Informed Consent: A Monthly Review

August 2022

This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_August 2022

The patient suffering from acute respiratory failure COVID-19 related who refuses medical treatment: an emblematic case

The patient suffering from acute respiratory failure COVID-19 related who refuses medical treatment: an emblematic case
Francesca Maghin, Massimo Salvetti, Maria Lorenza Muiesan, Adelaide Conti
Internal and Emergency Medicine, 2 July 2022
Open Access
Respiratory failure related to COVID-19 may evolve into acute respiratory distress syndrome, which may require invasive treatment. Through the analysis of a concrete clinical case, we want to clarify how to manage patients suffering from serious acute pathologies, which require timely intervention, even invasive, but refuse medical treatment. The Italian law 219/2017 states strongly the freedom of the patient to choose, independently whether to start or stop at any time any type of medical treatment through their informed consent. The law, of course, addresses in several parts the problem of the refusal of the subject to certain choices. The law also provides that if the patient refuses therapies or interventions, putting his life at risk, the doctors need to engage in further communication with the support of other professionals, informing the patient of the consequences, promoting every support action, and involving family members. Judgment on the level of impaired capacity, which makes a patient incompetent to make therapeutic decisions, should ideally reflect the balance between respecting patient autonomy and protecting the patient from the consequences of a wrong decision. For the physicians, it is a matter of balancing the need to save the life of the person, or at least to avoid the establishment of permanent damage, with the subject itself expressly stated, including an explicit refusal to carry out maneuvers or therapies or interventions when it is in danger of life, even if such treatments could save it.

Developing and Implementing Electronic Consent Procedures in Response to Covid-19 Restrictions

Developing and Implementing Electronic Consent Procedures in Response to Covid-19 Restrictions
Julie R Bromberg, Evelyn Nimaja, Andrew W Kiragu, Karla A Lawson, Lois Lee, Isam W Nasr, Charles Pruitt, Stephanie M Ruest, Michael J Mello
Ethics and Human Research, July 2022; 44(4) pp 39-44
The Covid-19 pandemic resulted in unprecedented restrictions on many public, private, and workplace activities throughout the United States and elsewhere. When restrictions were imposed, we were conducting a type III hybrid effectiveness-implementation trial in 10 pediatric trauma centers. In response to several pandemic-based restrictions, we had to develop procedures for engaging with potential research participants while limiting nonclinical, in-person interactions. This manuscript describes the procedures and challenges of obtaining electronic informed consent and assent in a multisite trauma center-based research study. We developed, tested, and trained staff to implement three options for obtaining informed consent. Twenty-five participants were enrolled in the effectiveness-implementation multisite trial during the first six months of utilization of the consent options, with eleven of these individuals enrolled using hybrid or electronic consent procedures. The challenges we identified involving electronic consent procedures included confusion over who would complete the electronic consent process and difficulties reconnecting with families. Lessons learned can strengthen electronic consent and assent procedures for future studies. More research is needed to further strengthen this process and increase its utilization.

A mother’s perspective of consent for maternal and neonatal COVID-19 testing: can we do more?

A mother’s perspective of consent for maternal and neonatal COVID-19 testing: can we do more?
Natalie Anne East, Sunitha Ramaiah, Kimberley Morris, Sangeeta Pathak
British Journal of Midwifery, 28 June 2022; 30(7)
There is ongoing research on the effects of COVID-19 on pregnancy and whether vertical viral transmission occurs.
This study aimed to determine maternal opinions of COVID-19 testing for pregnant women and newborns in order to influence future clinical practice while advancing global knowledge of the impact of testing on patient experiences.
This service evaluation assessed the opinions of 292 pregnant women who were tested for COVID-19 along with their newborn babies using nasopharyngeal swabs and the SARS-CoV-2 reverse transcription polymerase chain reaction test between 28 April and 21 May 2020.
Many women felt their own (60%) and their baby’s (61%) swab was compulsory and did not feel sufficiently informed about the risks and benefits for themselves (43%) or their baby (52%) being tested. Some women did not understand the implications of a positive test for themselves (43%) or their baby (42%). Most participants reported they would agree to themselves (97%) and their baby (86%) being tested in future pregnancies.
Communication to pregnant women regarding the COVID-19 swabbing process is critical and requires improvement. This service evaluation highlighted where women felt under-informed. These areas should be covered in more detail for consenting women for COVID-19 testing in future.

Participants’ informed consent in adaptive, platform drug trials in hospitalized COVID-19 patients: Not all approaches are ethically acceptable

Participants’ informed consent in adaptive, platform drug trials in hospitalized COVID-19 patients: Not all approaches are ethically acceptable
Rafael Dal-Ré, Arthur L Caplan, Teck Chuan Voo
European Journal of Internal Medicine, 27 June 2022
Open Access
…Obtaining participants’ informed consent is one of the basic safeguards for ensuring ethically conducted clinical research. Investigators must provide potential participants all reasonable relevant trial information so that they can make an informed decision. How investigators seek participants’ informed consent should be consistent with international ethical standards. First, informed consent must be obtained from patients with capacity. If a patient is incapable of consenting (e.g., intubated patient), the investigator must seek informed consent from their legal representative. During the pandemic, at the trial design stage, investigators of the four aforementioned ad-RCTs (Table 1) decided that deferred consent was an acceptable approach as they realized that many potential trial participants would be incapable of providing consent and having access to the patient’s legal representative could be extremely difficult to obtain. Their decisions were backed by the research ethics committees involved in the review and approval of the ad-RCTs’ protocols. Patients unable to consent were included in the trial and informed consent obtained once they were able to provide it (or when the legally authorized representative became available), rendering the consent deferred. However, deferred consent must fulfil several conditions to be ethically acceptable. Second, trial investigators should seek the informed consent of potential participants before randomization, which ensures that all participants receive the same information on the trial procedures and available treatments in all study arms. This is applicable to any RCT, but it is even more relevant when it is likely that the legal representative of many participants will be involved. The participant’s legal representative should decide considering to what extent study participation promotes the individual’s clinical interests, and to this end should know all the therapies under assessment…

Consent for orthopaedic trauma surgery during the COVID-19 pandemic

Consent for orthopaedic trauma surgery during the COVID-19 pandemic
Selmi H, Davies A, Walker J, Heaton T, Sabharwal S, Dani M, Fertleman M, Reilly P
BMJ Open Quality, 1 June 2022, 11(2)
The COVID-19 pandemic has brought a series of new challenges to the management of surgical patients. The consent process relies on a foundation of open and non-coerced discussion between clinician and patient, which includes all the potential risks of surgery. This must be updated to incorporate the additional risks of surgery during the pandemic including infection with the SARS-CoV-2 and increased risks of complications with the potential requirement for intensive care support.
The aim of this multi-cycle quality improvement project was to ensure all patients were fully informed of the risks of developing COVID-19 and the possible need for intensive care unit (ICU) support.
We investigated the quality of the consent process for patients undergoing surgery for trauma at our major trauma centre. Our baseline data collection included a review of all orthopaedic trauma consent forms over a 4-week period in March 2020. We subsequently undertook three further Plan-Do-Study-Act (PDSA) cycles over separate 4-week periods. First, in June 2020, after education measures and presentation of baseline data, second in July 2020 after further education and regular digital reminders were sent to staff, and third in September 2021 after the implementation of an electronic consent form.
At baseline, only 2.6% of consent forms mentioned the risk of COVID-19 and none mentioned the risk of requiring ITU support. Through three PDSA cycles this increased to 97% of cases where consent forms displayed the additional risks of COVID-19 and the potential need for ITU admission.
Our quality improvement project improved the informed consent procedure at our trust. By incorporating these additional risks into the template of an electronic consent form, we hope to achieve sustained improvement in practice.

Keys to improving the informed consent process in research: Highlights of the i-CONSENT project

Keys to improving the informed consent process in research: Highlights of the i-CONSENT project
Jaime Fons-Martinez, Cristina Ferrer-Albero, Javier Diez-Domingo
Health Expectations, 27 July 2022
Open Access
    The ethical and legal governance of all aspects of informed consent in research is becoming increasingly extensive and complex. Instead of a single directive, informed consent is governed by a series of international rules applied to biomedical research, clinical trials and biobanks, while various ethical guidelines for research have been published by different international bodies.

Informed consent is an essential part of any research involving humans, but the array of available guidelines can complicate the informed consent process for sponsors, researchers and participants. Sponsors, in particular, find it difficult to adapt the informed consent process to the characteristics of the participants. Moreover, because of the length and complexity of informed consents, some participants may misconstrue key points and agree to participate in a trial that they do not fully understand. In these cases, the decision on their participation is mainly based on discussions with the researcher, which lacks traceability…

Success rate of acquiring informed consent and barriers to participation in a randomized controlled trial of laparoscopic versus open surgery for non-curative stage IV colon cancer in Japan

