What are the important considerations in the protection of human subjects and confidential information in your project? How will you assure an ethical and protective process for all involved in this project, including patients and other stakeholders?
“In adult patients aged 18 years and older at Changing Lives Adult and Youth Services with a diagnosis of depression, will implementing the National Institute of Health and Clinical Excellence (NICE) Guidelines for exercising impact depression scores over 8-10 weeks”?
In the past, some research studies such as the Tuskegee syphilis trial, the Nuremberg trials, were conducted in violation of human rights, welfare, and ethical standards such as informed consent, racism, unfair subjects’ selection, maleficence, honesty, and justice. This led to the establishment of the Institutional Review Board (IRB) by the federal government. IRB is tasked with the responsibility of reviewing research with human participants to ensure that ethical standards are met, participants’ privacy and confidentiality are maintained (Aldridge, 2022; Hicks et al., 2021). The IRB must determine that certain standards such as risks to participants are minimized, risks are reasonable when compared to the benefits, the selection of participants is equitable, and informed consent is obtained before a research study or project.
In compliance with the IRB standards, patient and stakeholder protection will be at the forefront of this project. To maintain anonymity, participants’ information will be protected during this project as their Beck’s Depression Inventory [BDI scores] (Beck et. al., 1961) will be collected without identifying data, and the scores will be reported in aggregate form, and data will be stored in a password-protected computer in an encrypted electronic file and kept for seven years (Stavor et al., 2017). Informed consent explaining the reason for the project, its potential risks, and benefits will be explained and provided before the onset of the project. The one anticipated risk for participants is an exacerbation of participant depression symptoms and a need for further resources from the clinic. The participants are informed of the resources of mental health support in the informed consent and offered the phone number with confidential access if they require further counseling or referral to mental health facilities related to exacerbation of their depression.
Please give an update on your project status. Is IRB approval required from your project site? If so, have you started this process? If not, do you have a letter from the site stating that IRB is not required?
IRB approval is not required from my project site. The site has provided a letter stating that IRB is not required.
Aldridge. (2022). Maneuvering the institutional review board process: A guide for critical care nurses and researchers. Dimensions of Critical Care Nursing, 41(1), 24–28. https://doi.org/10.1097/DCC.00000000 (Links to an external site.) (Links to an external site.)
Beck, A. T., Ward, C. H., Mandelson, M., Mock, J., & Erbaugh, J. (1961). An inventory for measuring depression. Archives of general psychiatry, 4, 561–571. https://doi.org/10.1001/archpsyc.1961.01710120031004 (Links to an external site.)
Hicks, R. W., Hines, K., & Henson, B. (2021). Demystifying the institutional review board. AORN Journal, 114(4), 309-318. https://doi.org/10.1002/aorn.13498
Stavor, D. C., Zedreck-Gonzalez, J., & Hoffmann, R. L. (2017). Improving the use of evidence-based practice and research utilization through the identification of barriers to implementation in a critical access hospital. The Journal of nursing administration, 47(1), 56–61. https://doi-org.chamberlainuniversity.idm.oclc.org/10.1097/NNA.0000000000000437