Informed Consent: A Monthly Review

May 2019

This digest is intended to aggregate and distill key content around 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 GE2P2 Global Foundation’s Center for Informed Consent Integrity, which is solely responsible for its content. Comments and suggestions should be directed to:

Paige Fitzsimmons, MA
Associate Fellow
GE2P2 Global Foundation

David R. Curry
President & CEO
GE2P2 Global Foundation

PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_May 2019

The Informed Consent in Pediatrics – A Child’s Right

The Informed Consent in Pediatrics – A Child’s Right
Dana Elena Mindru, Mioara Calipsoana Matei, Aurica Rugina, Irina Mihaela Ciomaga, N. Nistor, Laura Florescu
The Medical-Surgical Journal, 29 March 2019; 123(1)
Consent signifies the patient’s knowingly authorization of a medical intervention. Revealing the truth about the patient’s condition refers to the provision of information by the physician regarding the diagnosis and the treatment, as well as their understanding by the patient. His or her decision-making capacity refers to the ability of understanding the data that have been provided. The independent decision refers to the patient’s right to make a free decision regarding his or her treatment, without constraint or manipulation. Informed consent is one of the most sensitive issues of the physician-patient, researcher-subject relationship. Minors do not have the capacity of independent decision; therefore, the decision by substitution given by parents or legal representatives is required. The minor child’s consent to the medical treatment and pediatric scientific research expresses itself under the form of assent, which is valid starting with the age of 14. Doctors should ask for parental consent before medical interventions (except in cases of emergency, when parents cannot be contacted). From a practical standpoint, when it comes to obtaining a valid consent, it is useful to make a distinction between the problem-solving process and the decision-making process. The permission given by parents includes all standard elements of informed consent. In each case, the doctor has to make sure that he or she has a valid consent because, in legal terms, treating a patient without his or her consent is a crime, while treatment based on inadequate consent constitutes negligence.

Editor’s note: We note that this is a Romanian publication and therefore the abstract noting assent beginning at age 14 is local to the Romanian context.

Informed Consent for Bedside Procedures in Pediatric and Neonatal ICUs: A Nationwide Survey

Informed Consent for Bedside Procedures in Pediatric and Neonatal ICUs: A Nationwide Survey
Arnolds, Marin M., Feltman, Dalia M.
Pediatric Critical Care Medicine, 5 April 2019
Primary objectives were to discover current practices of informed consent for bedside procedures in the PICU and neonatal ICU and how trainees learn to obtain consent. We also attempted to gauge if program directors felt that one method of consent was subjectively superior to another in the way it fulfilled established ethical criteria for informed consent.
An online anonymous survey. Participants were asked about how and by whom informed consent is currently obtained, training practices for fellows, and attitudes about how different consent methods fulfill ethical criteria.
All U.S. fellowship programs for neonatology (n = 98) and pediatric critical care (n = 66) in the fall of 2017.
Neonatal and pediatric critical care fellowship program directors.
Measurements and Main Results 
The overall response rate was 50% (82 of 164). The most common method for obtaining consent in both ICU types was via a written, separate (procedure-specific) consent (63% neonatal ICUs, 83% PICUs); least common was verbal consent (8% neonatal ICUs and 6% PICUs). Fellows were reported as obtaining consent most often (91%), followed by mid-level practitioners (71%) and residents (66%). Residents were one-fifth as likely to obtain consent in the PICU as compared with the neonatal ICU. Sixty-three percent of fellowship directors rated their programs as “strong” or “very strong” in preparing trainees to obtain informed consent. Twenty-eight percent of fellowship directors reported no formal training on how to obtain informed consent.
Most respondents’ ICUs use separate procedure-specific written consents for common bedside procedures, although considerable variability exists. Trainees reportedly most often obtain informed consent for procedures. Although most fellowship directors report their program as strong in preparing trainees to obtain consent, this study reveals areas warranting improvement.

