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THE EMPOWERED NURSE
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THE HEART
This column examines the ethics in research. How do we ensure that the rights and welfare of
human subjects are protected? This crucial concept is at the heart of nursing research.
VUMC Resource for Human Research
Protection: HRPP/IRB
The Human Research Protections Program, also known as There is a great resource under “Tool Kit.” This Tool Kit is
the Institutional Review Board (IRB) has many resources. There where the Investigators Handbook is located. These resources
are resources not only to help researchers navigate the review are specific to either biomedical, social or behavioral research
process, but also resources for research participants. On the and provide a great overview of what the IRB does, and why,
HRPP website at www.vumc.org/irb, the contact information and how the design of a project should ensure protection and
of HRPP staff, IRB Committee Rosters, as well as VUMC re- welfare of human subject participants. The handbook also pro-
search policies and procedures (yes, all 157 policies and proce- vides guidelines on the review levels of the IRB as well as how to
dures) are housed. These are some of the more commonly conduct the informed consent process and what is required
accessed resources as well as an “announcements” section which within that document.
links to a Twitter account where changes and updates are
tweeted in real-time. These announcements are also embedded
into the applications in DISCOVER-e, VUMC’s online applica-
tion system.
However, there are some useful hidden and rarely accessed
resources that are helpful when just getting started or needing
some advice outside of the IRB hotline where an analyst is on-
call Monday-Friday for general calls and questions.
The “Forms and Tools” section in the menu offers template
consent documents as well as common language that can be
used when creating consent documents or applying for review
by the IRB.
Another excellent resource is the section labeled “For Partic-
ipants.” This section includes a Subject’s Bill of Rights that can
be provided to potential participants or printed for reference dur-
ing the consenting process. There are also links for potential par-
ticipants to learn more about other trials or research being
conducted across both VU and VUMC as well as a VUMC
newsletter for research participants. Additionally, a section has
been created called “Questions to Ask” which contains a list of
10 questions that assist potential participants in understanding
the proposed research and deciding if participation is appropri-
ate. Questions include: