DNP-825 Topic 1 DQ 2

DNP-825 Topic 1 DQ 2

DNP-825 Topic 1 DQ 2

Describe the purpose of the Institutional Review Board (IRB) and the types of determinations the board makes. Provide an example of a scenario in which a quality improvement project would require IRB approval. Use relevant literature to support your response.

REPLY TO DISCUSSION

Oct 29, 2022, 7:44 PM

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Greetings Class,

What was new to you with this discussion / topic? How do you see this impacting your practice and /or academic journey?

Oct 31, 2022, 1:33 PM

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Checking back in on this.

Oct 31, 2022, 3:35 PM

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Dr. Terry, this whole process is very new to this learner. I was lucky enough to spend some time with the IRB nurse at my practice site in DNP815A so I had a little knowledge. When she was talking to me, it was like she was speaking another language. After the research for this discussion post, some of the terminology that she was using is making more sense now. It is still foreign territory but this learner is excited to learn more about this subject over the next 8 weeks.

Nov 2, 2022, 5:56 AM

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Oh how I understand and I love your example that it was like she was speaking another language! That is one of the many things I love about GCU….each course builds on introduction and knowledge related to the research process and the DPI project.

Thanks for responding!

Oct 31, 2022, 5:05 PM

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A piece of fascinating and new information learned from this topic is that the IRB committee has to constitute a minimum of five members and there has to be one member from the community with no affiliations at all.

Nov 2, 2022, 6:00 AM

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Oct 31, 2022, 5:40 PM

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I hope you are doing well. In combining your questions from both topics one and two, I learned that IRBs had faced several challenges during the COVID-19 pandemic, the most important of which is the need to rapidly review an influx of applications in a way that will avoid unnecessary delays in promising science during a public health emergency while simultaneously making sure that Hsu appropriately protects the rights, welfare, and interests of research participants, (Hsu, N. S., et, al., (2021).   A snapshot of how a group of HRPPs approached the review of COVID-19-specific protocols at the start of the pandemic in the USA, as well as the number and types of studies reviewed during this time and IRB turnaround speed, was surprising to me because of the critical nature of the pandemic.  A review of COVID-19-specific protocols by Hsu N. S. et al. (2021)  determined that IRBs were identifying the same type of administrative, regulatory, and ethical concerns in these protocols as those typically placed in the general review of research.   Common institutional approaches included efforts to manage IRB workloads (and other institutional resources) through administrative review before board review and increasing IRB responsiveness by moving COVID-19-specific protocols to the front of the queue, holding additional meetings, or relying on COVID-19-specific review panels. Research shows that IRBs received a substantial number of new protocols but could take advantage of regulatory pathways intended to minimize the burden, including exemption and expedited review, for most of them. This likely enabled IRBs to focus on the smaller number of COVID-19-specific protocols in need of more significant oversight due to increased risk and complexity.

Hsu, N. S., Hendriks, S., Ramos, K. M., & Grady, C. (2021). Ethical considerations of COVID-19-related adjustments to clinical research. Nature medicine27(2), 191–193. https://doi.org/10.1038/s41591-020-01216-2

Nov 2, 2022, 6:01 AM

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Oct 31, 2022, 6:16 PM

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Good evening Dr. T,

I found this topic to come at the perfect time. My Quality manger had just asked if my project will require IRB because she has noticed more of more universities asking for it. I informed her that we were doing this discussion and due to that I am sure it will. She approves many of them, but I had to complete research to ensure she could. It was interesting to real all the different ways approval happens. I learned that in some of our other facilities the CNO can provide it while others ask the quality department. I do wonder if GCU will have a specific individual they require we obtain it form or will it be the site to choose the person.

Nov 2, 2022, 6:24 AM

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Thanks so much for your response. The process can vary depending on the projct topic, population, and setting.

Your site may have their own IRB process, and GCU has their process as well. While you are learning about this general topic in this course…..you can also check out the GCU DC Network and locate information there as well. Once you get to the courses where the IRB process happens, you will also have a GCU faculty Chair assigned for the DPI project courses.

I hope this helps!

Oct 31, 2022, 10:59 PM

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Institutional Review Board (IRB) or research ethics committee approval is designed to protect the rights of an individual subject, wherein ethical guidelines in conducting research protect the integrity of the research process (Oermann et al., 2021). IRB reviews all research studies involving human subjects to meet the regulations and ethical standards. 

Categorizing a project by the QI oversight committee or project team members will depend on the decision to submit a project for IRB review and approval, which is done before starting a project (Gautham & Pearman, 2021). All processes may vary, but Institutional Review Board (IRB) has mechanisms to evaluate a project proposal, including validating A QI project with good use of its resources and does not cause harm to any patients.

Any QI projects not involving human subjects do not need IRB approval. Research topics in relation to patient safety and quality should be subject to IRB review and approval, ensuring privacy, safety, and confidentiality to protect the patient’s welfare (Gautham & Pearlman, 2021). Quality improvement activities such as implementing a practice to improve the quality of patient care and collecting patient or provider data regarding the practice for clinical, administrative, or practical purposes do not meet the definition of research and do not need IRB review (Oermann et al., 2021). Sepsis alert is a QI project to improve diagnosis and treatment requiring IRB approval. Outcomes are reviewed on how often a patient receives antibiotics and intravenous fluids and draw blood cultures and lactate levels. The alert was designed to supplement other institutional initiatives to improve sepsis outcomes.

