Consent Guidelines Research Articles

IRB Consent Guidelines: Potential Barriers to Diversity in Research.

Despite initiatives aimed at improving study participation and inclusion among ethnic and racially minoritized and marginalized populations, participation remains low. While necessary to ensure ethical practice in human participant research, certain Institutional Review Board (IRB) guidelines may introduce additional barriers in research involving these populations. This work outlines guidelines pertaining to consent translation for non-English speaking populations and offers discussion on a greater emphasis for more inclusive methods for marginalized communities. The University of Wisconsin's IRB approved alternative oral consent processes after the community partner determined that standard translation processes would be inefficient. Researchers used translated consent materials for four different ethnic groups (Hmong, Karen, Karenni, and Burmese). We provided recorded consents in each respective language to participants before study participation and obtained verbal consent prior to study participation at the study location. We experienced time and resource constraints in both access to translators and the consent-translation process itself. Furthermore, many participants were unable to read in their native language making standard written consent processes both difficult and impractical. Oral discussion and verbal consent processes were efficient. Adjustments to consent-related guidelines may prevent and eliminate time and resource-related barriers in consent processes. In eliminating such barriers, subsequent improved efficiency in both study design and study promotion areas can work to better promote diversity in research among populations that emphasize oral language and in instances where literacy rates in written non-English language may be lower.

The participant’s voice: crowdsourced and undergraduate participants’ views toward ethics consent guidelines

ABSTRACT The informed consent process presents challenges for psychological trauma research (e.g. Institutional Review Board [IRB] apprehension). While previous research documents researcher and IRB-member perspectives on these challenges, participant views remain absent. Thus, using a mixed-methods approach, we investigated participant views on consent guidelines in two convenience samples: crowdsourced (N = 268) and undergraduate (N = 265) participants. We also examined whether trauma-exposure influenced participant views. Overall, participants were satisfied with current guidelines, providing minor feedback and ethical reminders for researchers. Moreover, participant views for consent were similar irrespective of trauma-exposure. Our study has implications for IRBs and psychological researchers.

A Comparison of the Free, Prior, and Informed Consent (FPIC) Guidelines and the “Implementation of Governance, Forest Landscapes, and Livelihoods” Project in Lao PDR: The FPIC Team Composition and the Implementation Process

Free, prior, and informed consent, or FPIC, is a crucial component of reducing emissions from deforestation and forest degradation in developing countries (REDD+) projects. This study addresses a significant research gap regarding FPIC in the context of REDD+ projects, with a focus on the Implementation of Governance, Forest Landscapes, and Livelihoods (I-GFLL) project in the Lao People’s Democratic Republic (Lao PDR). This research aimed to evaluate the FPIC’s components and implementation. We employed a literature review of the FPIC implementation reports from 242 targeted villages involved in the I-GFLL project and face-to-face interviews with 12 key informants. The research found positive aspects, such as female team membership, boosting ethnic women’s participation; the exclusion of forestry officials to foster an open dialogue; and respect for project rejections, displaying adherence to the FPIC principles. However, some challenging aspects were also highlighted, such as the exclusion of civil society organizations (CSOs) and non-government organizations (NGOs) and the loss of their expertise; limited team knowledge of forestry/climate change, hindering communication; short consultation durations; and an incomplete understanding of technical terms due to the project’s novelty, raising concerns. The study emphasizes the importance of crafting FPIC teams that promote communication, respect community rights, and, ultimately, ensure successful project implementation.

Key interoperability Factors for patient portals and Electronic health Records: A scoping review

AimTo identify the key requirements and challenges to interoperability between patient portals and electronic health records (EHRs). IntroductionPatient portals provide patients with access to their health information directly from EHRs within hospitals, primary care centres and general practices (GPs). Patient portals offer many benefits to patients including improved communication with healthcare providers and care coordination. However, many challenges exist with the integration and automatic and secure sharing of information between EHRs and patient portals. It is critical that countries learn from international experiences to successfully develop interoperable national patient portals. MethodsA scoping review methodology was undertaken. A search strategy using index terms and keywords was applied across four key databases, an additional grey literature search was also run. The identified studies were screened by two reviewers to determine eligibility against defined inclusion criteria. Data were abstracted from the eligible studies and reviewed to identify the key requirements and challenges to interoperability of patient portals with EHRs. ResultsAfter screening 3,462 studies, 34 were included across 11 countries. Of the 29 unique patient portals studied, few offered patients access to their entire healthcare record across multiple sites and a number of different functionalities were available. Key interoperability requirements and challenges identified were: Data Sharing Incentives & Supports; Heterogenous Organisations & Information Systems; Data Storage & Management; Available Information & Functionalities; Data Formats & Standards; Identification of Individuals; User Access, Control & Consent; and Security & Privacy. ConclusionSeamless exchange of health information across patient portals and EHRs required organisational and individual factors, as well as technical considerations. Interorganisational collaboration and engagement of key stakeholders to determine standards and guidelines for consent and sharing of information, as well as technical standards and security measures were recommended.

