Consent In Clinical Trials Research Articles

Succinct Cancer Clinical Trial Consent Forms in Rural Patients With Cancer: A Secondary Analysis of a Randomized, Double-Blinded study.

Rural patients are often underrepresented in cancer clinical trials. This is a secondary analysis of a study that tested short (2000 word) versus long (6000 word) consent forms with a focus on rurality. Among 240 patients, 89 (37%) were rural. Seventy-one (80%) rural and 117 (77%) nonrural patients signed a consent form of any length (P = .68). Forty-one of 47 (87%) rural patients signed a short consent form; in contrast, 30 of 42 (71%) signed a long form. These trends suggest rural patients are more likely to sign short consent forms. Further study is indicated.

Using Blockchain Integration Patterns to Ensure Data Integrity in the Health Care Industry

Security is crucial in the healthcare industry. Between 2012 and 2019, almost 179 million health records were exposed to data breaches. The intruders got into homes and companies to take credit card and banking information, as well as health and genetic research data. Blockchain is a fantastic technology for applications in the area of protection because it can keep an incorruptible, decentralized, and open record of all patient data. It is, nevertheless, secure and keeps any person's identity hidden. When dealing with decentralized technology, patients, doctors, and hospital personnel may all share the same information. On a blockchain, the cost of verifying a single transaction is negligible. You can audit a single piece of data in real time, and it's entirely visible to everyone. As a result, costless verification is economically possible. Recent audits of healthcare data, for example, have necessitated the time-consuming and costly examination of tiny units of transactions. This procedure had to be interrupted and redone on a frequent basis prior to blockchains in order to comply with regulations. Compared to traditional healthcare information management solutions, blockchain provides five potential benefits. Blockchains are ideal for decentralized administration applications, such as when hospitals, consumers, and payers want to work together without the need for a middleman. The second advantage of blockchains is that they may offer immutable archives of sensitive data, which makes them ideal for static databases (e.g., insurance claim records). Blockchains are very useful for tracing the origins and histories of digital artifacts (e.g., patient consent in clinical trials). According to cryptographic protocols, changing the ownership of an item can only be done by the person who owns it. Furthermore, the attributes' origins may be traced, making previously confirmed evidence considerably more reusable. The fourth advantage of blockchains is that they ensure the longevity, consistency, and accessibility of records. As a result, they're perfect for long-term records storage and availability (e.g., the electronic health records of patients). Patients' personal keys encrypt the data, which is only accessible with their consent, making it safer and more private. There is no method to access personal information even if the network is hacked by a hostile entity.

113 Simplifying consent - Use of the novel integrated consent model in paediatric clinical research

Abstract Primary Subject area Hospital Paediatrics Background Obtaining informed consent from patients to participate in clinical research has traditionally been a cumbersome process, often requiring lengthy documentation and the involvement of trained research staff. Moreover, this process can be a burden to the patient/family. As a result, progress in paediatric research and enabling continual improvement in care has been slow. In the last decade, research ethicists have proposed a new “integrated consent model” (ICM) for obtaining informed consent for pragmatic clinical trials that compare standard-of-care interventions, where there is clinical equipoise. In most cases of ICM, only a brief discussion with verbal consent is required, along with a handout on study purpose, risks, benefits, and procedures. This allows for a more condensed consent process, which maximizes clarity and minimizes information overload. ICM also allows the patient/family to maintain prospective autonomy and decision-making, as compared with deferred or waived consent. The ICM model allows staff in the circle of care to obtain consent, which minimizes the stress of meeting an additional person. To our knowledge, ICM has not yet been used in the paediatric population. Objectives The objective of this abstract is to report on the utility of ICM in a non-randomized clinical trial carried out in the inpatient setting of a tertiary children’s hospital. Design/Methods We compared two widely accepted standards of care for maintaining peripheral intravenous catheter patency in a cohort of children, namely continuous infusion (“to keep the vein open” or TKVO) versus saline lock (SL). The ICM process was reviewed and approved by REB. Nurses in the circle of care received a study package that included an REB approved “consent script” to be read to the patient/family, a single page information sheet, and instructions on documenting the obtained verbal consent in the patient’s chart (Graphic 1). Results With ICM, 79% of participants were recruited into the trial by a nurse. Patient recruitment was completed 4 months ahead of the predicted schedule (Figure 1). Nursing, research, and medical staff were satisfied with ICM and found it easy to administer. ICM occurred smoothly and quickly for patients/families, with no interference with their medical care and practically no disruption to their daily schedule. Conclusion ICM is a practical alternative to laborious traditional consent models, is associated with higher patient recruitment rates, and is less burdensome for the patient/family. Paediatricians should be aware of the utility of this novel consent model.

