Consent Practices Research Articles

PSYCHIATRIC GENOMICS RESEARCHERS’ PERSPECTIVES ON BEST PRACTICES FOR RETURNING RESULTS TO INDIVIDUAL PARTICIPANTS

Large-scale array-based and sequencing studies have advanced our understanding of the genetic architecture of psychiatric disorders, but also increased the potential to generate an exponentially larger amount of clinically relevant findings. As genomic testing becomes more widespread in psychiatry research, urgency grows to establish best practices for offering return of results (RoR) to individuals at risk or diagnosed with a psychiatric disorder. We interviewed an international sample (n = 39) of psychiatric genetics researchers to examine conceptualizations of “best practices” for RoR to individual research participants. While the vast majority of researchers do not offer RoR, most believed medically actionable findings (85%) and clinically valid but non–medically actionable findings (54%) should be offered. Researchers identified three main areas for improvement: interfacing with individual participants; interdisciplinary training, guidance, and integration; and quality planning and resource allocation for returning results. There are significant gaps between researchers’ visions for “best” versus “actual” RoR practices. While researchers call for participant-centered practices, including consent practices that consider any special needs of participants with psychiatric disorders, return of individually meaningful results, and effective follow-up and provisions for treatment, the current reality is that consent and RoR practices lack standardized and evidence-based norms.

Variability in Informed Consent Practices for Non-Emergent Procedures in Pediatric Emergency Departments.

Although informed consent is a cornerstone of medical ethics, it is unclear if the practice for obtaining informed consent is consistent among pediatric emergency departments. This study's goal is to describe the current practice for written informed consent in academic pediatric emergency departments for non-emergent procedures. A questionnaire distributed to pediatric emergency medicine fellowship directors queried whether written informed consent was standard of care for 15 procedures and assessed departmental consent policies and use of "blanket" consent-to-treat forms. Response rate was 80% (n = 64). Institutions obtained written consent for a mean of 4.4 procedures. Written informed consent was most commonly obtained for procedural sedation (82.5%), blood transfusion (72.9%), and lumbar puncture (66.5%). Twenty-one institutions (32.8%) had policies specifying procedures requiring written consent. Thirty-five institutions (54.7%) used "blanket" consent-to-treat forms. Our results suggest that there is variability in the use of written informed consent for non-emergent procedures among academic pediatric emergency departments.

Fostering Justice and Stability: Rights Protection and National Sovereignty in the Honduran Zones for Employment and Economic Development (ZEDE)

Honduras's National Congress overwhelmingly approved a bold solution to confront the institutional instability, corruption, and violence that have undermined the protection of basic human rights. The solution, originally inspired by Nobel-Prize-winning economist Paul Romer's charter cities concept, was to form new, independent governing institutions for designated zones of the country, established by popular consent and international best practices for governance. Thus were born the Zonas de Empleo y Desarrollo Economico (Zones of Employment and Economic Development or ZEDEs). Established by constitutional amendment and organic law, the ZEDEs are intended to adopt new public management models operating with a high degree of autonomy, yet without renouncing Honduran sovereignty. Given their novelty and their troubled emergence against a backdrop of institutional failure, the ZEDEs have encountered understandable skepticism, confusion, and criticism. The main concerns have been that the ZEDEs do not protect individual rights and instead expose the Honduran people to abuse and exploitation by foreign companies. Many authors also assert that the ZEDEs undermine Honduran sovereignty. As strong supporters of human rights and institutional accountability, the authors take these concerns seriously. Both are engaged in a multi-year effort to analyze and strengthen the ZEDE legal regime, including its human rights protections. This paper is a product of those efforts. This paper addresses the question of whether the ZEDEs are consistent with Honduran sovereignty and human rights by way of constructing a general rule for ZEDE autonomy that defines the scope of what a ZEDE can legally do. This construction is made by applying principles of statutory construction accepted both internationally and in Honduras to the laws establishing the ZEDEs. This general rule establishes respect for sovereignty and human rights as limitations or outer bounds on ZEDE autonomy, thereby forcing ZEDEs to not transgress these core principles. Thus, while the general rule for ZEDE autonomy allows the ZEDEs wide latitude to develop new laws and administrations, it also ensures consistency with human rights norms and Honduran sovereignty. Moreover, it helps position the ZEDEs to greatly improve the status of human rights and institutional strength in Honduras. This paper begins by highlighting the major challenges facing Honduras today. It then analyses the laws creating the ZEDEs to formulate the general rule of ZEDE autonomy. It then details the human rights safeguards that ZEDEs must comply with and, finally, the relationship between ZEDE autonomy and Honduran sovereignty. As a result, the paper clarifies the ZEDE’s legal obligations regarding human rights and national sovereignty, thus helping define the scope of ZEDE autonomy.

