The Institutional Review Board (IRB)

| The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations

Another issue with the implementation of Informed consent arises when the patient waives the right to Informed consent and leaves the right to make the decision on the physician. Though legally correct, this can cause psychological stress for the physician especially when the decision is about a life threatening medical condition. Moreover, this also makes the patient vulnerable to abuse. (Manthous, DeGirolamo, 2003)

After termination of the study, the government implemented and has regulated several changes that impact nursing and public policy today. After ethical concerns had been publically raised and the study was terminated, the National Research Act was signed into law in 1974. This policy was used in the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which proved helpful in identifying policy issues such as the lack of identified basic principles of research conduct and lack of informed consent. Regulations were passed according to this panel’s recommendations that required voluntary consent from all persons involved in studies which are funded or conducted by the Department of Health, Education and Welfare (DHEW) (CDC, 2013). For nurses, this involves a responsibility to ensure that research participants are advocated for and the consent being obtained is used as an educational, informative

Respect for human dignity includes two rights; the right to self-determination and the right to full disclosure. When conducting a research study these two rights must be maintained to ensure that the participants are not coerced into participation and that they are making the choice of their own free will. Patients must be provided with all the information necessary to make an informed decision and voluntarily participate. No deception or concealed data collection can be done because it will violate the patients’ rights.

Institutional Review Board is also known as IRB for short. The IRB is in charge of protecting the rights and welfare of the individuals involved in the research. The board reviews the plans for research involving human test subjects. The Food and Drug Administration (FDA) and the Office of Human Research Protection (OHRP) set the guidelines and regulations governing human subject research and IRBs is set.

In 1932, researchers from Tuskegee University conducted a study of the effects of syphilis on untreated subjects. Six-hundred sharecroppers from Alabama, 399 that had previously contracted the disease and 201 that had not, were studied and not treated for syphilis even when Penicillin was found to be an effective cure. This continued until 1972, when information was leaked and the study ended. In response, Congress passed the National Research Act, which stated guidelines for human research and created Institutional Review Boards (IRB). Institutional Review Boards were created to protect subjects of human research, but their authority is so broad that they do more harm than good. They license the research of scientists and have total control

The Belmont principles are a set of guidelines the IRB uses to interpret whether or not a research is ethical. The three principles are Autonomy, Beneficence and Justice. First of all, autonomy requires researchers to treat the subjects as autonomous agents. That is to say, they need to respect the participants’ judgments and their freedom to act upon those judgments. Additionally, researchers cannot influence the participants’ judgements by withholding necessary information with no justifiable reason of doing so. It is also required within this principle to protect those with diminished autonomy. These vulnerable populations include (but not limited to) children, pregnant woman and prisoners. This is because vulnerability and informed consent do not go hand-to-hand. Secondly, the principle of beneficence requires researchers do no harm and

Institutional Review Boards (IRBs) is a committee used in research in the Unite Sates that protects the rights and welfare of people recruited to participate in research (Royse, 2009). The IRBs purpose is to facilitate research and to ensure to protect human participants from harmful, risky or research not respectful of human rights and dignity and to ensure human subjects are protected during their participation. The IBRs are independent committee whom review and approve research. IBRs were established by the 1907s for concern about unethical research experiences oversee research in organizations receiving federal funds, hospitals, and other entities (Royse, 2009). The IBRs boards are usually comprised of professionals who are knowledgeable

“Researchers refer to populations which have low autonomy as "vulnerable populations"; these are groups which may not be able to fairly decide for themselves whether to participate in clinical trials. Vulnerable populations include…the incarcerated/detained, children, women, prisoners, soldiers, migrants, mentally insane or any other condition which precludes their autonomy, and to a lesser

Any human participant is given the right to autonomy, meaning that they can decide whether or not to take part in a study without any pressure. In addition, full disclosure means that researchers must provide all available information about the study, including the person’s right to refuse and risk vs benefits. Finally, the right of justice imply that participants must be treat fairly while also

Principally, the difference between a full and a minimal IRB review is the level of impact the study could have on the study subjects. Subjects must endure almost no physical, psychological, financial, or identifiable duress from the study. Study subjects must possess sufficient mental capabilities to understand the ramifications of the study on the subject. In addition to the previous quality, a subject must feel that they have complete control of their decision-making in relation to the study process. Children, prisoners, pregnant women, and the mentally challenged typify the class of vulnerable populations. This population is of special concern due to an increased possibility of violation of their autonomy.

An institutional review board is an advisory group that has been formally assigned to endorse, screen, and survey biomedical and behavioral exploration including people. They regularly direct some type of risk advantage study in an attempt to figure out or not which exploration must be completed. The reason for the audit procedure is to guarantee, both ahead of time and by intermittent survey, that proper steps are taken to secure the rights and welfare of people taking an interest as subjects in an exploration study. A key objective of IRBs is to shield human subjects from physical or mental damage, which they endeavor to do by looking into examination conventions and related materials. The convention audit surveys the morals of the examination and its routines, advances completely educated and willful cooperation by planned subjects equipped for settling on such decisions (or, if that is unrealistic, educated consent given by a suitable intermediary), and looks to expand the security of subjects.

There was no mention in the article that IRB consent was given. Participants gave implied consent when they agreed to complete the survey. I think that it participants were coerced in completing the survey because they were offered extra credit to complete the survey. I think participants were misled in this survey because I don’t think they knew what was trying to be determined from this survey. I think the Review of Literature was not complete, appropriate to the research question, and unbiased. The references articles used for reference were not current, they were older

Informed Consent must be obtained for all types of human subjects research including; diagnostic, therapeutic, interventional, social and behavioral studies, and for research conducted domestically or abroad. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, the procedures to be undergone, and the potential risks and benefits of participation. Subjects in the study must participate willingly. Vulnerable populations (i.e. prisoners, children, pregnant women, etc.) must receive extra protections. The legal

The project itself had a two-consent process, requiring study subjects to consent to the study as well as a photo release. The photo release served the purpose of using the photos for the public exhibits or any publications related to the study. Additionally, the IRB process also required participants to obtain photo release forms from anyone they photographed. This restricted study participants in ability to photograph, as many wanted to capture essential parts of the daily lives such as family, friends and significant others, but were uncomfortable or unsure of how to explain the release process. As a result, participants brought photos that could not be used, even though they received verbal permission for those photographed, but did not have signed released forms, causing anger and disappointment among many participants. In this instance, the researchers in the study should have utilized extra efforts to thoroughly explain not only the release form but its importance in the study, while also providing the participants with ways to reach them if they needed help explaining or getting others to sign the release form. While the study reports that researches did have conversation about the photograph plans and release, this was not enough to explain the importance or significance of this factor. This lack of understanding caused what could have been a significant part of the