Research Study Privacy Notice

Effective Date of this Privacy Policy: April 20, 2018.

 

Participant Coordinator: PEGUS Research, Inc. (“PEGUS”, “we”, “our”)

 

Thank you for your interest in being a participant in the Study.  This Privacy Notice explains the types of personal information we expect to collect from Study participants and how we, PEGUS, and our partners involved with the Study will use that personal information.  If you have any questions or concerns regarding this Notice please discuss them with PEGUS.

 

How do we collect your personal information?

PEGUS assists research study sponsors in locating individuals interested in participating in research studies through a variety of media, including radio, newspaper, and television advertisements, telephone, direct mail and social media such as Facebook.  Our initial contact with you is often through one of our PEGUS Subject Screening Interviewers whom you may have spoken with on the telephone prior to the meeting with the Principal Investigator or other study staff.  We also collect your personal information when you provide it to the Principal Investigator or site study staff, Data Collection Interviewers, or study Nurses.  You may also provide information to us when you visit a study website and self-enter your personal information.  Generally, we obtain personal information about you by virtue of you providing us with such information.  The only personal information about you that we collect from third parties is information that you provide in an opt-in fashion.  For example, we do not have access to your medical records except in cases where we obtain permission from you to request those records or as part of a service to a medical professional from whom you have obtained services and with whom we have an appropriate data privacy agreement in place.

 

What kind of personal information do we collect?

Upon our first contact with you, we typically gather some basic information from you such as your full name, email address, mailing address, phone number, and demographic information (such as age and gender).  Per our standard procedures, our Subject Screening Interviewers would have explained generally the type of personal information we collect and what it will be used for.  Your meeting with the Principal Investigator or site study staff, interviews with our Data Collection Interviewers or study Nurses, will include gathering additional personal health information including, perhaps, medical information, ailments and/or injuries, medical conditions, concomitant medications, family history, and other inclusion/exclusion information related to the Study enrollment criteria as well as other demographic information such as race, ethnicity and educational level.

 

How does PEGUS use your personal information?

Your personal information will be accessed and used for purposes of coordinating your participation in the Study.  For example, one of our Data Collection Nurses may contact you one or more times during the Study to ask questions relating to your participation in the Study, how you have been feeling, and whether you are experiencing any side effects.  We also may contact you on behalf of the Study Sponsor to provide you important communications regarding the Study.  Once you are accepted into the Study, you will be assigned a unique Subject Number that will be used to identify you for purposes of the Study.  You will only be identified by your Subject Number throughout the study, unless you agree otherwise, applicable law permits or requires otherwise, or as otherwise described here.  We do not sell, trade or rent to any unaffiliated third parties your personal information collected as part of, or for purposes of, our studies. We may need to provide the study Sponsor and those associated with the Study, and regulatory agencies with your personal and health information or access to such information, and such information is only to be used for the study or other purposes permitted or required by law.

 

If you wish to be contacted for possible participation in one or more future studies, and consent to be contacted for that reason, we separately store your name, contact information, age, and gender for that purpose. We will ask you to confirm in writing that you consent to being contacted for future studies.

 

 

What if you don’t want to provide certain personal information?

You are under no obligation to provide any information requested by PEGUS and the Principal Investigator or study staff; though if you refuse to provide certain information you may not be eligible to participate in the Study and may not be entitled to compensation, if any is available for participation in this particular Study.

 

What kind of security measures does PEGUS use to protect personal information?

We will maintain the integrity of your personal information in private and secure systems requiring strict permissions and layered access.  We protect our servers from unauthorized access by utilizing firewalls.  Firewalls are controlled barriers that prevent network traffic from flowing between computers without specific permission.  We use various techniques to protect your personal information both online and offline.  All Study staff must have passwords to access these servers and access is reviewed on a periodic basis.  We restrict access to all information we receive or maintain, including your personal information.  Only employees, business associates or subcontractors who require access to perform a specific job function are granted access to your personal information, and such access is password-controlled.  All of our employees are educated on our security and privacy policies, as well as being required to review these policies on a regular and periodic basis, as well as any time the policies change.

 

Examples of Uses and Disclosures

  • Research:  If you are participating in a clinical research study governed by an IRB, your information may be disclosed as described in the informed consent / authorization to use and disclose protected health information form.  Members of the Sponsor or internal staff may review information during quality assurance audits. Health and personal information may need to be sent to the study Sponsors pharmacovigilance team for purposes of adverse event and product complaints reporting, which may then be reported to regulatory agencies, such as the Food and Drug Administration (FDA), which also may review study records.
  • Payment:  Members of the staff may use information in your records to provide you compensation for participation in a study, when such compensation is included in a study’s protocol.
  • Public Health:  As required by law, we may disclose your health information to public health or governing authorities, such as the FDA and EPA, charged with preventing or controlling disease, injury or disability.
  • Law Enforcement:  We may disclose personal health information as required by law or in response to a valid subpoena.
  • Sub-Contractors:  We may provide some services through contracts with subcontractors also referred to as “business associates”.  Examples may include, a copy/printing service, research site staff or outsourcing agencies.

 

Your Individual Rights

When it comes to your health information, you have certain rights. This section explains your rights and some of our responsibilities to help you understand those rights.

  • You can ask to see or get a copy of the health information we have about you. We will provide a copy or a summary, usually within 30 days of your request.  We may charge a reasonable, cost-based fee.
  • You can ask us to correct your records and health information if you think they are incorrect or incomplete. We may refuse your request, but we will tell you why in writing within 60 days.
  • You can ask us to contact you in a specific way (for example by home or office phone) or to send mail to a different address. We will consider all reasonable requests, and must say “yes” if you tell us you would be in danger if we do not.
  • You can ask us not to use or share certain health information for treatment, payment, or our operations. We are not required to agree to your request, and we may refuse if it would affect your participation.
  • You can ask for a list (accounting) of the times we have shared your health information (for six years prior to the date you ask), who we shared it with, and why. We will include all the disclosures except for those about treatment, payment, operations, and certain other disclosures (such as any you asked us to make).  We’ll provide one accounting per year for free but will charge a reasonable, cost-based fee if you ask for another one within 12 months.
  • You can ask for a paper copy of this Notice at any time, even if you have agreed to receive the Notice electronically. We will provide you with a paper copy promptly.
  • If you have given someone medical power of attorney or if someone is your legal guardian, that person can exercise your rights and make choices about your health information. We will make sure the person has this authority and can act on your behalf before we take any action.
  • You can report a problem if you feel we have violated your rights by contacting us or the U.S. Department of Health and Human Services using the information below.

 

Our Responsibilities

  • We are required by law to maintain the privacy and security of your protected health information.
  • We will let you know promptly if a breach occurs that may have compromised the privacy or security of your information.
  • We must follow the duties and privacy practices described in this Notice and give you a copy of it.
  • We will not use or share your information other than as described here unless you tell us we can in writing.  If you tell us we can, you may change your mind at any time.

 

How to Get More Information or to Report a Problem

If you have questions or would like additional information, you may contact the PEGUS Privacy Officer at 1-800-949-0089, email Privacy@pegus.com, or by sending a letter to:

 

PEGUS Research, Inc.

331 South Rio Grande, Suite 100

Salt Lake City, UT 84101

 

You can also report problems with the U.S. Department of Health and Human Services Office for Civil Rights by sending a letter to 200 Independence Avenue, S.W., Washington, D.C. 20201, calling 1-877-696-6775, or visiting www.hhs.gov/ocr/privacy/hipaa/complaints/. We will not retaliate against you for filing a complaint.