Falls Church, VA (PRWEB)
September 27, 2017
Informed Consent for Clinical Trials, 2017
**An FDAnews Book**
A lot can go wrong with informed consent documents and things are becoming more complicated.
Clinical Trials sponsors already had enough to do thinking about the most common errors including:
Lack of proper signatures and dates
- Non-English speakers signing English consent forms
- Lack of signatures from legally authorized representatives
- Forged signatures
- Consent obtained from subjects who lacked the capacity to give consent
- Inadequate disclosure of risks associated with a trial protocol
- Consent forms used without IRB approval
And now a new rule is about to go into effect.
On January 19, 2018 revisions to the Protection of Human Subjects Regulations, known as the Common Rule, will go into effect. If manufacturers conduct clinical research under the jurisdiction of the FDA or one of 15 other federal agencies, they need to know exactly what that means.
Sponsors have to navigate new requirements for the content and structure of the information they give prospective research subjects. They will also be required to publicly post an IRB-approved version of the consent form on a new federal website.
Researchers have to be ready for those new things and the deadline is just a few months away.
FDAnews’ new edition of Informed Consent for Clinical Trials explains the changes that are coming and gives clinical trial operators all the resources they need to comply with informed consent rules all in one place
Who Will Benefit:
- Site managers
- Trial sponsors
- Principle investigators