Implementation of documented and written informed consent for clinical trials of communicable diseases: Lessons learned, barriers, solutions, future directions identified during the conduct of a COVID-19 clinical trial

Background and objectiveThe communicable nature of many infectious diseases, including SARS-CoV-2, creates challenges for implementing and obtaining regulatory-compliant written informed consent. The goal of this project was to identify and evaluate processes that address these barriers while maintaining clinical and research staff safety. MethodsWe reviewed Federal Drug Administration (FDA), World Health Organization (WHO), and VA Office of Research and Development (ORD) guidance about informed consent during the COVID-19 pandemic, and identified and pilot-tested several mechanisms for obtaining regulatory-compliant consent during our COVID-19 therapeutics clinical trial. ResultsSeveral processes were identified. These included a standard face-to-face consent with a plan for maintaining a paper copy of the signed consent form, a phone or video chat consent process that included taking a picture of the signed consent form or a screen shot of the signed document during a video chat, integration of the consent forms into software embedded within the electronic health record, and secure software programs with electronic signature. These processes are FDA-compliant but time-intensive, often requiring four or more hours of coordination between the clinical team, research staff, patients, and legally authorized representatives. ConclusionsFuture studies could evaluate how to improve efficiency, and whether some elements of the consenting process, such as the requirement for documented written signed consent, rather than a witnessed oral consent, is an acceptable standard for research participants with communicable diseases.

Role of Health Literacy, Acculturation, and Socio-Demographics on Perception of Voluntariness during Informed Consent for Pediatric Leukemia Clinical Trials

