Informed consent for whole blood donation
Brian Grainger, Peter Flanagan
Vox Sanguinis, 21 October 2019
Open Access
Abstract
Background and objectives
It is recognized that blood transfusion services have an ethical duty to obtain informed consent from their voluntary, non-remunerated donors. This right was most recently affirmed by the 2017 revision of the International Society of Blood Transfusion (ISBT) Code of Ethics. However, the constituent elements necessary to adequately inform such consent have not been definitively established.
Materials and methods
This review evaluates the historical background to informed consent in medicine and as it has been applied to blood donation. The question of what information should be disclosed is then considered with regard to existing statutory requirements in both the United States and EU as well guidance from relevant international organizations. The emerging ethical issues around repurposing of donated blood for sale as recovered plasma and use in research are included in this analysis.
Results
A reasonable basis is found in the literature to advocate that valid informed consent of blood donors should encompass: the donation process itself and potential adverse effects, the need for pre-donation transfusion-transmissible infection (TTI) screening, potential non-transfusion uses of derived products, requirements to obtain and store personal information, the consequences that non-disclosure of such information may have for both the donor and the recipient and reassurance as to the confidentiality of this information.
Conclusion
Informed consent is a key component of the duty of care between a blood service and its donor. We identify essential elements that should be present for such consent to be considered valid.

Editor’s note: Vox Sanguinis is an International Society of Blood Transfusion publication.

Cardiologists’ and patients’ views about the informed consent process and their understanding of the anticipated treatment benefits of coronary angioplasty
Survey Study
Felicity Astin, John Stephenson, Joy Probyn, Janet Holt, Keith Marshall, Dwayne Conway
European Journal of Cardiovascular Nursing, 9 September 2019
Abstract
Background: Percutaneous Coronary Intervention (PCI) is a common revascularisation technique. Serious complications are uncommon, but death is one of them. Seeking informed consent in advance of PCI is mandatory. Research shows that PCI patients have inaccurate perceptions of risks, benefits, and alternative treatments. Aim: To assess cardiologists’ and patients’ views about the informed consent process and anticipated treatment benefits. Methods: Two cross-sectional, anonymous surveys were distributed in England. An electronic version to a sample of cardiologists, and a paper based version to patients recruited from 10 centres. Results: A sample of 118 cardiologists and 326 patients completed the surveys. Cardiologists and patients shared similar views on the purpose of informed consent; however, over 40% of patients and over a third of cardiologists agreed with statements that patients do not understand, or remember, the information given to them. Patients placed less value than cardiologists upon the consent process and over 60% agreed that patients depended on their doctor to make the decision for them. Patients’ and cardiologists views on the benefits of PCI were significantly different; notably, 60% of patients mistakenly believed PCI was curative. Conclusions: The PCI informed consent process requires improvement to ensure that patients are more involved and accurately understand treatment benefits to make an informed decision. Redesign of the patient pathway is recommended to allow protected time for health professionals to engage in discussions using evidence based approaches such as ‘teach back’ and decision support which improve patient comprehension.

Informed Consent: Process and Practice in the Context of Office-Based Oral Surgery Eric R. Bernstein
Office-Based Maxillofacial Surgical Procedures, 18 October 2019; pp 125-141
Abstract
Informed consent is a mechanism for adherence to the ethical principle of patient autonomy; moreover, as a corollary to the ethical principle, it is a practical way of ensuring that patients are not deceived or coerced into or out of particular treatment decisions. Though informed consent is often “practiced” as merely the act of getting a signature on a form, it is more aptly conceptualized as a process with both ethical and legal implications. This chapter approaches informed consent first from a general overview of the concept and then with a focus on some issues of particular relevance in the context of office-based oral surgery. After presenting a brief history of informed consent, different approaches to informed consent are described and legal standards are discussed. The second half of the chapter explores informed consent with specific respect to elective procedures, pediatric patients and special needs patients, prescribing opioids, the administration of anesthesia, and implications of technology on informed consent.

Changes to the consent process for mandibular third molar surgery
Garmon Bell, Stephen Henderson, Aubrey Craig
Faculty Dental Journal, 30 September 2019; 10(4) pp 126-133
Abstract
Changes to the delivery of oral surgical services, the production and review of clinical guidelines, increased availability of cross-sectional imaging and the introduction of alternative techniques for surgical management of third molar disease have subtly changed the care that a patient will receive. In reviewing those changes, this article aims to promote continued discussion by the profession as to how patients can be best treated while avoiding a protectionist approach to patient care.

