research involving human participants.Since its inception in 1964,the DoH has undergone several revisions,reflecting a dynamic evolution in our understanding of research ethics,spurred by gaps identified within the document,harms discovered,challenges identified during ongoing research activities,scientific advancements and societal shifts in values.The DoH addresses a challenge and a conflict that may arise between two key aspects of medical research:On one hand,the fundamental obligation of physicians to do no harm,and on the other,the essential need to ensure the efficacy and safety of medical interventions by testing them on human research participants or healthy volunteers.With each revision,increasing emphasis is given to distributive justice and beneficence and not only to patient autonomy.Despite being a comprehensive and concise document,occasional criticism is reported,such as with regards to the impracticability of obtaining informed consent amongst other challenges.This essay will examine the key changes across the DoH's iterations,highlighting the progressive strengthening of participant protection and the evolving relationship between research,societal benefit,and individual rights.展开更多
The introduction of next-generation sequencing(NGS) technology in testing for hereditary cancer susceptibility allows testing of multiple cancer susceptibility genes simultaneously. While there are many potential bene...The introduction of next-generation sequencing(NGS) technology in testing for hereditary cancer susceptibility allows testing of multiple cancer susceptibility genes simultaneously. While there are many potential benefits to utilizing this technology in the hereditary cancer clinic, including efficiency of time and cost, there are also important limitations that must be considered. The best panel for the given clinical situation should be selected to minimize the number of variants of unknown significance. The inclusion in panels of low penetrance or newly identified genes without specific actionability can be problematic for interpretation.Genetic counselors are an essential part of the hereditary cancer risk assessment team, helping the medical team select the most appropriate test and interpret the often complex results. Genetic counselors obtain an extended family history, counsel patients on the available tests and the potential implications of results for themselves and their family members(pre-test counseling), explain to patients the implications of the test results(post-test counseling), and assist in testing family members at risk.展开更多
Our study describes the reported rate of the Institutional Review Board(IRB)approval,declaration of Helsinki(DoH),and informed consent in the case reports and case series and investigates factors associated with the e...Our study describes the reported rate of the Institutional Review Board(IRB)approval,declaration of Helsinki(DoH),and informed consent in the case reports and case series and investigates factors associated with the ethical approval report.We searched PubMed for case reports and case series from 2006 to 2017.Annually,we obtained the first 20 articles of a case report cluster from 20 distinct publications.This analysis initially contained at least 2400 papers,with 100 papers each study design and year.Only 26(5.4%)of 480 included studies reported IRB approval,DoH approval,and participant informed consent;58(12.1%)reported two out of three ethical statements(DoH,informed consent,IRB);and 151(31.5%)reported only one,leading to nearly 245 studies(51.0%)did not report any ethical approval item.Both clusters mentioned the DoH the least.Only years,ages,ethical item types,and cluster types were associated with ethical reporting practices.This study found the serious under‐reporting of ethical practices in both case reports and case series.展开更多
文摘The work in this paper is based on primary research on how to obtain informed consent to medical treatment and or procedure among patients;this study was carried out in Papua New Guinea in both urban and rural health settings across customs,cultures,and languages in two provinces,on the basis of qualitative interviews with healthcare professionals including doctors,nurses,other healthcare workers,patients,and traditional healers.We emphasize the views of consent with participants of customs,cultural,and languages regarding informed consent.There are factors between peoples of differing circumstances which can greatly alter how they view consent.Some groups would involve people in the decision-making process that may not traditionally be involved in the decision making of a medical decision.Other groups may dislike certain medical procedures as in Papua New Guinea(PNG).And certain people have different views on what should be disclosed of the patient’s condition.Customs,cultures,and languages are common phenomena which continue to affect the daily lives of many thousands of people.It is unclear in PNG about the characteristics of customs,culture,and language on health care because there is no published information on informed consent and issues that affect the making of informed consent.