Introduction :Valid consent for research requires that the decision be both informed and voluntary. For parents and legal guardians, it is essential that they fully understand their role when giving consent to participation of their child in research. Previous studies on parental informed consent in pediatric settings have focused largely on disclosure and understanding (Kodish, JAMA, 2004; Chappuy, Arch Dis Child, 2010) and motivations for agreeing to or declining research participation (Petersen, Pediatr Blood Cancer, 2013). When presented with a cancer clinical trial for their child, parents often do not understand the many components of informed consent, including voluntariness of participation (De Vries, BMC Med Ethics, 2011). In addition, individuals with limited English proficiency have reported lower understanding and satisfaction during informed consent (Breese, J Empir Res Hum Res Ethics, 2007). There is limited research on perception of voluntariness of participation in pediatric leukemia clinical trials. The aim of this study was to examine socio-demographic and contextual correlates of perception of voluntariness, decisional regret, and satisfaction in parents who had consented to participation of their child in a clinical trial for leukemia treatment. We focused on characterizing differences between non-Hispanics and Hispanics, as the latter is the fastest growing ethnic group in the U.S.Methods :Parents/guardians (n=97) of children aged 0-17 years with newly diagnosed leukemia, who had consented to participation of their child in a clinical trial for leukemia treatment at Rady Children's Hospital San Diego were prospectively recruited. Of the 135 parents approached to participate in our study, 26 (19.3%) declined and 12 (11.0%) withdrew after enrollment. Reasons for declining or withdrawing included feeling overwhelmed, having no time, or having no interest in the study. Participants completed questionnaires assessing perception of voluntariness, decisional regret, satisfaction, health literacy, socio-demographics, and acculturation level, if Hispanic (Table 1). Perception of voluntariness, decisional regret, and satisfaction outcomes were analyzed by socio-demographics, health literacy, and acculturation levels using logistic regression.Results :Ninety-seven participants were surveyed, including 50 (51.5%) Hispanic and 47 (48.5%) non-Hispanic. Demographic characteristics of the participants are shown in Table 2. We found that higher health literacy was associated with higher perception of voluntariness (p<0.001), socioeconomic status (SES) (p<0.001), and acculturation (p<0.001). Hispanic participants reported lower health literacy (p<0.001) compared to non-Hispanic participants. Spanish-speaking participants reported lower health literacy (p<0.001), lower perception of voluntariness (p=0.048), and lower acculturation (p<0.001) compared to English-speaking participants. In addition, participants with Medicaid reported lower health literacy (p<0.001) and lower SES (p<0.001) compared to participants with private insurance. Finally, participants with lower education levels reported lower health literacy (p<0.001). Decisional regret was overall low and satisfaction was overall moderately high across all subgroups and neither was significantly impacted by socio-demographics, health literacy, or acculturation.Conclusions :In this study, with equivalent numbers of Hispanic and Non-Hispanic participants, we found that Hispanic parents of children with newly diagnosed leukemia, and particularly Spanish-speakers, had inadequate health literacy and perception of voluntariness, despite overall high rates of satisfaction with the informed consent process for clinical trials. To our knowledge, this is the first study to associate lower health literacy with lower perception of voluntariness in parents of children with newly diagnosed leukemia. True voluntariness in participation is essential to the ethical practice of informed consent, and our study suggests that many Hispanics parents and those with limited English proficiency are not making truly informed decisions for their child with cancer. It is imperative to improve the informed consent process and facilitate informed decision making with culturally and linguistically appropriate interventions tailored to this vulnerable population. [Display omitted] DisclosuresAristizabal:American Society of Hematology Scholar Award: Other: ASH Scholar Award for the submitted abstract, Research Funding; American Society of Pediatric Hematology/Oncology Clinician-Educator Award: Research Funding; Alex Lemonade Stand Foundation Psychosocial Grant: Research Funding; NIH/CTSA: Other: Pilot Grant, Research Funding. M:University of California San Diego School of Medicine Research Fellowship: Research Funding.

External validity of randomized clinical trial studying preventing depressive symptoms following acute coronary syndrome.

ObjectiveThe objective of the current study was to quantitatively explore aspects of external validity, both researcher's choices (eligibility) and patient's choices (consent), of a recently conducted clinical trial.MethodsA cohesive comparison between the MEDACIS trial (NCT02451293) database and a national quality and research database was conducted. Comparisons between both participants and nonconsenting patients (patient consent) and participants and noneligible patients (researcher selection) were performed. Comparisons of outcomes were depressive and anxiety symptoms, demographics, and somatic or psychiatric comorbidity.ResultsNoneligible patients had significantly higher levels of depressive symptoms and anxiety and were older and more likely to suffer from unstable angina pectoris. Furthermore, noneligible patients were less likely to be married, had a lower educational level, used more medication, and had a higher frequency of comorbidity. Nonconsenting patients had significantly higher levels of depressive symptoms and anxiety and were older and more likely to be females compared to participants.ConclusionSignificant differences were present between noneligible patients and participants; however, more troublingly significant differences were shown between nonconsenting patients and participants. The presence of depressive symptoms and anxiety has a significant impact on patients’ willingness to give informed consent in clinical trials in cardiology with a focus on psychological outcomes.

Randomized, Double-Blind Trial on the Impact of Word Count in Cancer Clinical Trial Consent Forms.

