Consent Standards Research Articles

Informed consent in episiotomy: Co-analysis with midwives and distillation of best practice.

Performing an episiotomy where clinically indicated is a key intervention in the Obstetric Anal Sphincter Injury Care Bundle (OASI-CB) implemented across England and Wales to reduce the risk and increase the detection of severe perineal trauma after birth. Standards of consent provided to people in maternity care generally and for episiotomy specifically have been reported as suboptimal. Compromising birthing people's personal autonomy or sense of control has been linked to a dissatisfying birth experience, negative psychological sequelae, and litigation. This study explored experienced midwives' practice of informed consent for episiotomy during a midwife-led birth. We sampled 43 midwives across eight NHS Trusts in England and Wales using online focus groups and telephone interviews about their experience of consent in episiotomy. Using qualitative content analysis and art-based co-analysis methods with eight midwives from across the research sites, we co-analyzed and co-constructed three themes and four practice recommendations from the data. Three themes were constructed from the data: Assent rather than consent, Change in culture to support best practice, and Standardized information. These themes informed the shaping of four recommendations for best practice in episiotomy informed consent. This study has shown how variations in midwifery practice and culture may impact birthing people's experience of informed consent in episiotomy. Midwives may not have the knowledge or skills to conduct a detailed consent conversation, leading to variation in practice and messages for birthing people. The use of antenatal discussion aids can offer women the opportunity to become informed and fully participate in the decision-making process.

Prevention and Management of Intraoperative Pain During Cesarean Section Under Neuraxial Anesthesia: A Technical and Interpersonal Approach

(Anaesthesia. 2022;77:588–597) The term failure in literature has several different meanings including no blockage, partial blockage, or the need for general anesthesia. In an effort to support clinicians and patients during anesthesia, this article outlines eleven recommendations created by the Obstetric Anaesthetists’ Association working group and the Obstetric Anaesthetists' Association Executive Committee that are designed to improve care and provide minimum standards for consent, assessment of pain, management of intraoperative pain, follow-up communication, and communication as a whole. A group of varied anesthetists and a psychologist formed these recommendations based on 44 studies and literature published in Medline, Embase, CINAHL, and PubMed through the years of 1980 and 2020.

Consent during labour and birth as observed by midwifery students: A mixed methods study

BackgroundWhile consent is an integral part of respectful maternity care, how this is obtained during labour and birth presents conflicting understandings between midwives’ and women’s experiences. Midwifery students are well placed to observe interactions between women and midwives during the consent process. AimThe purpose of this study was to explore the observations and experiences of final year midwifery students of how midwives obtain consent during labour and birth. MethodsAn online survey was distributed via universities and social media to final year midwifery students across Australia. Likert scale questions based on the principles of informed consent (indications, outcomes, risks, alternatives, and voluntariness) were posed for intrapartum care in general and for specific clinical procedures. Students could also record verbal descriptions of their observations via the survey app. Recorded responses were analysed thematically. Findings225 students responded with 195 completed surveys; 20 students provided audio recorded data. Student’s observations suggested that the consent process varied considerably depending on the clinical procedure. Discussions of risks and alternatives during labour were frequently omitted. DiscussionThe student’s accounts suggest that in many instances during labour and birth the principles of informed consent are not being applied consistently. Presenting interventions as routine care subverted choice for women in favour of the midwives’ preferences. ConclusionsConsent during labour and birth is invalidated by a lack of disclosure of risks and alternatives. Health and education institutions should include information in guidelines, theoretical and practice training on minimum consent standards for specific procedures inclusive of risks and alternatives.

Do I Need Institutional Review Board Approval? Applying the 2018 Institutional Review Board Revised Common Rule to Athletic Training Educational Research

Do I Need Institutional Review Board Approval? Applying the 2018 Institutional Review Board Revised Common Rule to Athletic Training Educational Research

Does the affirmative consent standard increase the accuracy of sexual assault perceptions? It depends on how you learn about the standard.

