Protocol: Strategies to Enhance Inclusion in Informed Consent Practice for People With Vision and/or Hearing Support Needs: A Systematic Review

At its core, the practice of medicine is an information-intensive endeavor. Most of what physicians do involves the collection, review, and management of information. Examples of such activities include obtaining and recording patient information, consulting colleagues, reading the scientific literature, planning diagnostic procedures, devising strategies for patient care, interpreting tests, and conducting research. The ever-increasing biomedical knowledge base that must be considered to deliver optimal patient care only adds to the challenges facing medicine today. Successfully addressing these challenges to deliver the best health care possible requires not only the existence of valid and generalizable data sets derived from systematic basic, clinical, and epidemiological research efforts but also the ability to apply the knowledge derived from these research efforts at the point of care. It is easy to understand, therefore, why the field of biomedical informatics, a field that is concerned with collecting, managing, and optimally using information in health care and biomedicine, is critical to the current and future practice of medicine and the study of healthcare outcomes that result from such practice.1,2 Biomedical informatics approaches and related health information technology (health IT) platforms are key to enabling knowledge-driven healthcare and practice improvement initiatives based on a solid research foundation. Similar biomedical informatics approaches and resources are also critical to advancing outcomes research. Indeed, such technologies such as electronic health records (EHRs), clinical data repositories, and research-specific data management systems are already transforming the way we practice medicine and conduct research. This transformation is being further advanced by federally directed funding and research infrastructure development efforts.3,4 In the sections that follow, we provide an overview of how biomedical informatics and health IT processes and tools can affect the conduct of research and the delivery of evidence-based health care from our perspective. Given the current state of development …

There is growing evidence that the quality of informed consent in clinical research is often sub-optimal. To explore the conformity of patient recruitment with recommended informed consent procedures among patients who were invited to participate in a clinical study at a general teaching hospital, and to examine the association between consent procedures and the patients' decision to participate. All inpatients discharged during a 1-month period were invited to complete a mailed survey in which they reported whether they were invited to participate in a study and whether 13 recommended elements of informed consent actually occurred. Among 1303 respondents, 265 (20.3%) reported that they had been invited to participate in a study, and 191 (72.1%) accepted. While the majority of potential participants were fully informed about practical issues related to the study (e.g. what their participation would consist in), <50% were informed of possible risks or benefits, and only 20% about the origin of the study funds. Only 60% reported satisfactory answers to items assessing the overall information process (e.g. explanations were easy to understand). Older and sicker patients reported lower levels of conformity with informed consent procedures, as did patients who refused to participate in a study. Our results confirm that informed consent procedures fail to meet standards for many patients. In particular, consent information should be adapted to the needs of older and sicker patients. Improving the quality of informed consent may increase patients' participation in clinical research.

Please mind the gap—about equity and access to care in oncology

Barriers to research participation by racial and ethnic minority group members are multi-factorial, stem from historical social injustices and occur at participant, research team, and research process levels. The informed consent procedure is a key component of the research process and represents an opportunity to address these barriers. This manuscript describes the development of the Strengthening Translational Research in Diverse Enrollment (STRIDE) intervention, which aims to improve research participation by individuals from underrepresented groups. We used a community-engaged approach to develop an integrated, culturally, and literacy-sensitive, multi-component intervention that addresses barriers to research participation during the informed consent process. This approach involved having Community Investigators participate in intervention development activities and using community engagement studios and other methods to get feedback from community members on intervention components. The STRIDE intervention has three components: a simulation-based training program directed toward clinical study research assistants that emphasizes cultural competency and communication skills for assisting in the informed consent process, an electronic consent (eConsent) framework designed to improve health-related research material comprehension and relevance, and a "storytelling" intervention in which prior research participants from diverse backgrounds share their experiences delivered via video vignettes during the consent process. The community engaged development approach resulted in a multi-component intervention that addresses known barriers to research participation and can be integrated into the consent process of research studies. Results of an ongoing study will determine its effectiveness at increasing diversity among research participants.