This randomized, double-blind study sought to understand whether cancer clinical trial consent form verbosity detracts from patients' decision making on trial enrollment. This trial tested mock consent forms of 2,000, 4,000, and 6,000 words. The first two comprised the two experimental arms and the third the control arm. Phase II was conducted to identify the promising arm, which, in phase III, was compared with the control arm. Each consent form described the same trial. Eligible adult patients reported a cancer history and English literacy. The primary end point used a patient-reported Likert scale to assess the relationship between information in the consent form and trial decision making. In phase II, 93 patients were accrued and prompted the selection of the 2,000-word consent form for phase III. In phase III, 182 patients were recruited, resulting in 240 total evaluable patients to compare the 2,000-word versus the 6,000-word arm (control). For the primary end point, 103 (84%) and 107 (91%) patients in the 2,000- and 6,000-word arms, respectively, strongly agreed or agreed with the following: "The information in this consent form helped me make a decision about whether or not to enroll in the trial" (two-sided, P = .14). Median time to read each consent form was 8 and 12 minutes, respectively (two-sided, P < .0001). Among those assigned these consent forms, 84% and 73%, respectively (two-sided, P = .04) signed or expressed a willingness to sign. This study's primary end point was not met. However, secondary outcomes suggest a need to further study the efficiency and efficacy of shorter consent forms for cancer clinical trial enrollment.

Informed Consent by Any Other Name: Consent Processes for Emergency Use Authorization.

Informed Consent by Any Other Name: Consent Processes for Emergency Use Authorization.

Are we undermining the value of palliative care through advanced cancer clinical trial consent language?

Informed consents for advanced cancer trials contain language that misrepresents palliative care as an alternative to trial participation. This language should be revised to highlight that palliative care is appropriate at any point in the illness trajectory and alongside disease‐directed therapy.

Heterogeneity of national legislation and practice on clinical trials with vulnerable patients based on the EU Clinical Trials Directive by the example of adults permanently incapable of giving informed consent.

In principle, persons wishing to participate in a clinical trial must give informed consent in advance after comprehensive information has been provided. Under certain conditions, it is possible to deviate from this requirement in the European Union (EU) in order to enable the participation of so-called vulnerable persons who are incapable of giving their informed consent. Kuthning et al. [1] have already dealt with general and specific aspects of vulnerable patients and the principle of informed consent in clinical trials. One group of vulnerable persons, for example, are adults temporarily or permanently incapable of giving consent due to their state of health. For a long period of time, no systematic and uniform legal basis for clinical trials existed in the EU as a whole. The Clinical Trials Directive (CTD) [2], adopted in 2001, aimed to change this by harmonizing all legal regulations on clinical trials applicable in the EU, but nevertheless allowing national deviations in implementation into national laws through opening clauses and aspects that were left unregulated. In view of the Clinical Trials Regulation (CTR) [3] which, according to the current status, will with high probability be applied from 2022 on, and which in future will be the legal basis for clinical trials with medicinal products in humans, applied directly in all EU member states, the necessity to take stock of the effects of the CTD was evident.The national deviations with regard to the participation of patients incapable of giving informed consent were investigated qualitatively and quantitatively by means of a systematic analysis of legislation in 16 EU countries and a retrospective database analysis of a European clinical trial registry over a ten-year observation period. Although the analysis initially showed a predominantly homogeneous picture, the differences between the EU member states became apparent in a detailed examination. The database analysis yielded a clear result, since in some countries the majority of clinical trials are carried out. The clearest difference was found between the legal analysis and the results of the evaluated clinical trials concerning adults who are permanently incapable of giving informed consent. A presumed association between the “degree of liberality” of the national law and the frequency of clinical trials conducted in the respective country could not be confirmed. In the past, the selection of countries for conducting a clinical trial was based less on legal requirements and more on experience and financial considerations.

Clinical effect of normal saline injectate into interscalene nerve block catheters given within one hour of local anesthetic bolus on analgesia and hemidiaphragmatic paralysis

BackgroundPrevious case reports describe the reversal of phrenic nerve blockade from the interscalene nerve block using normal saline injectate washout. This randomized clinical trial aimed to evaluate whether using normal...