Colleges and universities are increasingly adopting affirmative consent standards of sexual assault, in which consent is defined as conscious and voluntary "yeses" given throughout a sexual interaction. We examined the impact of affirmative consent standards on perceptions of assault and consent. We hypothesized that in sexual assault scenarios involving physical force or verbal coercion, exposure to the consent standard would increase perceptions of assault and decrease perceptions of consent relative to not being exposed to the standard. We then explored whether dehumanization of the perpetrator or the victim mediates the association between assault type and sexual assault perceptions and how this relation changes on the basis of exposure to the affirmative consent standard. We exposed 909 participants (predominantly women: n = 574; predominantly White: n = 677; age: M = 28.61 years, SD = 11.10; students: n = 363, Mechanical Turk workers: n = 546) to an affirmative consent standard in a written policy, a video using a "cup-of-tea" metaphor to describe the consent standard, or no information on the standard. Participants rated perceptions of assault, consent, and dehumanization of a man and woman involved in a sexual interaction involving physical force, verbal coercion, or a consensual agreement. Participants who saw the affirmative consent video were more likely to perceive physical assault as assault compared with participants in the no-exposure control condition. Participants who read the affirmative consent definition were no more or less likely to perceive physical assault as sexual assault compared with participants in the control condition. Participants exposed to the text definition perceived the consensual interaction as more assaultive than did participants in the video and control conditions. Perpetrator dehumanization also emerged as a mediator of the relation between assault type and assault perceptions. These results suggest that exposure to consent standards sometimes aids sexual assault decision-making but also leads to confusion, even in scenarios in which consent is normally discernable. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Friday, June 17, 20228:00 AM - 9:00 AM GPP01 Presentation Time: 8:00 AM: Prospective Randomized Clinical Trial of Patient Treatment-Related Anxiety Following the Use of a Gynecologic Brachytherapy-Specific Educational Video

<h3>Purpose</h3> High dose rate brachytherapy is a highly technical and integral component of the definitive treatment of multiple gynecologic cancers. Gynecologic brachytherapy requires extensive treatment coordination, and patients associate high-quality care with the ability to participate in the decision-making process.Provider explanation of treatment complexities can be overwhelming despite in-depth discussion leading up to informed consent. This study sought to engage and educate the patient regarding the expected treatment trajectory using audiovisual mixed multimedia that comprehensively discusses the entire brachytherapy procedural process. We report on the utilization of this educational video and the effect on patient treatment-related anxiety. <h3>Materials and Methods</h3> This prospective, randomized, clinical trial included patients receiving treatment with gynecologic high dose rate brachytherapy. Patients were randomly assigned to the standard clinic consultation/ education (group A) or enhanced video education intervention arm (group B) using 1:1 block randomization. All patients met with the treating radiation oncologist and had the standard of care procedure consent performed. Patients in the intervention arm had access to view the brachytherapy educational video (https://vimeo.com/403385455/d0716e3cc8https://vimeo.com/403385455/d0716e3cc8) prior to the brachytherapy procedure. Patients' friends and family members were also provided access to the video. A previously validated, modified NCCN Distress Tool including a distress score and symptom survey to assess patient treatment-related anxiety as well as a treatment-specific patient reported satisfaction survey were collected from each patient at 3 timepoints: baseline, before the brachytherapy procedure, and after the brachytherapy procedure. <h3>Results</h3> Between 2/10/2020 and 1/28/2022, 80 patients with gynecologic cancer were enrolled and randomized to receive the standard of care consent process alone (n=40, group A) or online access to the gynecologic brachytherapy patient education video in addition to the standard of care consent process (n=40, group B). Of the 40 patients enrolled in the video intervention arm, 19 patients (48%) viewed the video - 14 of the 19 (74%) patients watched the video to completion, and 17 of 19 (89%) watched greater than 50% of the video. Patients' friends and family were less likely to view the video, with 10/40 (25%) friends and family viewing the video at all, and only 4 of these 10 completed the video. The mean (±SD) distress scores (scaled from 0 to 10, with 0 being "no distress or anxiety") were 4.31 (±3.26) vs 3.93 (±3.11) at baseline, 4.59 (±3.01) vs 4.63 (±2.72) prior to brachytherapy, and 3.90 (±3.58) vs 3.22 (±2.94) after brachytherapy for group A and group B, respectively. The mean (±SD) scores for the symptom survey, composed of 13 mental and physical symptoms scaled from 0 ("none at all") to 5 ("very much,") were 32.41 (±12.45) vs 30.78 (±13.17) at baseline, 29.90 (±14.26) vs 26.44 (±12.90) prior to brachytherapy, and 31.10 (±18.33) vs 26.67 (±16.24) after brachytherapy for group A and group B, respectively. There was no statistically significant difference in distress scores or symptom survey scores between groups. <h3>Conclusions</h3> This is the first prospective trial investigating the use of an educational video intervention in gynecologic brachytherapy to better understand the impact of this tool on patient distress and symptom scores. We did not see a difference in patient-reported treatment-related anxiety for patients given access to the video. However, less than 50% of the patients assigned to the video arm attempted to view the video and less than 25% of patients' friends and family access the video. Of note, patients in both arms had relatively low distress and symptom survey scores at all three timepoints in our study. Further work is needed to understand the factors contributing to treatment-related anxiety and how to create and implement strategies to improve this experience for patients.

