INFORMED CONSENT

Informed consent is the idea that before someone participates in research, that they understand the risks, benefits, and consequences – and are capable of making an informed choice about whether or not to proceed. It’s the opposite of how we give consent every day on the web, or on phones. Clicking “ok” may create a digital contract, but it’s not informed consent. Indeed in many cases design is applied to make the consent as uninformed as possible.

Consent and medicine and health have a long history. Rather than attempt to rewrite that which is written so well elsewhere, instead we have curated a set of links for further reading and investigation.

The Stanford Encyclopedia of Philosophy has a powerful, detailed, and highly recommended overview of the entwining of informed consent and bioethics. For a physician-centric perspective on consent, we recommend the American Medical Association resource. Wikipedia’s article on the subject is also recommended.

Informed consent forms are typically reviewed by neutral Institutional Review Boards (IRBs) to make sure they are compliant with the goals of informed consent. The FDA’s guidance to IRBs is a good place to understand how an IRB evaluates and decides whether or not to approve clinical research.

Portable Legal Consent is part of a new approach to informed consent called “open consent” – laid out in a seminal article in Nature Reviews Genetics (April 2008) by Jeantine E. Lunshof, Ruth Chadwick, Daniel B. Vorhaus and George M. Church. Vorhaus also has a collection of posts about open consent worthy of reading.

Download our forms

If you’d like to read our forms, or examine our online process for informed consent, please feel free to download the documents below. They are free to copy for any purpose but are not licensed for derivative works – as these were approved word-for-word by Western Institutional Review Board, we cannot make changes or allow changes to them without submitting those changes in turn for approval. If you would like to make a derivative work (for example to use a modified version of PLC in your own clinical study) please email us at ctr@weconsent.us for additional permissions.

Consent form: PLC-CGR-Consent-WithOptions-WIRB Approved-Aug2012

Software “wizard”: PLC-CGR-Wizard-WithOptions-WIRB Approved-Aug2012