Participant-Centered Consent (PCC) Toolkit - exploring a visual approach to assisting the “informedness” part of informed consent for clinical studies.
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README.md

README.md

Participant-Centered Consent Toolkit

Included in this resource are 'Design Documents and Templates' as well as 'Icons and Animations' which support a visual approach to assisting the "informedness" part of informed consent for clinical studies.

It’s a set of tools, not a product.



Our clinical protocols are available on request. Because we do not wish to imply that one can simply download one of our protocols, adapt it, and proceed to start research on humans, we do not make them openly licensed or linked here. Contact John Wilbanks with requests for copies.


IRB Review

These tools are provided for information, and for reuse. However, remember that any informed consent document or interface should always be reviewed by an independent ethics board – usually called an IRB. Never, ever, ever begin collecting research data about people until you get approval by an IRB for your work. And don’t assume IRB approval is enough – you should also be finding and working with ethicists as you develop studies.

Seriously. It’s essential that you get someone outside your project to review your ethics. It’s good for you as well as your participants and your data users.


Disclaimer

The toolkit is provided by the copyright holders and contributors "as is" and any express or implied warranties, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose are disclaimed. In no event shall the copyright holder or contributors be liable for any direct, indirect, incidental, special, exemplary, or consequential damages (including, but not limited to, procurement of substitute goods or services; loss of use, data, or profits; or business interruption) however caused and on any theory of liability, whether in contract, strict liability, or tort (including negligence or otherwise) arising in any way out of the use of this toolkit, even if advised against the possibility of such damage.