Legally Effective but Ethically Inadequate: Institutional Review Board Policies for Consent from Legally Authorized Representatives
Robert R. Harrison
Ethics & Human Research, 27 March 2023
Abstract
The prevailing approach to enrolling decisionally impaired adults in clinical research is to rely on permission from a default surrogate, one identified by law rather than by the prospective research participant. Reliance on a surrogate transfers the focus of ethical protection from a researcher-participant relationship to a researcher-surrogate relationship; the selection and role of the surrogate are therefore important. The Common Rule defers to state law governing default surrogate consent to research, but most states have no such law; for those states, the Common Rule defers to institutional policy. I reviewed twenty-five of the study sites with the highest National Institutes of Health funding levels to elaborate the content of institutional review board (IRB) policies and compare those to a suggested paradigm for ethically defensible policies. My findings suggest that IRB policies provide inadequate protection because they recognize surrogates who lack knowledge of the subject’s current values and preferences without imposing adequate additional safeguards.

Minor Consent Laws for Sexually Transmitted Infection and Human Immunodeficiency Virus Services in the United States: A Comprehensive, Longitudinal Survey of US State Laws
Kimberly M. Nelson, Alexandra Skinner, Claire D. Stout, Will Raderman, Emily Unger, Julia Raifman, Madina Agénor, Michele L. Ybarra, Shira I. Dunsiger, S. Bryn Austin, Kristen Underhill
American Journal of Public Health, 8 March 2023
Abstract
Objectives
To assess changes in minor consent laws for sexually transmitted infection (STI) and HIV testing, treatment, and prevention services in all 50 US states and the District of Columbia from 1900 to 2021.
Methods
We coded laws into minor consent for (1) health care generally; (2) STI testing, treatment, and prevention; (3) HIV testing, treatment, and prevention; and (4) pre- or postexposure prophylaxis for HIV prevention. We also coded confidentiality protections and required conditions (e.g., threshold clinician judgments).
Results
The largest increase in states allowing minors to consent to STI services occurred during the 1960s and 1970s. By 2021, minors could consent independently to STI and HIV testing and treatment in all 50 states plus DC, STI prevention services in 32 jurisdictions, and HIV prevention services in 33 jurisdictions. Confidentiality protections for minors are rare. Prerequisites are common.
Conclusions
Although the number of states allowing minors to consent independently to STI and HIV services has increased considerably, these laws have substantial limitations, including high complexity, prerequisites requiring clinician judgments, and neglect of confidentiality concerns.

Waivers of informed consent in research with competent participants and the Declaration of Helsinki
Perspective
Rafael Dal-Ré
European Journal of Clinical Pharmacology, 8 March 2023
Open Access
Excerpt
The World Medical Association started revisions to the Declaration of Helsinki in 2022 and it will have to address numerous issues that have arisen in research ethics since the last 2013 revision [1]. In the face of critical issues that have surfaced during the COVID-19 pandemic, less salient but nevertheless critically important issues may go unnoticed. One of these concerns is the conditions under which it is ethically permissible to modify or waive written informed consent in research with competent participants…

Informing a European guidance framework on electronic informed consent in clinical research: a qualitative study
Research
Evelien De Sutter, Pascal Borry, Isabelle Huys, Liese Barbier
BMC Health Services Research, 21 February 2023; 23(181)
Open Access
Abstract
Background
Electronic informed consent (eIC) may offer various advantages compared to paper-based informed consent. However, the regulatory and legal landscape related to eIC provides a diffuse image. By drawing from the perspectives of key stakeholders in the field, this study aims to inform the creation of a European guidance framework on eIC in clinical research.
Methods
Focus group discussions and semi-structured interviews were conducted with 20 participants from six stakeholder groups. The stakeholder groups included representatives of ethics committees, data infrastructure organizations, patient organizations, and the pharmaceutical industry as well as investigators and regulators. All were involved in or knowledgeable about clinical research and were active in one of the European Union Member States or at a pan-European or global level. The framework method was used for data analysis.
Results
Stakeholders underwrote the need for a multi-stakeholder guidance framework addressing practical elements related to eIC. According to the stakeholders, a European guidance framework should describe consistent requirements and procedures for implementing eIC on a pan-European level. Generally, stakeholders agreed with the definitions of eIC issued by the European Medicines Agency and the US Food and Drug Administration. Nevertheless, it was raised that, in a European guidance framework, it should be emphasized that eIC aims to support rather than replace the personal interaction between research participants and the research team. In addition, it was believed that a European guidance framework should include details on the legality of eIC across European Union Member States and the responsibilities of an ethics committee in the eIC assessment process. Although stakeholders supported the idea to include detailed information on the type of eIC-related materials to be submitted to an ethics committee, opinions varied on this regard.
Conclusion
The creation of a European guidance framework is a much needed factor to advance eIC implementation in clinical research. By collecting the views of multiple stakeholder groups, this study advances recommendations that may facilitate the development of such a framework. Particular consideration should go to harmonizing requirements and providing practical details related to eIC implementation on a European Union-wide level.

