The publisher would like to draw the reader's attention to the following errors.Informed consents were not included in the published version of the following articles that appeared in previous issues of Grain&...The publisher would like to draw the reader's attention to the following errors.Informed consents were not included in the published version of the following articles that appeared in previous issues of Grain&Oil Science and Technology.The authors were contacted after publication to request informed consents for the following articles.The appropriate informed consents,provided by the authors,are included below.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
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
This study explores how doctors and patients in Papua New Guinea(PNG)perceive informed consent in medical settings.Doctors and patients from National Capital District and Central Province who responded to the survey w...This study explores how doctors and patients in Papua New Guinea(PNG)perceive informed consent in medical settings.Doctors and patients from National Capital District and Central Province who responded to the survey were the participants of the study.Researchers asked the participants to fill out questionnaires regarding their knowledge about informed consent for each group,namely,the doctors and participants.From those who responded,six randomly selected participants were chosen to join the focus group discussion which aimed to get experiences from the doctors and patients regarding medical procedures.Results show that both doctors and patients lack knowledge of the legalities of informed consent.Based on the experiences of doctors,they do not use consent forms when seeking permission from patients.Patients,on the other hand,do not see consent forms as important and only served as a formality.Customs,culture surrounding PNG were found to have an impact on how patients perceived informed consent.展开更多
During the last four decades the doctrine of in- formed consent (IC) has become a legal stan- dard and an essential component of ethical guidelines in medicine, due to its relevance for basic human rights such as auto...During the last four decades the doctrine of in- formed consent (IC) has become a legal stan- dard and an essential component of ethical guidelines in medicine, due to its relevance for basic human rights such as autonomy and re- spect of dignity. Over the last few years, this legal formula has gained importance in veteri- nary medicine, thereby influencing the everyday activities of the veterinary practitioners. This paper briefly describes the ethical and legal background of IC in Italy and examines how it relates to the practice of veterinary medicine, considering the change in social sensibility to- wards animals. It also outlines the discussion that should take place between Veterinarian and client before a planned procedure.展开更多
Background: Every human being of adult years and sound mind has a right to determine what shall be done with his/her own body. Patient autonomy and the practice of informed patient consent are now pivotal in medical p...Background: Every human being of adult years and sound mind has a right to determine what shall be done with his/her own body. Patient autonomy and the practice of informed patient consent are now pivotal in medical practice. Aim: To assess patient’s knowledge of Patients’ Rights Charter and whether patients receive adequate information to enable them make an informed consent to a particular treatment. Methodology: Patients who were undergoing elective surgery from selected surgical departments of Komfo Anokye teaching hospital in Kumasi were randomly selected and assisted to answer structured questionnaire without the knowledge of their doctors. The study period was in June to December (2014). Descriptive analysis was done using SPSS (II) of the results. Results: 84.7% (144) had no idea about the Patients’ Rights Charter of the Ghana Health Service. 75% (128) did not know or had not heard of informed patient consent. Of those who knew of the charter, 85% (37) had ever stayed in a developed country. 60% (102) did not know of their diagnosis. 79% (134) said the doctor only asked them to either sign or thumb print the consent document without giving them treatment options or possible complications. Conclusion: Most of respondents undergoing various surgical procedures at the Komfo Anokye Teaching Hospital were not aware of the existence of the Patients’ Rights Charter of the Ghana Health Service. Again, practitioners did not provide sufficient information to patients for them to make an informed decision about their health.展开更多
This paper examines informed consent in medical practice.We have explored the notion of consent and determined its underlying theory and important attributes.We argue that consent is a permissive state of mind that wa...This paper examines informed consent in medical practice.We have explored the notion of consent and determined its underlying theory and important attributes.We argue that consent is a permissive state of mind that waives the right to bodily integrity.Once communicated to the actor the permission takes effect by justifying the intervention and legitimizing the virtuous exercise of the doctor’s power.The process is usually formally documented by the reading and signing of a“consent form”by both the patient and the doctor who is proposing the treatment that takes place within a clinical setting.Many people grow up in the traditional communities where the idea of informed consent is undeveloped and tend to be passive in their roles in the informed consent process.We have gathered from this study that people tend to stick to their traditional customs and custom has become a source of their rules,brings people together,shares food,and uses for resolving issues in family,land,water rights,and compensation following disputes.In other words,peoples’ways of life revolve around their traditional customs.Family wellbeing decisions and especially health care are usually a family matter but not an individual.Going to receive health care services at the hospital or modern health care center for medical treatment is enough to make a patient say they do not want to follow through the clinical procedure including the process of informed consent.A medical consent form is a common form used in health care facilities to obtain medical consent for a certain treatment or medical procedure or dental.We found in the interview questionnaires that many patients do not understand the use of consent forms.We examined informed consent in the context of the people’s culture and how the healthcare professionals handle the situation with patients that have widespread customs,beliefs and opinions which they strictly adhere to and practice.展开更多
