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Keyword: informed consent

Best practices and new models of health literacy for informed consent: review of the impact of informed consent regulations on health literate communications – 2014 [US]

This paper (81 pages), from Linda Aldoory et al, was commissioned by the Institute of Medicine’s Roundtable on Health Literacy. This paper focuses on best practices in communicating with patients about informed consent. The authors collected, filtered, and analysed over 120 research studies, government reports, videos, toolkits, and presentations, and then interviewed eight experts in informed consent. The research emphasised written communication and recommended reducing complex and confusing wording of documents. A combination of written, verbal, and some multimedia formats was generally more effective in adhering to federal requirements while gaining participant understanding. This report summarises the themes found in the literature review and lessons learned from interviewees, and then lists best practice suggestions.

http://www.iom.edu/Activities/PublicHealth/HealthLiteracy/~/media/Files/Activity%20Files/PublicHealth/HealthLiteracy/Commissioned-Papers/Informed_Consent_HealthLit.pdf

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How to Achieve Informed Consent for Research from Spanish-Speaking Individuals with Low Literacy: A Qualitative Report

This article by Cortes et al (2010) present findings from a qualitative study conducted with Spanish-speaking individuals with low-literacy designed to refine the Agency for Healthcare Research and Quality's Informed Consent and Authorization Toolkit for Minimal Risk Research. Findings from this study indicate that familiarity with providing informed consent and authorization for research or the experience of being a research participant appear to play key roles in an individual's ability to understand the consent and authorization process.

http://www.tandfonline.com/doi/abs/10.1080/10810730.2010.499990

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The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research

The Agency for Healthcare Research and Quality (AHRQ) has developed the Informed Consent and Authorization Toolkit for Minimal Risk Research to facilitate the process of obtaining informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization from potential research subjects. This toolkit contains information for people responsible for ensuring that potential research subjects are informed in a manner that is consistent with medical ethics and regulatory guidelines. Download as a PDF (300KB).

http://www.ahrq.gov/fund/informedconsent/

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A Practical Guide to Informed Consent

This publication focuses on ways to improve full informed consent—both the process and the written forms—as it is employed in everyday (i.e., NOT research) patient care settings. Developed by Temple University, the publication aims to improve the patient-physician communication that is so crucial in creating truly informed patient decision-making about major treatment options, with a focus on health literacy and its barriers.

http://www.templehealth.org/ICTOOLKIT/html/ictoolkitpage1.html

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Communicating Risks and Benefits: An Evidence-Based User’s Guide

Effective risk communication is essential to the well-being of any organization and those people who depend on it. Ineffective communication can cost lives, money, and reputations. Communicating Risks and Benefits: An Evidence-Based User's Guide provides the scientific foundations for effective communication. Developed by the FDA in the US. The full text of the publication is available to download at no cost as a PDF at the URL, or by clicking on the book image.

http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm268078.htm

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A Conversation on Cultural Competence with Cindy Brach, Senior Health Policy Researcher, AHRQ

This dialogue with Cindy Brach discusses the importance of health literacy initiatives being recognised and implemented alongside cultural competence in interventions. Brach focuses in this case on interactions of minorities in the health system, and barriers that can be overcome using a culturally competent and health literacy approach.

http://www.innovations.ahrq.gov/content.aspx?id=3187

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Health Literacy and Cancer Communication

This article from Davis et al. provides insight into the complex array of difficulties patients with low health literacy encounter in cancer screening and in understanding symptoms of cancer.

http://onlinelibrary.wiley.com/doi/10.3322/canjclin.52.3.134/pdf

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Simple Language for Assent Forms

This article from Lowenhaupt illustrates the use of simple or Plain English within forms to gain assent and understanding from children (and parents). Principles are well demostrated; this is a useful resource.

http://www.firstclinical.com/journal/2011/1102_Assent.pdf

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How Accurate is Patients’ Anatomical Knowledge: a Cross-Sectional, Questionnaire Study of Six patient groups and a General Public Sample

This article from Weinman et al. investigates levels of anatomical knowledge of different patinet groups and general public. The research found that many patients and general public do now know the location of key body organs, even those in which their medical problem is located.

http://www.biomedcentral.com/content/pdf/1471-2296-10-43.pdf

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PRISM Readability Toolkit

This comprehensive toolkit (81 pages) is an initiative by Group Health and provides information and recommendations to improve the readability of health material; an includes processes to create consent forms in plain language.

http://www.grouphealthresearch.org/capabilities/readability/ghchs_readability_toolkit.pdf

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