Preview

Institutional Review Boards

Good Essays
Open Document
Open Document
690 Words
Grammar
Grammar
Plagiarism
Plagiarism
Writing
Writing
Score
Score
Institutional Review Boards
Running Head: UNIT 5 ASSIGNMENT

Unit 5 Assignment Template
Candeece Lucas
July 21, 2014
HN410 - Human Services & Delivery
Kaplan University

IRB is an abbreviation for the institutional review board. Informed by the need to review human biomedical and behavioral research to the mutual benefit of the researcher and the sample population oversight, responsibilities have to be designated to an impartial body. In light of this, the IRB is also commonly referred to as the independent ethics committee or the ethical review board. Indeed, biomedical and behavioral research on humans is not a light discipline as some of the research tenets border on life and death. It is thus important to evaluate whether the research being conducted has manageable or no risk to the human being. The IRB thus comes in by performing a risk benefit analysis aimed at identifying whether or not the research in question should be conducted or not (Byerly, 2009). It is therefore noteworthy that IRB is informed by facts in terms of risk to determine whether the research in question is worthwhile and can be conducted.
As earlier identified, the priority for IRB is to protect the human subjects involved or ensure that those involved in the research do not face physical or psychological harm. In the United States for example, the IRB has divided the mandate to the food and drug administration (FDA) and the department of health and human services. The IRB has three identifiable methods of review namely: exempt review, expedited review and full review. The exempt review invoked by IRB is where the research that the party wants to conduct is exempt from the regulations. Given the fact that IRB draws her regulatory authority through law and policies in place, these policies and laws also provide situations where the researcher is exempt from these requirements. It is noteworthy that despite the exemption requirements, the researcher has to seek the exempt review from



References: Byerly, W. (2009). Working with the institutional review board. American Journal of Health-System Pharmacy: AJHP: Official Journal Of The American Society Of Health System Pharmacists, 66(2), 176-184. Retrieved from http://library.kaplan.edu/content.php?pid=150035 Grady, C. (2010). Do IRBs protect human research participants? JAMA, 304(10), 1122-1123. Retrieved from http://jama.jamanetwork.com/article.aspx?articleid=186530 Millum, J., & Menikoff, J. (2010). Streamlining Ethical Review. Annals of Internal Medicine, 153(10), 655-W.219. Retrieved fromhttp://library.kaplan.edu/content.php?pid=150035

You May Also Find These Documents Helpful

  • Better Essays

    Fda Research Paper

    • 2368 Words
    • 10 Pages

    Leonard, E. (2009, Summer). Right to experimental treatment: FDA new drug approval, constitutional rights, and the public 's health. Journal of Law, Medicine & Ethics, 37 (2), 269-79. doi:10.1111/j.1748-720X.2009.00371.…

    • 2368 Words
    • 10 Pages
    Better Essays
  • Good Essays

    Dr. Haslet's Case Summary

    • 1352 Words
    • 6 Pages

    Beringers request and argue that being a research subject is not the right way to go because it’s risky and especially in this case where they have to cut a hole in the skull which is dangerous and could cause more harm to Dr. Beringer overall. An IRB member could say that we need to follow the principle of beneficence. The principle of beneficences says that we should the most good to others and avoid doing them harm. They would say this because Dr. Beringer would suffer in the long run as she would not benefit from the research. They could say she would not benefit from the research because it would take many years to even come up with technology for vision restoration. They could also say that the risk of the procedure is too dangerous to be performed on a human subject who does not need there skull opened for any reason and the procedure would only be for mere research. I would argue that this IRB member who votes against the request Dr. Beringer and Dr. Haslet would be restricting Dr. Beringers autonomy. This restriction of autonomy relates to the principle of paternalism in this case. The principle paternalism is the overriding of a person’s action or decision making for their own good. Since this IRB member would vote against Dr. Beringers request they would go against her voluntary decision to be a research subject. I would argue that she is an informed voluntary subject and understands the information being given to her by Dr. Haslet as she is a retired biology professor and is knowledgeable. She also understands the risk she is getting into as a subject and she can overcome this risk because she produce more good for people who have impaired vision and researchers as well by providing new information for new technology. Another argument that could arise from an IRB member to vote against the request of Dr. Beringer could argue that her decision to be a subject could not be the right…