Knowledge and practice of informed consent by physiotherapists and therapy assistants in KwaZulu-Natal Province, South Africa.

BackgroundInformed consent is a doctrinal prerequisite in accordance with the National Health Act 2003 and professional ethical guidelines. Current regulations stipulate that healthcare professionals obtain informed consent from patients prior to treatment. Misconduct charges relating to inadequate information disclosure have been recorded against South African physiotherapists.ObjectivesThis study evaluated knowledge and barriers to informed consent practice among physiotherapists and assistants at Ethekwini District public health institutions.MethodsThis cross-sectional study utilised self-administered questionnaires. Statistical Package for Social Sciences was used to analyse variables. Significance level and attitude correlation was determined using chi-squared tests, Pearson’s correlation and Spearman’s coefficient.ResultsForty-nine respondents (43 physiotherapists, 3 technicians, 3 assistants) completed this study. Mean age and professional experience of respondents were 38 and 14 years, respectively. The majority were female (93%); 56% spent 5 to 10 min obtaining informed consent, mostly verbally (89%); while 47% correctly identified age of consent to routine treatment (12 years). Information provided to patients by respondents included treatment benefits (100%), common risks (81%) and ‘all material risks’ (31%). Fifty per cent of respondents showed positive attitudes to informed consent.ConclusionsSome practising physiotherapists and assistants in KwaZulu-Natal public healthcare institutions had only partial knowledge of informed consent regulations and local laws. Barriers to informed consent included language and excessive workload.Clinical implicationsPatient-centred care is quality healthcare, and adequate informed consent knowledge improves clinical outcomes, respects patients’ dignity and autonomy. Continued professional education on healthcare law and ethics should be provided to practising physiotherapists and assistants.

Informed consent in gynecologic surgery.

Informed consent is frequently used interchangeably with obtaining a signature on a form. This oversimplification shifts the value from the process of informed consent to the documentation. This review focuses on the recommended components of the consent process, barriers encountered, factors influencing patient satisfaction, attempts to improve the consent practice, and considerations in special populations. The process of informed consent is key to promoting shared decision-making and patient autonomy. Several barriers exist to providing optimal consent including time constraints as well as educational, cultural, and language barriers. Innovative approaches such as audiovisual aids show promise in overcoming barriers and improving the consent process. Patients seek expertise and knowledge to aid in making decisions that align with their care goals. Providers have an obligation to provide individualized and accessible counseling. Ongoing research is needed to optimize this process.

