Institutional Review Board process
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Please attached examples from
My colleagues for this topic
Topic is
“Each student should self-reflect on the IRB submission process and address:
What was the most difficult part of the IRB process?
Why is the IRB process necessary?”
Example 1
What was the most difficult part of the IRB process?
The Institutional Review Board (IRB) approval process can be long-winded. The IRB’s extensive review time has been a known impediment on research1. Due to the wait on approval many clinical human trials are stalled. Waiting for the permission can affect the study, the patient population, and the intervention. Much research is abandoned when investigators must undergo this lengthy procedure1. Misunderstanding the IRB process in conjunction with unpredictability of the IRB can cause confusion in investigators2. Though the IRB tries to follow protocol there is no set time or guarantee when one’s research will be approved. There are several factors that contribute to the delay in approval. Incomplete applications, complexity of research, failure to comply with additional requested information are some reasons why there can be a lag in approval1. Shoenbill et al states that due to the IRB process and inconsistency there has been obstruction and delays in institutional research projects. Evidently, the most challenging part of the IRB process is awareness of the indefinite duration of the approval process but also understanding the many moving parts.
Why is the IRB process necessary?
The IRB process is a system in place to have checks and balances on future research. The IRB mandates and regulates studies that are geared towards human investigation. The objective of IRB is to protect the well-being and rights of human participates created by federal guidelines1,3. The work of the IRB allows for ethical procedures to be adhere to by researchers or Principal Investigators (PI). To conduct research, one must know and understand the regulations set in place by the IRB3. Human research is imperative but can be an extensive process2. It is important to have structures in place that not only navigates a PI through an approval process but for thorough and just research. Shoenbill et al outline the criteria set by federal regulations that enforce human rights. The criteria include, protection for susceptible participants, patient safety through data monitoring, reasonable selection of participants, informed consent documentation, analysis of risk and benefits, privacy and confidentiality2. The IRB process is necessary because it regulates and standardizes research all while providing protection for human subjects.
Reference
1. Spellecy R, Eve AM, Connors ER, Shaker R, Clark DC. The Real-Time IRB: A Collaborative Innovation to Decrease IRB Review Time. J Empir Res Hum Res Ethics. 2018;13(4):432-437. doi:10.1177/1556264618780803
2. Shoenbill K, Song Y, Cobb NL, Drezner MK, Mendonca EA. IRB Process Improvements: A Machine Learning Analysis. J Clin Transl Sci. 2017;1(3):176-183. doi:10.1017/cts.2016.25
3. Phillips MS, Abdelghany O, Johnston S, Rarus R, Austin-Szwak J, Kirkwood C. Navigating the Institutional Review Board (IRB) Process for Pharmacy-Related Research. Hosp Pharm. 2017;52(2):105-116. doi:10.1310/hpj5202-105
Example 2.
Institutional Review Board
The Institutional Review Board (IRB) is a federally mandated organization that oversees the safety and welfare of humans participating in research.1 The IRB is necessary to protect human subjects, specimens, and data during medical interventions, observations, or other processes conducted for generalizable knowledge.2 The IRB was established to ensure ethical, moral, and humane treatment of research subjects and focuses on assuring there is minimal risk to human research subjects.1 The IRB seeks to protect all humans, particularly vulnerable individuals such as pregnant women, human fetuses, neonates of uncertain viability, prisoners, children, those involuntarily committed to a medical facility, students, educationally disadvantaged persons, those with language barriers, those with a cognitive disability, mentally disabled persons, and patients with life-threatening medical situations.2 Any investigator wishing to conduct a research study on human subjects must first apply for approval through the IRB.
The process of review and approval by the IRB can be challenging. First, the application involves meticulous thought and planning. Investigators must detail all research procedures, any possible risks, and protocols for managing any unforeseen risks to human subjects during the study. Also, certain local, state, and federal organizations need to be notified of proposed research studies on human subjects. Lastly, the turnaround time from application submission to to the time of IRB approval can take several weeks to several months. Until then, all parties involved in conducting the research will need to be on standby, ready to jump into action the moment the IRB approves the study.2 In the event the IRB requests more information from the investigator regarding the study, it is expected the IRB approval process will take even longer. Therefore, the investigator must know what information the IRB will need and go above and beyond to provide detailed information in the initial application.
Informed consent is emphasized during the IRB review process as it ensures that all individuals participating in the research understand the potential risks and their rights as a participant.2 Constructing informed consent documents in a manner that the layperson can understand is important. The informed consent must thoroughly explain the purpose, overview, and procedures of the study. Furthermore, participant requirements, risks, benefits, compensation, and use of their personal information must be detailed.2 Their confidentiality and rights must also be explicitly disclosed.2 Counsel by a legal advisor may be appropriate to ensure participant protection is addressed in the informed consent. This all occurs before the research study application is submitted for review by the IRB. After approval, a great amount of time must be spent to review the consent form with all potential participants and address any questions or concerns they may have.2
A common reason that the IRB would mount an incident report against a research study is due to serious noncompliance.2 Investigators that deviate from the initial investigation plan, fail to adhere to inclusion or exclusion criteria, or neglect the importance of obtaining informed consent will be held accountable.2 Submitting a research study on human subjects takes a great deal of preparation. It also takes patience with the IRB review process, but the benefits of persistence expand our general knowledge of humanity.
References
1. Grady C. Institutional Review Boards: Purpose and Challenges. Chest. 2015;148(5):1148-1155. doi: 10.1378/chest.15-0706
2. Lapid MI, Clarke BL, Wright RS. Institutional Review Boards: What Clinician Researchers Need to Know. Mayo Clinic proceedings. 2019;94(3):515-525. doi: 10.1016/j.mayocp.2019.01.020
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