This section outlines the Federal (U.S.) Policy for the Protection of Human Subjects - specifically related to 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) 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.

Includes valuable tips for: 1) creating a clear informed consent form, and 2) drafting the content in plain language.

Core mission is to provide accessible, relevant, useful, high-quality educational resources, programs, and services that increase awareness and understanding of the clinical research process;

The MRCT Center develops tools and resources that support adopting and implementing health literacy principles at all points of the clinical research life cycle.

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 Safe Practices 2003 has been superseded twice: first by Safe Practices 2006 and more recently by Safe Practices 2009.

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.

This NIH resource provides points to consider and sample language for informed consent of research studies which plan to use digital health technologies (such s wearable devices, sensor technologies, etc.

The MRCT Center efforts have resulted in the implementation of improved clinical research practices, greater transparency, clearer communication, increased diversity and inclusion, and improved safety for research participants.

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.

From the University of Kentucky Office of Research Integrity. Provides helpful links to consent form glossaries.

Provides information, resources, and instructions for completing the IRB review process and other important research components.

Assists former, current, or prospective Human Research Participants in obtaining information or offering input regarding research and clinical trials. It provides contact information for thebUMB Research Subject Advocate and answers frequently asked questions.