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 ...

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 ...

The Bureau of Labor and Industries issued the final rules regarding the changes to the manufacturing overtime laws on December 27, 2017. The rules became effective on January 1, 2018. You can view the ...

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 ...

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 ...

The University IRB applies all Department of Health and Human Services (DHHS) requirements for informed consent to greater than minimal risk research: DHHS general requirements (at 45 CFR 46.116) (see ...

Why do we ask authors to provide a consent form signed by the patient before we will publish an image or case history in CMAJ that might lead to the patient’s identification? Consent is needed because ...