基金Supported by the Ministry of Science and Technology of the People's Republic of China(2021ZD0201900)Project 5,No.2021ZD0201905Capital’s Funds for Health Improvement and Research,No.CFH 2022-2-4115.
文摘BACKGROUND Brain-computer interface(BCI)technology is rapidly advancing in psychiatry.Informed consent competency(ICC)assessment among psychiatric patients is a pivotal concern in clinical research.AIM To analyze the assessment of ICC and form a framework with multi-dimensional elements involved in ICC of BCI clinical research among psychiatric disorders.METHODS A systematic review of studies regarding ICC assessments of BCI clinical research in patients with six kinds of psychiatric disorders was conducted.A systematic literature search was performed using PubMed,ScienceDirect,and Web of Science.Peer-reviewed articles and full-text studies were included in the analysis.There were no date restrictions,and all studies published up to February 27,2025,were included.RESULTS A total of 103 studies were selected for this review.Fifty-eight studies included ICC factors,and forty-five were classified in ICC related ethical issues of BCI research in six kinds of psychiatric disorders.Executive function impairment is widely recognized as the most significant factor impacting ICC,and processing speed deficits are observed in schizophrenia,mood disorders,and Alzheimer’s disease.Memory dysfunction,particularly episodic and working memory,contributes to compromised ICC.Five core ethical issues in BCI research should be addressed:BCI specificity,vulnerability,autonomy,dynamic ICC,comprehensiveness,and uncertainty.CONCLUSION A Five-Dimensional evaluative framework,including clinical,ethical,sociocultural,legal,and procedural dimensions,is constructed and proposed for future ICC research in BCI clinical research involving psychiatric disorders.
文摘The major challenges militating against the proper practice of informed consent identified in our desk top review are related to cultural issues of the people.Many patients continue to value strongly their kinship ties with the past and believe in the traditional methods of healing sickness.The patients must be given some information about what the doctor proposes to do.The underlying spirit of informed consent is new in PNG,and it strives against the traditional attitudes of doctors that they know it best for the patients and the strong culture in customs and patients’misconceptions that affect their perceptions in making important health care decisions.Majority of the patients have some notion of informed consent,however not many people understand what it is.They still hang onto their traditional customs,beliefs and opinions that affect their health care decisions;they often look to their village elders,family and parents for advice in times of sickness or death in the family but where the law implies consent it is not often obtained.Summarization of current laws,reports of legal cases,and personal experiences were examined.Special requirements must be prescribed when patients are subjected to medical treatment.Documentation of a well-defined process,not only on paper,may not only protect the medical doctor from exposure to liability but increases the patient’s autonomy in decisions concerning health and encourages compliance with treatment;and advances the interests of both patient and doctor.Lack of informed consent can reinforce a claim of medical malpractice,and could well undermine relevant health care policy to protect patient autonomy.
文摘BACKGROUND Hip fractures are the most common reason for inpatient orthopaedic trauma admission.Urgent surgical intervention for hip fractures has remained a clinical priority throughout the coronavirus disease 2019(COVID-19)pandemic.Despite this,there is a paucity of clinical guidance addressing the informed consent process for hip fracture surgery in COVID-19 positive patients.This is of paramount medicolegal importance in a high-risk patient population.AIM To quantify the additional perioperative risks for COVID-19 positive patients undergoing hip fracture surgery and provide clinicians with an evidence-based framework to establish an informed consent process.METHODS Two hundred and fifty nine consecutive patients undergoing surgical intervention for hip fractures in four hospitals in the United Kingdom were recruited.51 patients were confirmed positive for COVID-19.Predefined outcomes were analyzed over a 30-d postoperative period.COVID-19 positive and COVID-19 negative patients were compared after adjustment for confounding factors.RESULTS COVID-19 positive patients had more intensive care admissions(27%vs 5%,P<0.001),longer inpatient stays(median 23 d vs 9 d,P<0.001)and a higher 30-d mortality(29%vs 10%,P=0.001)than COVID-19 negative patients.Postoperative complications were evident in 74.5%of COVID-19 positive patients.35.3%of COVID-19 positive patients suffered postoperative lower respiratory tract infections with 13.7%developing acute respiratory distress syndrome(ARDS)and 9.8%experiencing symptomatic thromboembolic events.CONCLUSION The COVID-19 pandemic has created uncertainty in the medical community worldwide and poses unique challenges in providing informed consent for surgery.COVID-19 positive patients undergoing hip fracture surgery should be consented for the additional risk of postoperative complications(including lower respiratory tract infection,ARDS,deep vein thrombosis and pulmonary embolism),increased requirement for intensive care admission,longer inpatient stay and higher risk of mortality.Further,clinicians must be transparent about the potential for unknown risks as research into the long-term surgical outcomes of COVID-19 positive patients continues to evolve.