Teaching good sex: The limits of consent and the role of the virtues

Abstract I offer an account of sexual ethics, and thus of an education in sexual morality, that tries to make some sense of how a view of consent as central to those ethics might be combined with an education in certain virtues. I do so by exploring what some see as the shortcomings of a standard of consent, namely, how it can deal with instances of prima facie bad sex. I consider and reject various attempts to show that consensuality is sufficient for morally good sex. I then show how a needed supplement to the standard of consent can appeal to a broader view of why consent matters. This in turn connects to those personal and interpersonal virtues that the 2019 Department of Education guidance on relationships and sex education suggests should be taught. Finally, I provide an account of why more than consensuality is needed in the case of sex. In short, I insist on the critical importance of consent but supplement the standard of consent by an appeal to why consent matters and does so especially in the case of sex.

Broad Consent-Are We Asking Enough?

Biobanks and health data repositories provide rich reservoirs of information for use in biomedical research. These repositories depend on participants donating identifiable health data and biospecimens that may be used in perpetuity by unlimited numbers of researchers for unnamed research topics. Since 1991, U.S. federal regulatory provisions, collectively known as the Common Rule, have required informed consent of participants in federally funded human subjects research, but recent changes to the Common Rule now sanction "broad consent" in the repository research context. Broad consent is not defined in the revised Common Rule; thus, researchers and their institutions are left to determine ad hoc what broad consent means and requires. Without leadership and guidance from the U.S. Department of Health and Human Services, stakeholders with potential conflicts of interest will reach their own conclusions and craft new and varied standards for consent. The result will be uneven protections for participants.

The need for a standard for informed consent for collection of human fetal material.

SummaryThe ISSCR has developed the Informed Consent Standards for Human Fetal Tissue Donation and Research to promote uniformity and transparency in tissue donation and collection. This standard is designed to assist those working with and overseeing the regulation of such tissue and reassure the wider community and public.

Data protection-compliant broad consent for secondary use of health care data and human biosamples for (bio)medical research: Towards a new German national standard

BackgroundThe secondary use of deidentified but not anonymized patient data is a promising approach for enabling precision medicine and learning health care systems. In most national jurisdictions (e.g., in Europe), this type of secondary use requires patient consent. While various ethical, legal, and technical analyses have stressed the opportunities and challenges for different types of consent over the past decade, no country has yet established a national consent standard accepted by the relevant authorities. MethodsA working group of the national Medical Informatics Initiative in Germany conducted a requirements analysis and developed a GDPR-compliant broad consent standard. The development included consensus procedures within the Medical Informatics Initiative, a documented consultation process with all relevant stakeholder groups and authorities, and the ultimate submission for approval via the national data protection authorities. ResultsThis paper presents the broad consent text together with a guidance document on mandatory safeguards for broad consent implementation. The mandatory safeguards comprise i) independent review of individual research projects, ii) organizational measures to protect patients from involuntary disclosure of protected information, and iii) comprehensive information for patients and public transparency. This paper further describes the key issues discussed with the relevant authorities, especially the position on additional or alternative consent approaches such as dynamic consent. DiscussionBoth the resulting broad consent text and the national consensus process are relevant for similar activities internationally. A key challenge of aligning consent documents with the various stakeholders was explaining and justifying the decision to use broad consent and the decision against using alternative models such as dynamic consent. Public transparency for all secondary use projects and their results emerged as a key factor in this justification. While currently largely limited to academic medicine in Germany, the first steps for extending this broad consent approach to wider areas of application, including smaller institutions and medical practices, are currently under consideration.

Equipoise, standard of care and consent: responding to the authorisation of new COVID-19 treatments in randomised controlled trials

In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way...

Consent for functional endoscopic sinus surgery: are we complying with the law?