Competence to Consent and Its Relationship With Cognitive Function in Patients With Schizophrenia

Competence to Consent and Its Relationship With Cognitive Function in Patients With Schizophrenia
Norio Sugawara, Norio Yasui-Furukori, Tomiki Sumiyoshi
Frontiers of Psychiatry, 12 April 2019
Decisional capacity to consent is an emerging ethical and legal concept, and is closely related to self-determination of patients facing important medical decisions or research participations. Recently, the MacArthur Competence Assessment Tool (MacCAT), a semi-structured interview consisting of four dimensions (Understanding, Appreciation, Reasoning, and Expression of a Choice), was developed to assess the decisional capacity. Decision-making capacity in a group of patients with schizophrenia, as measured by the MacCAT, has been shown to be impaired in comparison with healthy control people. However, this does not necessarily mean the presence of impaired decisional capacity in all cases. Considering the real-world practice of obtaining informed consent from patients with schizophrenia, it is important to evaluate the relationship between psychopathological features and decisional capacity of the illness. Negative symptoms of schizophrenia have been demonstrated to be related to the ability to understand information relevant to the decision, reason rationally, and appreciate a situation and its consequences. On the other hand, positive symptoms, such as delusions and hallucinations have been an inconsistent correlate of poor capacity. Furthermore, some studies indicate that impairment of cognitive function, a core symptom of schizophrenia, could be more largely associated with decisional capacity than positive and negative symptoms. Therefore, it is reasonable to assume cognitive enhancement would enlarge the capacity to consent and promote autonomy in medical treatment and research participation in patients with schizophrenia. Further studies are warranted to elucidate this and related issues.

Editor’s note: More information regarding the MacArthur Competence Assessment Tool (MacCAT) noted in the abstract is available here.

US State Regulation of Decisions for Pregnant Women Without Decisional Capacity

US State Regulation of Decisions for Pregnant Women Without Decisional Capacity
Research Letter
Erin S. DeMartino, Beau P. Sperry, Cavan K. Doyle, Julie Chor, Daniel B. Kramer, David M. Dudzinski, Paul S. Mueller
JAMA, 23 April 2019; 321(16) pp. 1629-1631
All US states have laws addressing decision making for individuals who cannot make their own medical decisions, including provisions for advance directives and processes authorizing relatives or interested persons to direct care as surrogate decision makers, although variation among state laws is increasingly recognized. However, the prevalence and content of state statutes and official advance directive documents addressing “treatment decisions for divisionally incapacitated pregnant women” is unknown.

Annals Graphic Medicine – Patient-Informed Consent

Annals Graphic Medicine – Patient-Informed Consent
Anna Brand, MD; Linde Gao, MD; Alexandra Hamann; Sophia Martineck; Verena Stangl, MD
Annals of Internal Medicine, 9 April 2019
Medical graphic narratives to improve patient comprehension and periprocedural anxiety before coronary angiography and percutaneous coronary intervention: a randomized trial.

Editor’s note: The full graphic is available via open access at the link above. Below you will find a small excerpt.

Picture 1Picture 2

Medical Graphic Narratives to Improve Patient Comprehension and Periprocedural Anxiety Before Coronary Angiography and Percutaneous Coronary Intervention: A Randomized Trial

Medical Graphic Narratives to Improve Patient Comprehension and Periprocedural Anxiety Before Coronary Angiography and Percutaneous Coronary Intervention: A Randomized Trial
Anna Brand, Linde Gao, Alexandra Hamann, Claudia Crayen, Hannah Brand, Susan M. Squier, Karl Stangl, Friederike Kendel, Verena Stangl
Annals of Internal Medicine, 16 April 2019
Written informed consent (IC) before such interventions as coronary angiography may not ensure that patients understand the rationale, procedural details, and potential risks involved. Barriers include patient anxiety, literacy, and differences in clinicians’ communication skills. Medical graphic narratives (“comics”) may communicate complex health information more clearly.
To assess whether supplementing standard IC (ICstandard) with a comic (ICcomic) improves patient comprehension, anxiety, and satisfaction.
From October 2016 to January 2018, a total of 135 consecutive hospitalized patients who were having coronary angiography at Charité – Universitätsmedizin Berlin, Campus Mitte, were screened for enrollment. Of these patients, 121 were randomly assigned to ICstandard (official consent form and conversation with physician) with or without ICcomic (graphic illustrations of central IC aspects based on the official consent form [available at]); the same physician explained the procedure to all participants. After all participants completed ICstandard, the ICcomic group additionally received the patient comic…

Attitudes of postnatal women and maternity staff towards audio recording of consent discussions

