Notice of Privacy Practices
A federal regulation, known as the “Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule”, requires that we provide detailed notice in writing of our privacy practices. This Notice of Privacy Practices describes how we may use and disclose health information about our research participants. It also describes your rights to access and control your protected health information. The HIPAA Privacy Rule requires that we protect the privacy of health information that identifies you, or where there is a reasonable basis to believe the information can be used to identify you.
For purposes of a research study, the study doctor and the study center will use medical information (Protected Health Information or “PHI”) collected or created as part of the study. PHI includes, but is not limited to: age; address; e-mail address; telephone and fax numbers; social security numbers; and your medical records, which may include mental health records and test results.
We are required by law to:
Maintain the privacy of protected health information about you. Give you this notice of our legal duties and privacy practices with respect to protected health information; and Comply with the terms of our Notice of Privacy Practices that is currently in effect.
How We May Use and Disclose Your Protected Health Information
When you sign consent to participate in a research study, you agree to allow the study doctor and the study center to obtain and use any of your records that they request for study purposes from your regular doctor and/or your other health care providers. The study doctor and study center will also gather information regarding your past and present medical history and medication usage to determine if you qualify to participate in the study. Tests and ECGs may also be performed as part of your participation in a study. Additionally, the study doctor and study center will compile data regarding your response to the treatment under investigation. The study doctor and the study center may use and share this information with the parties described below.
Unless required by law, the study doctor and the study center will share your records only with;
The study staff and other professionals involved with the study
The study sponsor and people who work for or with them
The U.S. Food and Drug Administration (FDA) and governmental agencies in the U.S. and in other countries where the study drug may be considered for approval
An Institutional Review Board
The purpose for using and sharing your records with these parties is to perform the study, to make sure the study data is correct, to check participant safety, and for other uses allowed by law.
There are national and state laws that require the study doctor to protect the privacy of your records. Although efforts will be made to protect the privacy of your records, absolute privacy cannot be guaranteed because of the need to share information as described above. Your records may be shared with parties who are not required to protect the privacy of your records.
Information about your participation in this study may be used in books, magazines, journals, or meetings. If this happens, your name or other information that could be used to personally identify you will not be used.
If you get hurt or sick possibly because of being in the study, and you seek medical treatment:
The study doctor and sponsor may obtain study-related records from your other health care providers to learn more about the effects of the study and your condition. Information about this study might be given to your health care payer for the purpose of resolving your claim.
The sponsor might give information that identifies you to its insurance carrier or other third parties for the purpose of resolving your insurance claim.
We may use and/or disclose your PHI to contact you to remind you that you have an appointment with us. We may also use and/or disclose PHI to provide you with information about treatment alternatives or health-related benefits and services that may be of interest to you. For example, you name and address may be used to send you information from our office regarding the services we offer or about other research studies. These may be sent to you through the USPS with our practice information on the envelope /postcard. You name will also be placed in our confidential database to be searched for future studies.
During the study, you may not see your study records. You will be allowed to see your records once the study is over.
You have the right to cancel your permission to use and share your records at any time by giving written notice to the study doctor. If you cancel your permission, the study doctor and the study center will no longer use or share your records, unless it is necessary to do so to preserve the scientific integrity of the study. Canceling your permission will not affect the use and sharing of your records that occurred before you cancelled your permission.
Unless you give your permission to use and share your records, or if you cancel your permission later, you will not be able to participate in the study, and you will not receive any treatment provided as part of the study. Unless and until you cancel your permission to use and share your records, your consent to share your information will remain valid as specified in the consent form.
Drug development begins with preclinical or laboratory research which can involve years of testing on human cells and in animals. If the information gathered looks promising, the pharmaceutical company sends the data to the FDA and requests permission for human subjects testing. This testing is comprised of Phases I-IV and takes 2 to 10 years to complete. Clinvest conducts Phase II-IV studies.
