Question

In nursing research, how are respect for the persons, potential benefits and burdens of the research, and justice kept in balance? Provide examples of how you would ensure this balance in your research. Please provide references

Answer 1

Ans) Benefit and burden influence research participation, including recruitment and retention.

- Dimensions of benefit and burden include physical, psychological, economic, familial, and social. Understanding the benefit-burden balance involved in the voluntary consent of human subjects is a fundamental tenet of research and important to ensure that subjects have made an informed decision regarding their decision to participate in clinical research.

- Clinical research is imperative to generate knowledge that will reduce the morbidity and mortality of human disease. In fact, the vast majority of clinical research relies on the voluntary participation of human subjects. Participation in a clinical trial (CT) requires obligations by cancer patients that may add to the burden of cancer diagnosis and treatment. For some, this “added burden” may not be acceptable for various reasons.

- An enduring historical medical ethics document, outlines three specific ethical principles for the protection of human subjects enrolled in clinical research: respect for persons, beneficence, and justice.

- The principle of beneficence obligates researchers not only to avoid patient harm but also to minimize the risks and maximize the benefits associated with research participation. Institutional review board (IRB) members consistently evaluate the risks and benefits of research to human subjects; what is not clear, however, is how patients actually balance the benefits and burdens of research participation and how they define these concepts for themselves.

- Understanding the benefit–burden balance involved in the voluntary consent of human subjects is a fundamental tenet of research and important in ensuring subjects have made an informed decision regarding their decision to participate in clinical research.

The benefits and burdens of research participation have not been adequately studied in seriously ill cancer patients enrolled in clinical research. The Office of Management and Budget first used the term “respondent burden” in an effort to improve response rates to surveys by asking researchers to minimize the time and effort required of respondents. Social scientists often equate burden with time commitment associated with filling out a survey questionnaire or conducting face-to-face or telephone interviews and question the best way to achieve an acceptable response rate.