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.

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.

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.

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.

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.

Genetic evaluation and testing for hereditary forms of cancer in the era of next-generation sequencing

The introduction of next-generation sequencing(NGS) technology in testing for hereditary cancer susceptibility allows testing of multiple cancer susceptibility genes simultaneously. While there are many potential benefits to utilizing this technology in the hereditary cancer clinic, including efficiency of time and cost, there are also important limitations that must be considered. The best panel for the given clinical situation should be selected to minimize the number of variants of unknown significance. The inclusion in panels of low penetrance or newly identified genes without specific actionability can be problematic for interpretation.Genetic counselors are an essential part of the hereditary cancer risk assessment team, helping the medical team select the most appropriate test and interpret the often complex results. Genetic counselors obtain an extended family history, counsel patients on the available tests and the potential implications of results for themselves and their family members(pre-test counseling), explain to patients the implications of the test results(post-test counseling), and assist in testing family members at risk.

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.

Heterogeneous information fusion recognition method based on belief rule structure

To solve the problem that the existing situation awareness research focuses on multi-sensor data fusion,but the expert knowledge is not fully utilized,a heterogeneous informa-tion fusion recognition method based on belief rule structure is proposed.By defining the continuous probabilistic hesitation fuzzy linguistic term sets(CPHFLTS)and establishing CPHFLTS distance measure,the belief rule base of the relationship between feature space and category space is constructed through information integration,and the evidence reasoning of the input samples is carried out.The experimental results show that the proposed method can make full use of sensor data and expert knowledge for recognition.Compared with the other methods,the proposed method has a higher correct recognition rate under different noise levels.

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.

Research on the Legality of Information Utilization in Epidemic Prevention and Control

Big data is playing an important role in preventing,control and monitoring COVID-19,but during the process,the legality of the use of personal information shall be paid attention to.Personal information should be divided into general information and sensitive information,and the use of sensitive information should take"Consent"as its legality basis.In the process of personal information collection,the subject qualification of the collection organization or personnel should be clearly defined,and the starting conditions and process specifications of the collection work should be determined.The use of personal information should be in accordance with legal provisions or agreed ways and purposes and should not violate individual privacy rights and other personality rights,and should not improperly display the"digital image"of individuals.

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.

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.

Legal and ethical considerations for the conduct of clinical trials with pediatric population especially in Europe

The objectives are to provide the ethical rationale as to why the conduct of scientific research in the pediatric population is moral responsibility?Also,the roles and responsibilities of the research ethics board are emphasized;Institutional Review Board to maintain and receive formal training and education to meet the ethical and regulatory standards for conducting scientific researches in the pediatric population.Another rationale is to ensure that the trial protocol involving the pediatric population conforms to ethical and legal requirements and to protect them while facilitating their participation in the scientific research process.Ethical and legal issues form a huge part of recent research;frauds and malpractices have been shown to throw a big part of healthcare funding and harm pediatrics health;however,improvements have been shown,but flaws are still there.

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.

Human Rights Jurisprudence in Hospice Care——Thoughts on the Concept and Boundary of “Death with Dignity”

Death with dignity is the embodiment of the dignity of human life in the context of end-of-life medical care.However,in the development of its concept,it has been alienated into a single way of death and is often confused with the concept of euthanasia.It is therefore a theoretical and practical necessity to re-expand the connotations of death with dignity Death with dignity is the subjective value of dignity reflected in the context of dying.It takes equality,freedom,and virtue as the core,and uses the right to life as its external support.It is projected onto the medical context and incorporates the patient’s right to informed consent.Subject to public interest,legal paternalism,and the principles of public order and good customs,the boundary of the right to death with dignity should be between active treatment and natural death,and active euthanasia in the form of giving up the right to life should not be included in the right to death with dignity.

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.

Analysis of Distributed and Adaptive Genetic Algorithm for Mining Interesting Classification Rules

Distributed genetic algorithm can be combined with the adaptive genetic algorithm for mining the interesting and comprehensible classification rules.The paper gives the method to encode for the rules,the fitness function,the selecting,crossover,mutation and migration operator for the DAGA at the same time are designed.

Visualizing Association Rules Using Linked Matrix,Graph, and Detail Views

Although association rule mining is an important pattern recognition and data analysis technique, extracting and finding significant rules from a large collection has always been challenging. The ability of information visualization to enable users to gain an understanding of high dimensional and large-scale data can play a major role in the exploration, identification, and interpretation of association rules. In this paper, we propose a method that provides multiple views of the association rules, linked together through a filtering mechanism. A visual inspection of the entire association rule set is enabled within a matrix view. Items of interest can be selected, resulting in their corresponding association rules being shown in a graph view. At any time, individual rules can be selected in either view, resulting in their information being shown in the detail view. The fundamental premise in this work is that by providing such a visual and interactive representation of the association rules, users will be able to find important rules quickly and easily, even as the number of rules that must be inspected becomes large. A user evaluation was conducted which validates this premise.

Attributes reduct and decision rules optimization based on maximal tolerance classification in incomplete information systems with fuzzy decisions

A new approach to knowledge acquisition in incomplete information system with fuzzy decisions is proposed. In such incomplete information system, the universe of discourse is classified by the maximal tolerance classes, and fuzzy approximations are defined based on them. Three types of relative reducts of maximal tolerance classes are then proposed, and three types of fuzzy decision rules based on the proposed attribute description are defined. The judgment theorems and approximation discernibility functions with respect to them are presented to compute the relative reduct by using Boolean reasoning techniques, from which we can derive optimal fuzzy decision rules from the systems. At last, three types of relative reducts of the system and their computing methods are given.

Design and Implementation of Book Recommendation Management System Based on Improved Apriori Algorithm

The traditional Apriori applied in books management system causes slow system operation due to frequent scanning of database and excessive quantity of candidate item-sets, so an information recommendation book management system based on improved Apriori data mining algorithm is designed, in which the C/S (client/server) architecture and B/S (browser/server) architecture are integrated, so as to open the book information to library staff and borrowers. The related information data of the borrowers and books can be extracted from books lending database by the data preprocessing sub-module in the system function module. After the data is cleaned, converted and integrated, the association rule mining sub-module is used to mine the strong association rules with support degree greater than minimum support degree threshold and confidence coefficient greater than minimum confidence coefficient threshold according to the processed data and by means of the improved Apriori data mining algorithm to generate association rule database. The association matching is performed by the personalized recommendation sub-module according to the borrower and his selected books in the association rule database. The book information associated with the books read by borrower is recommended to him to realize personalized recommendation of the book information. The experimental results show that the system can effectively recommend book related information, and its CPU occupation rate is only 6.47% under the condition that 50 clients are running it at the same time. Anyway, it has good performance.