I) These guidelines were developed by the Oncho Task Force at a meeting
held in New York City on 29, July 1993. The following individuals participated
in their development: John E. Donelson, Joseph A. Cook, Brian O. L. Duke,
Jeffrey Mecaskey, Eric A. Ottesen, and Cathy Steel, the Oncho Task Force
Coordinator. Recognizing the important distinction between infection and
disease, the impetus for this policy is to prevent clinical disease while
recognizing that definitive treatment for infection is currently unavailable.
The purpose of the guidelines is to insure the safety and well being of
human volunteers involved in the collection of the research resource, the
third stage larvae of O. volvulus.
II) Research for a vaccine against onchocerciasis is dependent upon a
steady and secure supply of the third stage larvae (L3's) of O. volvulus.
In the effort to create a protective vaccine, L3's are critical for identifying
and evaluating candidate antigens, and they are necessary for evaluating
those antigens in animal screening systems. To date, scientists have not
successfully replicated the complete life cycle of L3's in captivity. Consequently,
infected human volunteers have become an integral aspect of L3 collection
and production. Recognizing the ethical imperative to do no harm, the following
outlines the Foundation's policy with respect to the use of human volunteers
in the production of O. volvulus L3's.
III) Volunteer donors are by definition individuals infected by O.
volvulus, with relatively high levels of microfiladermia. Although
the Foundation's support for immunology research for a vaccine against onchocerciasis
requires a supply of L3's, the Foundation cannot support work that could
adversely affect the health of any human volunteers.
A) The period of employment with remuneration of any human volunteer
will be limited to a period of no more than 6 months. After this time,
the volunteer will be taken off the payroll and will be encouraged to take
treatment with ivermectin.
B) Volunteers will be again eligible to receive remuneration and
to assist in the collection of L3's approximately 9 to 12 months post-treatment,
after he/she has reached an appropriate level of microfiladermia.
C) Through the tenure of their service, volunteers will be clinically
examined at least 3 times over each 6 month term of service and will receive
medical treatment as indicated. If signs of onchocerca-induced pathology
are observed, volunteers will be taken off the payroll and encouraged to
take treatment with ivermectin.