文摘Recent advancements in next generation sequencing have allowed for genetic information become more readily available in the clinical setting for those affected by cancer and by treating clinicians.Given the lack of access to geneticists,medical oncologists and other treating physicians have begun ordering and interpreting genetic tests for individuals with cancer through the process of"mainstreaming".While this process has allowed for quicker access to genetic tests,the process of"mainstreaming"has also brought several challenges including the dissemination of variants of unknown significance results,ordering of appropriate tests,and accurate interpretation of genetic results with appropriate followup testing and interventions.In this editorial,we seek to explore the process of informed consent of individuals before obtaining genetic testing and offer potential solutions to optimize the informed consent process including categorization of results as well as a layered consent model.
文摘Biological residual materials can be obtained from surgical activities or from pathological waste material collected for analysis and stored in formalin. This material can be stored in biobanks with the purpose of future research. Formalin-fixed tissue and also formalin-fixed paraffin embedded tissues are not suitable for all kinds of genetic studies on DNA or RNA, as formalin solution is well known for damaging nucleic acids. Therefore, for the purpose of conducting genetic studies, samples should be frozen in order to maintain a good quality of DNA/RNA over time Biobanks, in which waste samples are frozen, are undoubtedly expensive to maintain; however, it could be useful and important to consider their possible implication in particular research, regarding for example the tumor cells growth process, or when the procurement of samples is difficult. Regarding the relationship between informed consent and tissue collection, storage and research, two choices are possible： irreversible or reversible sample anonymization. These procedures involve different approaches and possible solutions that we will seek to define. Also, an important ethical aspect in regard to the role of biobanks is encouraging sample donation. For donors, seeing human sample being kept rather than discarded and seeing them become useful for research highlight the importance of the human body and improve the attitude towards donation. This process might also facilitate the giving of informed consent more trustfully and willingly.
文摘Introduction: Informed consent is a process that enshrines respect for patients’ autonomy, their dignity, and their rights to determine what happens to their own bodies. We set out to describe the surgical informed consent process and evaluate its quality in patients undergoing elective gynaecological surgeries in two University Teaching Hospitals in Yaounde, Cameroon. Methods: This was a cross-sectional, prospective study over 9 month period, from October 1<sup>st</sup>, 2018, to June 30<sup>th</sup>, 2019 at the Yaounde Gynaeco-Obstetric and Paediatric Hospital (YGOPH) and the Yaounde Central Hospital (YCH). By administering a modified Brezis questionnaire 48 hours after surgery, we obtained data which enabled us to evaluate and score the informed consent process and obtained written reports of patients’ appreciation of key aspects of the informed consent process prior to surgery. We then called each participant 6 months after their surgery date to obtain information on the occurrence or not of post-operative complications. Results: We recruited 72 patients aged 24 to 68 years old (61 at YGOPH, 11 at YCH). The operating gynaecologist sought patient consent in 65.3% (49/72) of cases, while 61.1% (44/72) of the subjects would have loved to have more information on surgical risks;69.4% (50/72) were satisfied with the consent process;and 56.9% (41/72) could recall and repeat the information they received prior to surgery. While 37.5% (27/72) had poor quality (non-valid consent), 40.3% had good quality consent (valid). Consent administered by the gynaecologist (OR = 0.172;95% CI = 0.060 - 0.049) was a strong determinant of valid consent. Also, patients with non-valid consent significantly reported more complications (OR = 4.469;95% CI = 1.412 - 14.147) than those with valid consent. Conclusion: Informed consent prior to elective gynaecological surgeries in our study was poor. The timing of the consent process, as well as the person involved in the process affect the validity of the consent.
