Guidance on How to Document Written Informed Consent
October, 2003

 1.  Legally Effective Informed Consent

Each principal investigator of a JHM IRB approved study is responsible for assuring that the study team obtains the “legally effective informed consent of the subject or the subject’s legally authorized representative[‘LAR’].” The principal investigator, co-investigator, or consent designee identified in the protocol, must present to the potential participant the most recent JHM IRB approved, stamped, consent form.  Once the subject has read the form and the person responsible for the consent process is convinced that the subject understands the form and voluntarily agrees to its provisions, then the form should be signed and dated as provided below.

•  The participant, or the participant’s legally authorized representative (LAR), must sign and date the consent form.  In the case of minors, the child’s parent (or parents) or legal guardian must sign the form, unless the minor is authorized by law (and the JHM IRB approves the plan to obtain consent only from minors for the protocol) to consent on his or her own behalf.
  
• The participant and the person obtaining consent must sign the consent form BEFORE the study activity begins.  If the consent form is signed on the same day that the study activity begins, the research record should contain a note specifying that the signing preceded initiation of the study activity.
  
• The participant and the person obtaining consent must sign and date the consent form at the same time that the consent process is complete. This is a Hopkins institutional requirement.
  
•  The investigator or consent designee must give a copy of the signed and dated consent form to the subject or to the subject’s LAR.
  
• The original, signed and dated consent form, should be placed in the study records.

2.  Documentation of Consent in the Participant’s Medical Chart

•  The investigator must place a copy of the consent form in the subject’s medical chart, if there is one.  
  
•  If the consent form is signed the same day that the study activity beings, the medical chart should include a note stating that the signature preceded the start of the study activity.