7T Consent Script¶

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What this page tells you

Word-for-word script for consenting a participant to the 7T MRI study (818407), with trainer notes and red flags for each of ten steps: purpose, 80-minute scan, risks, voluntary participation, confidentiality, $50 compensation with W-9 and C-2, IRB understanding check, signing.

Epilepsy & Tumor Imaging Biomarkers on 7T MRI
This version includes trainer notes, red flags, and best practices so new study team understands not just the words, but the workflow and expectations.

What study team says: “Hi, my name is [Name], and I’m part of the research team for the Epilepsy and Tumor Imaging Biomarkers on 7T MRI study. Before we begin anything today, I want to walk you through the consent form. This helps you understand the study and decide if you’d like to participate.”
“You’re in control of this conversation. Please stop me anytime if something is unclear.”

Trainer notes:
- Set a calm tone.
- Make clear that consent is a conversation, not a signature task.
- Avoid rushing — especially with patients who may be anxious or fatigued.
Red flags:
- Participant seems confused, distracted, or pressured.
- Participant believes this is part of clinical care.

2. Explain the Study Purpose¶

Study team says: “This study uses a specialized MRI scanner called a 7‑Tesla MRI. It’s stronger than the MRI scanners used in routine care. We’re using it to better understand imaging biomarkers in people with epilepsy or brain tumors, and to compare those images with scans from healthy volunteers.”

Trainer notes:
- Keep it simple — avoid technical jargon.
- Emphasize research, not treatment.
Red flags:
- Participant thinks the scan will diagnose or treat their condition.

3. Describe What Will Happen Today¶

Study team says: “If you choose to participate, here’s what will happen:

You’ll complete a safety screening form.
You’ll have a 7T MRI scan, which takes about 80 mins.
You’ll lie still while we take detailed pictures of your brain.
Depending on whether you’re a patient or healthy volunteer, the imaging sequences may differ.”
“You won’t receive direct medical benefit, but your participation helps us improve future imaging approaches.”
Trainer notes:
- Be specific about time commitment.
- Clarify that the scan is research-only.
Red flags:
- Participant expects clinical results or feedback.

4. Review Risks & Discomforts¶

Study team says: “The risks are similar to a standard MRI:

The scanner is loud — we’ll give you ear protection.
The space can feel tight.
If you have epilepsy, there is a small chance of a seizure during the scan. A clinician is present for patient scans, and we have a clear safety plan.”
“There is no radiation involved.”
Trainer notes:
- Pause here — let participants absorb the information.
- For epilepsy patients, confirm they understand seizure protocol.
Red flags:
- Participant expresses fear but feels pressured to continue.

5. Emphasize Voluntary Participation¶

Study team says: “Participation is completely voluntary. Choosing not to participate will not affect your care or your relationship with Penn Medicine.”
“You can stop at any time — even during the scan — without any penalty.”

Trainer notes:
- This is one of the most important parts.
- Say it slowly and clearly.
Red flags:
- Participant believes their doctor wants them to do this.

6. Explain Confidentiality¶

Study team says: “We protect your information as required by Penn Medicine and federal regulations. Your data will be stored securely and used only for approved research.”
“Your name will not appear in publications.”

Trainer notes:
- Keep this simple — avoid technical data language.

7. Compensation (If Applicable)¶

Study team says: “You’ll receive a $50 prepaid credit card for completing today’s visit. To process this, we’ll ask you to fill out a W‑9 and a C‑2 voucher.”

Trainer notes:
- Explain why the W‑9 is required — many participants ask.

8. Understanding Check (Required by IRB)¶

Study team says: “Before we move on, I want to make sure everything is clear. Can you tell me, in your own words, what the study is about and what you’ll be doing today?”

Trainer notes:
- This is essential — not optional.
- Listen for misunderstandings and correct them gently.
Red flags:
- Participant cannot explain the study back to you.

Study team says: “If you feel comfortable participating, we’ll review the signature page together. Please take your time. You’ll receive a copy for your records.”

Trainer notes:
- Double-check all signatures and dates.
- Ensure study team signs and dates at the same time as participant.

10. Closing the Encounter¶

Study team says: “Thank you for taking the time to go through this. Your participation helps us advance imaging research for epilepsy and brain tumors.”

Trainer notes:
- Offer to answer additional questions.
- Transition smoothly into the screening and pre-scan workflow.