Remote Consent Clinical Research
Commentary
Sriram Preethi
Clinical Trials and Practice, 30 October 2019; 1(1) pp 39-41
Open Access
Abstract
Recruitment in clinical research trials can be challenging in trials that are time-sensitive and/or are rare disease and critical care trials. One of the hurdles for recruitment in these types of clinical trials is due to the consent process, and the need to have consent of the patient within a certain timeframe, or the patient unable to consent for themselves. This paper will discuss the usage of the utilization of remote consent options for these trials.

Would you like to participate in this trial? The practice of informed consent in intrapartum research in the last 30 years
Research Article
Mariana Widmer, Mercedes Bonet, Ana Pilar Betrán
PLOS One, 24 January 2020
Open Access
Abstract
Background
Informed consent is the cornerstone of the ethical conduct and protection of the rights and wellbeing of participants in clinical research. Therefore, it is important to identify the most appropriate moments for the participants to be informed and to give consent, so that they are able to make a responsible and autonomous decision. However, the optimal timing of consent in clinical research during the intrapartum period remains controversial, and currently, there is no clear guidance.
Objective
We aimed to describe practices of informed consent in intrapartum care clinical research in the last three decades, as reported in uterotonics for postpartum haemorrhage prevention trials.
Methods
This is a secondary analysis of the studies included in the Cochrane review entitled “Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis” published in 2018. All the reports included in the Cochrane network meta-analysis were eligible for inclusion in this analysis, except for those reported in languages other than English, French or Spanish. We extracted and synthesized data on the time each of the components of the informed consent process occurred.
Results
We assessed data from 192 studies, out of 196 studies included in the Cochrane review. The majority of studies (59.9%, 115 studies) reported that women were informed about the study, without specifying the timing. When reported, most studies informed women at admission to the facility for childbirth. Most of the studies reported that consent was sought, but only 59.9% reported the timing, which in most of the cases, was at admission for childbirth. Among these, 32 studies obtained consent in the active phase of labour, 17 in the latent phase and in 10 studies the labour status was unknown. Women were consented antenatally in 6 studies and in 8 studies the consent was obtained indistinctly during antenatal care or at admission. Most of the studies did not specified who was the person who sought the informed consent.
Conclusion
Practices of informed consent in trials on use of uterotonics for prevention of postpartum haemorrhage showed variability and substandard reporting. Informed consent sought at admission for childbirth was the most frequent approach implemented in these trials.

Assessing for Quality Informed Consent With Subjects Enrolling in Clinical Research
Case
Laura R. Holtz
SAGE Research Methods Cases: Medicine and Health, 2020
Abstract
Research subjects are asked to participate in the informed consent process before participating in research. The elements and regulatory requirements of informed consent are well documented. However, there is less known about the quality of informed consent discussions that are occurring with potential subjects. There is evidence that these discussions may be lacking in quality to effectively meet the intended goals. Research professionals may need additional training, skills, and tools to help increase subject’s understanding of informed consent. It is necessary to identify the characteristics of quality informed consent. In addition, tools and strategies, such as Teach Back and Documentation of Informed Consent process, can be utilized to operationalize the assessment of understanding when conducting informed consent. Quality may lead to increased engagement and compliance with study protocols and reductions in subject withdrawals. Both research staff and participants will benefit with increased confidence by addressing quality in informed consent.

Assessing readability and comprehension of informed consent materials for medical device research: A survey of informed consents from FDA’s Center for Devices and Radiological Health
Fabienne Santel, Isatu Bah, Katherine Kim, Ja-An Lin, Jack McCracken, Adaeze Teme
Contemporary Clinical Trials, October 2019; 85
Abstract
Legally effective informed consent has been a long-standing requirement for FDA-regulated clinical studies. However, informed consent forms (ICFs) are often thought to be too long, too complex, and too difficult for participants to understand. In this article, investigators from the FDAs Center for Devices and Radiological Health (CDRH) surveyed 399 ICFs from approved investigational device exemption (IDE) applications for fiscal years 2015 and 2016 to evaluate the readability of ICFs.

The investigators collected data from the ICFs, using variables related to structure, readability, and comprehension.