[Improper informed consent of the patient: legal and expert assessment]
Kratenko MV
Sudebno-meditsinskaia Ekspertiza, 1 January 2023; 66(1) pp 59-62
Abstract
The purpose of the study is to draw the attention of the legal and medical community to the problem of insufficient awareness of the patient about the upcoming medical intervention; to identify the scope of interaction between the court and the expert in relation to disputes related to improper information. Despite the fact that the conclusion about improper informing of the patient implies a legal assessment of the circumstances, special medical knowledge is needed to identify some defects of voluntary informed consent. The expert, in particular, can answer the questions of the court about what risks are characteristic of a certain type of medical intervention (perforations, bleeding, etc.) and how high their probability was in relation to a particular patient (taking into account his state of health, anatomical features); whether there were alternative treatment options. Based on the explanations received, the court will be able to assess whether the patient’s attention was focused on the relevant circumstances, whether his consent was conscious, and the complications that occurred were foreseeable.

Editor’s note: This is a Russian language publication.

Principles of Informed Consent for Perinatal and Neonatal Nurses
Rebecca L. Cypher
The Journal of Perinatal & Neonatal Nursing, January-March 2023; 37(1) pp 10-13
Excerpt
     An informed consent process includes a patient’s ability to make a decision, a conversation explaining pertinent information to make a choice, and an agreement to receive a definitive type of care. Malpractice disputes are sometimes centered on whether a patient received adequate consent from a clinician prior to a treatment or procedure. In fact, The Joint Commission reported 49 informed consent–related sentinel events over an 11-year period. Consent arguments may arise in perinatal and neonatal allegations when an action results in an adverse event. As an illustration, a family claims that an infant’s death from a subgaleal hemorrhage was caused by an operative vaginal birth. These allegations stem from an accusation that informed consent incorporating maternal and newborn risks was not attained beforehand.

Obtaining informed consent goes beyond a signature on a form. Consent for care is vital for communication and shared decision-making between a clinician (eg, physician or advanced practice nurse) and a patient, a newborn’s parent, or a guardian. This process is designed to provide precise measures that allow patients to have an opportunity to ask questions and make an informed decision. From a liability perspective, when individuals fully comprehend risks and benefits of a treatment, they may cope better with a less than optimal outcome resulting from any care provided. In some circumstances, patients may be less likely to file a malpractice claim. This column offers a primer addressing certain doctrines of informed consent in a perinatal or neonatal setting…

Informed Consent: Legal Obligation or Cornerstone of the Care Relationship?
Margherita Pallocci, Michele Treglia, Pierluigi Passalacqua, Roberta Tittarelli, Claudia Zanovello, Lucilla De Luca, Valentina Caparrelli, Vincenzo De Luna, Alberto Michele Cisterna, Giuseppe Quintavalle, Luigi Tonino Marsella
International Journal of Environmental Research and Public Health, 24 January 2023
Open Access
Abstract
The topic of informed consent has become increasingly important in recent decades, both in the ethical-deontological field and as a duty of law. The review covered all sentences issued by the 13th section of the Civil Court of Rome during the period January 2016–December 2020. During this period, 156 judgments were found in which a breach of consent was required; in 24 of these, specific liability was proven, and the corresponding compensation liquidated. Moreover, 80% of the cases concerned the lack of information provided. The most involved branches were those related to surgical areas: general surgery, plastic surgery and aesthetic medicine and orthopaedics. The total amount of compensation paid was EUR 287,144.59. The research carried out has highlighted how, in a broad jurisprudential context, the damage caused by the violation of the right related to informed consent is considered, and how it impacts on the economic compensation of damages. Additionally, it showed that the areas most affected by the information deficit are those related to the performance of surgical activities, which are characterized by greater invasiveness and a higher risk of adverse events. The data reported underline the exigency to consider informed consent not as a mere documentary allegation but as an essential moment in the construction of a valid therapeutic alliance, which is also useful for avoiding unnecessary litigation that is becoming increasingly burdensome for healthcare systems all over the world.

Case-Law on Informed Consent in Germany: A Model for Albania?
Ervin Pupe, Denard Veshi, Carlo Venditti, Raffaele Picaro, Kristel Haxhia
Liverpool Law Review, 10 January 2023
Abstract
Since the 1990s, Albania has recognized human dignity as one of the main constitutional principles. However, the national medical jurisprudence regarding informed consent has not been developed as in other Western European Countries. Germany is one of the countries that has a long tradition of protecting human dignity in patient-physician relations.This contribution studies the German law on informed consent to medical treatment, Gesetz zur Verbesserung der Rechte von Patientinnen und Patienten of February 2013 through the application of a case-law study. This law, which codifies the national courts’ decisions, highlights the ethical principle of autonomy. In other words, in the absence of a solid national medical jurisprudence, this paper investigates the possibility that Albanian judges could apply the legal arguments of their German colleagues since in the case of case-law study there is an absence of political interference, which can better demonstrate the ethical principle of autonomy and the right to self-determination.