    • 1352 Words
    • 6 Pages
    Good Essays
  • Good Essays

    CONSORT1 Task 3

    • 434 Words
    • 2 Pages

    The author mentions that this study was approved by the “National Health Service South-West 3 Research Ethics Committee (10/H0106/13)” (Betts et al, 2014). This study meets the conduct and procedures that were set by the Consolidated Standard of Reporting Trials (CONSORT) guideline. Diagrams, flow charts, and descripted details and rational for that aligns with the CONSORT guidelines can be obtained online.…

    • 434 Words
    • 2 Pages
    Good Essays
  • Satisfactory Essays

    A. The IRB is the board that maintains the Human Research Protection Program. The functionality of this board is to insure ethical reviews of research studies to ensure compliance of all federal, state, and local areas.…

    • 875 Words
    • 4 Pages
    Satisfactory Essays
  • Good Essays

    This is because a human life is valued more than any other subject used in clinical trials. In order to ensure the efficacy and legitimacy of treatment, human subjects are the most accurate compared to animals. Human subjects cultivate concrete information and data necessary for the improvement of medicine and health care as a whole. Baillie, McGeehan, T.M. Garrett, and R.M. Garrett (2013) stated, “…human experimentation is necessary for medical progress. Animal testing is useful, but it cannot provide the final word on either safety or efficacy” (p. 300). On the contrary, this does not excuse the researcher from disregarding a clinical participant’s life and safety. According to Baillie et al. (2013), humans are not objects that are used however the researcher desires (p. 293). Human experimentation, conversely, has a long history of abuse. Many rules and guidelines have been set in place to prevent researchers from taking advantage of human subjects all in the name of “science”. Due to these unfortunate events, Institutional Review Boards (IRBs) have been established to protect and oversee the organization and conduction of human experimentation (Baillie et al., 2013). One historical event that led to the development of stringent biomedical experimentation rules and guidelines was the Tuskegee syphilis research experiment (Head, 2012). This experiment was widely acknowledged and is known as…

    • 1010 Words
    • 5 Pages
    Good Essays
  • Good Essays

    Tuskegee Syphilis Study

    • 212 Words
    • 1 Page

    The study conducted by Katz at al. (2008), about the willingness of people to participate in research following the Tuskegee syphilis study was conducted ethically. This study involved two different races and took information from three different states (Katz et al., 2008). This study did not involve just one race unlike the original Tuskegee syphilis study. The researcher of the article got institutional review boards (IRB) approval from both The University of Connecticut Health Center and New York University (Katz et al., 2008). The IRB purpose is to “ensure that the proposed plans meet federal requirements for ethical research” (Polit & Beck, 2017, p. 151). Having IRB approval is vital when conducting a research and plays a crucial role…

    • 212 Words
    • 1 Page
    Good Essays
  • Better Essays

    Psyc 255 Synthesis Paper

    • 1264 Words
    • 4 Pages

    After gaining a clear understanding in regards to research, I’ve learned that it’s not necessarily what we find out from research but, where we gathered the information. We always need to be concerned with how we went about finding the information. With all information gathered, we must also gather participants. It is important to gather all participants to find the most accurate results, as well as ensuring equal treatment of all participants. One major step to ensure proper treatment is to gather informed consent. By doing so, this allows all participants to understand all parts of research that may affect their decision in participating. This obviously doesn’t indicate that we have given full disclosure, so that it doesn’t affect our end results. A safeguard is put in place to…

