FDA approval for our study of the use of LSD in the treatment of substance abuse was a victory, but we still need approval from an Institutional Review Board (IRB) before we can begin treating patients. This board assures that human rights are protected in the conduct of our research. Unfortunately, obtaining IRB approval for our controversial project has been very difficult. We have considered forming our own IRB at the suggestion of some folks from NIH and an independent IRB consultant.
On January 16th, 1994 we had the first meeting of the Orenda Institute IRB. Our members are currently considering ways to clarify the informed consent document used in our project. In the course of this first meeting questions of liability were raised by one member of the board. As we searched for information we found that insurance for an IRB may be costly, figures of up to $8000 a year have been mentioned, and a firm quote is in the works. Although insuring the board may require a formidable sum, if we can find support for the cost it would fully empower our review board. It would also enable the passage of future protocols (several are in the wings) and facilitate eligibility for federal funds. Our current board includes influential people whose approval of this project will facilitate its acceptance by our immediate community.
We are also considering other options, these may include trying to secure IRB approval from an IRB affiliated with the National Institute on Drug Abuse’s Addiction Research Center which is located in Baltimore. Eligibility for federal grants demands that the IRB must be within 50 miles of the research site.
We are currently seeking support for this project from a number of sources.