The work in this paper is based on primary research on how to obtain informed consent to medical treatment and or procedure among patients;this study was carried out in Papua New Guinea in both urban and rural health ...The work in this paper is based on primary research on how to obtain informed consent to medical treatment and or procedure among patients;this study was carried out in Papua New Guinea in both urban and rural health settings across customs,cultures,and languages in two provinces,on the basis of qualitative interviews with healthcare professionals including doctors,nurses,other healthcare workers,patients,and traditional healers.We emphasize the views of consent with participants of customs,cultural,and languages regarding informed consent.There are factors between peoples of differing circumstances which can greatly alter how they view consent.Some groups would involve people in the decision-making process that may not traditionally be involved in the decision making of a medical decision.Other groups may dislike certain medical procedures as in Papua New Guinea(PNG).And certain people have different views on what should be disclosed of the patient’s condition.Customs,cultures,and languages are common phenomena which continue to affect the daily lives of many thousands of people.It is unclear in PNG about the characteristics of customs,culture,and language on health care because there is no published information on informed consent and issues that affect the making of informed consent.展开更多
Ethical Statements and Participant’s Consents were not included in the published version of the following articles that appeared in previous issues of Allergy Medicine.The appropriate Ethical Statements and Particip...Ethical Statements and Participant’s Consents were not included in the published version of the following articles that appeared in previous issues of Allergy Medicine.The appropriate Ethical Statements and Participant’s Consents provided by the Authors,are included below:“Exploring drug-induced toxic epidermal necrolysis:A case series and comprehensive review”[Allergy Medicine,Volume 3,March 2025,100011]https://doi.org/10.1016/j.allmed.2024.100011 Ethical Statement:This research involves retrospective case analyses using de-identified patient data.There were no prospective interventions,and informed consent has been obtained.展开更多
BACKGROUND Brain-computer interface(BCI)technology is rapidly advancing in psychiatry.Informed consent competency(ICC)assessment among psychiatric patients is a pivotal concern in clinical research.AIM To analyze the ...BACKGROUND Brain-computer interface(BCI)technology is rapidly advancing in psychiatry.Informed consent competency(ICC)assessment among psychiatric patients is a pivotal concern in clinical research.AIM To analyze the assessment of ICC and form a framework with multi-dimensional elements involved in ICC of BCI clinical research among psychiatric disorders.METHODS A systematic review of studies regarding ICC assessments of BCI clinical research in patients with six kinds of psychiatric disorders was conducted.A systematic literature search was performed using PubMed,ScienceDirect,and Web of Science.Peer-reviewed articles and full-text studies were included in the analysis.There were no date restrictions,and all studies published up to February 27,2025,were included.RESULTS A total of 103 studies were selected for this review.Fifty-eight studies included ICC factors,and forty-five were classified in ICC related ethical issues of BCI research in six kinds of psychiatric disorders.Executive function impairment is widely recognized as the most significant factor impacting ICC,and processing speed deficits are observed in schizophrenia,mood disorders,and Alzheimer’s disease.Memory dysfunction,particularly episodic and working memory,contributes to compromised ICC.Five core ethical issues in BCI research should be addressed:BCI specificity,vulnerability,autonomy,dynamic ICC,comprehensiveness,and uncertainty.CONCLUSION A Five-Dimensional evaluative framework,including clinical,ethical,sociocultural,legal,and procedural dimensions,is constructed and proposed for future ICC research in BCI clinical research involving psychiatric disorders.展开更多
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
In the criminological system, passive euthanasia is an act that meets the constitutive elements. We should discard the traditional view of distinguishing between acts and omissions, but use genuine consent or presumpt...In the criminological system, passive euthanasia is an act that meets the constitutive elements. We should discard the traditional view of distinguishing between acts and omissions, but use genuine consent or presumptive consent under the patient’s right to self-determination as the basis for its justification. In general, the patient’s genuine consent takes precedence, but in case of the unavail-ability of the patient’s genuine consent, his or her presumptive consent should be applied as a substitute. The judgment of presumptive con-sent should follow the subsequence, with the living will of the patient applied first and then the substitute decision-making. If the patient’s personal will cannot be inferred after exhausting all available possi-bilities, the principle of prioritizing the interests of life should prevail, and the ongoing life-sustaining medical care should not be interrupted or terminated.展开更多
