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2018 Common Rule - §46.116 General Requirements for Informed Consent.
This section outlines the Federal (U.S.) Policy for the Protection of Human Subjects - specifically related to informed consent.
2018 Common Rule - §46.117 Documentation of informed consent.
This section outlines the Federal (U.S.) Policy for the Protection of Human Subjects - specifically related to the documentation needed for informed consent.
AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research
(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.
Clinical Trials and Older Adults
This easy-to-read booklet will help explain to volunteers for research studies what they need to know about the clinical trial process. Copies can be ordered from the National Institute on Aging.
Improving Patient Safety Through Informed Consent for Patients with Limited Health Literacy
The report contains a comprehensive synthesis of the key lessons learned by providers that adopted Safe Practice 10, as identified in Safe Practices 2003. Safe Practices 2003 has been superseded twice: first by Safe Practices 2006 and more recently by Safe Practices 2009.
Informed Consent and Health Literacy: Workshop Summary
The Institute of Medicine’s (IOM) Roundtable on Health Literacy convened this one-day public workshop featuring presentations and discussions that examine the implications of health literacy for informed consent for both research involving human subjects and treatment of patients.
NCCN Informed Consent Language (ICL) Database
The NCCN Informed Consent Language (ICL) database can assist researchers and clinical operations personnel with writing and amending informed consents for study participants. It contains standardized lay language descriptions of risks and events associated with clinical research.
Health Literacy and Informed Consent in the Literature