    • 1264 Words
    • 4 Pages
    Better Essays
  • Good Essays

    Currently, the Institutional Review Board (IRB) requires informed consent from participants in any research study (p. 50, 42). Although the IRB did not exist until the 1970s, after the conclusion of the Tuskegee Syphilis Study, there were certainly laws and measures put in place to prevent mistreatment of research participants that came about during the near half-century duration of the experiment. As stated previously, the Tuskegee Syphilis Study began with 600 black men. The researchers chose an impoverished town with the understanding that these men would be willing to participate and also not have the background to recognize or resist any unreliable factors in the study. The men of the Tuskegee Syphilis Study were deceived about the…

    • 751 Words
    • 4 Pages
    Good Essays
  • Satisfactory Essays

    As part of this research project it was necessary seek ethical consideration from the university (See Appendix A) to gain ethical approval. This form was completed with support from a research supervisor, and submitted to the ethics committee to consider the application for the research project. The ethics committee are required to scrutinise all research proposals to establish if they raise ethical issues. Ethical issues that may have been considered are: transparency, publicness and replicability (Malcom,…

    • 380 Words
    • 2 Pages
    Satisfactory Essays
  • Satisfactory Essays

    example that ethics can have a very powerful influence on research. If your ethics are not…

    • 297 Words
    • 1 Page
    Satisfactory Essays
  • Good Essays

    Below is a summary of a nursing study. Read the summary and then answer the factual questions that follow:…

    • 312 Words
    • 2 Pages
    Good Essays
  • Better Essays

    When determining ethical guidelines for research, most experts agree that cost of conducting the experiment must be weighed against the potential benefit to society the research may provide. While there is still a great deal of debate about ethical guidelines, there are some key components that should be followed when conducting any type of research with human subjects. All ethical research must be conducted using willing participants. Study volunteers should not feel coerced, threatened or bribed into participation.…

    • 1007 Words
    • 4 Pages
    Better Essays
  • Good Essays

    Anthropology Op-Ed

    • 688 Words
    • 3 Pages

    The Institutional Review Boards is a board that has been properly designed to approve, monitor, and review biomedical and behavioral research involving humans. The research must protect human research participants from undo harm by following the three basic ethical principles: Respect for Persons, Beneficence, and justice. The common rule has uniformed set of rules to protect human subjects that is followed by the IRB. In other countries, different names might be used for these committees. Such as in Canada where it is called Review ethics Boards who also review research done on human subjects taking in consideration their rights, values, and dignity.…

    • 688 Words
    • 3 Pages
    Good Essays
  • Powerful Essays

    Informed Consent

    • 2404 Words
    • 10 Pages

    “Human Subject Research Legislation in the United States.” Wikipedia. Wikimedia Foundation, 9 Dec. 2012.Web. 8 Mar. 2013.…

    • 2404 Words
    • 10 Pages
    Powerful Essays
  • Good Essays

    It is often claimed that the use of animals in testing is extremely dramatic and taxing on the animal’s health, and ultimately livelihood. While this is true in some cases, there are extreme restrictions on what scientists and researchers are allowed to do to these animals. With the most notable restrictions in the United Kingdom, where every researcher must have his procedural steps approved by a government organization known as the Home Office or HO, in England (Jha). The HO’s job is to first decide whether the use of animals is necessary, then to weigh the benefits of the research to the effect it has on the animals, and finally to minimize the suffering that the animal may endure by refining the process. This is known as the “three R’s”, which stands for Replacement, Reduction, and Refinement (Banner, 35). After all of these steps are taken, animals are finally allowed to be used in the research, while in the most humane possible way. This is especially implemented when used on primates (monkeys), where they are seen to have more human like qualities and minds, and seen to have a greater risk of having mental or physical discomfort (Randerson). Although it is more heavily implemented in primates, it is also taken in to great consideration for rats, mice, and fish that make up 95% percent of all research subjects (“Mice and Rats”). This should be especially pleasing,…

    • 1470 Words
    • 6 Pages
    Good Essays