文摘In this study,we are discussing the rationale behind informed consent in clinical trials in developing countries.It elaborates how informed consent has remained an ethical and practical issue.Poverty,endemic diseases,and a lack of investment in healthcare systems influence the ease of conducting and selecting trials that can benefit the people of developing countries.Differences in cultural perspectives,religious beliefs,a lack of formal training for clinical staff,children,time zone difference,literacy,vulnerable population,and language barriers for subject enrollment,protection,and informed are also challenges.This report doesn’t only highlight the right the wrongs of the past or reiterate cases where clinical trials have hurt subjects in developing countries.The current study investigates the conditions of human research in developing countries to make them more ethically sound.The extends proposals to investigators,scientists,governments,sponsors,and other groups who are interested where appropriate.
文摘The “informed consent principle” in human clinical trials is the product of the extension of the concept of human rights in the field of human trials and a reflection of the progress of human civilization in biomedical research. In recent years, the legal protection of the right to informed consent for research subjects has been gradually improved in China. The right to informed consent for research subjects has been improved from an ethical norm to a legal norm. The legal status of legal norms has also been gradually improved. Based on the public law regulations, private law relief has been added to the legal relief system for the infringement of the right to informed consent for research subjects. As a result, the protection of rights has been enhanced. The domestic informed consent protection system is partially in line with international norms. The protection of the right to informed consent depends on the perfection of the legal system and the social consensus to respect human rights and the right to self-determination.
文摘Guan Qiqian, a 42-year-old journalist in Yongqing of southeast China＇s Fujian Province, never expected his search for medical treatment of his psoriasis in 2000 ended up in hepatitis and uremia.
基金Claire Henchcliffe receives grant support from:NYSTEMNIH/NINDS+1 种基金Inmaculada de Melo-Martín receives grant support from:NYSTEMsupported by the Solomon Family Foundation and CV Starr Foundation
文摘Translation of recent advances in stem cell research into clinical trials for restorative therapies for human disease is accelerating dramatically,with a strong focus upon neurodegenerative disorders such as Parkinson’s disease（PD）,Huntington’s disease（HD）,and amyotrophic lateral sclerosis（ALS）.
文摘Background:Informed consent has medicolegal implications and is imperative in presentday medical practice.Aims and Objectives:The objectives of this study were to estimate the awareness regarding informed consent in interns and to determine the effectiveness of sessions in interns’orientation programs about informed consent.Materials and Methods:Pretest-Posttest study was conducted with a validated questionnaire distributed through Google Forms to interns attending the orientation program at our institute.Responses were recorded on the Likert scale(−2 to+2).Paired t-test was used to compare the mean pretest and posttest scores.The number of interns with a positive score(+1,+2)for every question in pretest and posttest were also compared.Results:One hundred and seventyone out of 232 interns who attended the program submitted both pretest and posttest responses.In the pretest,12 interns scored<50%and 46 interns scored more than 75%.A significant increase in posttest responses was seen in the mean score(P<0.001)and questions related to consent in research,radiological investigations,regarding the need for consent in the additional nonlifesaving procedure.There was an increase in the number of interns having a positive score(+1,+2)for all the questions in posttest as compared to pretest,but a statistically significant increase was seen in questions related to consent in ultrasound and need for consent in the additional nonlifesaving procedure.Conclusion:A wellstructured interns’orientation program is effective in improving awareness regarding consent.Certain gaps in knowledge regarding various aspects of consent need to be emphasized.
