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Surrogate Consent for Research

State & International Laws

Below are links to a select sampling of state and international laws or other legal resources on legally authorized representatives and surrogate consent for research. Not all such laws are listed. The list is provided for reference only. Some laws may have been amended or deleted since posting. Consult your local legal counsel for additional information.

California Health & Safety Code sec. 24178 ("Human Experimentation," "Surrogate Informed Consent") (2009)
Virginia Code Annotated sec. 32.1-162.18 ("Human Research," "Informed Consent") (2009)
Quebec (Canada) Civil Code (see Title 2, Chapter 1, Division 1, Article 21 (2009)
United Kingdom Statutory Instrument 2004 No. 1031, "Medicines for Human Use (Clinical Trials) Regulations 2004" (see Part 5, Schedule 1)
European Union Directive 2001/20/CE (Good clinical practice in the conduct of clinical trials on medicinal products for human use) (2001) (see Articles 2(j), 3(2) and particularly 5)

State and international laws or other legal resources on legally authorized representatives and surrogate consent for research may be added from time to time. Please feel free to suggest laws or other legal materials not listed here.

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CSS: This specification defines Cascading Style Sheets, level 2 (CSS2). CSS2 is a style sheet language that allows authors and users to attach style (e.g., fonts, spacing, and aural cues) to structured documents (e.g., HTML documents and XML applications). By separating the presentation style of documents from the content of documents, CSS2 simplifies Web authoring and site maintenance.
XHTML 1.1: This Recommendation defines a new XHTML document type that is based upon the module framework and modules defined in Modularization of XHTML [XHTMLMOD]. The purpose of this document type is to serve as the basis for future extended XHTML 'family' document types, and to provide a consistent, forward-looking document type cleanly separated from the deprecated, legacy functionality of HTML 4 [HTML4] that was brought forward into the XHTML 1.0 [XHTML1] document types. This document type is essentially a reformulation of XHTML 1.0 Strict using XHTML Modules. This means that many facilities available in other XHTML Family document types (e.g., XHTML Frames) are not available in this document type. These other facilities are available through modules defined in Modularization of XHTML, and document authors are free to define document types based upon XHTML 1.1 that use these facilities (see [XHTMLMOD] for information on creating new document types).
WAI-AAA: These guidelines explain how to make Web content accessible to people with disabilities. The guidelines are intended for all Web content developers (page authors and site designers) and for developers of authoring tools. The primary goal of these guidelines is to promote accessibility. However, following them will also make Web content more available to all users, whatever user agent they are using (e.g., desktop browser, voice browser, mobile phone, automobile-based personal computer, etc.) or constraints they may be operating under (e.g., noisy surroundings, under- or over-illuminated rooms, in a hands-free environment, etc.). Following these guidelines will also help people find information on the Web more quickly. These guidelines do not discourage content developers from using images, video, etc., but rather explain how to make multimedia content more accessible to a wide audience.

University of Texas Health Science Center at Tyler

Surrogate Consent for Research

State & International Laws