Informed Consent. The nature, purpose and potential risk of the study as well as the action of the BL-1040 myocardial implant will be explained to all patients both verbally and in writing. They will be given adequate time to consider the study before signing the consent form. Their questions will be actively encouraged. They will be informed that they may withdraw from the study at any time. This information is documented in the protocol and participants in the study will sign a consent form confirming that they have read and understood it; no study activities will take place until the consent form has been signed. They will also be given a Patient Information Sheet and copy of the consent form.
Appears in 7 contracts
Samples: License and Commercialization Agreement (Bellerophon Therapeutics, Inc.), License and Commercialization Agreement (Bellerophon Therapeutics LLC), License and Commercialization Agreement (Bellerophon Therapeutics LLC)