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

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 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 team members to see how a protocol might be designed.  

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

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

Example:

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

How will we know when the trial is definitive? Would it be unethical to treat patients with sub-optimal treatment? How will we understand that the advantages observed are long-term and not short-term? (This might be connected to the obligation to participants’ health and fairness theories- such as egalitarianism).

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