AUDIT ON VALIDITY AND ADEQUACY OF CONSENT FORMS FOR OPHTHALMOLOGY LASER PROCEDURES AND ANGIOGRAPHY IN A TERTIARY HOSPITAL

The importance of complete and valid written consent for medical procedure is indisputable. Written consent forms for ophthalmology related laser procedures and angiography were audited against guidelines regarding validity and adequacy. A full cycle clinical audit was carried out at a tertiary hospital providing ophthalmology service. A preintervention audit was performed in 2018 where consent forms of all ophthalmology related laser procedures and angiography were reviewed. Multiple interventions were taken to improve the adherence in obtaining a valid and adequate written consent prior to the post intervention audit. Standards of practice were compared to ‘Guidelines for Consent for Treatment of Patients by Registered Medical Practitioners’ by Malaysian Medical Council (MMC), and ‘Consent Forms in Ophthalmic Practice’ by Dr. Amit Khosla. A total of 412 consent forms were reviewed in the pre-intervention audit of 2018. Adherence to standard was 37.14%. In the post intervention audit, 256 forms were reviewed, and the adherence improved to 85.94%. Interventions taken include briefing to stakeholders, formulating a standardized risks checklist and multiple checks were done to ensure the interventions were adhered to by the doctors. The significant improvement in adequacy and validity of consent taking for ophthalmology related laser procedures and angiography showed that the interventions taken, were indeed useful. However, continuous effort in maintaining the standard is crucial for patient care and safety.

Stakeholder views on informed consent models for future use of biological samples in Malawi and South Africa

BackgroundCurrent advances in biomedical research have introduced new ethical challenges in obtaining informed consent in low and middle-income settings. For example, there are controversies about the use of broad consent in the collection of biological samples for use in future biomedical research. However, few studies have explored preferred informed consent models for future use of biological samples in Malawi and South Africa. Therefore, we conducted an empirical study to understand preferred consent models among key stakeholders in biomedical studies that involve collection of biological samples in Malawi and South Africa. The main objective of the study was to explore views of key stakeholders on current policies on informed consent in Malawi and South Africa.MethodsThis was a qualitative study involving in-depth interviews and focus group discussions. Thirty-four in-depth interviews and 6 focus group discussions were conducted with REC members, Funders, Policymakers, CAB members and Research Participants in Malawi and South Africa to gather their views on models of informed consent. The study was conducted in Cape Town, South Africa, and Blantyre and Lilongwe in Malawi.ResultsMost key stakeholders preferred broad consent and tiered consent to specific consent. Some participants expressed a strong preference for specific consent to other models of informed consent in biomedical research. Few participants did not have any preference for a consent model, opting for any consent model which provides adequate information about the proposed research and what their national consent regulations require. Finally, very few participants preferred blanket consent to other informed consent models.ConclusionsThis study aimed to help fill the gap in the scientific literature on key stakeholder views on consent models for future use of biological samples in Malawi and South Africa. The findings of the study have provided some evidence that may support policies on permissible consent models for future use of biological samples in sub-Saharan Africa considering the differences in informed consent regulations and guidelines. Finally, the findings can inform ongoing discussions on permissible consent models to be used for future use of biological samples.

Complications of Aesthetic Liposuction Performed in Isolation: A Systematic Literature Review and Meta-Analysis.

