Corrigendum regarding missing informed consents in previously published articles

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.

Incentivization and the moral problem of involuntary consent in medical research

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.

Culture within Informed Consent:Papua New Guinea Perspective

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.

The Landscape of the Legal Aspects of Informed Consent for Medical Treatment in Papua New Guinea

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.

Knowledge,Awareness,and Attitude of Doctors and Patients regarding Informed Consent to Medical Procedures in Papua New Guinea

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.

Delirium after emergency hip surgery-common and serious, but rarely consented for

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.

Informed consent in veterinary medicine: legal and medical perspectives in Italy

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.

Evidence-based approach to providing informed consent for hip fracture surgery during the COVID-19 era

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.

Informed Consent under the Ghana Health Service Patients Charter: Practice and Awareness

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.

Evidence Collection for the Unconscious and Unconsented Patient

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.

Data sharing among Biobanks in China:practitioners'attitudes towards inform consent

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.

Informed Consent Prior to Elective Gynaecological Surgery in Two Reference Hospitals in Yaoundé, Cameroon: A Mixed Methods Study

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 1st, 2018, to June 30th, 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.

Physicians’Perspectives of Informed Consent for Medical Procedures:A Qualitative Interview Study

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.

Informed consent process: ethical and practical challenges in clinical trials regarding subject enrollment, protection, and informed consent in developing countries (India, Pakistan & Iran)

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.

Consent and Quality of Information for Patients in Laparoscopic Surgery at the Academic Hospital Point“G”(Mali)

Objectives: To evaluate the quality of the information provided to patients for their consent to be operated laparoscopically in the “A” surgery service of Point “G” University Hospital in Bamako (Mali). Methodology: The study was transversal, descriptive and prospective from November 1, 2016 to December 31, 2017 (14 months). It was performed at the general and laparoscopic surgery department of the Point “G” University Hospital in Bamako. Laparoscopically operated patients in scheduled or emergency programm whom consented the study and answered the questions before and after the surgical procedure were included. Results: One hundred patients were retained. The sex ratio was 4.2 for women. The surgery was scheduled in 93% (programmed surgery) of cases versus 7% (urgent surgery). Gynecological and obstetric surgery was performed in 54%, digestive surgery in 43% and laparoscopic exploration in 3%. The information was provided by surgeons, anesthetists, fellowship and students in respec-tively 63%, 6%, 11% and 9%. The reflection period before consenting to the act was greater or equal to 3 days in 90%. The media used were found to be suitable in 62%. The information was considered satisfactory preoperatively in 54% and postoperatively in 88%. Patients wanted additional information on post-surgery outcomes in 21%. Conclusion: The establishment of an information system and a free and informed consent form is a prerequisite for the quality of care in laparoscopic surgery.

Legal Protection of the Right of Informed Consent of the Subjects of Human Clinical Trials in China

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.

Future needs for informed consent in stem cell clinical trials in neurodegenerative diseases

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

“服”,Adherence(顺许),Consent(洽同):三个中西修辞术语的相互阐映及其对比较修辞的启示

学术的日益全球化使得对任何修辞传统的表述或重构都不能不以在其他文化语境中发展起来的对应传统为参照。然而,这种"参照"虽然听起来简单易行,涉及到的却是具有异质、动态、自适应等特征的不同话语实践范式,以及将这些范式相互映衬比较时必然引起的诸多认识论、本体论、目的论及方法论问题,因而"参照"只能在一个具有突出"复杂系统"特征的语境中进行。在很大程度上,由于这一语境所施加的种种限制,或者说由于对这些限制认识不足,修辞的跨文化、跨体系研究至今仍然在艰难地探索一条可行的路径。笔者于2015年7月应邀在国际修辞史研究会第二十届双年会上作主旨报告,以三个中西修辞关键词的重构性比较为例,针对上述探索所面对的困境构想并示范了一条以"相互阐映"为目标的新路径。碍于篇幅,对这一路径的介绍拟分为两部分。第一部分系上述大会发言英文稿稍加再语境化后的汉译,第二部分则是笔者在大会发言的基础上,结合自己对比较修辞的长期实践、观察、思考,对所构想的"相互阐映"模式作出的初步理论阐述。下文为介绍的第一部分即大会发言稿的汉译。