Perceived barriers to assessing understanding and appreciation of informed consent in clinical trials: A mixed-method study.

Participants and research professionals often overestimate how well participants understand and appreciate consent information for clinical trials, and experts often vary in their determinations of participant's capacity to consent to research. Past research has developed and validated instruments designed to assess participant understanding and appreciation, but the frequency with which they are utilized is unknown. We administered a survey to clinical researchers working with older adults or those at risk of cognitive impairment (N = 1284), supplemented by qualitative interviews (N = 60). We found that using a validated assessment of consent is relatively uncommon, being used by only 44% of researchers who had an opportunity. Factors that predicted adoption of validated assessments included not seeing the study sponsor as a barrier, positive attitudes toward assessments, and being confident that they had the resources needed to implement an assessment. The perceived barriers to adopting validated assessments of consent included lack of awareness, lack of knowledge, being unsure of how to administer such an assessment, and the burden associated with implementing this practice. Increasing the use of validated assessments of consent will require educating researchers on the practice and emphasizing very practical assessments, and may require Institutional Review Boards (IRBs) or study sponsors to champion the use of assessments.

Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease.

Aims of the studyPatient comprehension is a critical part of meeting medical ethics standards of informed consent in study designs. The aim of the study was to determine if sufficient literature exists to require clinicians to disclose the specific risk that COVID‐19 vaccines could worsen disease upon exposure to challenge or circulating virus.Methods used to conduct the studyPublished literature was reviewed to identify preclinical and clinical evidence that COVID‐19 vaccines could worsen disease upon exposure to challenge or circulating virus. Clinical trial protocols for COVID‐19 vaccines were reviewed to determine if risks were properly disclosed.Results of the studyCOVID‐19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID‐19 disease via antibody‐dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID‐19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.Conclusions drawn from the study and clinical implicationsThe specific and significant COVID‐19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent.

Perceived Benefits and Burdens of Participation for Caregivers of Cancer Patients in Hospice Clinical Trials: A Pilot Study

ContextHospice is a service for those with a life expectancy of six months or less. Family caregivers suffer from depression and anxiety as they care for their loved one until they die. Little is known about how research participants decide to consent to participate in clinical trials in the hospice setting. ObjectivesThis pilot study sought to answer two research questions: 1) In what way do demographic characteristics, mental health, and perceived caregiving experience impact the decision by caregivers to participate in hospice clinical trials? 2) In what ways do the perceived physical, psychological, economic, familial, and social dimensions of caregivers' lives influence their decision to participate in hospice clinical trials? MethodsThe characteristics and stated reasons for consent of hospice caregivers participating in a clinical trial were compared with individuals who refused clinical trial consent and only consented to this pilot study. Demographic, mental health, and perceptions of caregiving experience were measured as influencers to the consent decision. Recruitment calls were recorded and coded using framework analysis to identify perceived benefits and burdens impacting the decision to consent to the clinical trial. ResultsOverall, trial participants were more often adult children to the patient (55% vs. 21%, P = 0.005), younger (56 vs. 63 years, P = 0.04), and employed (47% vs. 24%, P = 0.02) as compared with those who did not consent to participate in the trial. Reported levels of depression, anxiety, and quality of life were not significantly different between those who chose to participate in the clinical trial and those who participated only in this pilot study; however, caregiver burden was higher for those consenting to the clinical trial (4.05 vs. 7.16, P < 0.0001). Perceived benefits expressed by both groups were largely psychological as participants felt positive about contributing to science. Burdens expressed by both groups were predominately physical as they related to hesitation to participate in the intervention because of technology or the burdens of caregiving. ConclusionThe benefits and burdens model for clinical trial participation is applicable to the caregiver experience in the hospice setting. Understanding the perceptions and dimensions of benefits and burdens to potential study participants is critical to not only the intervention design but also the tailoring of recruitment contacts and informed consent process.

