Examples from CHOP's short consent form
The Children's Hospital of Philadelphia (CHOP) IRB uses a short form consent process for the incidental enrollment of non-English speaking research subjects. The English version, found below, includes the name of the protocol, the investigator's name and contact info, and emergency contact info. The following elements are also included:
You are being invited to participate in a research study.
Before you agree, the investigator must explain a number of things to you. These things include:
- The purpose of the study.
- How many people will be enrolled in the study and how long the study will last.
- The tests, procedures, or treatments that will be done.
- Which tests, procedures or treatments are experimental.
- Any risks from the study. There may be risks from a study drug or device, or from a study test or procedure.
- If the study will benefit you in any way.
- How you will be told if there is new information about the study that could affect your decision to continue with the study.
- Other options you have rather than participating in the study.
- What to do if you are injured or hurt during the study.
- Whether there are any costs to you for participating.
- Whether you will be paid anything for participating.
- Reasons the investigator may halt your participation in the study.
- Who can see or use information about you from the study.
- How your information and privacy will be protected.
By signing this form, you are indicating that
- The information in the Summary Document as well as any additional information conveyed by the person obtaining consent was presented to the subject in a language preferred by and understandable to the subject; and
- The subject's questions were interpreted and the responses of the person obtaining consent were presented in a language preferred by and understandable to the subject.
- At the conclusion of the consent conference, the subject was asked in a language preferred by and understandable to the subject if s/he understood the information in the Summary Document as well as any additional information conveyed by the person obtaining consent (including responses to the subject's questions) and responded affirmatively.