Introduction: Aesthetic liposuction represents one of the most commonly performed cosmetic procedures worldwide. The purpose of this article is to examine and synthesize reported complication rates and explore the analytical prospect of possible patient or procedure-related predictive factors associated with specific complications. Methods: A systematic review was performed using the Pubmed, Cochrane, and Embase databases in line with specific criteria set to ensure an accurate assessment of complication rates; extracted data was synthesized through a random-effects model and meta-analysis of proportions. Results: A total of 60 studies were included in the meta-analysis, representing 21,776 patients undergoing aesthetic liposuction. Most studies followed an observational design. The overall complication rate was 12% (95% confidence interval [CI] 8%, 16%). When stratifying according to specific complications, the incidence of contour irregularities was determined to be 2% (95% CI 1%, 2%), seroma 2% (95% CI 1%; 2%), hematoma 1% (95% CI 0%, 1%), surgical site infection 1% (95% CI 1%, 2%), fibrosis or induration 1% (95% CI 1%, 2%), and pigmentary changes 1% (95% CI 1%, 1%), among others. A meta-regression to identify patient- or procedure-related factors associated with greater complication rates proved infeasible given the nature of the available data. Conclusion: Overall, liposuction demonstrated a relatively low complication rate profile, however, a considerable degree of heterogeneity exists within the examined literature preventing the recognition of predictive risk factors. While this calls for efforts to establish consensus on unified methods of outcomes reporting, the present meta-analysis can serve to provide practitioners with an evidence-based reference to improve informed consent and inform clinical guidelines, specifically pertaining to the incidence of commonly encountered complications in aesthetic liposuction, of which presently available survey studies and database queries remain devoid.

Nurses' awareness and adherence with national ethical guidelines for research in North India.

A large number of nurse researchers do not adhere to ethical standards while performing the research. Moreover, there is far less data on knowledge of existing national ethical guidelines. This study was, therefore, done to assess awareness and adherence to current national ethical guidelines among nursing students and faculty members. A cross-sectional descriptive study was done among nursing faculty members and theses carried out by postgraduate nursing students between 2012 and 2017. Using the convenience sampling technique, seven states of North India were selected. In each of the selected seven states, one government and one private nursing college was selected. Thus, a sample of 14 nursing colleges was selected. Then, using simple random sampling, a total of 140 nursing faculty members and 280 postgraduate nursing theses were selected from all the chosen institutes to be part of the study. Data analysis was done using descriptive statistics. The study has been approved by the institutional ethical committee (ECR/737/Inst/UK/2018/RR-18). In addition, written permission from the head of each nursing institute was obtained before conducting the study. After participants read the Participation Information Sheet, they were asked for written informed consent before data collection. Confidentiality of the information and anonymity of the participants were maintained throughout the study. The majority (81.8%) of the participants were females. It was found that compared to private nurses, government college nurses were more adhered to the research guidelines on research project approval (68.6% vs 22.1%), informed consent guidelines (74.3% vs 25%), providing patient information sheets (55.7% vs 10%), maintaining information confidentiality (82.9% vs 72.1%), maintaining anonymity (76.4% vs 22.9%) and obtaining custodian permission (97.8 vs 89.3%). It was also shown that nurses were more aware of the informed consent process domain (4.3 ± 0.3) followed by the general ethical principles domain (3.8 ± 0.8). Government college nurses adhered more to the research guidelines as compared to those employed in private settings. Most of the faculty members were not part of any clinical trials and had no research ethics training at all. Therefore, it is needed to provide an instructional programme to raise awareness of the research ethical standards.

Cookies ‘n’ Consent: An empirical study on the factors influencing of website users’ attitude towards cookie consent in the EU.

Since GDPR came into enforcement in 2018, various firms have been found violating or circumventing the ePrivacy Directive known as the Cookie Law which lays out the cookie consent guidelines for websites. To improve the GDPR compliance rate, several conversations are going on between EU commission, Data protection agencies, business & websites owners and ad vendors regarding their cookie policy, obtaining user consent for data collection and its usage. One of the key stakeholders who are the website users, whose privacy is in question seems to be left out from the discussions. The study aimed to understand user perception towards website cookie banners, which are mandatory under GDPR, and the influence of factors like awareness of cookies, user experience, consent banner design, privacy risk, brand trust on user’s willingness for accepting all cookies, to develop recommendations to improve customer’s motivations to give consent. Using a quantitative approach, the primary data was collected from 132 internet users residing in the EU region through an online survey questionnaire shared in social media networks. The results showed that the (i) majority of respondents had more than moderate level of awareness about cookies (ii) they are more likely to accept cookies for quick access or task completion, (iii) acceptance of cookies was varied across different categories of online activity and (iv) given a choice they are more likely to opt-out of 3rd party cookies which are widely used for targeted advertising. Since 3rd party cookies will be phased out in the near future and are likely to be replaced with more advanced customer tracking technologies which are harder to opt-out of, this study proposes a framework for Consent for Advertising Directive (CAD) to go beyond the existing Cookie Law, which will improve user data protection regardless of the tracking technology used, and help brands to improve transparency about their data collection and avoid GDPR violations.