MULTI-CENTRIC, DOUBLE BLIND STUDY OF EMAMI BLENDED EDIBLE VEGETABLE OIL (EBEVO1) ON IMMUNITY

Background: The composition of Emami Blended Vegetable Oil (EBEVO1) is refined soyabean oil (75% by wt) and refined rice bran oil (25% by wt) with add on vitamins such as A, C, D, E &amp; omega 3 fatty acids in order to enrich its nutritional value. Vit. A is involved in the development of the immune system and plays regulatory roles in cellular immune responses and humoral immune processes. Vit. A has demonstrated a therapeutic effect in the treatment of various infectious diseases. Crucial immune organs need constant dietary intake to maintain Vit. A concentration. Vitamin C is important in all stressful conditions that are linked to inflammatory processes and involve immunity. Study objectives: The sponsor, M/s Emami Agrotech Pvt. Ltd., developed the Emami Blended Edible Vegetable Oil (EBEVO1) which was evaluated upon the user acceptability and efficacy parameters. The baseline data of the evaluating parameters was compared with the results obtained by the end of the study (90days). Trial Design: The study was a randomized, multicentric, double-blind and controlled. The clinical trial protocol, information sheets, and consent forms were approved by the Ethical Committee of the Independent Research Ethics Society. The study was conducted after receiving the consent from the Ethics Committee (March 15, 2019). The Investigators have strictly followed the Standard Operating Procedures (SOPs) for the study following the Good Clinical Practice (GCP) and adhered to the Declaration of Helsinki. He/she thoroughly examined the study participants in his/her specific centre(s). Result: The results are encouraging where Group - A Oil shows better results than Group – B Oil due to value addition through Vitamins. Conclusion: Emami Blended Vegetable Oil contains 5 essential nutrients such as vitamin A, C, D, E and Omega 3 that have already been clinically confirmed in numerous trials around the world. The special blend of added nutrients that enhance the metabolic functions to enhance immunity to prevent minor general disorders or infections.

Nothing to lose: a grounded theory study of patients\u2019 and healthcare professionals\u2019 perspectives of being involved in the consent process for oncology trials with non-curative intent

BackgroundClinical cancer research trials may offer little or no direct clinical benefit to participants where a cure is no longer possible. As such, the decision-making and consent process for patient participation is often challenging.AimTo gain understanding of how patients make decisions regarding clinical trial participation, from the perspective of both the patient and healthcare professionals involved.MethodsIn-depth, face to face interviews using a grounded theory approach. This study was conducted in a regional Cancer Centre in the United Kingdom. Of the 36 interviews, 16 were conducted with patients with cancer that had non-curative intent and 18 with healthcare professionals involved in the consent process.Results‘Nothing to lose’ was identified as the core category that underpinned all other data within the study. This highlighted the desperation articulated by participants, who asserted trial participation was the ‘only hope in the room’. The decision regarding participation was taken within a ‘trusting relationship’ that was important to both patients and professionals. Both were united in their ‘fight against cancer’. These two categories are critical in understanding the decision-making/consent process and are supported by other themes presented in the theoretical model.ConclusionThis study presents an important insight into the complex and ethically contentious situation of consent in clinical trials that have non-curative intent. It confirms that patients with limited options trust their doctor and frequently hold unrealistic hopes for personal benefit. It highlights a need for further research to develop a more robust and context appropriate consent process.

Utilization of telemedicine to meet the demand throughout the COVID-19 pandemic at a community oncology practice.

