I'm listening. I've been listening all along. I'm simply not agreeing.
The Belmont Report, found here
http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/, states:
"It is commonly said that benefits and risks must be "balanced" and shown to be "in a favorable ratio." The metaphorical character of these terms draws attention to the difficulty of making precise judgments. Only on rare occasions will quantitative techniques be available for the scrutiny of research protocols. However, the idea of systematic, nonarbitrary analysis of risks and benefits should be emulated insofar as possible. This ideal requires those making decisions about the justifiability of research to be thorough in the accumulation and assessment of information about all aspects of the research, and to consider alternatives systematically. This procedure renders the assessment of research more rigorous and precise, while making communication between review board members and investigators less subject to misinterpretation, misinformation and conflicting judgments. Thus, there should first be a determination of the validity of the presuppositions of the research; then the nature, probability and magnitude of risk should be distinguished with as much clarity as possible. The method of ascertaining risks should be explicit, especially where there is no alternative to the use of such vague categories as small or slight risk. It should also be determined whether an investigator's estimates of the probability of harm or benefits are reasonable, as judged by known facts or other available studies.
Finally, assessment of the justifiability of research should reflect at least the following considerations
i)Brutal or inhumane treatment of human subjects is never morally justified.(ii)Risks should be reduced to those necessary to achieve the research objective. It should be determined whether it is in fact necessary to use human subjects at all. Risk can perhaps never be entirely eliminated, but it can often be reduced by careful attention to alternative procedures.(iii)When research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk (looking usually to the likelihood of benefit to the subject -- or, in some rare cases, to the manifest voluntariness of the participation).
(iv)When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. A number of variables go into such judgments, including the nature and degree of risk, the condition of the particular population involved, and the nature and level of the anticipated benefits.
(v)Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process."
Risk/Benefit ratio's are categorized into different classifications, from low to high. Patients are already being seen by unsupervised nurses, as a result this would be a low risk study; no previous studies have shown significant outcome disparities between NP/MD care. As I've stated many times,
the risk benefit ratio would be in the researchers favor.