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.

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.

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?

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.

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.

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）.

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.

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.

The Subtle Colourings of （Informed） Consent in Performance Enhancement： Implications for Expertise

The analytic method, part of the epistemonic method, provides us with a way to cope with perplexed cases, without even referring to the world out there. We are able to predict all possible variations of consent, and go on forming minimum logical quadripoles, 8-poles, 16-poles, etc., before even trying to make any connection to the world. This way, there are two major outcomes： All possible scenarios are predicted, and, because of that, our ＂logical generator＂ produces scenarios we couldn＇t even think of. Consent is, therefore, neither binary （existence or absence）, nor just a continuum from existence to absence, but a cladistic tree stemming from the basic quadripole ＂existence of consent/not existence of consent/absence of consent/not absence of consent.＂ The complexity increases rapidly when other terms are included; try： ＂existence of informed consent＂ or ＂existence of unintentional consent.＂ More levels develop as we examine relevant terms, such as ＂exposure,＂ ＂protection,＂ or ＂consumption.＂ In our case-study, we shall examine how different aspects of consent are expressed regarding the issue of performance enhancement and consider some implications for the notion of expertise within an SEA （Science of Exceptional Achievement） context. Many different terms may describe the most common situations, namely, ＂uniformed consent,＂ ＂unintentional consent,＂ ＂non-intentional consent,＂ ＂not absence of consent,＂ and also, ＂unintentional exposure,＂ ＂intentional non-protection,＂ and so on. In Greek language, the possible variations are even more （there are two kinds of negation in Greek）. All the aforementioned terms have different ethical consequences. We shall also examine whether doping is an inherent part of expertise attainment.

Application of Presumptive Consent in Passive Euthanasia

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.

复杂环境下基于改进Informed RRT*的无人机路径规划算法

针对无人机在复杂环境中进行路径规划时,快速搜索随机树(RRT)算法易出现规划时间长、路径冗余、狭窄空间中易陷入局部约束导致规划失败的问题,提出一种改进的Informed RRT*算法.首先,引入人工势场法使采样点按照势场下降的方式向目标点移动,以提高RRT树扩展的目的性和方向性.然后,考虑随机树在扩展过程中全局环境的复杂度,引入自适应步长调整策略以增加随机树在无障碍环境下的扩展速度,并在随机树扩展的过程中加入相关约束条件以确保生成路径的可行性.在找到第一条可达路径后,采用变化的椭圆或椭球采样域限制采样点选取和自适应步长的扩展范围,加快算法收敛到渐进最优的速度.最后,在复杂二维和三维环境下进行传统算法和改进算法的对比实验,仿真分析表明:改进算法可以在很少的迭代次数下找到更优的初始路径,更快地锁定椭圆或椭球采样域,从而给路径优化留出更多时间,算法规划效果更好.

基于改进APF-Informed-RRT^(*)的机械臂避障路径规划

针对Informed-RRT^(*)算法在避障路径规划中缺乏目的性和方向性,存在规划时间长、迭代效率低等问题,提出了结合人工势场法和Informed-RRT^(*)算法的避障规划算法。首先,针对传统人工势场法存在目标点不可达、易与障碍物碰撞的问题,提出了改进后的人工势场法,并将其融入Informed-RRT^(*)算法中,使随机树沿势场下降的方向生长,增强其方向性;其次,依据随机树与障碍物间的距离,提出了一种自适应生长步长策略,提高了对空间的探索能力;最后,引入贪心算法的思想,在生长时直接判断随机树能否直达目标点,提高了路径规划效率。在二维和三维环境下对改进后的算法与传统算法及其衍生算法进行对比实验,仿真结果表明改进后的Informed-RRT^(*)算法相较于原始算法规划的路径长度和规划耗时分别减少了17.42%和36.21%。