Optimising informed consent in school-based adolescent vaccination programmes in England: A multiple methods analysis

The process of obtaining informed consent for school-based adolescent immunisation provides an opportunity to engage families. However, the fact that parental consent needs to be obtained remotely adds complexity to the process and can have a detrimental effect on vaccine uptake. We conducted a multiple methods analysis to examine the practice of obtaining informed consent in adolescent immunisation programmes. This involved a thematic analysis of consent related data from 39 interviews with immunisation managers and providers collected as part of a 2017 service evaluation of the English adolescent girls’ HPV vaccine programme and a descriptive statistical analysis of data from questions related to consent included in a 2017 survey of parents’ and adolescents’ attitudes to adolescent vaccination. The findings indicated that the non-return of consent forms was a significant logistical challenge for immunisation teams, and some were piloting opt-out consent mechanisms, increasing the proportion of adolescents consenting for their own immunisations, and introducing electronic consent. Communicating vaccine related information to parents and schools and managing uncertainties about obtaining adolescent self-consent for vaccination were the main practical challenges encountered. Survey data showed that parents and adolescents generally agreed on vaccine decisions although only 32% of parents discussed vaccination with their teenager. Parental awareness about the option for adolescents to self-consent for vaccination was limited and adolescents favoured leaving the decision-making to parents. From the interviews and variability of consent forms it was evident that health professionals were not always clear about the best way to manage the consent process. Some were also unfamiliar with self-consent processes and lacked confidence in assessing for ‘Gillick competency’. Developing pathways and related interventions to improve the logistics and practice of consent in school-based adolescent immunisation programmes could help improve uptake.

Why deprescribing antipsychotics in older people with dementia in long-term care is not always successful: Insights from the HALT study.

Antipsychotic medications are commonly used to manage behavioural and psychological symptoms of dementia despite their side effects and harms. While the Halting Antipsychotic Use in Long-Term care (HALT) deprescribing trial was successful at reducing antipsychotic use, 19% of participants had their antipsychotics represcribed or never reached a dose of zero. The aim of this study was to investigate the reasons for represcription of antipsychotic medication and factors associated with ongoing antipsychotic use, relating to care staff requests and perceived behavioural changes. Thirty-nine of 133 HALT participants never ceased their antipsychotic medication or were represcribed a regular or pro re nata (PRN) antipsychotic after initial deprescribing. The views of nursing staff, general practitioner, and family on the circumstances leading up to these outcomes were collected via a questionnaire-based approach. This information was triangulated with observation and detailed file audit (including progress notes, medical notes, medication charts, incident reports, and hospital discharge summaries). A consensus panel reconstructed the represcribing context. Nurses were the most common drivers of represcribing (63.2%), followed by family members (39.5%), GPs (23.7%), specialists (13.2%), and hospital staff (10.5%). There were multiple drivers for antipsychotic use in 46.2% of participants. Increased agitated and aggressive behaviours were the most commonly reported reasons for represcribing even though these changes were not identified over time on objective measures. Consent and dosage practices remained poor despite education. Nursing staff are the key drivers of deprescribing particularly in response to perceived worsening agitation and aggression among male residents. The train-the-trainer model used in the HALT trial may have been insufficient on its own to improve staff competence and confidence in applying nonpharmacological approaches when responding to behaviour change.

Clinical holding: ethical guidance for children's nurses working in the UK.

This article explores ethical decision-making surrounding clinical holding of children and young people in healthcare environments with the aim of enhancing autonomy and engagement on their behalf. A considerable body of evidence, published over the last 20 years, suggests that this complex and challenging area of practice is not always well managed, with mixed messages about the nature of consent, choice and negotiated practice countered by best interests decisions taking precedence ahead of the child's wishes. An ethical framework is proposed comprising four levels of value-based interventions and how they may be applied in clinical practice, allowing for increased engagement, empowerment and support on behalf of children and young people in relation to clinical holding decisions.

How Do We Really Communicate? Challenging the Assumptions behind Informed Consent Interventions.

It is generally accepted that ethical research requires valid informed consent and that current informed consent practice frequently fails to attain it. Interventions concerning the content and methods of communication in informed consent have met with limited success. One explanation is that they reflect an outdated and limited model of how communication functions, the transmission model of communication. This model assumes that communication is linear, is limited in time, and succeeds when the content of a message is passed from one person to another without distortion. Later communication models have challenged the limitations and inaccuracies of this model, emphasizing the continuous, contextual, and relational nature of communication. Looking beyond these assumptions behind current interventions can open multiple paths of research and intervention that have the potential to affect and improve the informed consent process in much greater ways than have been achieved previously.

