Legal & Ethical Issues

Critique 3 Answer Sheet:

Legal & Ethical Issues

1. Briefly discuss institutional review board approval for the study.

According to Langabeer et al. (2018), the study was approved by the Institutional Review Board at the University of Texas Health Science Center at Houston. Since this is a large, research institution, this ethics review should have been sufficient to approve this experimental study (University of Texas Health Science Center at Houston, 2020).

2. Explain how ethical principles of research (beneficence, justice, & respect for human dignity) were followed to protect subjects’ rights (freedom from harm, privacy, autonomy, & disclosure), if that was explained or implied.

Patient navigators screened and consented patients for this study. Unfortunately, none of those details are mentioned, so the reader cannot tell if privacy and autonomy were maintained. Patients should have been taken to a private room for the consent process in order to keep their participation private and their data confidential (Gray et al., 2017). We can assume that the subjects had the freedom to leave the study if they wished, since only 65.7% completed the study.  Finally, the intervention is very low risk, including some health education and blood pressure monitoring.  The reader can assume that the benefits of better blood pressure management would outweigh any risks to the subjects during the study.

3. If the study included subjects from a vulnerable population, describe any additional safeguards used to protect them.

According to Gray et al. (2017), vulnerable populations in research include neonates, children, adults with diminished capacity, pregnant women, and prisoners. Since this study enrolled consenting adults from a medical center, no special safeguards were needed.

Measurement Tools

Fill out the table below for the major variables in the study (NOT demographic variables).  You can add rows as needed, depending on how many measurement tools were used.  Boxes can be expanded for more content.

Data Collection

1. Describe data collection procedures described in the study, and how clear and complete they were.

The first and last BP readings were done in the clinic by the provider. The reader can assume that the providers were skilled in measuring blood pressures.  Langabeer et al. (2018) do not say who administered the QOL scale, or who did heights and weights.  It was most likely either the patient navigators or clinic providers.  Data collection is not well described and is incomplete.  If the personnel who collected the data were not well trained or supervised, there could have been measurement error.  If the error was big enough, the intervention might not actually have been effective.

2. If more than one data collector was used for the study, describe the training of the data collectors, and how/whether interrater reliability was adequately assessed?

There were multiple patient navigators enrolling subjects in the study and conducting the education sessions.  Their training and interrater reliability should have been described, but they were not (Gray et al., 2017).  Again, this brings the accuracy of the data into question.