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.