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
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
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
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
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
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
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 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
Background:Clinical trials continue to be the gold standard for determining the efficacy of novel cancer treatments,but they may also expose participants to the potential risks of unpredictable or severe toxicities.Th...Background:Clinical trials continue to be the gold standard for determining the efficacy of novel cancer treatments,but they may also expose participants to the potential risks of unpredictable or severe toxicities.The development of validated tools that better inform patients of the benefits and risks associated with clinical trial participation can facilitate the informed consent process.The design and validation of such instruments are strengthened when we leverage the power of pooled data analysis for cancer outcomes research.Main body:In a recent study published in the Journal of Clinical Oncology entitled "Determinants of early mortality among 37,568 patients with colon cancer who participated in 25 clinical trials from the adjuvant colon cancer endpoints database," using a large pooled analysis of over 30,000 study participants who were enrolled in clinical trials of adjuvant therapy for early-stage colon cancer,we developed and validated a nomogram depicting the predictors of early cancer mortality.This database of pooled individual-level data allowed for a comprehensive analysis of poor prognostic factors associated with early death;furthermore,it enabled the creation of a nomogram that was able to reliably capture and quantify the benefit-to-risk profile for patients who are considering clinical trial participation.This toolcan facilitate treatment decision-making discussions.Conclusion:As China and other Asian countries continue to conduct oncology clinical trials,efforts to collate patient-level information from these studies into a large data repository should be strongly considered since pooled data can increase future capacity for cancer outcomes research,which,in turn,can enhance patient-physician discussions and optimize clinical care.展开更多
Background: The Institutional Review Board (IRB) or Research Ethics Committees (RECs) is established to review the research proposals and ensure that participants’ ethical standards, scientific merit, and human right...Background: The Institutional Review Board (IRB) or Research Ethics Committees (RECs) is established to review the research proposals and ensure that participants’ ethical standards, scientific merit, and human rights are protected. Purpose: The authors report the experience of the REC at Qassim Region, Saudi Arabia over 10 years period. Methods: All proposals submitted to Qassim REC during the period 2008-2017 were studied using a 30 items data collection form based on The National Committee of Bioethics Regulations. Data extracted included;principal investigator characteristics, numbers of proposals reviewed, applications completeness, approval decision status, reported ethical issues, classification of the ethical review, and committee review duration. The structure, workload, and review process of Qassim REC were addressed redundant. Results: During 10 years, Qassim Research Ethics Committee (QREC) witnessed a progressive increase in the number of submitted proposals, from 9 to 149 proposals. Out of 508 submitted applications, 439 (86.4%) proposals were eligible for ethical review. Of these, 50 (11.4%) proposals were incomplete due to nonresponse of the principal investigators to the QREC comments. The final decision was made for 389 (88.6%) completed proposals. The approval rate was 85.4%, while the rejection rate was only 1.1%. The median time taken for ethical review was 13 days. Proposals that underwent full board review had a long review duration (Median: 19 days) in comparison to the expedited review (Median: 10 days). Incomplete Committee requirements, unclear research methodology, or possible ethical violation opportunities were the main reasons for delayed decisions. Conclusion: The workload of the Qassim ethics committee is high and growing progressively. However, the process indicators as per National Bioethics Committee rules were satisfactory. Rejection of proposals was rare as most of the reviewed proposals were descriptive studies with infrequent ethical matters.展开更多
The goal of this paper is to present the ethical issues that are relevant at the concept development stage and inspiring its development during the CONFIDENCE （Ubiquitous Care System to Support Independent Living） p...The goal of this paper is to present the ethical issues that are relevant at the concept development stage and inspiring its development during the CONFIDENCE （Ubiquitous Care System to Support Independent Living） project. We propose that the technology must support principles such as human rights, privacy, safety, and dignity. The voluntary contribution of people as participants in research must undergo the scrutiny of research plans by ethical review boards. Informed consent processes and procedures must be observed in this realm. Ethical issues arising in heterogeneous fields involving technology, end-users, service providers, and formal and informal caregivers pose important challenges. Attempting to maximize the ethical compliance of the results of this ICT （information and communication technology） project, we explore and suggest preventive measures for possible scenarios of misuse of this or related technology. Concluding, the observation of ethical principles throughout the development process can empower users to make informed decisions on the acceptance of ICT systems and services when these reach the market.展开更多