Editor’s note: The FDJ, produced by the Faculty of Dental Surgery of The Royal College of Surgeons of England, is an independent dental journal that provides expert opinion on contemporary issues and controversies relevant to the whole dental community.

To Consent, or Not to Consent, That Is the Question; Ethical Issues of Informed Consent for the Use of Donor Human Milk in the NICU Setting
Kelly McGlothen-Bell, Lisa Cleveland, Britt Frisk Pados
Advances in Neonatal Care, October 2019; 19 (5) pp 371–375
Abstract
Background
Evidence supports the superiority of mother’s own milk (MOM) in reducing the comorbidities common to prematurity and very low birth weight. In situations where an insufficient amount of MOM is available or maternal contraindications prevent its use, pasteurized donor human milk (DHM) is a viable substitution. When DHM is deemed best, a common practice in many neonatal intensive care units (NICUs) is for parents to provide their consent. However, no universal mandate for informed consent exists. Often, healthcare providers present and obtain the consent for DHM use prior to delivery or shortly after birth and this consent may be “bundled” along with other standardized NICU treatment consents. This approach is likely less than ideal since it provides insufficient time for decision making and often precedes the mother’s ability to initiate the expression of her own milk.
Purpose
To review the history of DHM use and the ethics surrounding the consenting process including the ethical principles involved in infant feeding decision making. We argue for the standardization and consistent use of informed consent for DHM in the NICU and offer clinical practice implications.
Findings/Results/Implications for Practice and Research
Providers face several challenges in the consenting process for the use of DHM in the NICU setting. These include limited time to support parents and educate them appropriately during the decision-making process. Standardized and consistent use of informed consent is essential to address the ethical concerns surrounding the use of DHM in the NICU setting.

Transplant candidates’ perceptions of informed consent for accepting deceased donor organs subjected to intervention research and for participating in post‐transplant research
Original Article
Elisa J. Gordon, Elizabeth Knopf, Caitlin Phillips, Adam Mussell, Jungwha Lee, Robert M. Veatch, Peter Abt, Sue Dunn, Peter P. Reese
American Journal of Transplantation, 24 September 2019
Abstract
Deceased donor organ intervention research holds promise for increasing the quantity and quality of organs for transplantation by minimizing organ injury and optimizing function. Such research will not progress until ethical, regulatory, and legal issues are resolved regarding whether and how to obtain informed consent from transplant candidates offered intervention organs given time constraints intrinsic to distribution. This multi‐center, mixed‐methods study involved semi‐structured interviews using open‐ and closed‐ended questions to assess wait‐listed candidates’ preferences for informed consent processes if offered an organ after undergoing intervention. Data were analyzed thematically. Sixty‐one candidates participated (47% participation rate). Most were male (57%), white (61%), with a mean age of 56 years. Most candidates (79%) desired being informed that the organ offered was an intervention organ before accepting it, and were likely to accept an intervention organ if organ quality was good (defined as donor age 30) (81%), but fewer candidates would accept an intervention organ if quality was moderate (i.e., donor age 50) (26%). Most perceived informed consent important for decision‐making, while others considered it unnecessary given medical necessity to accept an organ and trust in their physician. Our findings suggest that most candidates desire an informed consent process before accepting an intervention organ and post‐transplant data collection.

Informed consent guidelines for ionising radiation examinations: A Delphi study
C. W. E. Younger, C. Douglas, H. Warren-Forward
Radiography, 16 September 2019
Abstract
Introduction
Informed consent for ionising radiation medical imaging examinations is currently undertaken inconsistently in Australian radiographic practice. There is no uniform informed consent process, and opinions vary about how it should be undertaken, and by whom, if indeed it needs to be undertaken at all. To ensure that patients’ rights are maintained, the informed consent process must be consistent, proactive in the provision of information, and must empower the patient to formulate and ask questions about their care, and to make voluntary decisions.
Methods
The Delphi technique utilises a group of experts whose individual responses are used to create a collective consensus on a process. This ten-expert (five radiographer, five radiologist) Delphi study examined a basic modelling of the process of informed consent for ionising radiation medical imaging examinations and made recommendations for an ideal process.
Results
A series of consensus statements were developed, seeking to rectify areas of the process that were inconsistent, unclear, or ethically unsound. These statements were then considered alongside current codes of professional practice, and Australian law on the duty of disclosure. A model of the ideal process was then developed using these consensus statements and adhering to codes of practice.
Conclusion
The final process model has a continuity of care and a continuity of information provision. The model eliminates the radiographer as a delegatee, and emphasises physician involvement. The referrer and the radiologist have a shared responsibility of providing risk disclosure information.
Implications for Practice
For a non-pregnant adult, the ionising radiation dose from conventional radiography is considered insignificant, and does not require risk disclosure, ameliorating the time commitment needed for the process.

