The Process of Research: The Institutional Review Board

1524 Words4 Pages

Introduction During the process of research, professionals collect data or identifiable private information through intervention or interaction. While this is a vital part of the scientific and medical fields, every precaution must be taken by researchers to protect the participants' rights. Ethics, outlined by the Belmont report; requirements, described by the Department of Health and Human Services (DHHS); and regulations, laid out by the Food and Drug Administration (FDA) are verified by an Institutional Review Board (IRB). This procedure assures that all human rights are safeguarded during the entire research process. The Institutional Review Board The IRB is an administrative body which has been established to make sure research participants' rights are protected. IRBs review all aspects of the researchers' project: the study design, the recruitment process, the participant population, the informed consent document and process, the risk/benefit ratio, privacy and confidentiality, data storage and protection, and safeguards for vulnerable participants (University of St. Francis, n.d.). In this way, participants' rights are protected because the effort is made even before the research begins. The review process ensures that participants are chosen fairly and informed adequately and the information collected during research is safeguarded through collection, use, and storage. Research using human participants is such an important part of medicine that it is imperative it is performed in a way that its intrigue is not compromised. The Institutional Review Board Process Applying for exempt research study approval from the IRB at the University of St. Francis involves submitting a copy of the work, an application, and a... ... middle of paper ... ...ects of their study before presenting it to an IBR to be certain it does protect the particpants' rights of respect, beneficience, and justice. Research is an important component of medical advancement; but only if it is performed in an ethical way following all requirements and regulations. Works Cited U.S. Department Of Health & Human Services (2013). Health information privacy. Retrieved from http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/research/ The University Of Iowa (2014). A summary of the Belmont report. Retrieved from http://hso.research.uiowa.edu/summary-belmont-report University Of St. Francis (2010). Institutional review board: Policy manual. Retrieved from https://www.pdffiller.com/en/project/18274764.htm?form_id=19363729 University Of St. Francis (n.d.). Cutting through the red tape: A guide to navigating the IRB [PowerPoint slides].

Show More
Related

  • 4. Why Is Deception Sometimes Used In Psycho-Logical Research?

    1278 Words  | 3 Pages

    Institutional review boards (IRBs) were put in to place to assure the health and safety of all research participants and to make sure all research is being conducted to the APA’s standard of ethics. Since people without specialties are required to be one each panel it is often times argued that many propels are denied because these boards may fail to get the merit of the work due to a lack of understanding the material. People also argue that the boards may not be focused enough on psychological studies and based in the medical field. This requires the researchers to add irrelevant content to their studies. IRB’s

    Read More

  • Government Testing on Human Subjects and the Intricacies of Informed Consent

    2010 Words  | 5 Pages

    Coleman, C. (2005). The ethics and regulation of research with human subjects. 3–50.50 Code of Federal Regulations, 46(102).

    Read More

  • Institutional Review Board (IRB)

    268 Words  | 1 Pages

    All colleges in the United States who offer doctorate degrees have an Institutional Review Board (IRB). The purpose of this protocol is for the protection of human subjects used in research studies. During the dissertation process, the third milestone is the IRB application and approval process. Once the Dissertation Proposal is approved, the doctoral candidate must submit the IRB application for approval from the IRB. Because data collection requires the approval from IRB,

    Read More

  • Essay On Cancer Chemoprevention

    1663 Words  | 4 Pages

    To sum things up, the ethical demeanor of research involves respect for the safety and rights of subjects during the sequence of the trial. This includes protecting privacy and confidentiality, monitoring the condition of research subjects to assure their safety, terminating study participation in the case of hostile events, and notifying enrolled subjects about new risks, benefits, or other information that may bear upon subjects’ decisions to continue enrollment in the research. As new evidence shows itself, trial investigators and data safety monitoring boards (DSMBs) can alter the study plan, initiate notice of enrolled subjects, make changes to the informed consent policies, or stop the trials earlier than intended. Investigators should soon classify a technique for ensuring effective communication between the IRB and DSMB throughout these studies.

    Read More

  • Ethnographic Study In Nursing Practice

    875 Words  | 2 Pages

    3). By receiving approval, it can be inferred that the study was ethically acceptable and the rights of the participants are protected (Houser, 2015, p. 61). To ensure human subjects are protected during research studies, researchers use three ethical principals: respect for persons, beneficence and justice (Houser, 2015, p. 52). Respect for persons protects the individuals right to make their own decisions, beneficience is do not harm, and justice provides the right for every individual who wants the opportunity to partipate in the study can (Houser, 2015, pp. 52-53). Respect for persons was protected by the researchers because they provided informed consent prior to data collection, data collection would remain confidential, and the participants can withdraw from the study at any time (Bjerknes & Bjork, 2012, p. 3). Beneficence was protected in this study because the researcher wasn’t an employee from the hospital; this allowed new nurses’ to share their perceptions freely, preventing any fear of retribution from being honest (Bjerknes & Bjork, 2012, p. 3). Justice was not clearly stated in this study because the researchers did not clearly state if the study was open to all new nurses on all the wards of the hospital (Bjerknes & Bjork, 2012, p.