Reference

Gautham, K.S. & Pearlman, S. (2021). Do quality improvement projects require IRB approval?

Journal of Perinatology, 41 (6).

https://lopes.idm.oclc.org/login?url=https://search.ebscohost.com/login.aspx?direct=true&db=edsgao&AN=edsgcl.666409482&site=eds-live&scope=site&custid=s8333196&groupid=main&profile=eds1

Oermann, M.H., Barton, A., Yoder-Wise, P.S., & Morton, P.G. (2021). Research in nursing education and the institutional review board/ ethics committee. Journal of Professional Nursing, 37 (2), 342- 347.

https://lopes.idm.oclc.org/login?url=https://search.ebscohost.com/login.aspx?direct=true&db=edselp&AN=S875572232100003X&site=eds-live&scope=site&custid=s8333196&groupid=main&profile=eds1

Oct 31, 2022, 10:21 PM

Researchers and Clinicians involving human participants in their research are expected to display transparency concerning consent and the safety of the participants. Thus, the need for Institutional review boards (IRBs). They are crucial for the safety, ethical, and standardized conduct of human participant research (Lapid et al., 2019). Formally appointed in federal regulations to review and monitor biomedical research involving human participants by US Food and Drug Administration (FDA) regulations possesses the authority to approve, require modifications in (to secure approval), or disapprove research. FDA and the Office for Human Research Protections with detail in the Code of Federal Regulations Title 21 Part 56 mandated that IRB regulates research in humans (Lapid et al., 2019).

Reference to the outrage of the historical infamous Tuskegee syphilis study on African American men in the 1930s by the federal government resulted in the passage of the National Research Act of 1974 to establish Department of Health and Human Services policy for the protection of human research participants and led to required IRB review and approval of all human participants research in the United States (Lapid et al., 2019).

The composition of an IRB membership is specified and includes scientific reviewers with biomedical or behavioral expertise, nonscientific reviewers with little or no medical experience, community members to bring a layperson perspective, and IRB staff trained to conduct IRB activities This diversity should consider race, cultural background, and sensitivity to the issues for acceptability from a social, legal, and institutional perspective (Lapid et al., 2019). While the IRB reviews must include an evaluation of the research for compliance with ethical principles in federal regulations in the United States, it extends beyond the International Council for Harmonization guidance for Good Clinical Practice for international research. Transparency will aid in accountability, improve the quality of their decision-making, facilitate consistency in board decisions, as well as permit the empirical study of IRBs while promoting research efficiency, and trust (Lynch, 2018).

Reference

Lapid, M. I., M.D., Clarke, B. L., M.D., & Wright, R. S. (2019). Institutional review boards: What clinician researchers need to know. Mayo Clinic Proceedings, 94(3), 515-525. doi:https://doi.org/10.1016/j.mayocp.2019.01.020

Lynch, H. (2018). Opening Closed Doors: Promoting IRB Transparency. Journal of Law, Medicine & Ethics, 46(1), 145-158. doi:10.1177/1073110518766028

Oct 31, 2022, 7:03 PM

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Many of us are too young to remember clearly the origins of the Common Rule, the basis for the institutional review boards(IRB). But I’m sure you all know that German physicians performed abominable experiments on prisoners during WWII, and these atrocities led to the Nuremberg Code, which articulated 10 principles for ethical research on humans. Even then, many investigators assumed the Code applied only to egregious offenses, and many post-war medical advances were based on research that appears ethically questionable in retrospect. The Tuskegee Study, which withheld treatment from black men with syphilis who lived in an impoverished rural region in Alabama, definitively changed the dialogue. The Belmont Report, released in 1978, codified principles of ethical human experimentation that now constitute the heart of the Common Rule.

My site does not have IRB there for an IRB is not needed. (IRB) play vital roles in protecting human research subjects. They review initial research plans to make certain that the plans provide subjects with adequate opportunity to provide informed consent and do not expose subjects to unreasonable risks. They also conduct continuing review of approved research to ensure that human-subject protections remain in force. They carry out their initial and continuing review functions in accord with Federal regulations first established in the 1970s and applicable to all research funded by the U.S. Department of Health and Human Services or carried out on products regulated by the Food and Drug Administration. The IRB process is rooted in trust, assuming the best of intentions of investigators and sponsors. This tradition makes substantive continuing review suspect. It holds that the IRB’s job is to ensure protections upfront, not to serve as “watchdogs” or “police.” 

The IRBs’ limited efforts in conducting continuing review of active research is a serious national issue because it compromises their protection of human subjects. It inhibits their capacity to identify and address situations where unacceptable risks emerge, or research results prove to be too favorable to continue, or protocols stray beyond approved limits. It also inhibits their capacity to ensure that the subjects have sufficient understanding of the risks they may incur in the research process.

