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.

Implications of genetic testing and informed consent before and after genetic testing in individuals with cancer

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.

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.

Informed consent for digestive endoscopy

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?

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.

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-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 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.

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）.

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.

Use of Residual Material in Biobanking： Solidarity, Common Good, and Informed Consent

Biological residual materials can be obtained from surgical activities or from pathological waste material collected for analysis and stored in formalin. This material can be stored in biobanks with the purpose of future research. Formalin-fixed tissue and also formalin-fixed paraffin embedded tissues are not suitable for all kinds of genetic studies on DNA or RNA, as formalin solution is well known for damaging nucleic acids. Therefore, for the purpose of conducting genetic studies, samples should be frozen in order to maintain a good quality of DNA/RNA over time Biobanks, in which waste samples are frozen, are undoubtedly expensive to maintain; however, it could be useful and important to consider their possible implication in particular research, regarding for example the tumor cells growth process, or when the procurement of samples is difficult. Regarding the relationship between informed consent and tissue collection, storage and research, two choices are possible： irreversible or reversible sample anonymization. These procedures involve different approaches and possible solutions that we will seek to define. Also, an important ethical aspect in regard to the role of biobanks is encouraging sample donation. For donors, seeing human sample being kept rather than discarded and seeing them become useful for research highlight the importance of the human body and improve the attitude towards donation. This process might also facilitate the giving of informed consent more trustfully and willingly.

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.

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.

Untying the Knot: Realization of Informed Consent in Hospitals

Guan Qiqian, a 42-year-old journalist in Yongqing of southeast China＇s Fujian Province, never expected his search for medical treatment of his psoriasis in 2000 ended up in hepatitis and uremia.

A Study of Information-packaging Constructions in the News and Sports Sections of The Guardian

The paper studies the use of information-packaging structures in newspaper from a pragmatic point of view. It is based on the 800 corpus examples randomly chosen from the news and sports sections of Guardian. The paper studies the structures preposing, postposing, inversion, extraposition, and dislocation, as well as existential, cleft and passive constructions. It shows that that the news and sports sections of The Guardian are not extensively marked by the use of information-packaging structures.

How Well Informed of Participants in Clinical Trials: A Case Study of China

Background: With the development of globalization, the rising cost of clinical trials in Europe and the United States, and the huge drug consumption market in developing countries, multinational pharmaceutical giants have set their sights on emerging developing countries. As a leader in developing countries, China has unparalleled advantages, so more and more clinical trials are registered and carried out in China. Objective: The objective of the study is to understand the current practice of informed consent in clinical trials in public hospitals in Xuzhou. Methods: In this study, a 15-question questionnaire was distributed to 369 subjects in the affiliated hospital of Xuzhou medical university. Each question was graded on a 3-point scale (1 = no, 2 = unsure, 3 = yes). The sum of the scores for the 15 questions represented the level of awareness of clinical trials. Results: Valid questionnaires were received from 300 subjects. A considerable number of subjects still had insufficient understanding of clinical trials, especially concerning the nature of clinical trials, understanding of informed consent forms, contact with researchers, and ethics committee. (The “yes” rate was around or below 50%). Factors associated with responses to the survey include education, occupation, and source of medical expenses. Conclusion: Overall, this study showed that the implementation of informed consent in China remained room for improvement. Legislators, ethics officers, and researchers should work together to protect the interests of subjects.

Diagnostic CT: Are Patients Adequately Informed?

AIM: CT scanning is a widely utilised effective diagnostic tool. We aimed to establish whether patients are adequately informed prior to undergoing CT investigations. Methods: All adult patients with mental capacity attending the department for a CT study over a week period were invited to fill out a brief questionnaire prior to their scan. Results: 57 patients returned completed questionnaires. Overall 23% of patients were unsure or incorrect about the type of scan scheduled. Of patients attending with a new condition, 46% of them did not know their provisional diagnosis. Only 32 % of patients had insight into how a CT scan worked. This was taken to mean that the patient had included some reference to either x-rays, radiation or cross sectional imaging. Only 23% of patients were aware of potential complications of CT scans. Conclusion: Although written consent prior to CT scan is probably a step too far in providing patients with relevant risks/benefits of their investigation, we propose all patients undergoing CT have prior access to a written information sheet should they wish to be further informed regarding their procedure.

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.

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.

《民法典》背景下个人信息保护的司法考察与制度完善

大数据时代,为充分保障个人的信息安全,我国相继施行的《民法典》《个人信息保护法》对此作出了较为全面的规定。考察相关规则的司法适用,发现我国个人信息保护存在个人信息与隐私权界定不清、损害赔偿威慑作用不足、公益诉讼制度效用未充分发挥、“知情—同意”标准不一且流于形式等问题。为解决上述问题,可通过构建可识别的场景化模式界定个人信息,引入情境脉络完整性理论判定隐私,审慎引入惩罚性赔偿,明晰个人信息保护公益诉讼的适用条件,构建“国家—行业—平台”三层规则体系实现实质同意,全面保护个人信息。