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
The recent pandemic crisis has highlighted the importance of the availability and management of health data to respond quickly and effectively to health emergencies, while respecting the fundamental rights of every in...The recent pandemic crisis has highlighted the importance of the availability and management of health data to respond quickly and effectively to health emergencies, while respecting the fundamental rights of every individual. In this context, it is essential to find a balance between the protection of privacy and the safeguarding of public health, using tools that guarantee transparency and consent to the processing of data by the population. This work, starting from a pilot investigation conducted in the Polyclinic of Bari as part of the Horizon Europe Seeds project entitled “Multidisciplinary analysis of technological tracing models of contagion: the protection of rights in the management of health data”, has the objective of promoting greater patient awareness regarding the processing of their health data and the protection of privacy. The methodology used the PHICAT (Personal Health Information Competence Assessment Tool) as a tool and, through the administration of a questionnaire, the aim was to evaluate the patients’ ability to express their consent to the release and processing of health data. The results that emerged were analyzed in relation to the 4 domains in which the process is divided which allows evaluating the patients’ ability to express a conscious choice and, also, in relation to the socio-demographic and clinical characteristics of the patients themselves. This study can contribute to understanding patients’ ability to give their consent and improve information regarding the management of health data by increasing confidence in granting the use of their data for research and clinical management.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
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
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
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
Informed consent is necessary in good clinical practice.It is based on the patient’s ability to understand the information about the proposed procedure,the potential consequences and complications,and alternative opt...Informed consent is necessary in good clinical practice.It is based on the patient’s ability to understand the information about the proposed procedure,the potential consequences and complications,and alternative options.The information is written in understandable language and is fortified by verbal discussion between physician and patient.The aim is to explain the problem,answer all questions and to ensure that the patient understands the problems and is able to make a decision.The theory is clear but what happens in daily practice?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
A quarter of patients admitted with a proximal femoral fracture suffer from an acute episode of delirium during their hospital stay.Yet it is often unrecognised,poorly managed,and rarely discussed by doctors.Delirium ...A quarter of patients admitted with a proximal femoral fracture suffer from an acute episode of delirium during their hospital stay.Yet it is often unrecognised,poorly managed,and rarely discussed by doctors.Delirium is important not only to the affected individuals and their families,but also socioeconomically to the broader community.Delirium increases mortality and morbidity,leads to lasting cognitive and functional decline,and increases both length of stay and dependence on discharge.Delirium should be routinely and openly discussed by all members of the clinical team,including surgeons when gaining consent.Failing to do so may expose surgeons to claims of negligence.Here we present a concise review of the literature and discuss the epidemiology,causative factors,potential consequences and preventative strategies in the perioperative period.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
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
Forensic nurses are faced with making an ethical decision when an unconscious patient presents with signs of sexual assault. If the patient is unable to consent, the nurses need to decide whether or not to perform a f...Forensic nurses are faced with making an ethical decision when an unconscious patient presents with signs of sexual assault. If the patient is unable to consent, the nurses need to decide whether or not to perform a forensic exam. Hospitals have policies in place regarding consent for emergency care, but not all of them consider the collection of forensic evidence. The window of opportunity for forensic collection may disappear before contacts are made or proper consent is established. Ethical, legal, and policy considerations that complicate this scenario are discussed.展开更多