Attitudes of postnatal women and maternity staff towards audio recording of consent discussions
Ivermee C, Yentis SM
Anaesthesia, 11 April 2019
Audio recording consent discussions, and giving a copy of the recording to the patient to keep, might improve the consent process and reduce the risk of misunderstandings, complaints or medicolegal claims. However, there may be concerns over confidentiality and how being recorded could affect the consent discussion. We ascertained the views of 50 postnatal women and 100 maternity staff (25 anaesthetists, 25 obstetricians and 50 midwives) on making audio recordings of consent discussions. There was a wide range of opinions, with women and staff similarly supportive of audio recording overall, but the women were more supportive of recording than the staff when asked if they were against it, or whether they would support recording the discussion if the patient requested it; and less concerned than the staff regarding the potential disadvantages of audio recording. There were no significant differences in the views between anaesthetists, obstetricians and midwives.

Consent Plus: Improving the Consent Process in Elective Lower Limb Arthroplasty

Consent Plus: Improving the Consent Process in Elective Lower Limb Arthroplasty
Lee, A. P. Chandratreya
Orthopsedic Proceedings, 4 April 2019; 101B(3)
Background of study
Following the Montgomery ruling, consent is now a matter of law. The medical professionals have to show proof that risks and implications and material risks are explained to the patient and that they have accepted to go ahead with surgery.
Materials and Methods
We devised a free web based programme ( which introduces a documented checkpoint to the consent process in hip and knee replacement surgery. It enables reproducible high-quality bite-sized information delivery to patients and their families in an optimal environment. It utilises the flip classroom principle to facilitate dialogue between doctors and patients. It generates physical documentation to show patients’ knowledge and understanding of the risks; to produce a truly informed consent.
1567 users completed the Consent PLUS process over 28 hospitals across the UK. 98.1% of users were satisfied with Consent PLUS in terms of quality of service and information delivered. Users’ self-rated knowledge increased by 29%, independent of age group, prior knowledge or check-point scores. Supportive documentation for 100% of the users, which facilitated the consent process but did not replace the consultation. 60% of users accessed the system via desktop computers, 23% via tablet and 17% via mobile phone. 55 consultant surgeons and 28 hospitals have been registered into the system by the users. 96.9% of users found Consent PLUS useful and 96.3% would recommend it to their friends. 92.6% would use it again.
Consent PLUS can facilitate information delivery and improve patients’ understanding of the risks of surgery and its implications subjectively and objectively. Consent PLUS is a tool designed to enhance and facilitate the consent process, not to replace the current consent forms.

Editor’s Note: The mission statement of Consent PLUS as taken from the website on 17 April 2019 is as follows: “Consent PLUS has enabled the healthcare team to improve patient experience, save consultant time and standardise information delivery processes. Using Consent PLUS at the hospital in an access-controlled manner has enabled competent clinicians to give individual patients and their carers much more quality information about the procedure, including the material risks and benefit involved for that individual. From the healthcare provider point of view, it saves a considerable amount of time, checklist and videos help standardised the information delivery, rather than the clinician having to repeat them. The form is stored on the server and can be scanned back into the system once signed.”

When Is It Ethical for Physician-Investigators to Seek Consent From Their Own Patients?

When Is It Ethical for Physician-Investigators to Seek Consent From Their Own Patients?
Stephanie R. Morain, Steven Joffe, Emily A. Largent
The American Journal of Bioethics, 17 April 2019; 19(4) pp 11-18
Classic statements of research ethics advise against permitting physician-investigators to obtain consent for research participation from patients with whom they have preexisting treatment relationships. Reluctance about “dual-role” consent reflects the view that distinct normative commitments govern physician–patient and investigator–participant relationships, and that blurring the research–care boundary could lead to ethical transgressions. However, several features of contemporary research demand reconsideration of the ethics of dual-role consent. Here, we examine three arguments advanced against dual-role consent: that it creates role conflict for the physician-investigator; that it can compromise the voluntariness of the patient-participant’s consent; and that it promotes therapeutic misconceptions. Although these concerns have merit in some circumstances, they are not dispositive in all cases. Rather, their force—and the ethical acceptability of dual-role consent—varies with features of the particular study. As research participation more closely approximates usual care, it becomes increasingly acceptable, or even preferable, for physicians to seek consent for research from their own patients. It is time for a more nuanced approach to dual-role consent.