"How many IRB
members does it take to screw in a light bulb?"
Author Anonymous
As documented in 45 CFR 46.107(a), this review
board must consist of
five or more members, and at least one of these members must possess a
background in Electrical Engineering. In addition, at least one of the
members
must come from a home without any electricity. Any
member of the IRB who owns stock in an
electrical utility or who regularly pays bills to an electrical utility
should
recuse themselves from participation in the review of this research.
If the bulb should burn too brightly, burn too dimly, or flicker, then
an adverse event report should be sent to the IRB (21 CFR
312.32). If the light bulb is dropped, then a serious adverse event
report
should be sent to the FDA by telephone or by facsimile transmission no
later
than seven calendar days after the sponsor's initial receipt to the
information. If this is a multi-center light bulb trial, then a data
and safety
monitoring board (DSMB) may be needed (NIH Policy for Data and Safety
Monitoring, June 10, 1998, http://grants.nih.gov/grants/guide/notice-files/not98-84.html,
accessed on October 9, 2002). The DSMB should review any adverse event
reports
and interim results. If the clinical equipoise of the light bulb is
lost, then
the DSMB should terminate the study and provide all previously
recruited light
bulbs with the best available light bulb socket.
In order to maintain scientific integrity, the use of a placebo socket
may be necessary. The placebo socket should have the same taste,
appearance, and smell of a regular socket and the fact that this socket
has no
electricity should be hidden from the light bulb and from the person
screwing
in the light bulb. According to the 2000 revision of the Declaration of
Helsinki, paragraph 29, the use of placebo sockets is acceptable where
no
proven prophylactic, diagnostic, or therapeutic socket exists.
A systematic review of all previous research into light bulbs must be
presented so that the IRB can determine, per 45 CFR 46.11(a)(2),
that the risks to the light bulb are reasonable in relation to
anticipated
benefits. The IRB should also insure that the selection of light bulbs
is equitable [45 CFR
46.11(a)(3)]. If the light
bulb has less
than 18 watts of power,
then additional
requirements (45
CFR 46.401 through
409) apply.
The IRB
must insure that an informed consent document be prepared in language
that the light bulb understands (45 CFR 46.116). This document should
explain
the expected duration of the light bulb's participation in the
research, any
reasonably foreseeable risks, and the extent to which the
confidentiality of the light bulb will be maintained. This
document should also
emphasize that participation is voluntary and the light bulb can
withdraw
itself from the socket at any time without any penalty or loss of
benefits.
Newsletter, September 2004-Text