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.

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.

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.

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.

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）.

Effectiveness of a Structured Orientation Program for Medical Interns in Increasing the Awareness of Informed Consent

Background:Informed consent has medicolegal implications and is imperative in presentday medical practice.Aims and Objectives:The objectives of this study were to estimate the awareness regarding informed consent in interns and to determine the effectiveness of sessions in interns’orientation programs about informed consent.Materials and Methods:Pretest-Posttest study was conducted with a validated questionnaire distributed through Google Forms to interns attending the orientation program at our institute.Responses were recorded on the Likert scale(−2 to+2).Paired t-test was used to compare the mean pretest and posttest scores.The number of interns with a positive score(+1,+2)for every question in pretest and posttest were also compared.Results:One hundred and seventyone out of 232 interns who attended the program submitted both pretest and posttest responses.In the pretest,12 interns scored<50%and 46 interns scored more than 75%.A significant increase in posttest responses was seen in the mean score(P<0.001)and questions related to consent in research,radiological investigations,regarding the need for consent in the additional nonlifesaving procedure.There was an increase in the number of interns having a positive score(+1,+2)for all the questions in posttest as compared to pretest,but a statistically significant increase was seen in questions related to consent in ultrasound and need for consent in the additional nonlifesaving procedure.Conclusion:A wellstructured interns’orientation program is effective in improving awareness regarding consent.Certain gaps in knowledge regarding various aspects of consent need to be emphasized.

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.

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.

公共卫生干预研究知情同意书伦理审查问题分析

目的 提高公共卫生干预研究知情同意书的完整性和规范性,保障研究参与者的合法权益。方法 汇总整理本机构2016年1月—2023年8月进行初始审查的公共卫生干预研究项目的伦理委员会审议决议,根据自拟的“知情同意书审查要素表”,对相关问题进行统计分析。结果 进行初始审查的39项公共卫生干预研究项目,知情同意书存在问题的项目共有36项(占92.3%)。主要问题包括干预试验内容告知不全(占91.7%),干预试验费用承担者及补偿措施的告知模糊(占38.9%),权益和风险的告知不充分(占55.6%),个人信息和生物样本收集、使用及保护措施的告知不全(占30.6%),知情同意书语言表达不规范(占27.8%)。结论 本机构公共卫生干预研究的知情同意书撰写仍存在很多问题,干预试验的相关各方可采取多种措施以提高知情同意书的完整性和规范性。伦理委员会可以向研究者提供知情同意书撰写模板,加强审查能力,根据审查要素表编写伦理审查指引,提高审查效率和质量,保护研究参与者的合法权益。

Leveraging the power of pooled data for cancer outcomes research

Background:Clinical trials continue to be the gold standard for determining the efficacy of novel cancer treatments,but they may also expose participants to the potential risks of unpredictable or severe toxicities.The development of validated tools that better inform patients of the benefits and risks associated with clinical trial participation can facilitate the informed consent process.The design and validation of such instruments are strengthened when we leverage the power of pooled data analysis for cancer outcomes research.Main body:In a recent study published in the Journal of Clinical Oncology entitled "Determinants of early mortality among 37,568 patients with colon cancer who participated in 25 clinical trials from the adjuvant colon cancer endpoints database," using a large pooled analysis of over 30,000 study participants who were enrolled in clinical trials of adjuvant therapy for early-stage colon cancer,we developed and validated a nomogram depicting the predictors of early cancer mortality.This database of pooled individual-level data allowed for a comprehensive analysis of poor prognostic factors associated with early death;furthermore,it enabled the creation of a nomogram that was able to reliably capture and quantify the benefit-to-risk profile for patients who are considering clinical trial participation.This toolcan facilitate treatment decision-making discussions.Conclusion:As China and other Asian countries continue to conduct oncology clinical trials,efforts to collate patient-level information from these studies into a large data repository should be strongly considered since pooled data can increase future capacity for cancer outcomes research,which,in turn,can enhance patient-physician discussions and optimize clinical care.