Informed consent and ethical reporting of research in clinical trials involving participants with psychotic disorders

Informed consent is critical for protecting vulnerable individuals interested in research participation, like those with psychotic disorders (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, etc.). Individuals with psychotic disorders may have fluctuating capacity to consent and capacity assessment prior to research participation can help determine decisional status. However, there is little research on how, or if, these assessments are conducted in clinical research. A systematic review of randomized medication or device trials that specifically recruited individuals with psychotic disorders to understand the use and reporting of capacity assessment to consent was conducted. A total of 646 articles were reviewed using a developed questionnaire on ethical reporting of consent practices and capacity assessment. Less than 10% (n = 34; 5.3%) of the studies reported an assessment of capacity to provide informed consent and less than half of those used a standardized assessment. Sixty-four (9.9%) of the articles reported capacity to provide informed consent in the study's inclusion and exclusion criteria. Additionally, 66 (10.2%) of the articles did not provide a statement about institutional review board (IRB) approval; and given the large number of medication and device trials, one out of five articles (n = 134; 20.7%) reported no statement about potential conflicts of interest. Future research should continue to examine these issues and to better understand the benefits and challenges of research participation with psychotic individuals and their decisional capacity in this context.

Can dynamic consent facilitate the protection of biomedical big data in biobanking in Malaysia?

As with many other countries, Malaysia is also developing and promoting biomedical research to increase the understanding of human diseases and possible interventions. To facilitate this development, there is a significant growth of biobanks in the country to ensure continuous collection of biological samples for future research, which contain extremely important personal information and health data of the participants involved. Given the vast amount of samples and data accumulated by biobanks, they can be considered as reservoirs of precious biomedical big data. It is therefore imperative for biobanks to have in place regulatory measures to ensure ethical use of the biomedical big data. Malaysia has yet to introduce specific legislation for the field of biobanking. However, it can be argued that its existing Personal Data Protection Act 2010 (PDPA) has laid down legal principles that can be enforced to protect biomedical big data generated by the biobanks. Consent is a mechanism to enable data subjects to exercise their autonomy by determining how their data can be used and ensure compliance with legal principles. However, there are two main concerns surrounding the current practice of consent in biomedical big data in Malaysia. First, it is uncertain that the current practice would be able to respect the underlying notion of autonomy, and second, it is not in accordance with the legal principles of the PDPA. Scholars have deliberated on different strategies of informed consent, and a more interactive approach has recently been introduced: dynamic consent. It is argued that a dynamic consent approach would be able to address these concerns.

Assessing informed consent practices during normal vaginal delivery and immediate postpartum care in tertiary-level hospitals of Bangladesh.

INTRODUCTIONThis study was conducted to assess the informed consent practices during normal vaginal delivery (NVD) process and immediate postpartum care in the tertiary-level hospitals of Bangladesh.METHODSA cross-sectional study was conducted at Dhaka Medical College Hospital (DMCH) and Sir Salimullah Medical College & Mitford Hospital (SSMCH) in November 2015. The study population and respondents were mothers who gave normal vaginal childbirth within the past 24 hours and received postpartum care in the study sites (N=190). The interview of every alternate mother from the patient register was conducted by researchers using a structured questionnaire. Descriptive analysis of findings was carried out using MS Excel 2013.RESULTSThe study findings revealed the complete absence of informed consent practices during NVD and postpartum care in the tertiary-level hospitals in Bangladesh. Consent (not informed consent) was taken from 95% of the mothers before proceeding with the NVD process, 50–72% of examinations (except breast examination, 0%) and 8–72% of procedures during postpartum care. Choice and preferences of mothers for taking an alternative process/examination/procedure were absent in all cases.CONCLUSIONSThe Respectful Maternity Care (RMC) Charter endorsed informed consent as one of the basic rights of child-bearing women. Absence of informed consent practices in the study sites indicates disrespect to maternity care and violation of this right. The Standard Clinical Management Protocols of Bangladesh also lacks clarification of this right. Improvement of the existing protocol, increased awareness and practices are essential to address protection of this right.