Decision-making, attitudes, and understanding among patients and relatives invited to undergo genome sequencing in the 100,000 Genomes Project: A multisite survey study

PurposeThe purpose of this study was to assess decisions, attitudes, and understanding of participants (patients, parents, relatives) having genome sequencing for rare disease diagnosis. MethodsThis study involved a cross-sectional observational survey with participants in the 100,000 Genomes Project. ResultsSurvey response rate was 51% (504/978). Most participants self-reported that they had decided to undergo genome sequencing (94%) and that this was an informed decision (84%) with low decisional conflict (95%). Most self-reported that they had chosen to receive additional findings (88%) and that this was an informed decision (89%) with low decisional conflict (95%). Participants were motivated more by the desire to help others via research than by the belief it would help them obtain a diagnosis (Z = 14.23, P = 5.75 × 10–46), although both motivations were high. Concerns were relatively few but, where expressed, were more about the potential psychological impact of results than data sharing/access (Z = 9.61, P = 7.65 × 10–22). Concerns were higher among male, Asian or Asian British, and more religious participants. General and context-specific understanding of genome sequencing were both moderately high (means 5.2/9.0 and 22.5/28.0, respectively). ConclusionThese findings are useful to inform consent guidelines and clinical implementation of genome sequencing.

Understanding the ethical and legal considerations of Digital Pathology.

Digital Pathology (DP) is a platform which has the potential to develop a truly integrated and global pathology community. The generation of DP data at scale creates novel challenges for the histopathology community in managing, processing, and governing the use of these data. The current understanding of, and confidence in, the legal and ethical aspects of DP by pathologists is unknown. We developed an electronic survey (e‐survey), comprising 22 questions, with input from the Royal College of Pathologists (RCPath) Digital Pathology Working Group. The e‐survey was circulated via e‐mail and social media (Twitter) through the RCPath Digital Pathology Working Group network, RCPath Trainee Committee network, the Pathology image data Lake for Analytics, Knowledge and Education (PathLAKE) digital pathology consortium, National Pathology Imaging Co‐operative (NPIC), local contacts, and to the membership of both The Pathological Society of Great Britain and Ireland and the British Division of the International Academy of Pathology (BDIAP). Between 14 July 2020 and 6 September 2020, we collected 198 responses representing a cross section of histopathologists, including individuals with experience of DP research. We ascertained that, in the UK, DP is being used for diagnosis, research, and teaching, and that the platform is enabling data sharing. Our survey demonstrated that there is often a lack of confidence and understanding of the key issues of consent, legislation, and ethical guidelines. Of 198 respondents, 82 (41%) did not know when the use of digital scanned slide images would fall under the relevant legislation and 93 (47%) were ‘Not confident at all’ in their interpretation of consent for scanned slide images in research. With increasing uptake of DP, a working knowledge of these areas is essential but histopathologists often express a lack of confidence in these topics. The need for specific training in these areas is highlighted by the findings of this study.

342 A Closed Loop Audit on The Quality of Documented Consent in Orthopaedic Procedures

Abstract Aim A thorough discussion of associated risks is essential when obtaining informed consent for any surgery. The consent form serves as a permanent record of the conversation and can have implications as a legal document in court. The aim of this audit was to assess the quality of documentation on consent forms for Orthopaedic procedures. Method Prospective data was collected from consent forms for patients undergoing 6 prespecified procedures and compared to British Orthopaedic Association (BOA) guidelines for consent. We analysed how many of the risks had been documented on the form, and whether the incidence of these risk was emphasised. The data was then collated, analysed and presented at a local trauma meeting. Templates for consent were printed and inserted into consent booklets on the ward to serve as a memory aid. Data was prospectively collected again to complete the audit cycle. Results Prior to the implementation of the consent templates, 8% of consent forms mentioned all possible complications, with 12% emphasising the incidence of the main risks. Post intervention, all significant risks were listed in 29% of forms, with 33% listing the risks in a logical order and emphasising their incidence. Conclusions The process of obtaining consent is a complex but crucial component of surgical practice, with the consent form serving as an important medicolegal document. This study shows that the use of pre-printed consent templates to aid memory can improve documentation and can be adapted and individualised accordingly for each patient.

