Legal & Ethical Issues
1. Briefly discuss institutional review board approval for the study.
The study was reviewed and approved by the Research Ethics Committee of Shiraz University of
Medical Sciences, under the ethical ID IR.SUMS.REC.1397.938. This approval ensured that the
study adhered to ethical guidelines for conducting research with human participants.
Additionally, all participants provided informed consent before participating, indicating their
voluntary agreement to take part in the study.
2. Explain how ethical principles of research (beneficence/harm, justice, privacy, and autonomy)
were followed to protect subjects, if that was explained or implied.
The study adhered to ethical principles by maintaining participant confidentiality and ensuring
voluntary participation. The principle of beneficence was upheld by implementing an educational
intervention aimed at reducing caregiver burden and enhancing social support for older adults.
The study also ensured justice by recruiting participants without discrimination and maintaining
fairness in the intervention process. Privacy and autonomy were respected by informing
participants about the study's purpose and obtaining their consent before data collection. No
indications of harm or ethical violations were reported.
3. If the study included subjects from a vulnerable population as described in the textbook,
describe any additional safeguards used to protect them.
Older adults, a vulnerable population, were included in this study, necessitating additional
safeguards. To ensure their well-being, the study implemented an informed consent process to
confirm their willingness to participate. Furthermore, the intervention focused on educating
caregivers, which indirectly benefited the older adults by improving the quality of care they
received. Measures were also taken to protect their privacy and dignity throughout the research
process.
Measurement Tools
Level of Reliability
Name of Tool Validity Reported
Measurement Reported
Caregiver Burden Inventory Cronbach’s
Ordinal Established in prior research
(CBI) (Novak & Guest, 1989) alpha = 0.96
KMO coefficient = 0.87,
Perceived Social Support Cronbach’s
Ordinal Bartlett’s Test = 2485.89 (p <
Scale (Zimet et al., 1988) alpha = 0.87
0.0001)
Instrumental Activities of Cronbach’s
Ordinal Established in prior research
Daily Living (IADL) Scale alpha = 0.96
Data Collection
1. Describe data collection procedures described in the study. Include who collected the data, at
what time points, and how data was collected. Evaluate how clearly and completely the