A critical review of thyroidectomy consent in the UK.

In 2015-16, the National Health Service (NHS) Litigation Authority received 10,965 claims for clinical negligence, with surgery having the highest number of claims. Currently a sum amounting to 25% of the annual NHS budget has been ring-fenced to meet extant claims. Claims made on a basis of inadequate informed consent are increasingly seen with many achieving a successful plaintiff outcome. There are presently no UK guidelines for thyroidectomy consent. A prospective study was performed to investigate current consent practice among the British Association of Endocrine and Thyroid Surgeons (BAETS) membership and patients having previously undergone thyroidectomy. For surgeons, the Bolam legal test applied where surgeons declared what risks and complications they routinely consented for during their practice. A study was also undertaken in patients who had previously undergone thyroidectomy for cancer applying the rule of Montgomery. Consent practice from 193 surgeons and data from 415 patients was analysed. In total thyroidectomy for cancer, 95% of surgeons consent for Recurrent Laryngeal Nerve (RLN) injury and temporary or permanent voice change. 70% specifically consent for External Laryngeal Nerve (ELN) injury, 50% for tracheostomy and 55% for general anaesthetic associated complications. Analysis of patient data showed they would like to be consented for far more risks than they are presently informed about in general medical practice. There was significant variation in the consenting practice in BAETS surgeons. A BAETS approved consensus guideline to standardise UK consent practice would be appropriate. This may reduce complaints, litigation claims and guide expert witnesses.

Assessment of Use, Specificity, and Readability of Written Clinical Informed Consent Forms for Patients With Cancer Undergoing Radiotherapy

Appropriate informed consent processes are crucial to preservation of patient autonomy and shared decision making. Although half of patients with cancer receive radiotherapy, it is unknown whether current consent practices are comprehensible for patients. To characterize use, specificity, and readability of clinical informed consent forms for radiotherapy, hypothesizing that forms would be higher than the recommended sixth- to eighth-grade readability level. This nationwide cross-sectional survey study and readability analysis was conducted from 2016 to 2018 and included 89 academic radiation oncology departments that were part of the 2016 Electronic Residency Application Service. Department leaders (clinical directors, chairs, and personal contacts of study authors) at academic radiation oncology departments were contacted via email. Readability levels were measured by 7 validated readability indices, including the Ford, Caylor, Sticht (FORCAST) index for nonnarrative texts. Difficult words were identified using The Living Word Vocabulary, which describes the readability grade levels of 40 000 common words. Of 89 departments, 67 (75%) responded to questions and 57 (64%) provided 113 forms for analysis. Departments providing forms did not differ substantially from others in terms of region, residency size, research output, rural vs urban location, or public vs private institution status. All departments obtained patient written informed consent before radiotherapy; 38 (57%) used body site-specific forms. Using the most conservative (low-score) estimate, mean form readability ranged from grade level 10.6 to 14.2. By 7 distinct indices, only 9 (8%) of 113 forms met the recommended eighth-grade readability level, and 4 (4%) forms met a sixth-grade level. Not a single form met either recommendation based on the FORCAST index. Forms used an average of 7.2 difficult words. Body site-specific forms had considerably better readability than general consent forms. This nationwide study of informed consent practices for cancer treatment with radiotherapy demonstrates that while all US academic radiotherapy departments use written consent forms, it is rare for templates to meet the recommended readability levels for patient materials. These data suggest the need for reevaluation and modification of the approach to radiotherapy consent, ideally with guidance and templates designed by national professional organizations.

