The information may be given to the FDA. It may also be given to governmental agencies in other countries. This is done so the sponsor can receive marketing approval for new products resulting from the research. The information may also be used to meet the reporting requirements of governmental agencies.
The results of the research may be published in scientific journals or presented at medical meetings, but your identity will not be disclosed.
The information may be reviewed by WIRB®. WIRB is a group of people who perform independent review of research as required by regulations.
What if I decide not to give permission to use and give out my health information?
By signing this consent form, you are giving permission to use and give out the health information listed above from the pre-study screening for the purposes described above. If you refuse to give permission, you will not be able to be in this pre-study screening.
May I review or copy the information obtained from me or created about me?
You have the right to review and copy your health information.
May I withdraw or revoke (cancel) my permission?
Yes, however this authorization will not automatically expire. You may withdraw or take away your permission to use and disclose your health information at any time. You do this by sending written notice to Dr. Davidson. If you withdraw your permission, you will not be able to continue being in the pre-study screening and will not be able to participate in research studies at New Phase Research & Development.
When you withdraw your permission to continue with the pre-screening procedures, no new health information which might identify you will be gathered from that point. Information that has already been gathered will be destroyed once the written withdrawal notice is received.
Is my health information protected after it has been given to others?
If you give permission to give your identifiable health information to a person or business, the information may no longer be protected. There is a risk that your information will be released to others without your permission. New Phase Research & Development does not see or give out subject information to businesses or individuals without your written permission.
AUTHORIZATION
By signing this consent form, you have not given up any of your legal rights. You will receive a signed and dated copy of this authorization for your records.
CONSENT
I have read the information in this consent form (or it has been read to me). This pre-study screening and confidentiality information has been explained to me and I voluntarily agree to participate or allow my child to participate. I may refuse to participate or allow my child to participate and withdraw at any time without penalty and without loss of benefits to which I/my child is otherwise entitled. I was given an opportunity to ask questions, and they were answered to my satisfaction.
I authorize the use and disclosure of my (my child’s) health information to the parties listed in the authorization section of this consent for the purposes described above.
By signing this consent form, I have not given up any of my/my child’s legal rights.