The investigators found that the mean grade-reading levels of the ICFs ranged from 10th grade to college level (Table 2), higher than the recommended 6th to 8th grade level, when measured by major readability evaluation tools (the SMOG readability grade level formula, the Flesch-Kincaid Index Grade Level Readability Formula, the Flesch Reading Ease test, and the Dale-Chall readability formula).

Overall, the ICFs and informed consent (IC) processes, as described in the IDE application, lacked components that enhanced participants’ comprehension, such as short sentences (e.g., no more than 8 to 10 to words) and the use of pictures, tables, and diagrams.

CDRH investigators believe that information about ICFs’ readability, comprehension, and structure will help support current and future efforts to improve the IC process. The intent of the article is to demonstrate that improvements are needed in the IC process and to encourage clinical trial stakeholders to consider implementing those approaches that optimize patient comprehension in the development of their IC processes.

Electronic Informed Consent in Clinical Research
White Paper
Medidata, 2019
Open Access
Executive Summary
Medidata is conducting a study to understand the regulatory positions, adoption and the variability regarding electronic informed consent (eConsent) around the world. This exercise has come about due to the extensive number of regulatory relevant inquiries Medidata gets from sponsors and organizations managing trials in research. The life science industry is keen to have the option to leverage electronic means for consenting trial participants but are uncertain of the regulatory positions on the topic. The only way to seek clarity on this topic was to directly engage with relevant authorities.

The study initially focused on the countries in the European geographic region but has evolved to other regions including Asia Pacific and the Americas. The study prioritized countries where there was an aspiration to utilize electronic informed consent by organizations running clinical trials…

Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit
Research
Jessica Hodson, Christiana Garros, Jodie Jensen, Jonathan P. Duff, Gonzalo Garcia Guerra, Ari R. Joffe
Journal of Intensive Care, 16 December 2019; 7(60)
Open Access
Abstract
Background
The aim of the study was to determine opinions and knowledge regarding the process of obtaining informed consent to participate in observational research in pediatric intensive care.
Methods
Survey 1 asked decision makers what model(s) of consent was acceptable for each type of observational research both before and after background information. Survey 2 asked decision makers about the experience of being asked for consent to observational research, and knowledge regarding the consent process both before and after background information.
Results
Cooperation rate was 100/117 (85%). The proportion in favor of any of the offered alternatives to signed informed consent for observational research, after receiving all the background information, was 74-80%, lowest for observational prospective research with a minimal risk intervention 37/50 (74%; 95% CI 60–84%). The proportion who agreed they felt overwhelmed by being approached for consent to observational research was 26 (52%; 95% CI 39-65%). Most respondents (from 60 to 74%) felt they understood the concepts regarding observational research; however, after reading background information, most (from 60 to 74%) felt their understanding had improved “a great deal”.
Conclusion
Understanding of risk, practical difficulties, consent bias, and Research Ethics Board safeguards was poor. Future study is needed to confirm our finding that most agreed with alternative methods of consent for observational research.

Reporting of ethical approval and informed consent in clinical research published in leading nursing journals: a retrospective observational study
Research Article
Yanni Wu, Michelle Howarth, Chunlan Zhou, Mingyu Hu, Weilian Cong
BMC Medical Ethics, 5 December 2019; 20(94) 
Open Access
Abstract
Background
Ethical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research published in leading international nursing journals.
Methods
This is a retrospective observational study. All clinical research published in the five leading international nursing journals from the SCI Journal Citation Reports between 2015 and 2017 were retrieved to evaluate for evidence of ethical review.
Results
A total of 2041 citations have been identified from the contents of all the five leading nursing journals that were published between 2015 and 2017. Out of these, 1284 clinical studies have been included and text relating to ethical review has been extracted. From these, most of prospective clinical studies (87.5%) discussed informed consent. Only half of those (52.9%) reported that written informed consent had been obtained; few (3.6%) reported oral consent, and few (6.8%) used other methods such as online consent or completion and return of data collection (such as surveys) to denote assent. Notably, 36.2% of those did not describe the method used to obtain informed consent and merely described that “consent was obtained from participants or participants agreed to join in the research”. Furthermore, whilst most of clinical studies (93.7%) mentioned ethical approval; 92.5% of those stated the name of ethical committee and interestingly, only 37.1% of those mentioned the ethical approval reference. The rates of reporting ethical approval were different between different study type, country, and whether financial support was received (all P < 0.05).
Conclusion
The reporting of ethics in leading international nursing journals demonstrates progress, but improvement of the transparency and the standard of ethical reporting in nursing clinical research is required.

