Evaluating and extending the Informed Consent Ontology for representing permissions from the clinical domain

The purpose of this study was to evaluate, revise, and extend the Informed Consent Ontology (ICO) for expressing clinical permissions, including reuse of residual clinical biospecimens and health data. This study followed a formative evaluation design and used a bottom-up modeling approach. Data were collected from the literature on US federal regulations and a study of clinical consent forms. Eleven federal regulations and fifteen permission-sentences from clinical consent forms were iteratively modeled to identify entities and their relationships, followed by community reflection and negotiation based on a series of predetermined evaluation questions. ICO included fifty-two classes and twelve object properties necessary when modeling, demonstrating appropriateness of extending ICO for the clinical domain. Twenty-six additional classes were imported into ICO from other ontologies, and twelve new classes were recommended for development. This work addresses a critical gap in formally representing permissions clinical permissions, including reuse of residual clinical biospecimens and health data. It makes missing content available to the OBO Foundry, enabling use alongside other widely-adopted biomedical ontologies. ICO serves as a machine-interpretable and interoperable tool for responsible reuse of residual clinical biospecimens and health data at scale.

Biobank Participants’ Attitudes Toward Data Sharing and Privacy: The Role of Trust in Reducing Perceived Risks

Biobank participants are often unaware of possible uses of their genetic and health information, despite explicit descriptions of those uses in consent forms. To explore why this misunderstanding persists, we conducted semi-structured interviews and knowledge tests with 22 participants who had recently enrolled in a research biobank. Results indicated that participants lacked understanding of privacy and data-sharing topics but were mostly unconcerned about associated risks. Participants described their answers on the knowledge test as largely driven by their trust in the healthcare system, not by a close reading of the information presented to them. This finding may help explain the difficulties in increasing participant understanding of privacy-related topics, even when such information is clearly presented in biobank consent forms.

Nutrition Information Sources Used By Amateur Bodybuilding Athletes Around Polokwane Municipality In Limpopo Province, South Africa

Background: There is a growing number of athletes participating in bodybuilding sport around the Limpopo Province. However, little is known about the nutrition information sources used by these athletes to guide their decisions during sports performance. Therefore, the researcher aimed at closing this gap through the investigation of nutrition information sources used by the bodybuilding athletes around one of the largest municipalities (Polokwane) in Limpopo Province. Methods: A quantitative descriptive study design was adopted to purposively sample 51 out of 60 amateur bodybuilding athletes in gyms around Polokwane municipality. Ethical approval and permission were obtained from the MEDUNSA Research and Ethics Committee (MREC) and coaches respectively. Athletes signed informed consent forms after the purpose of the study was explained. Data were collected at gyms in the evenings using self-designed questionnaires. The athletes’ demography, training information, and nutrition sources were collected. The SPSS (23) was used to analyse data using descriptive tests. Results: A Few athletes (11.8%) trained as bodybuilders for ≤6 months, while most athletes (66.7%) had been training for >7 months to 2 years. The majority (86.3%) trained for ≥1hour during weekdays. Most of the athletes (37.3%) relied on coaches as their source of information, while 29.4% and 29.3% relied on social media and teammates respectively. Only 4.0% used a professional for nutrition information. Conclusion: The bodybuilding athletes around Polokwane municipality mostly used coaches as sources for nutritional information.Trial registration: Not Applicable.

Trait Mindfulness Predicts Helping Behavior toward Racial Ingroup and Outgroup Members

A study examined whether trait mindfulness would increase spontaneous helping behavior toward racial outgroup members (vs ingroup members). Self-identifying White participants scoring higher in basic trait mindfulness more frequently helped both racial outgroup and ingroup members in two randomly assigned lab-based helping simulations: (1) giving one’s seat to a person on crutches or (2) aiding an experimenter in picking up dropped consent forms. Men were 3.70 times as likely to help than women. Discussion focuses on the role of individual differences in mindful attention deployment in helping.

EP.WE.347An Audit On Our Procedural Consent Forms For Complication Of COVID-19 During The Pandemic

Introduction Aims Methods Conclusion

SP7.2.3 Documentation of risk discussions prior to elective inguinal hernia surgery, is it standardised for all?

Aims Obtaining consent is fundamental to surgical practice. Rising levels of litigation have led to increased scrutiny of the process. The Royal College of Surgeons (RCS) recommends a structured consent process enabling patients to make better informed decisions, increasing the legal robustness of the process. Our aim is to audit the documentation of risk discussions prior to elective inguinal hernia repair (EIHR). Methods Data was collected retrospectively for all patients who had undergone EIHR in a single surgical unit between January 2019 and 2020. Outpatient clinic letters and consent forms were reviewed. The grade of surgeon and documentation of consent discussions were recorded. The results were then analysed using basic statistical analysis. Results 146 patients (137 male and 9 female) were included in the audit, with an average age of 63 years (range 20-89 years). 77% of clinic letters recorded a consent discussion. Of these, chronic pain was the risk most commonly documented (62%), followed by recurrence (56%). 19.8% of clinic letters included the level of risk quoted. 86% of consent forms were legible. Documentation of risk was significantly more detailed on consent forms compared to clinic letters (p < 0.05). On these, infection was the most commonly documented (97%), followed by bleeding (91%). Overall, there was no significant difference in documentation relative to surgical grade. Conclusions This study has demonstrated considerable variability in consent process prior to EIHR. This can have both legal implications and impact upon patient experience. Adopting a strategy to ensure a consistent approach is essential.

EP.WE.568Compliance with the Royal College of Surgeons of England Guidelines on the Surgical Consenting Process in the Era of the COVID-19 Pandemic

Aims Due to the current COVID-19 pandemic, The Royal College of Surgeons of England released guidelines advising on additional considerations which should be discussed with patients as part of the informed consent process prior to surgery. We conducted a prospective audit on whether COVID-19 infection was mentioned as a possible complication during the consenting process for patients undergoing emergency and elective general surgical procedures at a District General Hospital. Methodology We prospectively collected data on the patients admitted for surgical procedures over a 2-week period. Consent forms were reviewed noting whether COVID-19 infection was listed as a possible complication. Results 35 patients were audited with a median age of 54 (12-94) years including 17 males and 18 females. Patients presented with varying surgical diagnoses, with 16 and 19 undergoing emergency and elective operations, respectively. 77.1% (27) of patients had COVID-19 infection mentioned as a possible complication on their consent forms. Five out of six consent forms completed by Clinical Fellows or CT trainees, 10 out of 13 by Registrars, 12 out of 16 by Consultants mentioned COVID-19 infection. We found no significant correlation between the grade of the consent taker and COVID-19 infection being mentioned as a possible complication. Conclusion Most of the consent takers were aware of the guidelines and mentioned COVID-19 infection as a possible complication during consenting. However, this awareness could be expanded. The results will be presented to the department before a plan to re-audit and close the loop in a few weeks.