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).It is likely that first-in-human intracerebral transplantation of cells derived from human embryonic stem展开更多
This work is based on an on-going research on medical informed consent in Papua New Guinea(PNG)with 19 doctors from hospitals,health care centers and private medical establishments in the National Capital District and...This work is based on an on-going research on medical informed consent in Papua New Guinea(PNG)with 19 doctors from hospitals,health care centers and private medical establishments in the National Capital District and Central Province who voluntarily participated in the study.The authors conducted an examination of doctors’understanding of informed consent for medical procedures through a qualitative interview study and we describe our findings.We saw a need to involved patients in decision-making about their care,ethical imperative and concerns about litigation and their complaints highlighted the issue of informed consent.In order for the patients to make an informed decision about medical procedure,the doctors involved in the proposed treatment should conduct the informed consent discussion.The discussion should include the treatment,the risks and benefits of treatment,and alternative therapies with associated risks and benefits.We studied doctors’perspectives of gaining informed consent for routine medical procedures.We used qualitative study methods using structured interviews selected by purposive sampling.The data collected were entered into a data base and were analyzed thematically.The discussion is based on review of legal decisions,commentaries and our personal experience in studying medical malpractice cases.We have utilized case reports and several informative writings that have appeared in the world literature,as well as selections from vast amounts of material available in USA,UK,Australia,India and PNG.The current informed consent processes do not appear to be ideal for many doctors in PNG.In particular,there are inhibiting factors that affect patients from making medical informed decisions,doctors find time not enough to run discussions on informed consent,Department of Health does not have a standard informed consent form,patients complain about no consent form,and they have not signed consent forms.These are but some issues that affect patients when trying to make informed decisions.We say that informed consent process flows from the relationship between doctor and patient,however when this does not occur,serious legal and ethical consequences may result.This report is not intended to be specific advice on any private legal matter.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
Neural network methods have been widely used in many fields of scientific research with the rapid increase of computing power.The physics-informed neural networks(PINNs)have received much attention as a major breakthr...Neural network methods have been widely used in many fields of scientific research with the rapid increase of computing power.The physics-informed neural networks(PINNs)have received much attention as a major breakthrough in solving partial differential equations using neural networks.In this paper,a resampling technique based on the expansion-shrinkage point(ESP)selection strategy is developed to dynamically modify the distribution of training points in accordance with the performance of the neural networks.In this new approach both training sites with slight changes in residual values and training points with large residuals are taken into account.In order to make the distribution of training points more uniform,the concept of continuity is further introduced and incorporated.This method successfully addresses the issue that the neural network becomes ill or even crashes due to the extensive alteration of training point distribution.The effectiveness of the improved physics-informed neural networks with expansion-shrinkage resampling is demonstrated through a series of numerical experiments.展开更多
Model-informed drug develop⁃ment(MIDD)is the application of a various math⁃ematical,statistical,and biological models to facilitate drug development,decision making and regulatory review.As a quantitative tool,MIDD ap...Model-informed drug develop⁃ment(MIDD)is the application of a various math⁃ematical,statistical,and biological models to facilitate drug development,decision making and regulatory review.As a quantitative tool,MIDD approaches allow an integration of information obtained from non-clinical studies and clinical trials in a drug development program.General understandings of the underlying biology,patho⁃physiology,and pharmacology can also be incor⁃porated into the model.MIDD is centered on knowledge and inferences generated from inte⁃grated models of the physicochemical character⁃istics of a molecule,its disposition in the body,and its mechanism of action,and how the drug might affect a disease from both an efficacy and a safety perspective.MIDD approaches have the potential to significantly streamline drug develop⁃ment,by improving clinical trial efficiency,opti⁃mizing dose and regimen and waive unneces⁃sary clinical studies.This presentation will use cases studies to demonstrate how to apply MIDD in early phase of clinical trials.展开更多
文摘The publisher would like to draw the reader's attention to the following errors.Informed consents were not included in the published version of the following articles that appeared in previous issues of Grain&Oil Science and Technology.The authors were contacted after publication to request informed consents for the following articles.The appropriate informed consents,provided by the authors,are included below.