Dual consent? Donors’ and recipients’ views about involvement in decision-making on the use of embryos created by gamete donation in research
Research Article
Baía, C. de Freitas, C. Samorinha, V. Provoost, S. Silva
BMC Medical Ethics, 2 December 2019; 20(90) 
Open Access
Abstract
Background
Reasonable disagreement about the role awarded to gamete donors in decision-making on the use of embryos created by gamete donation (EGDs) for research purposes emphasises the importance of considering the implementation of participatory, adaptive, and trustworthy policies and guidelines for consent procedures. However, the perspectives of gamete donors and recipients about decision-making regarding research with EGDs are still under-researched, which precludes the development of policies and guidelines informed by evidence. This study seeks to explore the views of donors and recipients about who should take part in consent processes for the use of EGDs in research.
Methods
From July 2017 to June 2018, 72 gamete donors and 175 recipients completed a self-report structured questionnaire at the Portuguese Public Bank of Gametes (response rate: 76%). Agreement with dual consent was defined as the belief that the use of EGDs in research should be consented by both donors and recipients.
Results
The majority of participants (74.6% of donors and 65.7% of recipients) were willing to donate embryos for research. Almost half of the donors (48.6%) and half of the recipients (46.9%) considered that a dual consent procedure is desirable. This view was more frequent among employed recipients (49.7%) than among non-employed (21.4%). Donors were less likely to believe that only recipients should be involved in giving consent for the use of EGDs in research (25.0% vs. 41.7% among recipients) and were more frequently favourable to the idea of exclusive donors’ consent (26.4% vs. 11.4% among recipients).
Conclusions
Divergent views on dual consent among donors and recipients indicate the need to develop evidence-based and ethically sustainable policies and guidelines to protect well-being, autonomy and reproductive rights of both stakeholder groups. More empirical research and further theoretical normative analyses are needed to inform people-centred policy and guidelines for shared decision-making concerning the use of EGDs for research.

Authority and the Future of Consent in Population-Level Biomedical Research
Mark Sheehan, Rachel Thompson, Jon Fistein, Jim Davies, Michael Dunn, Michael Parker, Julian Savulescu, Kerrie Woods
Public Health Ethics, 30 October 2019; 12(3) pp 225–236
Abstract
Population-level biomedical research has become crucial to the health system’s ability to improve the health of the population. This form of research raises a number of well-documented ethical concerns, perhaps the most significant of which is the inability of the researcher to obtain fully informed specific consent from participants. Two proposed technical solutions to this problem of consent in large-scale biomedical research that have become increasingly popular are meta-consent and dynamic consent. We critically examine the ethical and practical credentials of these proposals and find them lacking. We suggest that the consent problem is not solved by adopting a technology driven approach grounded in a notion of ‘specific’ consent but by taking seriously the role of research governance in combination with broader conceptions of consent. In our view, these approaches misconstrue the rightful location of authority in the way in which population-level biomedical research activities are structured and organized. We conclude by showing how and why the authority for determining the nature and shape of choice making about participation ought not to lie with individual participants, but rather with the researchers and the research governance process, and that this necessarily leads to the endorsement of a fully articulated broad consent approach.

Experimental infections in humans—historical and ethical reflections
G. Metzger, H.‐J. Ehni, P. G. Kremsner, B. G. Mordmüller
Tropical Medicine & International Health, 26 October 2019
Open Access
Abstract
Vaccine efficacy and prophylactic treatment of infections are tested best when the vaccinated or treated individual is challenged through deliberate infection with the respective pathogen. However, this trial design calls for particular ethical caution. Awareness of the history of challenge trials is indispensable, including trials that were problematic or even connected to abuse. We briefly introduce historical aspects of experimental infections in humans and the ethical debate around them and give estimates of the numbers of volunteers participating in human experimental infection models. Challenge models can offer a great chance and benefit for the development of medical interventions to fight infectious diseases, but only when they are appropriately controlled and regulated.