Arguments for ‘ocular donation’ as standardised terminology to reduce the ‘ick factor’ of ‘eye donation’

This brief report presents the global problem of the shortfall of donor corneal tissue for transplantation, a potential root cause (‘ick factor’ language), and a potential solution (modification of ‘ick factor’ language). Specifically, use of the term ‘eye donation’ is a potential hurdle to ocular tissue donation as it can stimulate the ‘ick factor.’ Verbiage such as ‘ocular (eye tissue)’ could be a method of providing terminology that is less emotive than ‘eye donor’ or ‘eye donation.’ The field of transplantation has experienced terminology shifts over time; for example, ‘cadaver’ has been replaced with ‘deceased donor,’ ‘harvest’ has been replaced with ‘recover,’ and ‘life support’ has been replaced with ‘ventilated.’ Notably, only a small number of regions worldwide are using ‘ocular’ terminology, yet it could be an important step to enhancing the informed consent process and improving donation rates, potentially increasing transplant and optimising patient quality of life for those with treatable blindness.

KNOWLEDGE AND AWARENESS OF INFORMED CONSENT AMONG DENTAL PATIENTS

Obtaining informed consent from the patient is fundamental. The consent document should be in local language and should be simple and easy to understand. The awareness and knowledge on informed consent among both patients and the physician is essential in order to practice an efficient process as it is a continuous, two- way communication where transparency and partnership plays an important role.This study was undertaken to examine patients knowledge and awareness about informed consent process. 100 patients attending the Out Patient department were interviewed through questionnaire to assess the awareness and knowledge of the informed consent process. The present study revealed the percentage of patients who were aware of the informed consent process and the information provided in it.

Doctors’ knowledge regarding decision-making capacity: A survey of anesthesiologists

Informed consent for anesthesia is an ethical and legal requirement. A patient must have adequate decision-making capacity (DMC) as a prerequisite to informed consent. In determining whether a patient has sufficient DMC, anesthesiologists must draw on their knowledge of DMC. Knowledge gaps regarding DMC may result in incorrect assessments of patients’ capacity. This could translate to an informed consent process that is ethically and legally unsound. This study examined the DMC-related knowledge of anesthesiologists in a group of four university-affiliated hospitals. The findings suggest that anesthesiologists have several areas of knowledge deficiency regarding DMC and DMC assessment. These findings could inform the development of undergraduate and postgraduate curricula.

Incidental findings in human subjects research: Is ignorance really bliss?

<p>Human subjects research has the potential to produce information beyond the aims of the research study. This information may, nevertheless, have health or reproductive significance for the research participant. With the development of sophisticated technologies, these occurrences, known as incidental findings (IFs), are becoming increasingly common. As yet, however, there is no consensus on how IFs in human subjects research should be managed. This paper examines the current law and guidelines relating to human subjects research, and in doing so determines that research participants are inadequately informed about IFs. Consequently, their ability to make an informed choice about and provide informed consent to research procedures is compromised. After addressing the ethical and practical issues most salient to IFs, a framework for their management is developed. The framework sets out the information that should be discussed with research participants during the informed consent process. Recommendations for how this framework should be implemented are then made. The paper concludes that guidelines establishing minimum standards for communicating the possibility and presence of IFs are urgently required so that the rights of research participants are sufficiently protected.</p>

Incidental findings in human subjects research: Is ignorance really bliss?

<p>Human subjects research has the potential to produce information beyond the aims of the research study. This information may, nevertheless, have health or reproductive significance for the research participant. With the development of sophisticated technologies, these occurrences, known as incidental findings (IFs), are becoming increasingly common. As yet, however, there is no consensus on how IFs in human subjects research should be managed. This paper examines the current law and guidelines relating to human subjects research, and in doing so determines that research participants are inadequately informed about IFs. Consequently, their ability to make an informed choice about and provide informed consent to research procedures is compromised. After addressing the ethical and practical issues most salient to IFs, a framework for their management is developed. The framework sets out the information that should be discussed with research participants during the informed consent process. Recommendations for how this framework should be implemented are then made. The paper concludes that guidelines establishing minimum standards for communicating the possibility and presence of IFs are urgently required so that the rights of research participants are sufficiently protected.</p>

Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies

Background The H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders. Methods An adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting. Results Fifty-three recommendations were evaluated. After the first round, 34 recommendations were judged “appropriate”; 19 were judged “uncertain”; and none was judged “inappropriate”. After the second round, 9 “uncertains” changed to “appropriate”. All recommendations rated medians of 6.5–9 on a 1–9 scale (1 = “extremely inappropriate”, 5 = “uncertain”, 9 = “extremely appropriate”). The sections “General recommendations” and “Gender perspective during the consent process for clinical studies” showed the highest “uncertainty” rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators’ communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant’s possible lack of health literacy and a glossary of terms. Conclusions The RAND/UCLA method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged “appropriate” by all stakeholders involved in the informed consent process.