What are the important considerations in the protection of human subjects and confidential information in your project?
PICOT: For adult surgical oncology patients in the preoperative setting, does the implementation of aromatherapy impact anxiety in 10 weeks?

What are the important considerations in the protection of human subjects and confidential information in your project?

Protecting the rights and privacy of all participants involved with the DNP project will be of the highest priority. Health Insurance Portability and Accountability Act (HIPPA) compliance will protect the sensitive patient health information obtained from being disclosed without the patient’s consent or knowledge. Participants who partake in the DNP project will first need informed consent provided by the DNP student. To appropriately gain informed consent, consents need to be simplistically written to allow for full participant understanding (LeCompte & Young, 2020). All surveys will be numbered. Names of participants and demographic information will be excluded from the project. De-identifying personal information safeguards participants’ protected health information. In addition, the data collected, will be kept for a total of 7 years on a password- protected computer, located in a locked office. The privacy of human subjects has become one of the crucial considerations in clinical research because of changes in research practice, predominately because of the sole use of electronic databases for private protected patient information (Nurmi et al., 2019). Vayena and Blasimme (2017) found that the public’s trust can be altered if there is a privacy breech given the robust data protection measures currently available for research institutions to utilize.

How will you assure an ethical and protective process for all involved in this project, including patients and other stakeholders?

IRB approval will be obtained from Chamberlain University and the practicum site before implementation. Submitting the project through these IRBs ensures that ethical and human rights are protected. Once approved by both, the DNP student will safely carry out the DNP project. Adhering to the outlined steps of the DNP proposal will ensure that the patient’s and stakeholder’s ethical and protective rights are guarded.

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?

About a year ago, our institution started using an electronic submission process. Took me a little bit to work my way through the electronic application, although I submitted my DNP proposal last week. Prior to that, I ran into many obstacles relating to “ownership.” My hospital is part of a larger conglomerate, the larger conglomerate is a large research-based institution, therefore they maintain the electronic IRB submission process. The lack of contact information or direction is discouraging. Despite many emails and calls I am stuck in one of the steps (COI disclosure forms for the other supporting staff in my project).

As I stated in a prior class, this has opened my eyes to the IRB process. I feel that there should be a delineation between research studies being submitted and DNP projects. They are not the same and most DNP projects do not require a lot of the research studies paperwork. School is my priority right now, although when I am done, I really think this aspect of the submission process needs to be changed. I also think there should be contact people within our own institution to help with this process. All in all, I am confident that I will get some answers soon and be on my way!

References

LeCompte, L.L. & Young, S.J. (2020). Revised common rule changes to the consent process and consent form. Ochsner Journal, 20(1), 62-75. https://doi.org/10.31486/toj.19.0055 (Links to an external site.)

Nurmi, S.M, Kangasniemi, M., Halkoaho, A., & Pietila, A.M. (2019). Privacy of clinical research subjects: An integrative literature review. Journal of Empirical Research on human Research Ethics, 14(1), 33-48. https://doi.org/10.1177/1556264618805643 (Links to an external site.)

Vayena, E. & Blasimme, A. (2017). Biomedical big data: New models of control over access, use and governance. Journal of Bioethical Inquiry, 14, 501-513. https://doi.org/10.1007/s11673-017-9809-6

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