Informed Consent [BOOK CHAPTER]
Sarah A. Markham, Dominick Gadaleta
Quality in Obesity Treatment, 16 October 2019; pp 353-364
Abstract
Informed consent is a complex process that has evolved over time, both in medical and legal practice. Rooted in the same ethical tenets as medicine, informed consent exists to protect both patients and physicians. It has evolved over time from a “reasonable physician” standard to a “reasonable patient” standard, reflecting the change in medicine from paternalism to patient autonomy. The current trend is toward “shared decision-making,” which involves an open discussion between the patient and his/her surgeon about the patient’s diagnosis, the natural history of the disease without treatment, various treatment options with their risks and benefits, and the expected outcomes. In this model, the surgeon and patient collaborate to select the intervention which best aligns with the patient’s goals and values. This is especially vital in the field of bariatric surgery, where the long-term outcome is predominately patient-driven. Patients pursuing weight loss surgery for an “easy fix” to obesity will be severely disappointed after surgery and may not recognize complications if they have not had comprehensive discussions with their surgeons. Research has shown that many patients continue to lack a clear understanding after informed consent, which can be improved by multimedia consent processes and repeat-back.

Production of Evidence-Based Informed Consent (EBIC) With Meaning Equivalence Reusable Learning Objects (MERLO): An Application on the Clinical Setting
Myrtha Elvia Reyna Vargas, Wendy Lou, Ron S. Kenett
Pedagogy for Conceptual Thinking and Meaning Equivalence: Emerging Research and Opportunities, November 2019; Chapter 5 pp 86-116
Abstract
Apparently, during an informed consent, patients remember little of the information given and their comprehension level is often overestimated by physicians. This study measures level of understanding of informed consent for elective cesarean surgery using an evidence-based informed consent (EBIC) model based on six MERLO assessments. MERLO recognition and production scores and follow-up interviews of 50 patients and their partners were recorded. Statistical comparison of scores within couples was performed by weighted kappa agreement, t-tests, and Ward’s hierarchical clustering. Recognition score means were high for patients and partners with low standard deviation (SD), while production scores means were lower with higher SD. Clustering analysis showed that only 70% (35/50) of couples were assigned to the same cluster and t-test yields significant difference of scores within couple. Kappa yields moderate agreement levels on all items except for items D and C, which are lower. Follow-up interviews show that participants consider MERLO assessments to be helpful in improving comprehension.

Can a ‘consent to contact’ community help research teams overcome barriers to recruitment? The development and impact of the ‘Research for the Future’ community
Debate
Katherine Grady, Martin Gibson, Peter Bower
BMC Medical Research Methodology, 22 October 2019; 19(195)
Open Access
Abstract
Background
Recruitment to health research remains a major challenge. Innovation is required to meet policy commitments to help patients take part in health research. One innovation that may help meet those policy goals is the development of ‘consent to contact’ systems, where people give generic consent to be contacted about research opportunities. Despite their potential, there are few empirical assessments of different ways of recruiting patients to such communities, or of the value of such communities to local research teams.
Main text
We describe the development of the ‘Research for the Future‘consent to contact community, outline the recruitment of patients to the community, and present data on their participation in research.
Discussion
Over 5000 people have been registered across 3 clinical areas. A range of recruitment strategies have been used, including direct recruitment by clinicians, postal invitations from primary care, and social media. In a 1 year period (2016–2017), the community provided over 1500 participants for a variety of research projects. Feedback from research teams has generally been positive.
Summary
The ‘Research for the Future‘consent to contact community has proven feasible and useful for local research teams. Further evaluation is needed to assess the cost-effectiveness of different recruitment strategies, explore patient and researcher experience of its advantages and disadvantages, and explore how the community can be more reflective of the wider population.

Informed Consent From Adults
Martyn Hammersley
SAGE Research Methods Foundations, 9 September 2019
Excerpt
Informed consent is widely regarded as a highly desirable, or even essential, basis for people’s participation in social research projects. This is true whether the participants are adults or children. It involves people deciding whether or not they are willing to participate, researchers giving them all the relevant information required to make a sound decision, and allowing them to withdraw from participation at any time. In the case of children, and some categories of “vulnerable” adults (e.g., those with learning difficulties), there can be challenging issues about how, and from whom, informed consent should be sought. However, there are also some more general questions about whether obtaining informed consent is always required, what it entails, and what function it serves. This entry focuses specifically on …