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This study explores how doctors and patients in Papua New Guinea(PNG)perceive informed consent in medical settings.Doctors and patients from National Capital District and Central Province who responded to the survey were the participants of the study.Researchers asked the participants to fill out questionnaires regarding their knowledge about informed consent for each group,namely,the doctors and participants.From those who responded,six randomly selected participants were chosen to join the focus group discussion which aimed to get experiences from the doctors and patients regarding medical procedures.Results show that both doctors and patients lack knowledge of the legalities of informed consent.Based on the experiences of doctors,they do not use consent forms when seeking permission from patients.Patients,on the other hand,do not see consent forms as important and only served as a formality.Customs,culture surrounding PNG were found to have an impact on how patients perceived informed consent.
文摘During the last four decades the doctrine of in- formed consent (IC) has become a legal stan- dard and an essential component of ethical guidelines in medicine, due to its relevance for basic human rights such as autonomy and re- spect of dignity. Over the last few years, this legal formula has gained importance in veteri- nary medicine, thereby influencing the everyday activities of the veterinary practitioners. This paper briefly describes the ethical and legal background of IC in Italy and examines how it relates to the practice of veterinary medicine, considering the change in social sensibility to- wards animals. It also outlines the discussion that should take place between Veterinarian and client before a planned procedure.
文摘Background: Every human being of adult years and sound mind has a right to determine what shall be done with his/her own body. Patient autonomy and the practice of informed patient consent are now pivotal in medical practice. Aim: To assess patient’s knowledge of Patients’ Rights Charter and whether patients receive adequate information to enable them make an informed consent to a particular treatment. Methodology: Patients who were undergoing elective surgery from selected surgical departments of Komfo Anokye teaching hospital in Kumasi were randomly selected and assisted to answer structured questionnaire without the knowledge of their doctors. The study period was in June to December (2014). Descriptive analysis was done using SPSS (II) of the results. Results: 84.7% (144) had no idea about the Patients’ Rights Charter of the Ghana Health Service. 75% (128) did not know or had not heard of informed patient consent. Of those who knew of the charter, 85% (37) had ever stayed in a developed country. 60% (102) did not know of their diagnosis. 79% (134) said the doctor only asked them to either sign or thumb print the consent document without giving them treatment options or possible complications. Conclusion: Most of respondents undergoing various surgical procedures at the Komfo Anokye Teaching Hospital were not aware of the existence of the Patients’ Rights Charter of the Ghana Health Service. Again, practitioners did not provide sufficient information to patients for them to make an informed decision about their health.
基金We would like to thank all the doctors who kindly gave their time to be interviewed for this study.We also thank the nurses and other healthcare workers in the National Capital District and Kwikila District in hospitals,healthcare centers and private medical centers who participated in the research.We also extend our sincere thanks to the traditional healers.Finally we thank the patients who attended the interviews,gave all their valuable times,and assisted the research team throughout the field work.We appreciate and value everyone that gave their support to this research.Authors would like to thank Tharapiyap Holdings(Ltd)(PNG)for providing financial assistance to conduct the research and financial assistance to support the administration expenses.