References

Bass, P. F., 3rd, & Maloy, J. W. (2020). How to Determine if a Project Is Human Subjects Research, a Quality Improvement Project, or Both. The Ochsner journal20(1), 56–61. https://doi.org/10.31486/toj.19.0087

Tsan M. F. (2021). Improving the Quality and Performance of Institutional Review Boards in the U.S.A. Through Performance Measurements. Journal of empirical research on human research ethics : JERHRE16(5), 479–484. https://doi.org/10.1177/15562646211018665

Nov 1, 2022, 4:47 AM

I agree with you that the institutional review boards (IRB) play vital roles in protecting human research subjects. Since its foundation, the board has been involved in nursing engagements that have transformed nursing practice (Barker et al., 2018). The Tuskegee Study, which withheld treatment from black men with syphilis who lived in an impoverished rural region in Alabama, definitively changed the dialogue. The institutional review boards entail healthcare experts and other related professionals who review initial research plans. The board can also advise on the best research plans based on its knowledge and understanding (Peled-Raz et al., 2021). They also conduct continuing review of approved research to ensure that human-subject protections remain in force. Different peer-reviewed publication and academic materials from IRB website has enabled nurses to access factual information at ease. The IRB process is rooted in trust, assuming the best of intentions of investigators and sponsors. Therefore, the board acts as a shrewd watchdog in nursing practice.

References

Barker, R. A., Carpenter, M. K., Forbes, S., Goldman, S. A., Jamieson, C., Murry, C. E., … & Weir, G. (2018). The challenges of first-in-human stem cell clinical trials: what does this mean for ethics and institutional review boards?. Stem Cell Reports10(5), 1429-1431. https://doi.org/10.1016/j.stemcr.2018.04.010

Peled-Raz, M., Tzafrir, S. S., Enosh, G., Efron, Y., & Doron, I. (2021). Ethics review boards for research with human participants: past, present, and future. Qualitative Health Research31(3), 590-599. https://doi.org/10.1177/1049732320972333

Nov 2, 2022, 1:39 PM

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It seems great minds think a like. Or as my mom would say… great minds think for themselves. LOL. I just wanted to touch bases on your post regarding the “Belmont Report, released in 1978, codified principles of ethical human experimentation that now constitute the heart of the Common Rule.” As issues such as withholding treatment, protecting the under served population and maleficence are issues that form the bases of the need for IRBs, we must also be aware of how the past continues to deter progress today. For example, the Tuskegee syphilis experiment, has been cited as a reason many African Americans were reluctant to receive the COVID vaccination. As I read this article, I also heard the voices of many of relatives and friends when asked why they opted out of the vaccination. The article states In “Tuskegee today, that 20th century tragedy is still very relevant, according to nurse Cheryl Owens, who grew up in the town. She’s been talking with friends and elderly relatives who say they’re afraid to get the COVID-19 vaccine.

“So, I asked why?” she says. “And it was like, ‘Well, you remember that Tuskegee syphilis study. That’s why.’ “

Unfortunately, minorities are often more likely to suffer from severe complications with the virus. As the article states combating these obstacles is going to require a lot of word of mouth, as reluctance and fear go hand in hand. If you have time to read the article you may find a ray of sunshine as a Tuskegee project survivor reports that he received the vaccination. And also, regardless of your political affiliation, you may find it noble that President Clinton issued a public apology on behalf of the US for the atrociousness associated with the event.

https://www.npr.org/2021/02/16/967011614/in-tuskegee-painful-history-shadows-efforts-to-vaccinate-african-americans

Oct 31, 2022, 6:25 PM

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An institutional review board (IRB) plays a very important part in any new research being conducted within an institution. These groups are designated to review and monitor any biomedical research involving human subjects (Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators, 1998). In general, their purpose is to ensure appropriate steps are taken to protect the rights and welfare of humans participating in research (Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators, 1998). Without an IRB, we would have no standards for the proper treatment of patients in this research. It is just as important to protect the rights of these participants as it is to perform the research in the first place.

Protecting the rights of human test subjects should be of paramount importance to all of us as healthcare providers. However, if our inherent need to do the right thing isn’t enough, federal regulations also require the use of these boards (Human Subjects Protections: Does My Research Need IRB Review?, n.d.). For my DPI project I plan to implement a care bundle to prevent surgical site infections. In my situation the care bundle will have a direct impact on the care being provided to the patient. This could be considered a strictly quality improvement project, but it could still impact the patients involved. In this case IRB review will be necessary to ensure the rights and welfare of the patients are maintained. This is a great example of how this process works.

Human subjects protections: Does my research need irb review? (n.d.). The University of Rhode Island. Retrieved October 31, 2022, from https://web.uri.edu/research-admin/office-of-research-integrity/human-subjects-protections/does-my-research-need-irb-review/#:~:text=IRB%20review%20and%20approval%20is,access%20to%20identifiable%20private%20information

Institutional review boards frequently asked questions: Guidance for institutional review boards and clinical investigators. (1998). U.S. Food & Drug Administration. Retrieved October 31, 2022, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions#:~:text=The%20purpose%20of%20IRB%20review,as%20subjects%20in%20the%20research.

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