Phase I studies are conducted in a small number of “normal, healthy” volunteers who stay at a research facility for one to several days. The purpose of these first studies is to evaluate drug safety and how the drug is processed by the human body. These studies also evaluate side effects that might occur as drug dose is increased. Approximately 70% of investigational drugs pass this testing phase.
Phase II studies are conducted in people who suffer from the disorder for which a drug is being developed. The drug’s efficacy, safety, and side effects are evaluated during this phase. The investigational drug is compared to a placebo or a standard treatment. Often, these studies are “blinded” so that neither the researchers nor the participants know who has been randomly assigned to receive the investigational drug. The second testing phase involves up to several hundred participants and lasts from several months to two years. Approximately 30% of investigational drugs reach Phase III testing.
Phase III studies are also “blinded” and involve several hundred to several thousand participants randomly selected to receive the study drug, placebo or a standard treatment. These studies involve many research sites, and may be conducted worldwide and provide more thorough information regarding the drug’s efficacy, safety and side effects. During this phase, information compiled from all the studies is presented to the FDA in hopes the drug will receive approval. The number of drugs that successfully complete this testing phase ranges from 70‒90%.
Phase I-III studies are well-controlled and closely monitored.
Phase IV studies are commonly referred to as Post Marketing Trials because they are conducted after a drug has received FDA approval. Drugs are further scrutinized for long-term effectiveness and safety. Additional objectives may include evaluating the drug for use in other circumstances, varying doses of the drug, and its cost-effectiveness or impact on participants’ quality of life.
- What personally identifiable information is collected from you through the web site, how it is used and with whom it may be shared.
- What choices are available to you regarding the use of your data.
- The security procedures in place to protect the misuse of your information.
- How you can correct any inaccuracies in the information.
Information Collection, Use, and Sharing
We are the sole owners of the information collected on this site. We only have access to/collect information that you voluntarily give us via email or other direct contact from you. We will not sell or rent this information to anyone.
We will use your information to respond to you, regarding the reason you contacted us. We will not share your information with any third party outside of our organization, other than as necessary to fulfill your request, e.g. to ship an order.
We use “cookies” on this site. A cookie is a piece of data stored on a site visitor’s hard drive to help us improve your access to our site and identify repeat visitors to our site. For instance, when we use a cookie to identify you, you would not have to log-in a password more than once, thereby saving time while on our site. Cookies can also enable us to track and target the interests of our users to enhance the experience on our site. Usage of a cookie is in no way linked to any personally identifiable information on our site.
We share aggregated demographic information with our partners and advertisers. This is not linked to any personal information that can identify any individual person.
We use an outside shipping company to ship orders, and a credit card processing company to bill users for goods and services. These companies do not retain, share, store or use personally identifiable information for any secondary purposes beyond filling your order.
We partner with another party to provide specific services. When the user signs up for these services, we will share names, or other contact information that is necessary for the third party to provide these services. These parties are not allowed to use personally identifiable information except for the purpose of providing these services.
This web site contains links to other sites. Please be aware that we are not responsible for the content or privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of any other site that collects personally identifiable information.
Your Access to and Control Over Information
You may opt out of any future contacts from us at any time. You can do the following at any time by contacting us via the email address or phone number given on our website:
- See what data we have about you, if any.
- Change/correct any data we have about you.
- Have us delete any data we have about you.
- Express any concern you have about our use of your data.
We take precautions to protect your information. When you submit sensitive information via the website, your information is protected both online and offline.
Wherever we collect sensitive information (such as credit card data), that information is encrypted and transmitted to us in a secure way. You can verify this by looking for a closed lock icon at the bottom of your web browser, or looking for “https” at the beginning of the address of the web page.
While we use encryption to protect sensitive information transmitted online, we also protect your information offline. Only employees who need the information to perform a specific job (for example, billing or customer service) are granted access to personally identifiable information. The computers/servers in which we store personally identifiable information are kept in a secure environment.