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Accreditation
Q&A
What is Accreditation?
Accreditation is a voluntary
process
designed to ensure quality
and
stimulate continuing
improvement in
human research protection
programs.
What
is the goal of Accreditation?
To protect the rights
and welfare of research
participants by fostering
and advancing the ethical
and professional conduct
of persons and organizations
that engage in research
with human subjects.
Who provides Accreditation?
The Association for
the Accreditation of
Human Research Protection
Programs (AAHRPP), a
non-profit organization
headquartered in Washington,
D.C.,
Uses an accreditation
process based on self-assessment,
peer review, and education
to achieve its mission:
“AAHRPP works
to protect the
rights and welfare
of research participants and
promote scientifically
meritorious
and ethically sound
research by fostering
and advancing the ethical
and professional conduct
of persons and organizations
that engage
in research with human
participants.”
What is the focus
of accreditation?
An institution's Human
Research Protection Program
is the basic focus of
accreditation, involving
the IRB, researchers,
and other elements within
the institution, including
the following:
Why
Accreditation?
- Sound ethics
in research
Improves
human research
protection programs -
organizations
make genuine, practical,
and demonstrable
improvements to
their protection
programs.
Improves
research quality -
the global benchmark
for research quality
is raised when
human research
protection is an
integral component
of a sound, quality-driven
research program.
Builds public
trust - accreditation
indicates a "culture
of concern"—a
tangible demonstration
to the public
that an organization
goes beyond minimal
legal requirements
in protecting
research participants.
- An advantage
in research compliance
Assures
regulatory compliance with
Department
of Health and
Human Services
(DHHS) and
Food & Drug
Administration
(FDA) regulations,
as well as
other applicable
regulations.
Reduces
burden from government
and industry inspections -
routine audits
from regulatory
agencies and sponsors
are less likely
for accredited
organizations.
Better risk
management programs -
accreditation reduces
an organization's
vulnerability due
to noncompliance,
and focuses attention
on areas that need
improvement.
Improved consistency . . . by correcting
over- or mis-interpretation of regulations.
- An advantage
in the research endeavor:
Helps in
recruiting research
subjects -
by assuring
interested
individuals
that the institution
is committed
to the well-being
of research
subjects and
puts subjects’ interests
first.
Attracts
high quality researchers -
signaling to researchers
the presence of
a quality program,
where scientific
rigor and ethical
standards are highly
valued. Researchers
can expect to find
a competent IRB
to review their
research and an
organization that
will support them.
Increases
efficiency and
reduces cost -
the self-assessment
and external evaluation
assist in streamlining
operations, eliminating
duplicative efforts,
and reducing costs.
How can I be involved?
An
improved Human Research
Protection Program
is a high priority
institutional goal,
as acknowledged by
accreditation. You
can assist by:
- Reviewing the basics:
- Re-read
the Belmont
report
- Take
advantage of educational
opportunities
- Staying informed:
- Check
the HSD web site
for announcements and
information
- Attend
meetings or other
informational sessions
- Participating
in the process:
- Provide
input and feedback
on materials and
process issues
- Be available for
site-evaluation
and other activities
- Facilitate
positive change
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