To assess the current standard of consent for functional endoscopic sinus surgery and determine whether it complies with the law following the Montgomery ruling. Ten complications following functional endoscopic sinus surgery were identified as common or serious from a literature search. Using questionnaires, ENT surgeons were asked which of these complications they discussed with patients, and patients were asked how seriously they regarded those risks using a five-point Likert scale. Consent practice from 21 ENT surgeons and data from 103 patients were analysed. The 'reasonable patient' would expect to be consented for all risks, except for pain, and scarring or adhesions. Most ENT surgeons would routinely discuss all risks that were considered significant, except for facial paraesthesia (29 per cent) and damage to the nasolacrimal duct (24 per cent). A negative change in sense of smell was not mentioned by 29 per cent of surgeons. This paper demonstrates that the current consent process for functional endoscopic sinus surgery is likely to be substandard medicolegally.

Advance Care Planning-further development of the patient advance directive : What the specialist in internal medicine must know

Trotz der zur Verfügung stehenden Vorsorgeinstrumente Patientenverfügung, Vorsorgevollmacht und Betreuungsverfügung ist der Behandlungswille des Patienten in der konkreten Situation oft nicht in handlungsleitender Weise bekannt. Ziele des systemisch angelegten Konzepts „Behandlung im Voraus Planen“ – advance care planning, sind die Ermittlung, Dokumentation und Umsetzung des Behandlungswillens des Patienten für den Fall, dass er selbst nicht (mehr) rechtsverbindlich über seine Behandlung entscheiden kann. Auf der individuellen Ebene unterstützt ein speziell geschulter Gesprächsbegleiter zunächst bei der Formulierung der Einstellungen zu Leben, schwerer Erkrankung und Sterben. Darauf aufbauend können die Behandlungswünsche für verschiedene medizinische Situationen besprochen und z. B. in einer Patientenverfügung dokumentiert werden. Hierzu gehören der Notfall, die Situation im Krankenhaus bei unklarer Dauer der Einwilligungsunfähigkeit und die Situation bei dauerhaftem Verlust der Einwilligungsfähigkeit. Durch achtsame, nichtdirektive Gesprächsführung im Sinne einer gemeinsamen Entscheidungsfindung („shared decision making“) wird der Vorausplanende befähigt, gut informiert und reflektiert zu entscheiden („informed consent“). Die an den zukünftigen Behandlungsentscheidungen beteiligten Personen, insbesondere der zukünftige Vertreter, werden möglichst frühzeitig einbezogen. Die institutionelle und regionale Implementierung des Konzepts fördert die Umsetzung des auf diese Weise ermittelten und wirksam dokumentierten Patientenwillens in der gesamten Versorgungskette. Durch den neuen § 132 g SGB V, der den Einrichtungen der stationären Altenhilfe und der Eingliederungshilfe ermöglicht, Behandlung im Voraus Planen zulasten der GKV anzubieten, ist eine zunehmende Verbreitung des Konzepts zu erwarten.Zusatzmaterial onlineDie Online-Version dieses Beitrags (10.1007/s00108-022-01333-9) enthält die Muster-Patientenverfügungen der DiV-BVP „Einstellung zu Leben, schwere Krankheit und Sterben“ und „Ärztliche Anordnung für den Notfall“ (© Deutsche interprofessionelle Vereinigung Behandlung im Voraus Planen e.V. (DiV-BVP), Frankfurt am Main, www.div-bvp.de).

Informed Written Consent for Orthopaedic Trauma in the Emergency Setting at a Tertiary Referral Centre: A Closed-Loop Audit.

IntroductionThe purpose of this investigation was to perform an audit of the standards of consent forms in which patients sign prior to operative intervention for orthopaedic trauma in an emergency setting in our institution, with comparison to the ‘Orthopaedic Surgical Consent’ standards, as set by the American Association of Orthopaedic Surgeons (AAOS). If required, the investigator aimed to close the loop in this audit by educating orthopaedic surgeons on the necessary standards of obtaining written consent for orthopaedic trauma.MethodsFollowing being granted approval by our institutional audit committee, a pre-intervention cycle was performed to assess the quality of consent obtained in written format using electronic patient records in consecutive patients over a four-week period. Following the analysis of this data, an education session was provided for all orthopaedic doctors responsible for obtaining informed written consent from patients who are planned to undergo operative management of a soft tissue or bony injury by the trauma and orthopaedic service in the emergency setting. Thereafter, a post-intervention cycle was performed with subsequent descriptive analysis using the GraphPad software.ResultsIn the pre-intervention audit cycle, all included (n = 107) consent forms (100%) correctly included the patient’s name, date of birth (DOB) and institutional board number (BN). However, only 79 consent forms (74.5%) were completed without using abbreviations or acronyms of any kind, whilst 81 consent forms (76.4%) were completed without correctly stating the side or site of the planned intervention. In the post-intervention cycle, all included (n = 40) consent forms (100%) correctly included the patient’s name, DOB and institutional BN. Additionally, a total of 37 consent forms (92.5%) were correctly completed without using abbreviations or acronyms of any kind (74.5% versus 92.5%, p = 0.02). Furthermore, a total of 39 consent forms (97.5%) were completed correctly stating the side or site of the planned intervention (76.4% versus 97.5%, p = 0.0015).ConclusionThis closed-loop audit found that the quality of informed consent obtained by orthopaedic surgeons in the emergency setting might potentially be significantly improved with at least one virtual education session. Such simple education sessions may potentially improve the documentation of the planned potential operative intervention by orthopaedic surgeons for cases of orthopaedic trauma to ensure patient safety is optimised. As the turnover of non-consultant hospital doctors is high in university teaching hospitals, regular education sessions on such topics may introduce a cultural shift in maintaining high standards when marking and consenting patients in the emergency setting.