文摘Background: With the development of globalization, the rising cost of clinical trials in Europe and the United States, and the huge drug consumption market in developing countries, multinational pharmaceutical giants have set their sights on emerging developing countries. As a leader in developing countries, China has unparalleled advantages, so more and more clinical trials are registered and carried out in China. Objective: The objective of the study is to understand the current practice of informed consent in clinical trials in public hospitals in Xuzhou. Methods: In this study, a 15-question questionnaire was distributed to 369 subjects in the affiliated hospital of Xuzhou medical university. Each question was graded on a 3-point scale (1 = no, 2 = unsure, 3 = yes). The sum of the scores for the 15 questions represented the level of awareness of clinical trials. Results: Valid questionnaires were received from 300 subjects. A considerable number of subjects still had insufficient understanding of clinical trials, especially concerning the nature of clinical trials, understanding of informed consent forms, contact with researchers, and ethics committee. (The “yes” rate was around or below 50%). Factors associated with responses to the survey include education, occupation, and source of medical expenses. Conclusion: Overall, this study showed that the implementation of informed consent in China remained room for improvement. Legislators, ethics officers, and researchers should work together to protect the interests of subjects.
文摘The legal and moral permissibility of clinical research entails that researchers must secure the voluntary,informed consent of prospective research participants before enrolling them in studies.In seeking the consent of potential participants,researchers are also allowed to incentivise the recruitment process because many studies would fail to meet enrollment goals without a financial incentive for participation.Some philosophers and bioethicists contend that the use of incentives to secure consent from research subjects is problematic because it constitutes undue inducement and a coercive offer.Some proponents of this view are Ruth Macklin(1981,1989)and Joan McGregor(2005).Macklin claims that it is ethically inappropriate to pay research subjects.The payment is likely to coerce the research subject,thereby violating the ethical requirement on the voluntariness of research participation.Also,such offers can prompt subjects to lie,deceive or conceal information that,if known,would disqualify them as participants.For McGregor,incentives could be undue and coercive because they make offerees better off relative to their baseline as well as constrain them to accept the offer of incentives as the only eligible choice or option.I argue that coercive offers are distinct from undue inducement.Coercive offers are essentially morally objectionable because by making people accept an offer through threats for the sake of some interests or ends,the offeror vitiates the offeree’s capacity to make informed,voluntary,and rational decisions and choices.I further claim that the quantity of an incentive does not render an inducement undue.I contend that the only condition under which incentives are regarded as an undue inducement and as such vitiates an agent’s voluntary consent is if they are offered through deceptive or manipulative means.
文摘This article explores the ethical considerations surrounding the reporting of offlabel and experimental treatments in medical case reports,with a focus on fields such as oncology,psychiatry,and pediatrics.It emphasizes the balance between innovation and evidence-based medicine,highlighting the critical role of case reports in disseminating clinical experiences and advancing medical knowledge.The discussion delves into the ethical framework guiding case reporting,including principles of patient autonomy,informed consent,non-maleficence,beneficence,justice,and transparency.Challenges such as negative outcome reporting,commercial interests,and the balance between innovation and caution are examined.Recommendations for ethical vigilance,the development of comprehensive guidelines,and the role of regulatory bodies are proposed to ensure patient safety and uphold scientific integrity.The article concludes by underscoring the importance of a collaborative effort among clinicians,researchers,ethicists,and regulatory bodies to foster the responsible advancement of medical science while adhering to the highest ethical standards.
基金support through an MTUN matching grant[Grant No.INDUSTRI(MTUN)/MEGATRAX/2024/FTKIP/I00089]supported by the Kesidang Scholarship awarded by UTeM to the main author.