406 Audit of Current COVID-19 Consent Process

AimContracting COVID-19 increases the risk of serious peri-operative morbidity and mortality. The current best practice for informed consent is to make patients aware of the risk of contracting COVID-19. We aimed to determine if our local orthopaedic unit was meeting this standard of practice.MethodWe performed a single centre, retrospective, closed loop audit. Data was collected using Bluespeir© and Clinical Portal© software. We first audited all emergency and elective consent forms (n = 51) between September-October 2020; mean age 58 years old (range 17-87). Results were circulated to all orthopaedic departmental staff in poster format and given 2 weeks of educational awareness before re-audit of all consent forms (n = 59) in November 2020; mean age 54 years old (range 17-80). Any patient with an Adults With Incapacity (AWI) form in place was excluded.ResultsInitially, COVID-19 was included as a risk in 21/51 (41.2%) of all consent forms; elective procedures 10/24 (41.7%) and emergency procedures 11/27 (40.7%). On re-audit this increased to 32/59 (54.2%) of all consent forms; elective procedures 23/47 (48.9%) and emergency procedures 9/12 (75%). During the audit period, 1 patient tested positive for COVID-19 pre-operatively and 1 patient post-operatively.ConclusionsThis audit improved local adherence to COVID-19 consent guidelines. There remains significant room for improvement, especially in elective practice. Further research is required to determine the true impact of COVID-19 on morbidity and mortality.

Electronic Video Consent to Power Precision Health Research: A Pilot Cohort Study.

BackgroundDeveloping innovative, efficient, and institutionally scalable biospecimen consent for remnant tissue that meets the National Institutes of Health consent guidelines for genomic and molecular analysis is essential for precision medicine efforts in cancer.ObjectiveThis study aims to pilot-test an electronic video consent that individuals could complete largely on their own.MethodsThe University of California, Los Angeles developed a video consenting approach designed to be comprehensive yet fast (around 5 minutes) for providing universal consent for remnant biospecimen collection for research. The approach was piloted in 175 patients who were coming in for routine services in laboratory medicine, radiology, oncology, and hospital admissions. The pilot yielded 164 completed postconsent surveys. The pilot assessed the usefulness, ease, and trustworthiness of the video consent. In addition, we explored drivers for opting in or opting out.ResultsThe pilot demonstrated that the electronic video consent was well received by patients, with high scores for usefulness, ease, and trustworthiness even among patients that opted out of participation. The revised more animated video pilot test in phase 2 was better received in terms of ease of use (P=.005) and the ability to understand the information (P<.001). There were significant differences between those who opted in and opted out in their beliefs concerning the usefulness of tissue, trusting researchers, the importance of contributing to science, and privacy risk (P<.001). The results showed that “I trust researchers to use leftover biological specimens to promote the public’s health” and “Sharing a biological sample for research is safe because of the privacy protections in place” discriminated opt-in statuses were the strongest predictors (both areas under the curve were 0.88). Privacy concerns seemed universal in individuals who opted out.ConclusionsEfforts to better educate the community may be needed to help overcome some of the barriers in engaging individuals to participate in precision health initiatives.

Ethical review and informed consent guidelines of high impact anthropology, business, and education research journals

AbstractWhereas participant protection protocols are norms in medical research, they are only recently being adopted in social and behavioural sciences. This study examined human subject guidelines in the top 40 high‐impact anthropology, business, and education research journals according to their impact factor as released in 2019. For these 120 journals, a unified classification framework was developed to capture the central elements of their ethical review and informed consent requirements. The findings suggest that the investigated journals do not view ethical review as an established norm for interview and survey studies. Only 10 (8%) journals required ethical review from all studies involving human participants. Informed consent was more frequently addressed, but none of the fields exhibited widely established guidelines similar to medical research journals. A total of 31 (26%) journals required informed consent from all studies involving human participants. There was little difference between the three disciplines investigated. Although the investigated journals represented social and behavioural sciences, their guidelines often concerned medical or intervention research with few requirements for interaction (e.g. survey) research. There is an opportunity for high‐impact journals to establish norms for adoption by researchers and other journals.