864 Adherence to British Hernia Society Standards in Consenting Practice for Inguinal Hernia Repair

Abstract Objectives Evaluation of adherence to BHS Standards in IHRs Consent. Primary goal was the documentation of “Mesh” on clinic letter and consent form. Secondary points were the enlisted postoperative complications and advice given to reduce the risk of complications. Introduction Mesh repair is the gold standard for elective inguinal hernias. Recurrence rate is 1-3%. Chronic pain, for different causes, is documented in 10-15% (Most frequent complication). Method Retrospective study looked at first 100 patients, who were subjected to open inguinal hernia repair, in one year time. Patients under 18 years, history of previous repair and laparoscopic repair were excluded. The sample was reduced to 94, as 6 cases had untraceable and insufficient records Results Despite using mesh in all patients, it was not written in 11.7% of the consent forms and half of the clinic letters. Postoperative readmissions were 6.4% ,8.5% and 1.1% at week, month and year, respectively. The main causes were pain (1%), wound dehiscence (1%), hematoma (2%), and recurrence (1%). Overall complications rate after one year was 5.5%. Although recurrence and chronic pain are linked to hernia repair, they were not mentioned in 10% and 15%. In contrast, non-specific complications were documented in &amp;gt; 90%. Damage to cord structures and post-operative advice were found in 60% and 30%. Conclusions All grades surgeons were not adequately adherent to BHS, exposing the firm to negligence and complains. Preprepared forms and leaflets are advised to improve the quality of service, in respect to the GMC Domains.

1434 An Audit of Surgical Consent Standards in Patients Undergoing Elective ENT Surgery

AimGood Surgical Practice (RCS England) and GMC guidelines inform a surgeon’s practice in the consent process for an operation. Since the Covid-19 pandemic, many surgical departments have converted from face-to-face to telephonic consultations. The clinic letter is of increased importance given that it forms a key part of the medical record which the patient should receive to ensure sufficient time and information to make an informed decision.MethodClinic letters of patients undergoing elective ENT surgery at our trust over a four-week period were examined in this retrospective audit of compliance with RCSEng and GMC guidelines. Additional data was collected on clinician grade and proportion of letters sent to patients. Patients rated satisfaction with consultation on a five-point Likert scale.Results135 eligible patients were included in our audit and the majority were listed by a consultant (57%). In all domains, consultant letters were more likely to be comprehensive as compared to registrars. Overall quality of clinic letters was highly variable regarding documentation of diagnosis (52%), surgical risks (50%), discussion of alternative or no treatment (30%) and registrar discussion with consultant (31%). There was also a stark difference between registrars and consultants sending patients copies of clinic letters (10% vs 47%). Only 10% of patients received a leaflet on their condition. 90% of patients were either satisfied or very satisfied with their clinic consultation.ConclusionsRefresher sessions on consent, updated template letters and increased provision of patient information leaflets will be introduced to the ENT department, and improvements monitored with further re-audit.

Consent for septoplasty: Are we meeting patients' expectations?

