Get SOP I-A-8: Review Of Investigator Consent Forms - University Of ... - Ecohsr Pitt

Introduction. Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention.

The entire consent process must include an impartial witness to the oral presentation. The IRB-approved English version of the consent form must be signed by the individual authorized by the IRB to obtain consent and signed by the impartial witness to the consent process.

The informed consent must describe explicitly the following information: The research nature of the study. The reasonable foreseeable risks and discomfort. The potential benefits and alternatives.

Generally, the IRB requires consent to be documented by a written consent form that includes all the required elements, and all appropriate optional elements, approved by the IRB prior to use. An IRB approved consent document will contain the date of IRB approval.

How to write a consent form: A step-by-step guide Step 1: Title and introduction. ... Step 2: Description of the activity. ... Step 3: Risks and benefits. ... Step 4: Confidentiality and data handling. ... Step 5: Voluntary participation and withdrawal. ... Step 6: Consent statement. ... Step 7: Signature and date. ... Step 8: Contact information.

Informed consent from the subject and/or his legally authorized representative must be obtained prior to initiating any research activities, including screening procedures unless the IRB grants a waiver to do otherwise.

Informed consent is documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of consent. A copy of the signed and dated consent form must be given to the person signing the form.

Informed consent may not include language that: the research subject is made to ignore or appear to ignore any of the research subject's legal rights, releases or appears to release the investigator, the sponsor, the institution, or its agents from their liability for negligence.