The Revised Common Rule requires all clinical trials to post an unsigned consent form on a publicly available website. The Revised Common Rule is in effect for studies approved on or after January 21, ...

The sample consent forms are being provided to you as a tool. They contain all of the required elements of an acceptable consent form. While we strongly recommend that you follow the format that we ...

The use of deception or incomplete disclosure limits the subject's ability to make a fully informed decision of whether to participate in the research — one of the essential ethical concerns in human ...

Informed consent is one of the primary requirements of research involving human participants. It is important to remember that informed consent is an ongoing process, not a document or single event.

Although exempt research is exempt from some of the federal regulations, in most cases of interaction with participants, a consent process is indicated. It’s important to understand that even though ...

Ethicists have suggested that written consent forms encourage participants in phase 1 cancer trials to expect benefit from the experimental agent and to overlook serious risks. Of 272 forms, 268 ...

Informed consent is a process that’s required for most medical procedures. However, there’s often confusion about what informed consent is, what it means, and when it’s needed. In a healthcare setting ...

The language used in consent forms for people volunteering to take part in medical experiments is too difficult for most people to understand, a survey has found. Legally and ethically, participants ...

These files may be useful to you if you are submitting a proposal to the IRB or developing written material for your project. Unless otherwise indicated, all files are Microsoft Word documents (.docx) ...

The European Union’s General Data Protection Regulation requires every organization that collects sensitive personal data from those residing in the EU to ask for clear and specific consent before ...