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Research Proposal: Ethical Principles
Research studies pose multiple moral and ethical dilemmas. These must be identified and
minimized to protect participants in the study (Ellis, 2019; Gray & Grove, 2020). This researcher
will carefully consider the four ethical principles in planning this research project. Careful
attention will be made to ensure non-maleficence (reducing harm to participants), beneficence
(including participants in the benefits of the study), autonomy (participant’s ability to make
decisions based on personal beliefs and values), and justice (fairly distributing the benefits and
risks of the study) (Hosseini et al., 2022). Prior to any collection of data, this researcher will
carefully consider obtaining informed consent and protecting participant privacy. Approval for
the study will be obtained from the XXXX Institutional Review Board, and the risk-benefit ratio
for the participants will be explained.
Informed Consent
While the researcher believes this study will qualify for expedited review, a thorough
review of the XXXXvStandard Operating Procedure regarding informed consent will be made.
All participants considered to be vulnerable participants will be excluded from this study. This
study will include adult patients with chronic health conditions, excluding psychiatric diagnoses.
Pregnant women, prisoners, and adults lacking the capacity to make informed decisions or those
requiring the signature of a durable power of attorney (DPOA) will be excluded from
participation. Those with limited cognitive ability, including those with diagnoses of Alzheimer's
or dementia, will also be excluded from the study. Written informed consent will be obtained by
a third party utilizing the XXXXX Health Information Management (HIM) department.
Patients who have participated or are currently participating in the XXXXX Bridge
Program will be contacted via written notification mailed to their address on file. An explanation
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of the limited data collected from the medical record, the purpose of the study, how their data
will be used, and how their data will be protected will be given. This data will be outlined in the
privacy section of this paper. Participants will be mailed a paper consent to sign and mail back to
the HIM department in a self-addressed, stamped envelope included in the mailing. Additionally,
a telephone number will be made available to participants to answer any questions they may
have. To maintain participant privacy, questions regarding consent or data collection methods
will be answered by the HIM department.
Maintaining Participant Privacy
Maintaining participant privacy in this study is of utmost importance to this researcher.
Once the participant has consented to their data being collected for this study, the assigned HIM
department representative will assign a number to the participant. A list of named participants
and their assigned numbers will be kept in the HIM department in a locked file along with the
signed consent. The information made available to the researcher will include a list of numbered
participants, their age, sex, race, medical diagnoses, and information regarding their participation
in the Bridge program pertinent to the research question. This information released by the HIM
department will be kept in a locked file cabinet in the researcher’s locked office. Any
information moved to a computer will only be transferred to an organization device, files
password protected, and will not be sent via any electronic means. Research will be completed at
the institution and will not be taken home by the researcher.
XXXX Institutional Review Board
To ensure protection from harm and the highest ethical standards, approval from the
Institutional Review Board is essential before starting any portion of this research study
(Oermann et al., 2021). The XXXX Institutional Review Board (XXIRB) requires that all
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process improvement and nursing research be presented within the context of the organization’s
service standards. The author believes that studying the effect of the XXXX Bridge program on
the number of unreimbursed Medicare dollars does address the organizational priorities of
stewardship, quality of care, patient experience, and patient safety. Additionally, the author
believes the research study design is specific, measurable, attainable, relevant, and time-bound,
in accordance with the organization’s requirement to develop SMART goals related to the study.
The XXIRB requires all nursing researchers to complete a five-step registration and training
program prior to performing any research within the organization. From there, the nurse
researcher will submit their project to the XXIRB for rigorous evaluation and guidance through
the study. This process includes a thorough review of literature be submitted, multiple
organizational checklists be completed, and the information included in the research proposal to
be submitted.
Risk-Benefit Ratio
Prior to seeking approval for a research study, the researcher must weigh the benefits of
the research with the risks to the participants (Gray & Grove, 2020). This researcher
hypothesizes that enrolling adult patients with chronic health conditions, presenting to the
XXXXX emergency department more than 9 times in a rolling 12-month period in the Bridge
program for comprehensive case management will decrease the number of unreimbursed
Medicare dollars to the organization over a 12 month period. This researcher will consider
potential risks to participants. Potential risks include inadvertent disclosure of private medical
information and hesitancy for the participant to return to the emergency department for care
when needed. Benefits to the participant include a higher quality of care with ongoing, continued
support and resources provided to the patient post-discharge. Benefits to the organization include
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the organization's better understanding of this program's impact on the quality of care provided
to patients in the community. The organization will be able to identify whether the program does
steward its resources wisely and if the program improves the quality of care provided to patients.
This researcher believes the benefits to both the participants and the community the XXXXX
organization serves outweigh the potential risks to participants.
Conclusion
The XXXX Bridge program seeks to fulfill the organization’s mission of XXXXX by
providing a comprehensive case management program to patients needing additional healthcare
resources to enhance their quality of life. The XXXX organization seeks to be wise stewards of
the resources God has given to effectively show compassion in a way that makes a difference
(King James Bible, 1769/2024, Jude 22) to all those the organization cares for. This researcher is
committed to maintaining the highest ethical principles throughout the study. Therefore, care
will be taken to ensure informed consent is obtained and the participant’s privacy is maintained.
To aid in this process, the researcher will follow, with careful detail, the XXXX Institutional
Review Board process throughout the study. The researcher will clearly communicate the risk-
benefit ratio to the Institutional Review Board and the participants before the study begins.
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References
Ellis, P. (2019). Ethical aspects of research. Wounds UK, 15(3), 87–88.
https://web.p.ebscohost.com/ehost/pdfviewer/pdfviewer?vid=5&sid=dd66faf0-5f8c-
4e5b-950c-16f98501ac14%40redis
Gray, J. R., & Grove, S. K. (2020). Burns and Grove's the practice of nursing research:
Appraisal, synthesis, and generation of evidence (9th ed.). Elsevier.
Hosseini, A., Jackson, A. C., & Bahramnezhad, F. (2022). Ethical considerations in
interventional studies: A systematic review ethics and interventional study. Acta Medica
Iranica, 60(10), 609–614. https://doi.org/10.18502/acta.v60i10.11550
King James Bible. (2024). King James Bible Online. https://www.kingjamesbibleonline.org/
(Original work published 1769)
Oermann, M. H., Barton, A., Yoder-Wise, P. S., & Morton, P. (2021). Research in nursing
education and the institutional review board/ethics committee. Journal of Professional
Nursing, 37(2), 342–347. https://doi.org/10.1016/j.profnurs.2021.01.003
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