Obtaining Participant Consent

For most studies, the first stage of an interview with a participant is a consent stage. During the consent stage, two things must happen: the participant must read and sign a consent form (or the participant may refuse to sign the form), and their consent (or refusal to consent must be registered in Onyx. Onyx allows studies to obtain and register consent in two ways: manually (using a paper form) and electronically (using an on-screen form and an electronic signature pad).

In Onyx, obtaining consent is a stage of the participant interview and can be controlled in the same way as other stages. The general procedures for controlling an interview stage apply to the consent stage—see this figure\.

All Onyx interview stages, including the consent stage, are highly customizable. Each study writes the content of its consent form, and decides in which ways the participant will be allowed to read and sign the consent form.

This chapter covers the following topics:

• An electronic consent form and its important features
• Key concepts related to obtaining consent
• Procedures used to obtain consent

Electronic Consent Forms

In Onyx, an electronic consent form is a file in PDF format (Portable Document Format). An electronic consent form contains the text that was defined by the study and that the participant must agree to in order to participate. The form is displayed on-screen during the consent stage so that the participant can read and sign it. The example in this figure\ shows some of the features of electronic consent forms. A consent form can contain buttons that click or check to select options and fields that you must click in and complete. PDF files have many display options that you can access by clicking on the consent from with the right mouse button. For some pointers, see Tips for Viewing an Electronic Consent Form\.

Key Concepts

This section contains key concepts related to obtaining participant consent.

Manual vs. Electronic Consent

Studies can customize how consent is obtained: Electronic Consent — The participant reads the consent form on the workstation screen, then signs on an electronic signature pad, and the electronic signature is stored on the electronic consent form. Paper Consent — The participant reads and signs a paper consent form, and a staff member makes a selection in Onyx that indicates that the participant signed a paper consent form. A study can customize Onyx to accept consent both electronically and manually Studies customize the text in the consent form and the name of the consent stage in Onyx.

Electronic Signature Pad

An electronic device used to capture an electronic signature. See this figure\. An electronic signature is any legally recognized electronic means that indicates that a person agrees to the contents of an electronic message. In this case, the electronic message is an electronic consent form.

Pointers for Viewing an Electronic Consent Form

Before you do an electronic consent stage with a participant, try out the following techniques for viewing and completing the form:

If the form is too large to be displayed all at once:

Use the scrollbar and scroll arrows to move around the consent form. They are located to the right of the form—see this figure\.

• To move down through the form, click the scroll-down arrow one or more times.
• To move up through the form, click the scroll-up arrow one or more times.
• To move up and through the form, click and drag on the scrollbar.

If the text is too large or too small:

• To make the text bigger, press and hold the Ctrl key and click the + key (the plus key) once or several times.
• To make the text smaller, press the Ctrl key and click the - key (the minus key) once or several times.

If you want to reset the form (to its original size and with all fields cleared):

• Click the Previous button and then the Next button.

Procedures

This section contains procedures used to obtain participant consent.

Obtaining Consent Manually

If your study uses paper consent forms (or if it allows both paper and electronic consent forms), there will be a consent stage in your version of Onyx. This section explains how to record the result of the paper consent process in Onyx.

Prerequisites

• Instruct the participant to read through the form and to sign it when they are ready.
• While the participant is reading the form, ensure that the participant's Interview page is displayed. See Entering the Interview Page\.
• Check that the Status of the consent stage is Ready.

Procedure

You can start this procedure while the participant is reading the consent form so that you are ready to register whether or not they signed the consent form when they have finished reading.

1. Select the Start link for the consent stage. An action window for starting the consent stage may be displayed.
2. If an action window is displayed, complete it. The action window closes and the stage window is displayed.
3. Enter your password, scan the participant's barcode (or enter their Participant ID manually) and select the Continue button.
4. If your study accepts electronic and paper consents, you will be prompted to select one or the other for the current participant. See this figure\. Select paper consent.
   If your study accepts consent in electronic and manual format, you will be prompted to select a format

   

5. Select the language of the form given to the participant.
6. When Onyx prompts you to select whether or not the participant has read and signed the consent, check if the participant has signed the consent form and select the appropriate response in Onyx.
7. When you have responded to all questions, select the Administration button. The Administration dialog is displayed
8. Select the Finish button. An action window for finishing the consent stage is displayed.
9. Scan or enter the Participant ID manually, then select the Continue in the action window. The action window closes and the Interview window is visible again.

Obtaining Consent Electronically

If your study records consent electronically (or if it accepts both electronic and paper consent), there will be a consent stage in your version of Onyx. You obtain consent electronically as explained in this section.

Prerequisites

• An electronic signature pad\ must be be connected to the Onyx workstation.
• Ensure that the participant's Interview page is displayed. See Entering the Interview Page\.
• Check that the Status of the consent stage is Ready.

Procedure

1. Select the Start link for the consent stage. An action window for starting the consent stage may be displayed.
2. If an action window is displayed, complete it. The action window closes and the stage window is displayed.
3. Enter your password, scan the participant's barcode (or enter their Participant ID manually) and select the Continue button.
4. If your study accepts electronic and paper consents, you will be prompted to select one or the other for the current participant. See this figure\. Select electronic consent, and follow the rest of the on-screen directions.If your study is set up for electronic consent, the forms you will see on-screen will be similar to those shown in this figure\.
   Example of an electronic consent form

   

5. Since the participant is completing the form on-screen, go over the following points:
   • Show them how to scroll up and down through the form, and adjust the text size if necessary. See Tips for Viewing an Electronic Consent Form\.
   • Point out any buttons or fields where the participant must make a selection or an entry.
   • Advise them to read the form carefully and ask them to tell you when they are ready to sign it.
6. When the participant is ready to sign the form, show the participant how to use the electronic signature pad (if you have to co-sign the form, you can demonstrate by signing your name in the field provided):
   • Using the mouse, click in the signature field in the onscreen form.
   • Use the stylus (attached to the signature pad) to sign your name in the window on the signature pad. As you write, the signature is displayed simultaneously on the signature pad and on the screen of the Onyx workstation.
   • If the signature is well done, use the mouse to click Accept on the Onyx screen. If you don't select Accept within a few seconds, the signature will be cleared and you will have to sign again.
   • When you are ready, select the Accept button at the bottom of the consent form.
7. Ask the participant to sign on the signature pad.
8. Ensure the participant has responded to any remaining questions on-screen.
9. If there is an Accept button, ask the participant to select it. An Action window may be displayed next—if so, go to this figure\.
10. If the Administration button is displayed in the lower left corner of the page, select it. The Administration dialog is displayed.
11. If you don't want to complete the stage now, select the Cancel Consent button. An action window for cancelling consent is displayed.
12. If you want to complete the stage now, select the Finish button. An action window for finishing the consent stage is displayed.
13. Scan or enter the Participant ID manually, then select the Continue or Cancel button in the action window. The action window closes and the Interview window is visible again.

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