Option 1 | When obtaining informed consent (IC), the possibility of IFs is not explained at all to the participant. |
Option 2 | When obtaining IC, the participant is informed that “IFs may be discovered, but will not be explained even if they are found.” |
Option 3 | When obtaining IC, the participant is informed that “IFs may be discovered, and if the principal investigator (PI) considers them suspect, s/he will notify the participant. However, a specialist (radiologist) does not check the images.” |
Option 4 | When obtaining IC, the participant is informed that “if IFs are suspected, a specialist (radiologist) will be asked to check the images. If a genuine problem appears to exist, the PI will notify the participant.” The cost for specialist consultation is obtained from the PI’s research funds. |
Option 5 | When obtaining IC, the participant is informed that “a specialist (radiologist) will check all images to discover IFs. If a genuine problem appears to exist, the PI will notify the participant.” The cost for specialist consultation is obtained from the PI’s research funds. |
Option 6 | When obtaining IC, the participant is informed that “a clinical device with more precision than that used for research will be initially used to detect IFs. A specialist (radiologist) will check all images, and the PI will notify the participant when a firm diagnosis is established.” The costs for the device and specialist consultation are obtained from the PI’s research funds. |