The objectives are to provide the ethical rationale as to why the conduct of scientific research in the pediatric population is moral responsibility?Also,the roles and responsibilities of the research ethics board are...The objectives are to provide the ethical rationale as to why the conduct of scientific research in the pediatric population is moral responsibility?Also,the roles and responsibilities of the research ethics board are emphasized;Institutional Review Board to maintain and receive formal training and education to meet the ethical and regulatory standards for conducting scientific researches in the pediatric population.Another rationale is to ensure that the trial protocol involving the pediatric population conforms to ethical and legal requirements and to protect them while facilitating their participation in the scientific research process.Ethical and legal issues form a huge part of recent research;frauds and malpractices have been shown to throw a big part of healthcare funding and harm pediatrics health;however,improvements have been shown,but flaws are still there.展开更多
Background: Informed consent forms and clinical study participation explanations contain many specialized words including medical terms that are difficult to understand. The difficulty is particularly obvious for chil...Background: Informed consent forms and clinical study participation explanations contain many specialized words including medical terms that are difficult to understand. The difficulty is particularly obvious for children with developmental disorders who show attention or similar problems. This study quantitatively evaluated the decision-making ability of these children using the Wechsler Intelligence Scale for Children-III (WISC-III) as a preliminary study for a multi-faceted investigation that would also use physiological indices. Methods: Participants were 11 children with Attention Deficit/Hyperactivity Disorder (AD/HD). The WISC-III was used for quantitative evaluation of their decision-making ability. Results of intelligence quotients (IQs), group indices, and subtest scores were analyzed. Results: The mean Performance IQ was four points lower than the mean Verbal IQ. The mean score for the Processing Speed index was lower by more than one standard deviation (SD). The mean scores for the Coding and Object Assembly subtests were lower by more than two SDs. Conclusion: The WISC-III results for IQ and group indices suggested the efficacy of auditory explanations. In addition, the subtest results suggested the necessity to pay sufficient attention to risk-benefit weighting in explanations. These findings suggested that the decision-making ability of children with AD/HD could be assessed using the WISC-III.展开更多
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.
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 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Background:Clinical trials continue to be the gold standard for determining the efficacy of novel cancer treatments,but they may also expose participants to the potential risks of unpredictable or severe toxicities.The development of validated tools that better inform patients of the benefits and risks associated with clinical trial participation can facilitate the informed consent process.The design and validation of such instruments are strengthened when we leverage the power of pooled data analysis for cancer outcomes research.Main body:In a recent study published in the Journal of Clinical Oncology entitled "Determinants of early mortality among 37,568 patients with colon cancer who participated in 25 clinical trials from the adjuvant colon cancer endpoints database," using a large pooled analysis of over 30,000 study participants who were enrolled in clinical trials of adjuvant therapy for early-stage colon cancer,we developed and validated a nomogram depicting the predictors of early cancer mortality.This database of pooled individual-level data allowed for a comprehensive analysis of poor prognostic factors associated with early death;furthermore,it enabled the creation of a nomogram that was able to reliably capture and quantify the benefit-to-risk profile for patients who are considering clinical trial participation.This toolcan facilitate treatment decision-making discussions.Conclusion:As China and other Asian countries continue to conduct oncology clinical trials,efforts to collate patient-level information from these studies into a large data repository should be strongly considered since pooled data can increase future capacity for cancer outcomes research,which,in turn,can enhance patient-physician discussions and optimize clinical care.