263 Background: A large community oncology practice in Tennessee participates in value-based payment arrangements, the success of which depends on close patient monitoring. Telemedicine as an innovative solution was initiated in 2017. The service was limited, due to regulation, licensure requirements, and lack of reimbursement, to survivorship visits, clinical trial consent visits, rural hospital consults and genetic counseling. During the COVID pandemic and loosening of restrictions, telemedicine services were expanded. Methods: We identified a cloud-based platform that allowed patients to use any device with a camera and microphone and required no software downloads. On-line training sessions were provided to clinical staff. All training and workflow implementation were completed in a 2-week time frame. Telemedicine was expanded to include surveillance, urgent care, psychology, palliative care and post-BMT visits as well as new patient consults for medical, radiation and gynecologic oncology patients. Patient satisfaction surveys were administered. Results: Our telemedicine visits increased weekly beginning March 1, peaking in the month of April with an average of 77 scheduled telemedicine visits per day across the practice. During the month of April, our practice saw a record clinical trial accrual in our Phase-1 Drug Development Unit with a 22% increase over the previous average. Patients who responded to a satisfaction survey were highly satisfied with the telemedicine visit with a 73% positive response rate. Nearly half of our eligible patients did not have the technology or broad-band access to be able to participate in telemedicine. Conclusions: Our prior experience with telemedicine, though limited, facilitated the development of an infrastructure that provided adequate number of devices and internet bandwidth capacity to support rapid expansion of telemedicine. We were able to maintain high quality care and access to clinical trials during the pandemic and see the value of this service long-term. We hope to add tele-pharmacy and care coordination services. Political leadership and patient advocacy groups should explore ways to ensure that all patients may benefit from this technology, especially those in under-served areas.

Same-Day Consent for Regional Anesthesia Clinical Research Trials: It's About Time.

Same-Day Consent for Regional Anesthesia Clinical Research Trials: It's About Time.

Informed consent approaches for clinical trial participation of infants with minor parents in sub-Saharan Africa: A systematic review.

BackgroundRegulations are vague regarding the appropriate decision-maker and authority to consent for children of minor parents participating in clinical trials. In countries with high rates of underage mothers, such as in sub-Saharan Africa, this lack of guidance may affect the rights of potential paediatric participants already bearing increased vulnerability. It can also influence the recruitment and generalizability of the research. We provide evidence and discuss informed consent management in such cases to inform best practice.Materials and methodsWe searched PubMed/MEDLINE, Embase, CINAHL, and Google Scholar for articles published up to March 2019. In total, 4382 articles were screened, of which 16 met our inclusion criteria. Studies addressing informed consent in clinical trials involving children with minor parents in sub-Saharan Africa were included. We performed descriptive and qualitative framework analyses. The review was registered in PROSPERO: CRD42018074220.ResultsVarious informed consent approaches were reported. Articles supporting individual consent by minor parents based on emancipation or “mature minor” status lacked evidence in the context of research. National laws on medical care guided consent instead. When no laws or guidance existed an interpretation of the local decision-making culture, including community engagement and collaboration with local ethics committees, defined the informed consent approach.ConclusionsThe review emphasises that the implementation of informed consent for children with minor parents may be variable and hampered by absent or ambiguous clinical trial regulations, as well as divergent local realities. It may further be influenced by the research area and study-specific risks. Clear guidance is required to help address these challenges proactively in clinical trial planning. We provided a set of questions to be considered in the development of an ethically acceptable informed consent approach and proposed information that should be integrated into international clinical trial guidelines.

Leveraging Tele-Critical Care Capabilities for Clinical Trial Consent

A severe coronavirus disease 2019 patient admitted to our institution for medical management was enrolled in a randomized placebo-controlled trial of an investigational therapeutic for coronavirus disease 2019. We leveraged existing video-telecommunication equipment to obtain informed consent. We found video-telecommunication use closely mirrored person-to-person contact for research consent by maintaining engagement and ensuring understanding. Video-telecommunication use facilitated clinical research while minimizing unnecessary exposure to coronavirus disease 2019 and conserving personal protective equipment. Prior to the coronavirus disease 2019 pandemic, research regulatory agencies were essentially silent on the matter of video-telecommunication consent. Regulatory guidance became available during the pandemic in response to increased isolation and social distancing practices. Virtual health and telemedicine use expanded greatly during the pandemic, and this increase will likely persist after the pandemic ends. We anticipate video-telecommunication adoption and implementation for research consent will also continue to grow after the coronavirus disease 2019 pandemic is over.