文摘The Swiss-Ghana Amendments to the Basel Convention mark a significant milestone in global e-waste(electronic waste)management,requiring Prior Informed Consent(PIC)for all transboundary movements of Waste Electrical and Electronic Equipment(WEEE),regardless of their hazard classification.However,developing nations encounter substantial challenges in adhering to these amendments due to regulatory gaps,limited infrastructure,and an increasing influx of illicit e-waste imports.This study uses Malaysia as a case study to evaluate the readiness of developing nations to implement amendments,highlighting transferable solutions and recommendations.This study employs a mixedmethods approach that combines qualitative thematic analysis and bibliometric mapping to analyze academic literature,official reports,and international case studies.The findings reveal that while Malaysia has foundational policies in place,significant challenges remain in addressing informal recycling practices,improving enforcement mechanisms,and building the institutional capacity to implement PIC procedures effectively.This study identifies key areas for improvement,including regulatory reforms,infrastructure development,and enhanced monitoring systems.To address these issues,this study proposes a six-key Integrated Decision Framework that emphasizes legislative and regulatory updates,infrastructure development,international cooperation,capacity building and training,public awareness and engagement,and robust monitoring and enforcement mechanisms.Although tailored to Malaysia,the framework offers transferable solutions to align e-waste management systems with the Swiss-Ghana Amendments,providing a pathway for developing nations to strengthen regulatory readiness,mitigate environmental risks,and contribute to global sustainability.
基金acknowledge Dr Thirumoorthy S/O Thamotharampillai for his inputs that were incorporated into the writing of this manuscript.
文摘The World Medical Association’s Declaration of Helsinki(DoH)serves as a key document of ethical guidance advocating principles of medical research involving human participants.Since its inception in 1964,the DoH has undergone several revisions,reflecting a dynamic evolution in our understanding of research ethics,spurred by gaps identified within the document,harms discovered,challenges identified during ongoing research activities,scientific advancements and societal shifts in values.The DoH addresses a challenge and a conflict that may arise between two key aspects of medical research:On one hand,the fundamental obligation of physicians to do no harm,and on the other,the essential need to ensure the efficacy and safety of medical interventions by testing them on human research participants or healthy volunteers.With each revision,increasing emphasis is given to distributive justice and beneficence and not only to patient autonomy.Despite being a comprehensive and concise document,occasional criticism is reported,such as with regards to the impracticability of obtaining informed consent amongst other challenges.This essay will examine the key changes across the DoH's iterations,highlighting the progressive strengthening of participant protection and the evolving relationship between research,societal benefit,and individual rights.
文摘The introduction of next-generation sequencing(NGS) technology in testing for hereditary cancer susceptibility allows testing of multiple cancer susceptibility genes simultaneously. While there are many potential benefits to utilizing this technology in the hereditary cancer clinic, including efficiency of time and cost, there are also important limitations that must be considered. The best panel for the given clinical situation should be selected to minimize the number of variants of unknown significance. The inclusion in panels of low penetrance or newly identified genes without specific actionability can be problematic for interpretation.Genetic counselors are an essential part of the hereditary cancer risk assessment team, helping the medical team select the most appropriate test and interpret the often complex results. Genetic counselors obtain an extended family history, counsel patients on the available tests and the potential implications of results for themselves and their family members(pre-test counseling), explain to patients the implications of the test results(post-test counseling), and assist in testing family members at risk.
文摘Our study describes the reported rate of the Institutional Review Board(IRB)approval,declaration of Helsinki(DoH),and informed consent in the case reports and case series and investigates factors associated with the ethical approval report.We searched PubMed for case reports and case series from 2006 to 2017.Annually,we obtained the first 20 articles of a case report cluster from 20 distinct publications.This analysis initially contained at least 2400 papers,with 100 papers each study design and year.Only 26(5.4%)of 480 included studies reported IRB approval,DoH approval,and participant informed consent;58(12.1%)reported two out of three ethical statements(DoH,informed consent,IRB);and 151(31.5%)reported only one,leading to nearly 245 studies(51.0%)did not report any ethical approval item.Both clusters mentioned the DoH the least.Only years,ages,ethical item types,and cluster types were associated with ethical reporting practices.This study found the serious under‐reporting of ethical practices in both case reports and case series.
