This document discusses considerations for protecting human subjects and confidential information in a research project. It outlines how the researcher will ensure an ethical process that complies with Institutional Review Board standards. Specifically, it states that participant information will be collected anonymously without identifying data. Beck's Depression Inventory scores will be aggregated and stored securely. Informed consent will explain risks and benefits. The only anticipated risk is possible exacerbation of depression symptoms, for which support resources will be provided. The site has provided a letter stating IRB approval is not required for this project.
1. [From 10$/Pg] Stavor Et Al
[From 10$/Pg] Stavor Et AlPetronilla OnwuWhat 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.ReferencesAldridge. (2022). Maneuvering the institutional review board process:
A guide for critical care nurses and researchers. Dimensions of Critical Care Nursing, 41(1),
2. 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.13498Stavor, 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