Subject Initials and Subject ID #: _________ _________
Current version of consent: _________
Date consent was signed: _________ Time consent was signed: _________
Note: HIPAA Authorization is included as part of the Informed Consent Form for this study. This Informed Consent Process Note also serves as documentation of HIPAA consent.
Person Obtaining Consent: Add initials to lines below to confirm that each item was addressed during the Informed Consent Process.
__Eligibility was reviewed prior to consent discussion and prospective subject was found to meet all inclusion/exclusion criteria prior to signing.
__Protocol was thoroughly explained to the prospective subject/LAR outlining the risks and benefits, alternate treatment and follow-up requirements of the study.
__Information was given in language understandable to the prospective subject/LAR.
__Prospective subject/LAR was given sufficient opportunity to consider whether or not to participate.
__Prospective subject/LAR was given an opportunity to ask questions about the protocol.
__Prospective subject/LAR was encouraged to take consent home to review and/or obtain family/friends input prior to signing.
__Prospective subject/LAR privacy was maintained.
__Opportunity was given for prospective subject/LAR to read the consent document before it was signed.
__No coercion or undue influence was used in the consent process.
__No research-related procedures were performed prior to obtaining informed consent.
__A copy of the signed consent was given to the subject/LAR.
__All signatures, dates and times were obtained.
__A copy of the consent was sent to Medical Records and the original was placed the subject’s research chart.
How was the informed consent process given? ____________________________________________________________________________
Describe the subject’s condition at the time of consent: ____________________________________________________________________________
Who was present during the Informed Consent process?
____________________________________________________________________________
Did the subject have any questions? Please list below along with any additional comments about the Informed Consent process._____________________________________________________________________________________________________________________________________________________________________________________________
Person Obtaining Consent (Signature) __________________________________ Date_______________________