Modern medical researches require standard bio-sample acquired from structured biobank.The mechanism of Intel-biobank data-sharing,which is vital in modern biobank construction,have not been established in China.This ...Modern medical researches require standard bio-sample acquired from structured biobank.The mechanism of Intel-biobank data-sharing,which is vital in modern biobank construction,have not been established in China.This survey was conducted using questionnaires and interview,which mainly focused on the following aspects of intel-biobank data-sharing:present situation,informed consent,additional authorization and expected adverse consequences.The research object of this study was directed to 114 staff members or managers from 34 facilities.We found that 13 biobankers form 10 facilities said they had been achieved data sharing between different biobank,39 biobankers from 9 facilities indicated that they were planning data sharing,62 from the rest 15 facilities have not planned inter-biobank data sharing yet.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
文摘The work in this paper is based on primary research on how to obtain informed consent to medical treatment and or procedure among patients;this study was carried out in Papua New Guinea in both urban and rural health settings across customs,cultures,and languages in two provinces,on the basis of qualitative interviews with healthcare professionals including doctors,nurses,other healthcare workers,patients,and traditional healers.We emphasize the views of consent with participants of customs,cultural,and languages regarding informed consent.There are factors between peoples of differing circumstances which can greatly alter how they view consent.Some groups would involve people in the decision-making process that may not traditionally be involved in the decision making of a medical decision.Other groups may dislike certain medical procedures as in Papua New Guinea(PNG).And certain people have different views on what should be disclosed of the patient’s condition.Customs,cultures,and languages are common phenomena which continue to affect the daily lives of many thousands of people.It is unclear in PNG about the characteristics of customs,culture,and language on health care because there is no published information on informed consent and issues that affect the making of informed consent.
文摘Ethical Statements and Participant’s Consents were not included in the published version of the following articles that appeared in previous issues of Allergy Medicine.The appropriate Ethical Statements and Participant’s Consents provided by the Authors,are included below:“Exploring drug-induced toxic epidermal necrolysis:A case series and comprehensive review”[Allergy Medicine,Volume 3,March 2025,100011]https://doi.org/10.1016/j.allmed.2024.100011 Ethical Statement:This research involves retrospective case analyses using de-identified patient data.There were no prospective interventions,and informed consent has been obtained.
基金Supported by the Ministry of Science and Technology of the People's Republic of China(2021ZD0201900)Project 5,No.2021ZD0201905Capital’s Funds for Health Improvement and Research,No.CFH 2022-2-4115.
文摘BACKGROUND Brain-computer interface(BCI)technology is rapidly advancing in psychiatry.Informed consent competency(ICC)assessment among psychiatric patients is a pivotal concern in clinical research.AIM To analyze the assessment of ICC and form a framework with multi-dimensional elements involved in ICC of BCI clinical research among psychiatric disorders.METHODS A systematic review of studies regarding ICC assessments of BCI clinical research in patients with six kinds of psychiatric disorders was conducted.A systematic literature search was performed using PubMed,ScienceDirect,and Web of Science.Peer-reviewed articles and full-text studies were included in the analysis.There were no date restrictions,and all studies published up to February 27,2025,were included.RESULTS A total of 103 studies were selected for this review.Fifty-eight studies included ICC factors,and forty-five were classified in ICC related ethical issues of BCI research in six kinds of psychiatric disorders.Executive function impairment is widely recognized as the most significant factor impacting ICC,and processing speed deficits are observed in schizophrenia,mood disorders,and Alzheimer’s disease.Memory dysfunction,particularly episodic and working memory,contributes to compromised ICC.Five core ethical issues in BCI research should be addressed:BCI specificity,vulnerability,autonomy,dynamic ICC,comprehensiveness,and uncertainty.CONCLUSION A Five-Dimensional evaluative framework,including clinical,ethical,sociocultural,legal,and procedural dimensions,is constructed and proposed for future ICC research in BCI clinical research involving psychiatric disorders.
文摘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.
基金the Beijing Social Science Foundation Project (Project Number 20221BS0009).
