||Assuring informed consent for
research participants is a very important practical and ethical
imperative. It is a clear mandate of the social work Code of
Ethics. Many materials and resources on informed consent can be found
online. A glossary
of terms is offered by NIH.
The US Department of Health and Human Services is the federal agency responsible for developing research guidelines relevant to social work and many other fields. The DHHS Office for Human Research Protections offers policy guidelines. This is a fine staring point for learning about informed consent.
A comprehensive overview I created for teaching purposes at Smith College School for Social Work is available here online. It is copyrighted, though it draws on federal documents, because the material discussing social work issues (diversity, multicultural issues) and surveys is new.
The origins of recent informed consent thinking and policies go back to the post-war Nurenberg trials. The 1979 Belmont Report on Ethical Principles and Guidelines for the Protection of Human Subjects of Research is a detailed policy statement.
The Code of Federal Regulations, Title 45 (Public Welfare), Part 46 details the federal regulations for protection of human subjects. The statutory basis for these regulations is also available. A flow chart or decision tree to determine if these regulations apply is also available.
The DHHS Office for Human Research Protections offers a terrific IRB Guidebook.
The DHHSl Office for Protection from Research Risks offers useful Tips for preparing human subjects review forms
An informed consent checklist of issues identified in the regulations is available to help you review your own work. This is very helpful!!
Information about obtaining consent from non-English speakers is also provided.
Informed consent must be obtained prospectively (that is, before you collect the data) in most circumstances. Information on the few exceptions is detailed here, along with the rationale for the regulations.
An online training course for reviewers is offered by NIH.
The University of California Davis offers a human subjects review/informed consent glossary.
The University of Iowa offers an Investigator's
Guide to HSR.
Scope and Applicability The DHHS regulations cover
institutions with federal funding, including research not specifically
funded by the federal government. Details
are available here.
Standards for Federally constituted Institutional Review Boards
The DHHS Office for Human Research Protections has complete Procedures
for Registering Institutional Review Boards and Filing Federal-wide
Assurances of Protection for Human Subjects
The IRB Guidebook also offers information of IRB standards