The Rights of Human Subjects - Assignment Example

1. In the article by Ito and Sharts-Hopko, what was the study design that was used? Why was this appropriate or not appropriate for the question theresearchers were trying to answer? What are the strengths and limitations of this design? (7 points) This study was a qualitative research design. The design was appropriate because this study was discovery oriented as it needed understand the experiences of Japanese women of pregnancy and childbirth in the US, a phenomenon which little was known about. The strength of this method are: data is based on respondents’ own categories of meaning, the method is useful for studying a limited number of cases in depth, the method can be used to study complex phenomena, it provides individual case information, provides emic viewpoints, among other strengths. The weaknesses include the fact that knowledge generated might not generalize to other people or settings, it is not easy to make quantitative predictions, it is more difficult to test hypotheses and theories with large participant pools, it might have lower credibility with some commissioners of programs, the data analysis is time consuming, and the results are more easily influenced by the researcher’s personal biases and idiosyncrasies. 2. In the article by Estruch et al., what was the study design? How were the three essential requirements for this type of design fulfilled in this study? Did the research topic and question “match” the study design? Please explain your reasons for your answer. (7 points) This was a quantitative research and more specifically an experimental design. Experimental designs must meet the following essential requirements: randomization, control, and manipulation. Randomization was met by assigning participants in a 1:1:1 ratio to one of the three groups by means of a computer-generated random-number sequence. Control was met by including a control group in the experiment – the group that received dietary training. Manipulation was met by offering Mediterranean-diet with different supplements to the two experiment groups. Indeed the topic, the question, and the design matched. The observational cohort studies and secondary prevention trial had shown an inverse association between adherence to the Mediterranean diet and cardiovascular risk. The design was therefore appropriate to find out the same. 3. In the article by Ito and Sharts-Hopko, what indicates that the investigators were attentive to the rights of human subjects? Is there anything about the article that causes ethical concerns? Please explain your answers. (5 points) There is evidence to suggest that the authors were attentive to the rights of human subjects. First, they note that the study was approved by the institutional review board at the university. This means that the approval was based on the compliance to ethical issues, legal issues and rights of subjects. Secondly, the presentation of results and the discussion thereof indicate that privacy and confidentiality of participants was upheld as no responses can be linked to a particular individual. The participants also seem to have been selected fairly by the researchers and also treated fairly as the interviews were conducted in the settings that they chose: at home or over the phone. It is not however clear whether consent to participate in the study was sought from the participants in the study after the approval by the university committee. This may be the ethical concern in this study as there is no evidence to suggest that consent was sought. 4. In the article by Estruch et al., what indicates that the investigators were attentive to the rights of human subjects? Is there anything about the article that causes ethical concerns? Please explain your answers. (5 points) This research adheres to the rights of the human subjects. First, the study protocol was approved by the institutional review boards at all study locations. They reported that the report adhered to the protocol laid out before the study. Secondly, the study lists the sponsors of the study and their roles in donating food and not in the study design, data analysis or reporting of results. Third, the authors note that all participants provided written informed consent. The participants were also free to leave the study and as shown, 11.3% of those in control group dropped out of the study while 4.9% of those in diet groups dropped out of the study. There was no harm to the participants in the study as no relevant diet-related adverse effects were noted. There is therefore nothing to suggest that the ethical concerns were not met as all the information regarding the ethical issues and the rights of participants are clearly outlines and the authors vouch for the accuracy and completeness of the data and for the fidelity of the report to the protocol where they also provide a reference point to get the protocol used. 5. What was the guiding theoretical framework or logical argument for the study conducted by Ito and Sharts-Hopko? What is the clinical significance of this study? Please explain your answers. (6 points) This study was based on the theory that culture plays a significant role on childbearing experience. The theoretical framework was therefore guided by this argument. This was important because the US is multicultural and it is therefore important that health professionals understand the culture of patients in order to serve them as individuals and not as stereotypes. The clinical significance of this study is that it offers an understanding of the experience of Japanese women as more of them are making use of the US health care system. The understanding of these experiences can aid in better service delivery to this population by health care professionals. 6. What was the theoretical rationale or logical argument for the study by Estruch et al.? How were key concepts defined in this study? What was its clinical significance? Please explain your answers. (8 points) The logical argument in this study was that adherence to the Mediterranean diet could reduce cardiovascular risk in individuals. The traditional Mediterranean diet was clearly defined as one “characterized by a high intake of olive oil, fruit, nuts, vegetables, and cereals; a moderate intake of fish and poultry; a low intake of dairy products, red meat, processed meats, and sweets; and wine in moderation, consumed with meals”. The cardiovascular risk factors were listed as: smoking, hypertension, elevated low-density lipoprotein cholesterol levels, low high-density lipoprotein cholesterol levels, overweight or obesity, or a family history of premature coronary heart disease. The clinical significance of this study is that it provides evidence for the use of diet in managing cardiovascular risks. From the study, it was noted that Mediterranean diet among persons with high cardiovascular risk reduced the incidences of major cardiovascular events. The results support the benefits of the Mediterranean diet for the primary prevention of cardiovascular disease. This is important to the clinical practice. 7. How did the study by Estruch et al. address the issues of reliability, validity and control? How certain are we sure that participants complied with instructions? Please explain your answers. (9 points) The study addressed reliability by performing a baseline and then comparing the trial results with the baseline results and they were consistent. This means that the measures used were stable over time. It is not clear whether the questionnaire was internally consistent as no reliability measures of Cronbach’s alpha were reported for the measures used. The measures were however consistent as the scales used for the questions on the demographics and other constructs show. Validity was achieved by having a larger sample size to give a good statistical power, having reliable measures, standardizing the experimental procedures, and having random samples. By randomization, the study controlled extraneous variables and therefore promoted validity. Given that a control group was present in the experimental design, it can be assumed that the results clearly show that the outcome is as a result of the treatment provided – the Mediterranean diet. 8. How did Ito and Sharts-Hopko’s study address the issues of control, trustworthiness of the data and integrity? (3 points) The authors addressed these issues in a number of ways. Open ended taped interviews that lasted 1-3 hours were conducted. The first interview was encoded, patterns identified and the subsequent encodings compared with the earlier interview. A comparative content analysis was done and new patterns identified. Constant reevaluations of the data and patterns were done. The validity was also addressed by having two experts review the transcripts and the coding system. Read More