    Read More

  • Improving Effectiveness of Informed Consent Process

    1840 Words  | 4 Pages

    Informed consent has been preserved as a sacred value since medicine started caring for the sick and it is still upheld today as a critical component of clinical research. Ensuring voluntary participation through an informed decision-making process in clinical research continues to be an ethical and moral obligation of the study team, quite often the study nurses. Over time these forms have reached a degree of unreasonableness; exceeding twenty pages, being too complex, and readability that exceeds the targeted populations. A deluge of literature over the past decade reaffirms and begs for change. In 2011, the federal government agency, Office of Human Research Protections, has responded by publishing and receiving comments on an Advanced Notice of Proposed Rule-Making (ANPRM); however, there has been no further public information of action. This brief aims to provide an overview of the issues, background, as well as several possible ways to lobby for action.

    Read More

  • Institutional Review Board Summary

    608 Words  | 2 Pages

    The purpose of the Institutional Review Board (IRB) is to ensure that all human research conducted is in accordance with federal guidelines, any institutions, and most importantly all ethical guidelines are enforced. The IRB is also known as the Independent Ethics Committee (IEC) is a committee assign to review, monitor and type of human research to ensure determined the type of research being proposed and to provide protection to the researcher from any violation of human rights, and safety and dignity to all individuals conducting research. There has been known times there are difficult interactions between the IRB and the investigator assigned to the research review (Fitch,

    Read More

  • Ethical Issues In Clinical Research

    1223 Words  | 3 Pages

    In the United States, the basis for ethical protection for human research subjects in clinical research trials are outlined by the Belmont Report developed in the late 1970’s. This document, published by the Nation Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, highlights three important basic principles that are to be considered when any clinical trial will involve human research subjects. They are; respect for persons, beneficence, and justice. (Chadwick & Gunn, 2004)

    Read More

  • Institutional Review Board Pros And Cons

    310 Words  | 1 Pages

    Institutional Review Board (IRB) is a group of people established to evaluate and monitor all research involving human subject. This group have the authority to approve, require changes to obtain approval and disapprove research. The group review a crucial role to provide perfect protection of human research subject. The primary purpose of IRB is to protect people who participate in the study and to make sure the steps are right. Consent form is one of the important part in the IRB approval to be given to the person who will participate in the study. Also, explain the benefit and risk of the study.

    Read More

  • The Goal: A Process of Ongoing Improvement

    1122 Words  | 3 Pages

    [1] Goldratt, Eliyahu M. and Cox, Jeff (2004). The Goal: A Process of Ongoing Improvement. Retrieved from http:// ishare.edu.sina.com.cn

    Read More

  • Ethics of the Nuremberg Code

    1060 Words  | 3 Pages

    Looking beyond the Nuremberg Code and applying it to modern medical research ethics, there are many challenges that it poses. Many have argued that the Code tries to provide for all unforeseen events, which restricts the researcher by requiring him to anticipate every situation, demanding the impossible. The most important contribution of the Code is the first principle, which says that voluntary consent of the human subject is absolutely essential. The subject involved should have legal capacity to give consent, should have free power of choice, as well as sufficient knowledge and comprehension of the experiment. This restricts that populations upon which some experiment may be conducted, since many do not have “legal capacity”. For instance, studies of mental illness and children’s diseases have been curtailed because neither of these populations has the legal capacity to give consent. Another group of people, prisoners, are never really able to give voluntary consent since they might be enticed by financial rewards, special treatment, and the hope of early release in exchange for participating in the human experimentation projects. British biostatitcian Sir Austin Bradford Hill also questioned whether it was important to inform a research subject who was receiving a placebo since it does...

    Read More

  • Institutional Review Board Reflection

    315 Words  | 1 Pages

    By participating in these sessions, I learned the importance of IRBs in protecting human subjects from any physical or psychological harm as well as protecting the investigators from falling into legal and ethical problems which might affect their reputation and future carrier. Taking decision sometimes is complicated and required weighing risk-benefit in an attempt to determine whether

    Read More

  • Ib Regulation

    606 Words  | 2 Pages

    The IRB, or institutional review board, serves to either approve or deny biomedical and behavioral research. The IRB was created after several cases of inhumane treatment or improperly conducting or performing experiments. Therefore the IRB was created to help regulate and prevent such catastrophes from happening again. However, much has changed now. I believe that there is an issue with regulations and procedures that govern research regarding human subjects. There needs to be smart, streamlined regulation rather than numerous regulations that prevent creative experiments or tests that may push the boundaries, within reason, to provide knowledge. Furthermore, certain regulations by the IRB are extraneous. This is why there needs to be a change to smarter regulation within the IRB.

    Read More

  • IRB Role In Biomedical Research

    727 Words  | 2 Pages

    • Follow written procedures for conducting initial trial and continuing review of research and reporting those findings to the investigator, giving priority to the project review first and more often, ensuring that no changed have been made before approved by IRB except where necessary to eliminate apparent immediate hazards to human subjects.

    Read More

  • The Ethical Structure Behind Human Experimentation

    3400 Words  | 7 Pages

    The history of medical research in the twentieth century provides abundant evidence which shows how easy it is to exploit individuals, especially the sick, the weak, and the vulnerable, when the only moral guide for science is a naive utilitarian dedication to the greatest good for the greatest number. Locally administered internal review boards were thought to be a solution to the need for ethical safeguards to protect the human guinea pig. However, with problems surrounding informed consent, the differentiation between experimentation and treatment, and the new advances within medicine, internal review boards were found to be inadequate for the job. This led to the establishment of the National Bioethics Advisory Commission by President Bill Clinton in the hopes of setting clear ethical standards for human research.

    Read More

More about The Process of Research: The Institutional Review Board

Open Document