Barriers and pathways to informed consent for ionising radiation imaging examinations: A qualitative study

IntroductionInformed consent for ionising radiation medical imaging examinations represents a recent change to medical imaging practice. This practice has not had a definitive and authoritative integration into clinical practice, and lack of direction has caused many health care professionals to be unsure of an appropriate consent methodology. Consent practices have been undertaken inconsistently and sometimes poorly. This research sought to investigate what barriers exist to meaningful informed consent, and what pathways are suggested to overcome these barriers. These views are then discussed in the context of practical health care consent practices. MethodsA semi-structured interview explored the views of radiographers and radiologists on the practice of disclosing the ionising radiation risk of a clinical medical imaging examination. Qualitative data was analysed using a nominal method of quantitative transformation. Responses were reviewed, and a set of definitive themes constructed. Participants considered the influences, logistics and barriers to the informed consent process. Participants were then asked what pathways might be developed that would improve the process. ResultsTwenty-one (21) radiographer participants and nine (9) radiologists were interviewed. The barriers to consent identified issues of time constraints, lack of a unified message, and patient presentations. Pathways suggested included limiting the scope of the consent practice, sharing the consent responsibility, and formulation of definitive consent guidelines. ConclusionA unified, definitive series of guidelines for informed consent for ionising radiation examinations would alleviate many of the identified barriers. Having the consent process consistently begin with the referring doctor would facilitate more meaningful consent.

Big data in healthcare research - how can we address public concerns of privacy

Big data is an emerging technological field that encompasses massive datasets. Its role in the healthcare field is currently being explored and has the potential to greatly improve healthcare and disease surveillance through pattern analysis of health data. Concerns had by the general public focus primarily on potential breaches of privacy and confidentiality of patient medical health records in the context of research. These concerns relate to the innate characteristics of big data, such as large size and fast data acquisition speed, which increases the risk of breaching confidentiality. Therefore, it is important for physicians to be mindful of privacy concerns and maintain trust as big data becomes more prominent. Doing so is a key factor in building public trust in the use. Understanding strategies and limitations of current practice standards will allow physicians to build on existing guidelines to incorporate the rise of big data. This means prioritizing privacy when handling big data through anonymization, creating safe havens and promoting dynamic informed consent practice standards.

Best Practices for Obtaining Genomic Consent in Pediatric Traumatic Brain Injury Research.

Precision health relies on large sample sizes to ensure adequate power, generalizability, and replicability; however, a critical first step to any study is the successful recruitment of participants. This study seeks to explore how the enrollment strategies used in a parent study contributed to the high consent rates, establish current best practices that can be used in future studies, and identify additional factors that contribute to consent into pediatric traumatic brain injury biobanks. Retrospective secondary analysis of data from a parent study with high consent rates was examined to explore factors affecting consent into biobanking studies. Of the 76 subjects who were approached, met the eligibility criteria, and reviewed the consent form, only 16 (21.1%) declined to participate. The consented group (n = 60) represents 64.5% of those who met the eligibility criteria upon initial screening (n = 93) and 78.9% of those with confirmed eligibility (n = 76). Analysis of screening data suggested there were no major barriers to consenting individuals into this pediatric traumatic brain injury biobank. There were no demographic or research-related characteristics that significantly explained enrollment. Ethically, to obtain true informed consent, parents need to understand only their child's diagnosis, prognosis, and medical care, as well as the purpose of the proposed research and its risks and benefits. Researchers need to implement best practices, including a comprehensive review of census data to identify eligible participants to approach, a prescreening protocol, and effective consenting process to obtain informed consent so that precision care initiatives can be pursued.

Informed consent practice for obstetric and gynaecologic procedures: A patients' perspective from a developing country.