文摘Background: The Institutional Review Board (IRB) or Research Ethics Committees (RECs) is established to review the research proposals and ensure that participants’ ethical standards, scientific merit, and human rights are protected. Purpose: The authors report the experience of the REC at Qassim Region, Saudi Arabia over 10 years period. Methods: All proposals submitted to Qassim REC during the period 2008-2017 were studied using a 30 items data collection form based on The National Committee of Bioethics Regulations. Data extracted included;principal investigator characteristics, numbers of proposals reviewed, applications completeness, approval decision status, reported ethical issues, classification of the ethical review, and committee review duration. The structure, workload, and review process of Qassim REC were addressed redundant. Results: During 10 years, Qassim Research Ethics Committee (QREC) witnessed a progressive increase in the number of submitted proposals, from 9 to 149 proposals. Out of 508 submitted applications, 439 (86.4%) proposals were eligible for ethical review. Of these, 50 (11.4%) proposals were incomplete due to nonresponse of the principal investigators to the QREC comments. The final decision was made for 389 (88.6%) completed proposals. The approval rate was 85.4%, while the rejection rate was only 1.1%. The median time taken for ethical review was 13 days. Proposals that underwent full board review had a long review duration (Median: 19 days) in comparison to the expedited review (Median: 10 days). Incomplete Committee requirements, unclear research methodology, or possible ethical violation opportunities were the main reasons for delayed decisions. Conclusion: The workload of the Qassim ethics committee is high and growing progressively. However, the process indicators as per National Bioethics Committee rules were satisfactory. Rejection of proposals was rare as most of the reviewed proposals were descriptive studies with infrequent ethical matters.
文摘The goal of this paper is to present the ethical issues that are relevant at the concept development stage and inspiring its development during the CONFIDENCE （Ubiquitous Care System to Support Independent Living） project. We propose that the technology must support principles such as human rights, privacy, safety, and dignity. The voluntary contribution of people as participants in research must undergo the scrutiny of research plans by ethical review boards. Informed consent processes and procedures must be observed in this realm. Ethical issues arising in heterogeneous fields involving technology, end-users, service providers, and formal and informal caregivers pose important challenges. Attempting to maximize the ethical compliance of the results of this ICT （information and communication technology） project, we explore and suggest preventive measures for possible scenarios of misuse of this or related technology. Concluding, the observation of ethical principles throughout the development process can empower users to make informed decisions on the acceptance of ICT systems and services when these reach the market.
文摘The objectives are to provide the ethical rationale as to why the conduct of scientific research in the pediatric population is moral responsibility?Also,the roles and responsibilities of the research ethics board are emphasized;Institutional Review Board to maintain and receive formal training and education to meet the ethical and regulatory standards for conducting scientific researches in the pediatric population.Another rationale is to ensure that the trial protocol involving the pediatric population conforms to ethical and legal requirements and to protect them while facilitating their participation in the scientific research process.Ethical and legal issues form a huge part of recent research;frauds and malpractices have been shown to throw a big part of healthcare funding and harm pediatrics health;however,improvements have been shown,but flaws are still there.
文摘Background: Informed consent forms and clinical study participation explanations contain many specialized words including medical terms that are difficult to understand. The difficulty is particularly obvious for children with developmental disorders who show attention or similar problems. This study quantitatively evaluated the decision-making ability of these children using the Wechsler Intelligence Scale for Children-III (WISC-III) as a preliminary study for a multi-faceted investigation that would also use physiological indices. Methods: Participants were 11 children with Attention Deficit/Hyperactivity Disorder (AD/HD). The WISC-III was used for quantitative evaluation of their decision-making ability. Results of intelligence quotients (IQs), group indices, and subtest scores were analyzed. Results: The mean Performance IQ was four points lower than the mean Verbal IQ. The mean score for the Processing Speed index was lower by more than one standard deviation (SD). The mean scores for the Coding and Object Assembly subtests were lower by more than two SDs. Conclusion: The WISC-III results for IQ and group indices suggested the efficacy of auditory explanations. In addition, the subtest results suggested the necessity to pay sufficient attention to risk-benefit weighting in explanations. These findings suggested that the decision-making ability of children with AD/HD could be assessed using the WISC-III.
