Question

Dr. Roberts works with a team of medical professionals who treat people who are HIV+. Several of his patients have complained about the side effects of one anti-viral drug. A couple of them insisted on taking a break. When they did, their viral loads actually dropped – indicating a decrease in the amount of virus in their bodies and, theoretically, an improvement in their health and life expectancy.

Dr. Roberts would like to test the anecdotal observations. He talks with other members of the team to see how a protocol might be designed.

If you were a member of Dr. Robert’s team and were going to design a research protocol with him – what questions or concerns do you think need to be included in the design of the project?

When you identify your questions - make sure you connect them with broader biomedical ethical principles in the codes for research.

Example:

Will this be a double-blind trial? Are we scientifically unsure about the comparative benefit to the different approaches to using anti-viral drugs? (This might be connected to principles of beneficence, for example)

How will we know when the trial is definitive? It would be unethical to treat patients with the sub-optimal treatment? How will be know that the advantages observed are long-term and not short-term? (This might be connected to the obligation to participants' health and/or to theories about fairness - such as egalitarian)

Answer 1

Concerns that needs to be included in the design of the project are :-

- Will it have any after affect to the patient

- Will it be ethical to provide less treatment to the patient

- Should we use randomisation for this

- What will be the complications related to this if it goes the other way round

- What will be the duration of the advantages caused by stoppage of drugs for certain period of time

- How come we know the therapy is effective