Success rate of acquiring informed consent and barriers to participation in a randomized controlled trial of laparoscopic versus open surgery for non-curative stage IV colon cancer in Japan
Journal Article
Tomonori Akagi, Kosuke Suzuki, Yohei Kono, Shigeo Ninomiya, Tomotaka Shibata, Yoshitake Ueda, Hidefumi Shiroshita, Tsuyoshi Etoh, Akio Shiomi, Masaaki Ito, Jun Watanabe, Kohei Murata, Yasumitsu Hirano, Manabu Shimomura, Shunsuke Tsukamoto, Yukihide Kanemitsu, Masafumi Inomata
Japanese Journal of Clinical Oncology, 22 July 2022
Successful achievement of randomized controlled trials (RCTs) is dependent on the acquisition of informed consent (IC) from patients. The aim of this study was to prospectively calculate the proportion of participation in a surgical RCT and to identify the reasons for failed acquisition of IC.
A 50-insitution RCT was conducted to evaluate oncological outcomes of open and laparoscopic surgery for stage IV colon cancer (JCOG1107: UMIN-CTR 000000105). The success rate of obtaining IC was evaluated in eight periods between January 2013 and January 2021. In addition, reasons for failed acquisition of IC were identified from questionnaires.
In total, 391 patients were informed of their eligibility for the trial, and 168 (42%) were randomly assigned to either the laparoscopic surgery group (n = 84) or open surgery group (n = 84). The success rate of IC acquisition ranged from 33 to 58% in three periods. The most common reasons for failed IC acquisition were the patients’ preference for one approach of surgery based on recommendations from referring doctors and family members, and anxiety/unhappiness about randomization.
The success rate of acquiring IC from patients for an RCT of laparoscopic versus open surgery for stage IV colon cancer was lower than the expected rate planned in the protocol. To obtain the planned rate, investigators should make efforts to inform patients and their families about the medical contributions a surgical RCT can make and recognize that the period in equipoise may be limited.

Future informed consent research – a step in the wrong direction!

Future informed consent research – a step in the wrong direction!
JM Clements, LJ Convie, SJ Kirk, M Clarke
British Journal of Surgery, 22 July 2022; 109(Suppl 4)
Open Access
Over 300 million invasive procedures occur globally every year, each requiring patient informed consent. No single outcome measure exists for measurement of the informed consent process. A core outcome set (COS) for informed consent for therapy consisting of 9 outcomes has been developed to define what outcomes matter to key stakeholders in the informed consent process. We aimed to identify the frequency of uptake of the COS consent outcomes in future randomised control trials.
A systematic review of prospectively registered randomised control trial protocols was performed. The online trial registries World Health Organisation (WHO) International Clinical Trials Registry Platform (ICTRP) and the US National Library of Medicine were searched. All studies assessing interventions designed to improve the informed consent process were considered.
627 registered protocols were identified of which 22 met the inclusion criteria. Only two core outcomes were reported in any prospective interventional consent trial protocols. Patient satisfaction with the consent process and patient satisfaction with the amount of information were observed which employed unvalidated tools. Patient knowledge was the predominant primary outcome measure (n=20). Unvalidated measurement tools were used in all cases. Patient anxiety, decisional regret and decisional conflict were the only outcomes consistently measured using validated measurement tools.
The use of unvalidated outcome measurement tools in future consent trials are widespread. This review has highlighted the clear disconnect between chosen outcomes in future consent trial protocols and an established informed consent COS, limiting the potential value of outputs in future consent trials.
Take-home message
A clear disconnect exists between the outcome measures used in prospective consent randomised trials and an established core outcome set for informed consent for therapy.

When is it impractical to ask informed consent? A systematic review

When is it impractical to ask informed consent? A systematic review
Review Article
Sara JM Laurijssen, Rieke van der Graaf, Wouter B van Dijk, Ewoud Schuit, Rolf HH Groenwold, Diederick E Grobbee, Martine C de Vries
Clinical Trials, 1 July 2022
Informed consent is one of the cornerstones of biomedical research with human subjects. Research ethics committees may allow for a modification or a waiver of consent when the research has social value, involves minimal risk, and if consent is impractical to obtain. While the conditions of social value and minimal risk have received ample attention in research ethics literature, the impractical condition remains unclear. There seem to be different interpretations of the meaning of impractical within academic literature. To address this lack of clarity, we performed a systematic review on the interpretation of impractical.
First, we examined international research ethics guidelines on their usage and interpretation of impractical. Next, we used international ethical guidelines to identify synonyms of the term “impractical.” Accordingly, PubMed, Embase, and Web of Science were searched for articles that included “informed consent” and “impractical” or one of its synonyms.
We found that there were only a few international ethics guidelines that described what could be considered impractical. Out of 2329 identified academic articles, 42 were included. Impractical was used to describe four different conditions: (1) obtaining informed consent becomes too demanding for researchers, (2) obtaining informed consent leads to invalid study outcomes, (3) obtaining informed consent harms the participant, and (4) obtaining informed consent is meaningless for the participant.
There are conditions that render conventional informed consent truly impractical, such as untraceable participants or harm for participants. At the same time, researchers have a moral responsibility to design an infrastructure in which consent can be obtained, even if they face hardship in obtaining consent. In addition, researchers should seek to minimize harm inflicted upon participants when harm may occur as a result of the consent procedure. Invalidity of research due to consent issues should not be regarded as impractical but as a condition that limits the social value of research. Further research is essential for when a waiver of informed consent based on impractical is also reasonable.