Balancing values and obligations when obtaining informed consent: healthcare professionals’ experiences in Swedish paediatric oncology
Regular Article
Anna Schröder Håkansson, Pernilla Pergert, Jonas Abrahamsson, Margaretha Stenmarker
Acta Paediatrica Nurturing the Child, 13 September 2019
Abstract
Aim
To explore Swedish healthcare professionals’ (HCPs) clinical experiences of the informed consent process (ICP) and to compare experiences between the professions.
Methods
In this nationwide study six paediatric oncologists (POs) and eight research nurses (ReNs) from all Swedish paediatric oncology centres were interviewed. The material was analysed using Grounded theory, a qualitative constant comparative method.
Results
The participants’ main concern was how to fulfil research obligations without putting too much strain on a family in acute crisis, which led to the core category of balancing values and obligations of both healthcare and research. To handle the challenges the participants’ struggled to safeguard the families from psychological harm, tried to adjust to the families, and gradually introduced research while building trust. The conceptual model developed in the study highlights potential consequences of this balancing act with a risk of diminishing the family’s autonomy through HCPs acting authoritatively (in particular POs) or with overprotection (in particular ReNs).
Conclusion
Paediatric oncology is a research integrated healthcare environment. The HCPs need personal, professional and institutional support regarding ICP‐related ethical issues, decisions and implications in this intertwined context. Furthermore, HCPs need to be aware of the potential long‐term risk of developing professional moral distress.

“Uninformed” Consent: Patient Recollection From Surgical Consent in Hand Surgery—A Quality Improvement Initiative
Research Article
Monica Yu, Herbert P. von Schroeder
HAND, 5 September 2019 
Abstract
Background
Informed surgical consent is necessary and routine; however, it can have significant inadequacies. Our purpose was to investigate patient recollection of the surgical consent process and evaluate adequacy from the patient’s perspective.
Methods
A quality improvement framework was used. Two patient surveys capturing information recall and satisfaction of the consent process were administered in 5 consecutive hand clinics. All patients who previously underwent elective hand surgery were included.
Results
There was exceptionally low recall of the risks and benefits of surgery in 103 consecutive patients who underwent hand surgery. Patients under age 35 had slightly better recall of surgical risks. Unexpected postoperative events affected patient perceptions of the consent process.
Conclusions
Patients who have undergone elective hand surgery have poor recollection of the information discussed during the surgical consent process, and therefore the process is lacking. Surgeons may falsely assume that the consent process is sound because it is erroneously perceived as being sufficient by most patients.

Is There a Difference Between the Readabilities of Informed Consent Forms Used for Elective and Emergency Procedures in Turkey?
Research Article
Mehmet Giray Sönmez, Leyla Öztürk Sönmez, Betül Kozanhan, Zerrin Defne Dündar
Therapeutic Innovation & Regulatory Science; 5 September 2019 
Abstract
Background
Informed consent is an important aspect of ethical medical practice. In legal terms, making an intervention without informed consent may mean negligence or malpractice and may lead to legal action, maltreatment, and even attack against the doctor. This study aims to evaluate the readability of informed consent forms (ICFs) used for elective (urology and general surgery) and emergency procedures (emergency medicine and intensive care) by comparing through readability formulas.
Methods
Elective and emergency ICFs were accessed through the web sites of national health care associations. A total of 387 consent forms were evaluated and the same forms were included only once. A total of 35 consent forms were evaluated for emergency procedures, while a total of 55 consent forms were evaluated for elective procedures. Ateşman and Bezirci-Yılmaz formulas defined for determining the readability level of Turkish texts and Gunning fog and Flesch Kincaid formulas measuring the general readability level were used for calculating the readability level of consent forms.
Results
Even though elective ICFs are more readable compared to those of emergency procedures according to Bezirci-Yılmaz formulas, this was statistically insignificant (P = .54). The readability of elective consent forms was found to be at a significantly more difficult level to read compared to Ateşman, Gunning fog, and Flesch Kincaid formulas (P = .002, P < .001, P < .001, respectively).
Conclusion
Even though the procedure is emergency or elective, a difficult readability level may cause problems for the doctor in legal phases. Readable and understandable consent forms should be available to be able to explain morbidity and mortality and improve prognosis. Education level of our country should also be considered while preparing these consent forms.