To assess the surgical informed consent (SIC) practices for obstetric and gynaecological (OB-GYN) procedures at different hospitals in Pakistan. Study was conducted in five hospitals (three public and two private) of Peshawar, Pakistan. A pretested structured tablet-based questionnaire was administered from October 2016 through January 2017 among post-op OB-GYN patients. About 27% of the patients (significantly more in private hospitals, P=0.001) did not remember a formal consent administration. Most patients (80%) felt they had no choice about signing the consent. About 65% (mostly in public as compared with private hospitals) mentioned that they would have signed it regardless of the specifics in it (P<0.001). Patients had increased odds to recall consent if they felt empowered, odds ratio (OR)=4.5; had an opportunity to ask questions, OR=7.2; wanted more explanation, OR=2.8; and had consent administered in their mother tongue, OR=6.9. Patients' recall of key elements of consent was low. The time spent with the patient for consenting was much shorter than recommended. The printed consent forms were mostly not available in patients' mother tongue. Consent practice for OB-GYN procedures was suboptimal in studied hospitals. Patients' attitude toward informed consent practices largely reflected providers' focus on obtaining a legally valid signed consent as opposed to administering a consent that empowers patients to make an informed decision in the absence of any external pressure.

Ethical Use of Student Profiles to Predict and Prevent Development of Depression Symptoms During Medical School.

Research investigations have repeatedly shown that medical school can be a period of high stress and deteriorating mental health for many students. There is a critical need for systematic guidance on how to personalize prevention and treatment programming to help those students at highest risk. The authors of this Invited Commentary respond to the report by Dyrbye and colleagues, published in this issue of Academic Medicine, that proposes a prognostic index to predict risk of developing depression symptoms in medical students. The commentary authors applaud Dyrbye and her coauthors for their innovative approach; their findings provide substantial insights relevant to the critical goal of enhancing medical student well-being. However, evidence indicates that students who identify as members of racial, ethnic, sexual, and/or gender minority groups are at heightened risk of depression, so any program that profiles students in relation to their mental health symptoms must be proactive in ensuring that its efforts do not perpetuate stigma, marginalization, and discrimination for these underrepresented and potentially vulnerable groups. The commentary authors suggest practices for ethically implementing recommended wellness programs while maintaining an inclusive learning environment that respects personal privacy and incorporates transparent consent practices.

The Challenges of Informed Consent in High-Stakes, Randomized Oncology Trials: A Systematic Review.

Importance. Oncology trials often entail high-stakes interventions where potential for morbidity and fatal side effects, and for life-prolongation or cure, intensify bioethical issues surrounding informed consent. These challenges are compounded in multistage randomized trials, which are prevalent in oncology. Objective. We sought to elucidate the major barriers to informed consent in high-stakes oncology trials in general and the best consent practices for multistage randomized trials. Evidence Review. We queried PubMed for original studies published from January 1, 1990, to April 5, 2018, that focused on readability, quality, complexity or length of consent documents, motivation and sickness level of participants, or interventions and enhancements that influence informed consent for high-stakes oncologic interventions. Exclusion criteria included articles focused on populations outside industrialized countries, minors or other vulnerable populations, physician preferences, cancer screening and prevention, or recruitment strategies. Additional articles were identified through comprehensive bibliographic review. Findings. Twenty-seven articles were retained; 19 enrolled participants and 8 examined samples of consent documents. Methodologic quality was variable. This body of literature identified certain challenges that can be readily remedied. For example, the average length of the consent forms has increased 10-fold from 1987 to 2010, and patient understanding was shown to be inversely proportional to page count; shortening forms, or providing a concise summary as mandated by the revised Common Rule, might help. However, barriers to understanding that stem from deeply ingrained and flawed sociocultural perceptions of medical research seem more difficult to surmount. Although no studies specifically addressed problems posed by multiple sequential randomizations (such as change in risk-benefit ratio due to time-varying treatment responses or organ toxicities), the findings are likely applicable and especially relevant in that context. Concrete suggestions for improvement are proposed.