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Simplified
Federalwide assurance (FWA) and IRB registration process
Last
year, the Office for Protection from Research Risks was
moved from the NIH to the Office
of the Secretary, Department of Health and Human Services,
and was renamed the Office for Human Research Protections
(OHRP). The new Director of OHRP, Dr. Greg Koski,
has begun to make major changes in how OHRP functions. One
recent change, announced on December 18, 2000, is the phasing
in of a simplified Federalwide assurance (FWA) and IRB
registration process. The old system of Multiple
Project Assurances (MPAs) and Single Project Assurances
(SPAs) will be phased out. Under the new system,
each IRB will be assigned a unique IRB number, each organization
operating an IRB will be assigned a unique organization
number, and each institution filing an assurance will be
assigned a unique assurance number. Note that institutions
would not be considered "engaged" in human subjects research
(and would not need an Assurance) if their involvement
is limited
to the following: (3) Institutions whose employees
or agents (i) inform prospective subjects about the availability
of research; (ii) provide prospective subjects with written
information about research (which may include a copy of
the relevant informed consent document and other IRB-approved
materials)
but do not obtain subjects' consent or act as authoritative
representatives of the investigators; (iii) provide prospective
subjects with information about contacting investigators
for information or enrollment; or (iv) obtain and appropriately
document prospective subjects' permission for investigators
to contact them (e.g., a clinician provides patients with
literature
about a research study, including a copy of the informed
consent document, and tells them how to contact the investigator
if
they want to enroll; a clinician provides investigators
with contact information about potential subjects after
receiving
explicit permission from each potential subject).
Assurances will be valid for three years. More
information is available at:
See also National Bioethics Advisory Commission Draft
Report and Recommendations |
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