1. Protection of Study Participant Privacy Kristen Warren, MBS
Regulatory Affairs Manager Department of Regulatory Affairs &
Research Compliance Office: 424-835-1330 Email:
[email protected] If, at any time, you have questions or
comments about the material within this webinar or participant
privacy in general, please feel free to contact us.
2. As a Sanguine Patient Advocate, you are responsible for
protecting all private and confidential information associated with
study participants. TABLE OF CONTENTS (p3) Definitions (p5) Scope
(p6) Sanguine Privacy Protection (p9) Your Responsibilities
3. Definitions Confidentiality refers to methods in which
identifiable private information will be handled, managed, and
disseminated Disclosure the release (intentional or unintentional)
of protected private information to parties who are not authorized
to have such information ex. Documents, Email, Conversations Coded
the removal of identifying information and replacement with a
number, letter, symbol, or combination thereof (i.e., the code); a
key that links the code to the identifying information exists
Private Information individually identifiable information provided
for specific research purposes and which the individual can expect
will not be made public 3
4. Definitions Personally Identifiable Information information
that can be used to distinguish or trace an individuals identity.
This includes Private Information & Protected Health
Information (PHI) Direct Identifiers Name SSN Phone Number Address
Email Address Biometric Record Indirect Identifiers Date of Birth
Mothers Maiden Name Place of Birth Zip Code Confidential 4
5. Scope Sanguine engages in human subjects research as defined
by Department of Health and Human Services Code of Federal
Regulations 45 Part 46 (45 CFR 46). We are dedicated to the
protection and security of private information collected from study
participants for research purposes. As a Patient Advocate, you are
responsible for the safety and privacy of the subjects from whom we
collect biospecimens. You are also responsible for compliance with
federal, state and local regulations and company policies.
6. Scope The Department of Health and Human Services (HHS)
"Common Rule" rights, safety, and welfare of research subjects,
including research subjects' privacy and the confidentiality of
information. Excerpts from The Common Rule 45 CFR 46.111(a)(6) When
appropriate, the research plan makes adequate provision for
monitoring the data collected to ensure the safety of subjects. 45
CFR 46.111(a) (7) When appropriate, there are adequate provisions
to protect the privacy of subjects and to maintain the
confidentiality of data.
7. How does Sanguine protect participant privacy? 1. Research
Protection 2. Administrative Policies & Procedures 3.
Electronic Barriers 4. Physical Barriers
8. 1. RESEARCH PROTECTION (learn more) Institutional Review
Board (IRB) (learn more) Human subjects research training (learn
more) Principal Investigator (PI) responsibilities Informed Consent
Process
9. 2. ADMINISTRATIVE POLICIES & PROCEDURES Privacy training
for all employees Limited access Employee discipline for
noncompliance
11. 4. PHYSICAL BARRIERS All private information is maintained
in locked buildings and cabinets Private information is destroyed
when it is no longer being used You are responsible for disposing
of private information appropriately
12. YOU are responsible for Protecting all Private Information
from potential disclosure Exercising reasonable caution, at all
times, to protect the Private Information under your control
Reporting privacy problems that you cannot fix by yourself
Following all federal, state and local privacy laws Complying with
Sanguine policies and procedures in place to protect privacy
13. THE GOLDEN RULE Give the Private Information under your
control the same respect for privacy that you'd like for your
own.
14. To complete your training, take the Privacy Protection Quiz
Questions or comments about the material within this webinar or
privacy in general? Please feel free to contact: Kristen Warren
Regulatory Affairs Manager Department of Regulatory Affairs &
Research Compliance Office: 424-835-1330 Email:
[email protected]