Achieve has a legal and ethical responsibility to safeguard patient privacy of all patients and protect the confidentiality of their health information and medical records. Your records may include information about your blood samples, physical examinations, medical history and any other data collected or reviewed during the course of a clinical research study – as described in the informed consent for that particular study. It may also include personal information such as social security number, date of birth, as well as medical records from your primary care physician. Health information that could be used to identify you is called “Protected Health Information” (PHI).
Patient privacy is fundamental here at Achieve. It is our policy that all employees and staff of Achieve respect and preserve the privacy and confidentiality of patient information.
By completing and signing a medical history form, your name and medical information will be placed in our internal database. Our database is accessible only to authorized employees and is checked periodically for patients who might meet specific study criteria. You may be called from time to time to see if you would be interested in participating in one of our studies. Participation is completely voluntary and you may request in writing, at any time, to have your name removed.
Under the Federal Privacy Rule, your PHI that is created or obtained during a research study cannot be “used” to conduct research or “disclosed” (given to anyone) for research purposes without your permission. This permission is called an “Authorization.” Therefore, you may not participate in any study unless you give your permission to use and disclose your PHI by signing an Authorization. By signing, you are agreeing to allow the study doctor and staff to use your PHI to conduct this study; to monitor your health status; possibly, to develop new tests, procedures and commercial products. Your PHI may be disclosed to the sponsor of the study and any agents, representatives or consultants working on behalf of the sponsor to conduct the study.
The study staff will assign a code number and/or letters to your records, which means that you will not ordinarily be identified in the records sent to the sponsor. However, the sponsor may look at your complete study records, which would identify you. In addition, the sponsor may visit the study site to oversee the conduct of the study and may review your PHI during these visits to make sure the information is correct. The sponsor will analyze and evaluate the PHI and may disclose it to the Food and Drug Administration. Additionally, the Institutional Review Board may have access to your PHI in relation to its responsibilities to protect human subjects.
Your identity will remain confidential and, except for the disclosures described above, will not be shared with others unless such disclosure is required by law.
Achieve patients have six fundamental rights under the Patient Privacy Rule:
- You have the right to request restrictions on uses and disclosures of PHI about you.
- You have the right to request different ways to communicate with you (e.g. at work only). We will make every effort to comply with your requests.
- You have the right to see and copy PHI about you (This may not be possible, in some instances, for example – while a clinical trial is still in process, however we will make every effort to comply with your request.)
- You have the right to request amendment of PHI about you.
- You have the right to a listing of disclosures we have made (applies to disclosures made after 4/14/03 and does not include any disclosures that you authorized).
- You have a right to a copy of this Notice.
If you think your patient privacy rights have been violated by us, or you want to complain to us about our patient privacy practices, you can contact the person listed below:
Ben Trevathan, CEO
860 Peachwood Drive
DeLand, FL 32720
You may also send a written complaint to the United States Secretary of the Department of Health and Human Services. If you file a complaint, we will not take any action against you or change our treatment of you in any way.
Achieve reserves the right to revise this notice in accordance with CFR Section 164.520. Patients have the right to request a copy of the revised notice.
Learn More About Clinical Trials:
What Types of Clinical Trials are Available?
Phase I Clinical Trials
Phase II Clinical Trials
Phase III Clinical Trials
Phase IV Clinical Trials
Glossary of Clinical Trial Terminology
Alabama Health Resources
Brief History of Clinical Trials
Find Clinical Trials