文摘In the criminological system, passive euthanasia is an act that meets the constitutive elements. We should discard the traditional view of distinguishing between acts and omissions, but use genuine consent or presumptive consent under the patient’s right to self-determination as the basis for its justification. In general, the patient’s genuine consent takes precedence, but in case of the unavail-ability of the patient’s genuine consent, his or her presumptive consent should be applied as a substitute. The judgment of presumptive con-sent should follow the subsequence, with the living will of the patient applied first and then the substitute decision-making. If the patient’s personal will cannot be inferred after exhausting all available possi-bilities, the principle of prioritizing the interests of life should prevail, and the ongoing life-sustaining medical care should not be interrupted or terminated.
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The recent pandemic crisis has highlighted the importance of the availability and management of health data to respond quickly and effectively to health emergencies, while respecting the fundamental rights of every individual. In this context, it is essential to find a balance between the protection of privacy and the safeguarding of public health, using tools that guarantee transparency and consent to the processing of data by the population. This work, starting from a pilot investigation conducted in the Polyclinic of Bari as part of the Horizon Europe Seeds project entitled “Multidisciplinary analysis of technological tracing models of contagion: the protection of rights in the management of health data”, has the objective of promoting greater patient awareness regarding the processing of their health data and the protection of privacy. The methodology used the PHICAT (Personal Health Information Competence Assessment Tool) as a tool and, through the administration of a questionnaire, the aim was to evaluate the patients’ ability to express their consent to the release and processing of health data. The results that emerged were analyzed in relation to the 4 domains in which the process is divided which allows evaluating the patients’ ability to express a conscious choice and, also, in relation to the socio-demographic and clinical characteristics of the patients themselves. This study can contribute to understanding patients’ ability to give their consent and improve information regarding the management of health data by increasing confidence in granting the use of their data for research and clinical management.
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.
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.
基金Supported by The research project,No.MZO 00179906 from the Ministry of Health,Czech Republic
文摘Informed consent is necessary in good clinical practice.It is based on the patient’s ability to understand the information about the proposed procedure,the potential consequences and complications,and alternative options.The information is written in understandable language and is fortified by verbal discussion between physician and patient.The aim is to explain the problem,answer all questions and to ensure that the patient understands the problems and is able to make a decision.The theory is clear but what happens in daily practice?
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A quarter of patients admitted with a proximal femoral fracture suffer from an acute episode of delirium during their hospital stay.Yet it is often unrecognised,poorly managed,and rarely discussed by doctors.Delirium is important not only to the affected individuals and their families,but also socioeconomically to the broader community.Delirium increases mortality and morbidity,leads to lasting cognitive and functional decline,and increases both length of stay and dependence on discharge.Delirium should be routinely and openly discussed by all members of the clinical team,including surgeons when gaining consent.Failing to do so may expose surgeons to claims of negligence.Here we present a concise review of the literature and discuss the epidemiology,causative factors,potential consequences and preventative strategies in the perioperative period.
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.
文摘Forensic nurses are faced with making an ethical decision when an unconscious patient presents with signs of sexual assault. If the patient is unable to consent, the nurses need to decide whether or not to perform a forensic exam. Hospitals have policies in place regarding consent for emergency care, but not all of them consider the collection of forensic evidence. The window of opportunity for forensic collection may disappear before contacts are made or proper consent is established. Ethical, legal, and policy considerations that complicate this scenario are discussed.
文摘Modern medical researches require standard bio-sample acquired from structured biobank.The mechanism of Intel-biobank data-sharing,which is vital in modern biobank construction,have not been established in China.This survey was conducted using questionnaires and interview,which mainly focused on the following aspects of intel-biobank data-sharing:present situation,informed consent,additional authorization and expected adverse consequences.The research object of this study was directed to 114 staff members or managers from 34 facilities.We found that 13 biobankers form 10 facilities said they had been achieved data sharing between different biobank,39 biobankers from 9 facilities indicated that they were planning data sharing,62 from the rest 15 facilities have not planned inter-biobank data sharing yet.
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.
