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…