Efficacy and Safety of Sipjeondaebo‐Tang (Shi‐Quan‐Da‐Bu‐Tang) for Chronic Fatigue Syndrome: Study Protocol for a Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Trial

Background. Sipjeondaebo‐tang (SDT), also known as Shi‐Quan‐Da‐Bu‐Tang, is a treatment for both qi and blood deficiency syndromes in traditional Korean medicine. It is also used to treat chronic fatigue syndrome (CFS) in Korea. Herein, we present the protocol for a study to assess the efficacy and safety of SDT for treating CFS. Methods. This will be a multicenter, randomized, double‐blind, controlled trial with two parallel‐treatment arms: an SDT group and a placebo group. Ninety‐six patients with CFS aged between 19 and 65 years will be recruited from two hospitals in Korea. Participants will be randomly allocated at a ratio of 1 : 1 between the two groups. Participants will receive 3 g doses of SDT or placebo thrice daily for 8 weeks. Follow‐up evaluations will be performed for 4–6 weeks after the drug administration period. The primary outcome will be the rating of participants’ fatigue symptoms using the Checklist Individual Strength questionnaire. Outcomes will be assessed at baseline, week 4, and week 8, as well as during follow‐up. An efficacy evaluation and safety assessment will be performed. This study will be based on the Consolidated Standards of Reporting Trials (CONSORT) guidelines and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statement. This protocol and informed consent guidelines were reviewed and approved by the institutional review board of Kyung Hee University Korean Medicine Hospital at Gangdong in the Republic of Korea (KHNMCOH 2017‐06‐004‐001). The protocol was registered with the Clinical Research Information Service. Written informed consent will be obtained from all study participants prior to enrollment in the study. Results will be published in a peer‐reviewed journal and presented at a scientific conference. Discussion. This study is expected to provide novel, accurate information regarding the 38 efficacy and safety of SDT for CFS in adults. Trial Registration. This trial is registered with https://cris.nih.go.kr; CRIS identifier (KCT0002684) registered on February 9, 2018.

Prospective exploration of the effect of adiposity and associated microbial factors on healing and progression of diabetic foot ulcers in Tanzania: study protocol of a longitudinal cohort study

BackgroundDiabetic foot ulcers (DFUs) are associated with high morbidity and mortality in low-income countries. This coexists with an increasing prevalence of obesity which has been reported to alter antimicrobial susceptibility...

Knowledge, attitude, and practices regarding informed consent for research purposes among postgraduate resident doctors

Background: Informed consent is an ethical and legal requirement for research involving human participants. Postgraduate (PG) residents are budding doctors who are in their interim phase of education and are engaged in thesis/research work, which mandates adequate knowledge of informed consent and regulatory guidelines. There exists paucity of data in literature on the informed consent process with regard to PG residents; therefore, this study was conducted to assess the knowledge, attitude, and practices (KAP) of informed consent among PG residents. Aims and Objectives: The aim of the study was to assess the level of knowledge and attitude about the informed consent process and assess practices adopted by PG residents for research purposes. Materials and Methods: It was a cross-sectional, observational and questionnaire-based study conducted from January 2018 to March 2018 at a tertiary care teaching hospital, Navi Mumbai. The study included PG residents of either sex pursuing specialty MD/MS courses. A validated KAP questionnaire was used to assess KAP of the informed consent process. Responses from the eligible participants were obtained and analyzed. Results: A total of 100 PG residents participated; 39% of males and 61% of females. Overall, the knowledge score was high and attitude toward informed consent was average. However, 34% participants felt that witness is not necessary, 20% felt that once the patient participates, they should not be allowed to withdraw and few felt that on voluntary withdrawal, participants are not liable for further standard care and compensation. In practice, few participants failed to explain consent in the local language and neglected to take the signature of an impartial witness. Conclusions: Overall, the KAP of informed consent among PG residents were adequate. Structured continuing medical education/workshops are necessary to advance informed consent practices.

160 The Development of Exception from Informed Consent and Waiver of Informed Consent Guidelines for Emergency Medicine Researchers

Without EFIC/WIC research, it is difficult to advance the care of patients with time-sensitive, incapacitating diseases like cardiac arrest or hemorrhagic trauma, which remove the possibility of informed consent. The concept of research without consent has ethical implications and is not widely understood by the public, or by researchers themselves. The aim of the present study is to synthesize clear EFIC/WIC guidelines to aid emergency medicine researchers, increase community awareness, and ultimately enhance the treatment of emergent disease.

Informed consent guidelines for ionising radiation examinations: A Delphi study

IntroductionInformed 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. MethodsThe 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. ResultsA 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. ConclusionThe 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.