HSCI705 Assignment Institutional Review Board (IRB)

Name

Liberty University  

After the atrocities of the war crimes and Tuskegee experiment, the IRB was created to

protect it participants. Their sole purpose is to ensure that the well being of the participants is protected. 1 THESSALONIANS 5:11 “Therefore encourage one another and build each other up, just as in fact you are doing.” The members of the Institutional Review Board (IRB) come from a wide variety of research subfields as well as the community in which the study is going to be carried out. According to TCNJ (2017), the IRB is an independent body that possesses the authority to validate or invalidate a study, as well as the authority to demand alterations in the way the research is going to be carried out. It should be noted that researchers who will be working with human subjects are expected to submit a request in advance of the beginning of the study that they want to conduct. This is the usual operating procedure.

There are many sorts of IRBs, two of which are accelerated review and full board review. In an accelerated review, the research procedure poses little danger to human participants, therefore only minor alterations may be necessary to have the study approved. It is also worth noting that the federal regulations 45 CFR 46.10 define nine instances where the accelerated review procedure may be applied. Expedited review may also be carried out because of minor revisions already indicated by the entire review board (Kaktins, 2014). The chair of the IRB or a selected reviewer who is a member of the review board may undertake the procedure for an accelerated review. The member or chair is not required to presume that the research exposes the human subject to little or no danger while carrying out the procedure. It is necessary because some components of the research, such as survey or interview questions, may be sensitive and hence expose participants to more than minimum risks. A full board review IRB is one in which the whole committee considers the study proposal. If the research is judged to expose humans to more than minimal danger, it is brought to a full board for evaluation. Furthermore, TCNJ (2017) states that regardless of the method, full board review may be necessary when research includes vulnerable people, sensitive themes, genetic testing, or when the study design is so complicated that it requires the evaluation of many experts.

The study findings are often presented and debated in a series of sessions. According to Kaktins (2014), quorum for such sessions is the total presence of the IRB members. Furthermore, the research is only permitted to proceed if a majority of the board’s members vote in favor of it.

The two forms of IRB reviews are comparable in that they both have the same goal of limiting the risk that participants face, such as discomfort or having their privacy invaded. As a result, it is their responsibility to guarantee that the risk is kept to a tolerable level (TCNJ, 2017). It is also worth noting that the IRB committee members are involved in reviewing the study process in both types of reviews. It is not certain that the research will be authorized. The judgment may be postponed pending the advice of further experts or even rejected.

The two evaluations differ in significant ways. First, an expedited review is only done by one person, who may be the chair or a committee member, but a full board review requires the attendance of the complete review board for the process to progress. It is crucial to remember, however, that the accelerated review may be submitted to the board for a complete review or an evaluation by a subject matter expert.

Informed Consent

ACTS 20:35 “In everything I did, I showed you that by this kind of hard work we must help the weak, remembering the words the Lord Jesus himself said: ‘It is more blessed to give than to receive.” In contrast, informed consent for research purposes entails a process of information exchange between researchers and participants in which people are told about the nature, risks, implications, and relevance of the study (Adams et al., 2017). The decision must be written, signed, dated, and acquired independently and freely by the client or participant in both circumstances. To be considered meaningful, genuine, and full, informed consent must meet four major criteria. The first is information disclosure, which states that the patient should be provided adequate information in a way that allows them to receive, comprehend, and process it to make autonomous decisions. This condition is met by ensuring that throughout disclosure, subjective, reasonable patient and physician criteria are followed (Shah et al., 2021). The second meaningful informed consent principle is competence, which argues that the patient should be able to make an educated clinical choice. The third condition is understanding, which means that the patient must comprehend the facts offered to them, and the fourth criterion is voluntariness, which means that permission should not be coerced (Kadam, 2017). However, because patients' decision-making capacity might be constrained by a variety of conditions, adopting informed consent can pose a multitude of ethical and legal challenges. These include the lack of time, the patient’s inability to comprehend difficult material, lengthy consent forms, fear and anxiety around new treatments, cognitive and other limitations that may impede competency, and lengthy consent forms. (Kadam, 2017)

Limitations of Informed Consent

GALATIANS 6:9 “Let us not become weary in doing good, for at the proper time we will reap a harvest if we do not give up.” There are many limitations When it comes to research projects, vulnerable groups are frequently placed in a disadvantaged position. It’s possible that they’ll have a harder time understanding the information that’s being presented to them, or that they’ll have a stronger impression that they’re being coerced into taking part in research. There is merit in considering each of these ideas. The criteria for informed consent contribute to the protection of vulnerable populations by ensuring that individuals within those populations are given all the information they require to make an educated choice about whether or not to participate in an activity. This choice may be whether to take part in the activity in question. In addition, participants in a study are given the opportunity to withdraw at any moment during the research if they determine that they are not comfortable with either the potential hazards or the potential benefits.

Another issue that could go wrong with vulnerable populations is that they might be underrepresented in research, and it is a possibility that they could even be denied the potential benefits of participating in research because of fears about their capacity to give informed consent. 

References:

Adams, P., Prakobtham, S., Limpattaracharoen, C., Suebtrakul, S., Vutikes, P., Khusmith, S.,Wilairatana, P., Adams, P., & Kaewkungwal, J. (2017). Ethical issues of informed consent in malaria research proposals submitted to a research ethics committee in Thailand: A retrospective document review. BMC Medical Ethics, 18(1). https://doi.org/10.1186/s12910-017-0210-0

Bustillos, D. (2013). Health care ethics and medical law. San Diego, CA: Bridgepoint

Education, Inc.

Cordasco, K. M. (2013). Obtaining Informed Consent from Patients: Brief Update

Review Retrieved October 1, 2022, from http://www.ncbi.nlm.nih.gov/books/NBK133402/

Farmer, L., & Lundy, A. (2017). Informed consent: Ethical and legal considerations for

advanced practice nurses. The Journal for Nurse Practitioners, 13(2), 124-130. https://doi.org/10.1016/j.nurpra.2016.08.011

Kadam, R. A. (2017). Informed consent process: A step further towards making it meaningful! Perspectives in clinical research, 8(3), 107– 112. https://doi.org/10.4103/picr.PICR_147_16

Kaktins, N. M. (2014). Faculty guide to the institutional review board process. Nurse educator, 34(6), 244-248.

TCNJ. (2017). Institutional Review Board - IRB. Retrieved from https://irb.pages.tcnj.edu/typesof-irb-review/

31 Bible Verses About Helping Others — GO InterNational. (2021, April 27). GO InterNational. Retrieved October 2, 2022, from https://www.gointernational.org/news/bibleverses-about-helping-others