Institutional Review Board Compliance with National Regulatory Body: A Successful Experience from Saudi Arabia

Background: The Institutional Review Board (IRB) or Research Ethics Committees (RECs) is established to review the research proposals and ensure that participants’ ethical standards, scientific merit, and human rights are protected. Purpose: The authors report the experience of the REC at Qassim Region, Saudi Arabia over 10 years period. Methods: All proposals submitted to Qassim REC during the period 2008-2017 were studied using a 30 items data collection form based on The National Committee of Bioethics Regulations. Data extracted included;principal investigator characteristics, numbers of proposals reviewed, applications completeness, approval decision status, reported ethical issues, classification of the ethical review, and committee review duration. The structure, workload, and review process of Qassim REC were addressed redundant. Results: During 10 years, Qassim Research Ethics Committee (QREC) witnessed a progressive increase in the number of submitted proposals, from 9 to 149 proposals. Out of 508 submitted applications, 439 (86.4%) proposals were eligible for ethical review. Of these, 50 (11.4%) proposals were incomplete due to nonresponse of the principal investigators to the QREC comments. The final decision was made for 389 (88.6%) completed proposals. The approval rate was 85.4%, while the rejection rate was only 1.1%. The median time taken for ethical review was 13 days. Proposals that underwent full board review had a long review duration (Median: 19 days) in comparison to the expedited review (Median: 10 days). Incomplete Committee requirements, unclear research methodology, or possible ethical violation opportunities were the main reasons for delayed decisions. Conclusion: The workload of the Qassim ethics committee is high and growing progressively. However, the process indicators as per National Bioethics Committee rules were satisfactory. Rejection of proposals was rare as most of the reviewed proposals were descriptive studies with infrequent ethical matters.

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.

Decision Making in Children with Attention-Deficit/Hyperactivity Disorder

Background: Informed consent forms and clinical study participation explanations contain many specialized words including medical terms that are difficult to understand. The difficulty is particularly obvious for children with developmental disorders who show attention or similar problems. This study quantitatively evaluated the decision-making ability of these children using the Wechsler Intelligence Scale for Children-III (WISC-III) as a preliminary study for a multi-faceted investigation that would also use physiological indices. Methods: Participants were 11 children with Attention Deficit/Hyperactivity Disorder (AD/HD). The WISC-III was used for quantitative evaluation of their decision-making ability. Results of intelligence quotients (IQs), group indices, and subtest scores were analyzed. Results: The mean Performance IQ was four points lower than the mean Verbal IQ. The mean score for the Processing Speed index was lower by more than one standard deviation (SD). The mean scores for the Coding and Object Assembly subtests were lower by more than two SDs. Conclusion: The WISC-III results for IQ and group indices suggested the efficacy of auditory explanations. In addition, the subtest results suggested the necessity to pay sufficient attention to risk-benefit weighting in explanations. These findings suggested that the decision-making ability of children with AD/HD could be assessed using the WISC-III.

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.

Ethically Justified,Practical Guidance for the Professionally Responsible Investigation of Maternal-Fetal Intervention for Fetal or Neonatal Benefit

This paper provides ethical guidance for the professionally responsible clinical investigation of maternal-fetal investigation for fetal or neonatal benefit and its transition into clinical practice.We present an ethical framework based on the ethical principles of beneficence,respect for autonomy,and justice,the professional virtue of integrity,and the ethical concept of the fetus as a patient.We identify the implications of this ethical framework for the qualifications that centers for maternal-fetal intervention should satisfy.These centers have the ethical obligation to provide prospective review and oversight of both innovation(an experiment undertaken to benefit an individual patient)and research(an experiment undertaken to create generalizable knowledge).We describe ethically justified criteria for innovation and early-phase research,for randomized clinical trials,and for the responsible transition into clinical practice.We also identify the elements of the informed consent process,including measures to prevent therapeutic misconception by pregnant patients during the informed consent process.The scientific,clinical,and ethical requirements of maternal-fetal investigation are demanding.However,the commitment to safety and quality requires that they be met.Fulfilling this commitment will result in well-documented professionally responsible investigation of maternal-fetal intervention for fetal and neonatal benefit.