Challenges Of Informed Consent Research Articles

Informed consent and trial prioritization for clinical studies during the COVID-19 pandemic. Stakeholder experiences and viewpoints.

Very little is known about the practice-oriented challenges and potential response strategies for effective and efficient translation of informed consent and study prioritization in times of a pandemic. This stakeholder interview study aimed to identify the full spectrum of challenges and potential response strategies for informed consent and study prioritization in a pandemic setting. We performed semi-structured interviews with German stakeholders involved in clinical research during the COVID-19 pandemic. We continued sampling and thematic text analysis of interview transcripts until thematic saturation of challenges and potential response strategies was reached. We conducted 21 interviews with investigators, oversight bodies, funders and research support units. For the first topic informed consent we identified three main themes: consent challenges, impact of consent challenges on clinical research, and potential strategies for consent challenges. For the second topic prioritization of clinical studies, we identified two main themes: perceived benefit of prioritization and potential strategies for prioritization. All main themes are further specified with subthemes. A supplementary table provides original quotes from the interviews for all subthemes. Potential response strategies for challenges with informed consent and study prioritization partly share common ground. High quality procedures for study prioritization, for example, seem to be a core response strategy in dealing with informed consent challenges. Especially in a research environment with particularly high uncertainty regarding potential treatment effects and further limitations for valid informed consent should the selection of clinical trials be very well justified from a scientific, medical, and ethics viewpoint.

Informed consent challenges and strategies: A qualitative study of the orthodontists' perspective.

To identify the barriers and strategies perceived by orthodontists when obtaining consent from their adult patients concerning patients' comprehension or recollection of treatment information. The sample comprised 12 orthodontists working in 8 different cities in Alberta, Canada. An exploratory investigation using qualitative inquiry was conducted. Participants were recruited through a combination of purposive, maximum variation and snowball sampling. Data were collected through audio-recorded, semi-structured interviews until saturation was reached. Then, data were analysed using thematic analysis. Quality and credibility were achieved by employing member checks, memo writing and analyst triangulation strategies. Two major themes were identified, with subthemes: (1) Challenges that may interfere with patients' comprehension and recollection of treatment information (i. patients' internal barriers, ii. patients' external barriers and iii. financial barriers); and (2) strategies to optimize information delivery and communication (i. tailoring the content to be delivered, ii. communication fashion, iii. communication timing and iv. being accommodative). The participants reported barriers that may be overlooked in the daily routine of orthodontic practices. Information is provided that may guide orthodontists to overcome or minimize these challenges, increase patient comprehension and improve the quality of informed consent processes.

Dental informed consent challenges and considerations for cognitively impaired patients.

Because the US population is living to an older age, the number of individuals with cognitive impairment and periodontitis is increasing, as both conditions/diseases increase with age. Dental informed consent best practices for dental/periodontal treatment of individuals with cognitive impairment have not been explored, yet warrant consideration, because complex dental treatments to address periodontal needs/edentulism raise challenges for informed consent in the elderly with cognitive impairment. The purpose of this review is to help practitioners better understand this topic and develop best practices in dentistry for informed consent of patients with cognitive impairment that need extensive dental treatment, including surgical and implant therapy.

Informed Consent and Shared Decision Making in Obstetrics and Gynecology: ACOG Committee Opinion Summary, Number 819.

Meeting the ethical obligations of informed consent requires that an obstetrician-gynecologist gives the patient adequate, accurate, and understandable information and requires that the patient has the ability to understand and reason through this information and is free to ask questions and to make an intentional and voluntary choice, which may include refusal of care or treatment. Shared decision making is a patient-centered, individualized approach to the informed consent process that involves discussion of the benefits and risks of available treatment options in the context of a patient's values and priorities. Some informed consent challenges are universal to medicine, whereas other challenges arise more commonly in the practice of obstetrics and gynecology than in other specialty areas. This Committee Opinion focuses on informed consent for adult patients in clinical practice and provides new guidance on the practical application of informed consent through shared decision making. The principles outlined in this Committee Opinion will help support the obstetrician-gynecologist in the patient-centered informed consent process.

Informed Consent and Shared Decision Making in Obstetrics and Gynecology: ACOG Committee Opinion, Number 819.

Meeting the ethical obligations of informed consent requires that an obstetrician-gynecologist gives the patient adequate, accurate, and understandable information and requires that the patient has the ability to understand and reason through this information and is free to ask questions and to make an intentional and voluntary choice, which may include refusal of care or treatment. Shared decision making is a patient-centered, individualized approach to the informed consent process that involves discussion of the benefits and risks of available treatment options in the context of a patient's values and priorities. Some informed consent challenges are universal to medicine, whereas other challenges arise more commonly in the practice of obstetrics and gynecology than in other specialty areas. This Committee Opinion focuses on informed consent for adult patients in clinical practice and provides new guidance on the practical application of informed consent through shared decision making. The principles outlined in this Committee Opinion will help support the obstetrician-gynecologist in the patient-centered informed consent process.

Informed consent challenges in first-in-human trials to combat serious neurological diseases: Why informed consent processes must account for the ethical salience of unique life circumstances

Informed consent challenges in first-in-human trials to combat serious neurological diseases: Why informed consent processes must account for the ethical salience of unique life circumstances

Privacy and Ethics in Pediatric Environmental Health Research—Part II: Protecting Families and Communities

BackgroundIn pediatric environmental health research, information about family members is often directly sought or indirectly obtained in the process of identifying child risk factors and helping to tease apart and identify interactions between genetic and environmental factors. However, federal regulations governing human subjects research do not directly address ethical issues associated with protections for family members who are not identified as the primary “research participant.” Ethical concerns related to family consent and privacy become paramount as pediatric environmental health research increasingly turns to questions of gene–environment interactions.ObjectivesIn this article I identify issues arising from and potential solutions for the privacy and informed consent challenges of pediatric environmental health research intended to adequately protect the rights and welfare of children, family members, and communities.DiscussionI first discuss family members as secondary research participants and then the specific ethical challenges of longitudinal research on late-onset environmental effects and gene–environment interactions. I conclude with a discussion of the confidentiality and social risks of recruitment and data collection of research conducted within small or unique communities, ethnic minority populations, and low-income families.ConclusionsThe responsible conduct of pediatric environmental health research must be conceptualized as a goodness of fit between the specific research context and the unique characteristics of subjects and other family stakeholders.