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Research Ethics Working Group, 2006-2007
Purpose of working group: To engage in a year-long, intensive exploration of a specific controversial issue in human research ethics, potentially culminating in published recommendations.
Topic chosen: Volunteers for an evaluation of the efficacy of an HIV preventive vaccine to produce mucosal immunity are selected on the basis of having a lethal disease. Administration of the vaccine would be followed by the application of HIV to the subjects’ mucosa (eg, of anus). The prognosis of the subject’s disease is such that he or she would be very unlikely to survive long enough to develop AIDS in the case that the vaccine proved ineffective. For a fuller description of the case, see below.
Meeting Schedule:
All meetings are on Fridays from 1:30-3pm at 87 Trumbull Street.
1. September 8, 2006
2. October 27, 2006
3. November 10, 2006
4. December 8, 2006
5. January 12, 2007
6. February 9, 2007
7. March 30, 2007
8. April 13, 2007
9. May 4, 2007
Purpose: To determine whether a vaccine designed to prevent HIV infection produces mucosal immunity.
Scientific design: Subjects will receive a single injection of the vaccine. 6 weeks later they will have their blood drawn to see if they have developed antibodies to the HIV antigen in the vaccine. If they have, then they will be inoculated with live HIV virus applied to the mucosa of the rectum or vagina. After this they will have their blood drawn weekly for 4 weeks to see if HIV can be detected.
Risks: The most important risk is that they could be infected with HIV. The probability that this would result in the development of AIDS will be reduced greatly by selecting subjects who are very unlikely to live long enough to develop the disease.
Selection of subjects: Eligible candidates for participation in this protocol will be adult individuals with intact immune systems who are likely to live long enough to complete participation in the protocol (3 months) and, because of their diseases, are highly unlikely to live long enough (2 years) to develop AIDS. Their diagnoses may include certain types and stages of cancer; however, since some (or most) chemotherapy may render patients ineligible because it would impair their immune responses, it will probably be necessary consider only those patients with cancer who have refused to accept chemotherapy. Patients with solid tumors of the gut or pancreas do this fairly often.
Other categories to be considered are patients with certain relentlessly progressive neurological diseases (eg, amyotrophic lateral sclerosis) and the ‘end stages’ of such conditions as lung disease; congestive heart failure (eg, with left ventricular ejection fractions below 25% and concomitant renal insufficiency); liver disease with ascites and low serum sodium levels, etc.
Informed consent: Patients must be capable of informed consent; no surrogates or proxies will be acceptable.
Financial considerations: Payments will be limited to reimbursement for out-of-pocket expenses. In the unlikely event that a subject develops AIDS, all costs of treatment will be paid by the sponsor of the research.