AN INNOVATIVE APPROACH TO ENHANCE THE INFORMED CONSENT PROCESS FOR PEOPLE WITH DEMENTIA: THE ENSURE PROJECT

In addition to general barriers of information exchange and communication in intersectoral healthcare processes, the healthcare process of dementia patients has unique requirements regarding the communication and information exchange of the various healthcare professionals and non-professional caregivers, such as relatives or their legal caregivers. We conduct a process analysis to determine the status quo of such healthcare processes in the region of Darmstadt, Germany and elicit existing gaps in the information and communication exchange. We identify key processes by performing a document analysis and conducting interviews with seven different healthcare professionals. The results of a weak point analysis based on advanced event driven process chains (EPC) point out 32 information and communication gaps summarized in four categories: &amp;ldquo;information exchange&amp;rdquo;, &amp;ldquo;information transfer&amp;rdquo; &amp;ldquo;information provision&amp;rdquo; and &amp;ldquo;activity impulse&amp;rdquo;. Our results show further opportunities regarding the support of caring relatives and primary care physicians.

Integrated primary care research in the Patient-Centered Medical Home (PCMH) presents unique challenges not found in other behavioral health or medical care settings. The PCMH service delivery principles and supporting systems are designed to maximize quality and outcomes of care while controlling health care costs. Conducting ethical research in this setting requires following processes and procedures established by federal statutes that threaten to disrupt this delicate balance. In addition, clinical researchers must consider the ethical requirements and guidance from their respective professional organizations to ensure they adhere to guidelines for conducting ethical research and practice. Given the setting, there is a high likelihood researchers from various disciplines who may adhere to different ethical standards will be collaborating. We present a case example of an ethical concern to illustrate the tension between research and clinical care, discuss federal and professional research guidelines, and propose recommendations for balancing ethical and effective research and clinical care in integrated primary care research in the PCMH.

Informed Consent in Radiation Oncology

‘Individualized medicine’ is an emerging paradigm in clinical life science research. We conducted a socio-empirical interview study in a leading German clinical research group, aiming at implementing ‘individualized medicine’ of colorectal cancer. The goal was to investigate moral and social issues related to physician–patient interaction and clinical care, and to identify the points raised, supported and rejected by the physicians and researchers. Up to now there has been only limited insight into how experts dedicated to individualized medicine view its problems. Interviews with researchers and clinicians ( n= 19) were based on a prestructured questionnaire. The content analysis revealed a broad spectrum of opinions. Major findings were (a) disappointments with the limits of the current therapy regimen and clinical practice; (b) problematic impacts on physician–patient relationship; and (c) an informed consent procedure which is mainly based on paternalistic assumptions. According to our analysis, major problems will be uncertainties related to the biomarker's sensitivity and specificity, and the identification of ‘non-responders’. However, the findings also indicate that experts expect evidence-based medicine to replace decisions based on gut feeling or hierarchical structures.

620 Creating a culture of clinical research in the clinic: Integrating clinical trials into the care of patients with lupus

Same-Day Consent for Regional Anesthesia Clinical Research Trials: It's About Time.

Workshop Proceedings: Informed Consent in Biobanking–from the Key Barriers, Challenges, and Perceptions to Digital Innovations

In this article we report on a study undertaken with 255 teachers working with learners with visual impairments. The focus of our discussion is teachers’ implementation of inclusive education policies with learners with visual impairments in full-service schools in South Africa. We foreground the ways in which the teacher participants relied on teacher collaborations to overcome some of the challenges they faced as a result of limited resource provisions in schools in this country. We implemented an instrumental case study design and followed the approach of participatory reflection and action (PRA). The sample included teachers (n = 255) from seven full-service and ten special schools from five provinces in South Africa. In addition, 50 expert stakeholders who work in the field of visual impairment were involved. For data generation and documentation, we utilised PRA-based workshops, the observation-as-context-of-interaction method, audio-visual techniques, field notes, and reflective journals. The findings of our research confirm that full-service schools face distinct challenges regarding limited resources as well as teachers that are inexperienced to accommodate learners with visual impairments. Even though the teachers in our study were initially reluctant to implement inclusive education practices, their collaboration with fellow teachers and other informed stakeholders enabled them to address some of the challenges they experienced and implement inclusive practices. They subsequently formed a team and learnt from one another to facilitate positive changes through the implementation of inclusive practices, thereby following a socio-ecological approach to inclusive practices in full-service schools in South Africa.

Effect of a multimedia-assisted informed consent procedure on the information gain, satisfaction, and anxiety of cataract surgery patients

Towards a standardized informed consent procedure for live donor nephrectomy: What do surgeons tell their donors?