The requirements for informed consent were modified in 2015 following the UK Supreme Court judgment of Montgomery v Lanarkshire Health Board. This marked a decisive shift from the traditional paternalistic 'doctor knows best' model towards a more patient-centred approach. This study examines the current standard of consent for septoplasty and whether it complies with the law. We also report whether the 'reasonable patient' and surgeon agree about which risks should be discussed during the consent process. Ten complications were identified as common or serious via a literature search. Using questionnaires, 21 Ears, Nose and Throat surgeons were asked which of these they routinely discussed, and 103 patients were asked how seriously they regarded those complications. Results were compared using the Test of Proportions. Most surgeons routinely discuss all risks except negative change in sense of smell and numbness of upper incisors. The 'reasonable patient' regarded these two complications as serious or very serious. However, less than 70% of surgeons mentioned them. A significant proportion of Ears, Nose and Throat surgeons do not routinely mention all the risks that the 'reasonable patient' would want to know about before undergoing a septoplasty. This may result in more clinical negligence claims, as managing a patient's reasonable expectations is an important factor.

Signalling Standards for Progress: Bridging the Divide Between a Valid Consent to Use Patient Data Under Data Protection Law and the Common Law Duty of Confidentiality.

ABSTRACTIn this article, we analyse the legal components of disclosing confidential patient information under the UK’s common law duty of confidentiality (CLDoC) and processing personal (health) data under the UK’s General Data Protection Regulation (GDPR) and Data Protection Act 2018. We describe the ostensible divide between the CLDoC and data protection law when it comes to the requirements of a valid signal of consent by a patient to use and disclose patient information, obtained by a health professional in the context of direct care, for health care and health research purposes. Ultimately, our analysis suggests that we are saddled, at least in the medium term, with two regimes operating with different standards of a valid consent—while putatively protecting similar interests. There is, however, opportunity for progress. It is possible to improve professional guidance on the interaction between the regimes and to achieve significant normative alignment without aligning the signalling standard for consent; this would promote consistent protection of reasonable expectations of patients across both regimes. Further coherence would require aligning not only the standard, but also the role played by consent under each regime. Here we argue that, in relation to direct care, any such shift should be away from consent as the normal justification. In relation to health research, on the contrary, it should be toward consent as the normal justification for use and disclosure of patient information under both the CLDoC and data protection law.

Governing secondary research use of health data and specimens: the inequitable distribution of regulatory burden between federally funded and industry research.

Some of the most promising recent advances in health research offer opportunities to improve diagnosis and therapy for millions of patients. They also require access to massive collections of health data and specimens. This need has generated an aggressive and lucrative push toward amassing troves of human data and biospecimens within academia and private industry. But the differences between the strict regulations that govern federally funded researchers in academic medical centers (AMCs) versus those that apply to the collection of health data and specimens by industry can entrench disparities. This article will discuss the value of secondary research with data and specimens and analyze why AMCs have been put at a disadvantage as compared to industry in amassing the large datasets that enable this work. It will explore the limitations of this current governance structure and propose that, moving forward, AMCs should set their own standards for commercialization of the data and specimens they generate in-house, the ability of their researchers to use industry data for their own work, and baseline informed consent standards for their own patients in order to ensure future data accessibility.

Do we achieve the Montgomery standard for consent in orthopaedic surgery?

The Montgomery v Lanarkshire Health Board (2015) case set a precedent that has driven the modernisation of consenting practice. Failure to demonstrate informed consent is a common source of litigation. This quality improvement project aimed to provide pragmatic guidance for surgeons on consent and to improve the patient experience during decision making. Elective orthopaedic patients were assessed and the quality of documented consent was recorded. Data were collected over two discrete cycles, with cycle 1 used as a baseline in practice. The following criteria were reviewed: grade of consenting clinician, alternative treatment options, description of specific risks, place and timing of consent and whether the patient received written information or a copied clinic letter. Cycle 1 results were presented to clinicians; a teaching session was provided for clinicians on the standard of consent expected and implementation of a change in practice was established with a re-audit in cycle 2. There were 111 patients included in cycle 1, and 96 patients in cycle 2. Consent was undertaken mostly by consultants (54%). Specific patient risks were documented in 50% of patients in cycle 1 and 60% in cycle 2. Risks associated with a specific procedure were documented in 42% in cycle 1 and 76% in cycle 2, alternative options in 48% (cycle 1) and 66% (cycle 2). A total of 14% of patients in cycle 1 and 8% in cycle 2 had documented written information provision. Copied letters to patients was only seen in 12% of all cycles. Documentation from dedicated consenting clinics outperformed standard clinics. Highlighting poor documentation habits and refining departmental education can lead to improvements in practice. The use of consenting clinics should be considered and clinicians should individually reflect on how to address their own shortcomings. Other units should strongly consider a similar audit. This article provides stepwise advice to improve consent and specifics from which to audit.