文摘This paper examines informed consent in medical practice.We have explored the notion of consent and determined its underlying theory and important attributes.We argue that consent is a permissive state of mind that waives the right to bodily integrity.Once communicated to the actor the permission takes effect by justifying the intervention and legitimizing the virtuous exercise of the doctor’s power.The process is usually formally documented by the reading and signing of a“consent form”by both the patient and the doctor who is proposing the treatment that takes place within a clinical setting.Many people grow up in the traditional communities where the idea of informed consent is undeveloped and tend to be passive in their roles in the informed consent process.We have gathered from this study that people tend to stick to their traditional customs and custom has become a source of their rules,brings people together,shares food,and uses for resolving issues in family,land,water rights,and compensation following disputes.In other words,peoples’ways of life revolve around their traditional customs.Family wellbeing decisions and especially health care are usually a family matter but not an individual.Going to receive health care services at the hospital or modern health care center for medical treatment is enough to make a patient say they do not want to follow through the clinical procedure including the process of informed consent.A medical consent form is a common form used in health care facilities to obtain medical consent for a certain treatment or medical procedure or dental.We found in the interview questionnaires that many patients do not understand the use of consent forms.We examined informed consent in the context of the people’s culture and how the healthcare professionals handle the situation with patients that have widespread customs,beliefs and opinions which they strictly adhere to and practice.
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).It is likely that first-in-human intracerebral transplantation of cells derived from human embryonic stem
文摘This work is based on an on-going research on medical informed consent in Papua New Guinea(PNG)with 19 doctors from hospitals,health care centers and private medical establishments in the National Capital District and Central Province who voluntarily participated in the study.The authors conducted an examination of doctors’understanding of informed consent for medical procedures through a qualitative interview study and we describe our findings.We saw a need to involved patients in decision-making about their care,ethical imperative and concerns about litigation and their complaints highlighted the issue of informed consent.In order for the patients to make an informed decision about medical procedure,the doctors involved in the proposed treatment should conduct the informed consent discussion.The discussion should include the treatment,the risks and benefits of treatment,and alternative therapies with associated risks and benefits.We studied doctors’perspectives of gaining informed consent for routine medical procedures.We used qualitative study methods using structured interviews selected by purposive sampling.The data collected were entered into a data base and were analyzed thematically.The discussion is based on review of legal decisions,commentaries and our personal experience in studying medical malpractice cases.We have utilized case reports and several informative writings that have appeared in the world literature,as well as selections from vast amounts of material available in USA,UK,Australia,India and PNG.The current informed consent processes do not appear to be ideal for many doctors in PNG.In particular,there are inhibiting factors that affect patients from making medical informed decisions,doctors find time not enough to run discussions on informed consent,Department of Health does not have a standard informed consent form,patients complain about no consent form,and they have not signed consent forms.These are but some issues that affect patients when trying to make informed decisions.We say that informed consent process flows from the relationship between doctor and patient,however when this does not occur,serious legal and ethical consequences may result.This report is not intended to be specific advice on any private legal matter.
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.
基金Project supported by the National Key Research and Development Program of China(Grant No.2020YFC1807905)the National Natural Science Foundation of China(Grant Nos.52079090 and U20A20316)the Basic Research Program of Qinghai Province(Grant No.2022-ZJ-704).
文摘Neural network methods have been widely used in many fields of scientific research with the rapid increase of computing power.The physics-informed neural networks(PINNs)have received much attention as a major breakthrough in solving partial differential equations using neural networks.In this paper,a resampling technique based on the expansion-shrinkage point(ESP)selection strategy is developed to dynamically modify the distribution of training points in accordance with the performance of the neural networks.In this new approach both training sites with slight changes in residual values and training points with large residuals are taken into account.In order to make the distribution of training points more uniform,the concept of continuity is further introduced and incorporated.This method successfully addresses the issue that the neural network becomes ill or even crashes due to the extensive alteration of training point distribution.The effectiveness of the improved physics-informed neural networks with expansion-shrinkage resampling is demonstrated through a series of numerical experiments.
文摘Model-informed drug develop⁃ment(MIDD)is the application of a various math⁃ematical,statistical,and biological models to facilitate drug development,decision making and regulatory review.As a quantitative tool,MIDD approaches allow an integration of information obtained from non-clinical studies and clinical trials in a drug development program.General understandings of the underlying biology,patho⁃physiology,and pharmacology can also be incor⁃porated into the model.MIDD is centered on knowledge and inferences generated from inte⁃grated models of the physicochemical character⁃istics of a molecule,its disposition in the body,and its mechanism of action,and how the drug might affect a disease from both an efficacy and a safety perspective.MIDD approaches have the potential to significantly streamline drug develop⁃ment,by improving clinical trial efficiency,opti⁃mizing dose and regimen and waive unneces⁃sary clinical studies.This presentation will use cases studies to demonstrate how to apply MIDD in early phase of clinical trials.
