Institutional Review Board Advantages And Disadvantages

Studies like the one in the Film “The Deadly Deception” where unethical studies with someone being experimented on and the tester didn’t fully explain the risks and the real dangers involved but the

One research study conducted in the United States that violated the rights of subjects or involved ethical misconduct was the Willowbrook study.  This study was conducted from the mid 1950's to the mid 1970's where Dr. Saul Krugman intentionally introduced hepatitis to mentally challenged patients where they were institutionalized (Rothman, 1982).   According to Rothman (1982), Dr Krugman states; "It is our duty and our right to perform an experiment on man whenever it can save his life, cure him or gain him some personal benefit” (p. 6).  This type of practice is not only unethical with no justification for the study, it did cause harm to a vulnerable population.  The participants in this study not only contracted hepatitis, they suffered complications from hepatitis,

In 1974, the National Research Act was signed into law. This led to the creation of the National Commission for the Protection of Human Subjects of the Biomedical and Behavioral Research. This policy change involved new principles to govern research conduct and ways through which these principles were to be followed. Also in addition, laws were passed in 1974 that required researchers to get adequate, voluntary and informed consent from all persons taking part in studies done or funded by the Department of Health, Education and Welfare (DHEW). A law was also made to make it a requirement that all researches involving human subjects be reviewed by Institutional Review Boards.

The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Retrieved December 13, 2011, from hhs.gov/ohrp/humansubjects/guidance/belmont.html

when completing a task, there are often rules and guidelines that need to be followed. Institutional Review Boards, also known as IRBs, are put in place to make sure rules are followed when they approve research done on human subjects of bio-medical and behavioral research. Two of these rules are that risks to subjects are minimized and risks to subjects are reasonable in relation to anticipated benefits. I believe that IRBs are needed when doing research, but need better understand, and be more aware about what is happening during the experiments.

Potential grave consequences that can result from irresponsible, or criminal, medical experiments. While we must be vigilant to protect innocent victims from such experimentation we cannot let that stifle our duty to continue making advances in healthcare and improving the lives of patients.

Institutional Review Boards (IRBs) are groups that are formally designated by an institution to protect the rights and the welfare of human subjects. This is done by reviewing, approving and monitoring the medical research (Layman & Watzlaf, 2009). However, in order to do this efficiently, there are 3 ethical theories that the IRB must rely on. The first theory is beneficence which means “do no harm/promote good”. The second theory is autonomy, and the third theory is justice. Furthermore, IRBs review all the research that is conducted via data sources regarding human participation (i.e. medical records, tumor registry, and Medicare data). That said, IRBs are important because they help protect the rights and welfare of those participating

Now we have the Belmont Report and the Declaration of Helsinki to guide researchers in the most ethical direction when they are conducting their research for studies. Luckily now researchers have to basically write out their entire plan throughout the study step by step. They must write out any way that the human subject may be harmed, what they will do if someone is harmed, any potential costs, and much more. Once all of this is written out researchers then have to get their study approved before they can move forward with their study (Neutens & Rubinson, 2014). The steps that have to be taken to conduct research may seem like a lot, however, it may save a lot of time and energy in court if something happens to go wrong during the trial.

In an article by “Vulnerable individuals represent a broad and vaguely defined group of people. Participants can be said to be vulnerable to the extent that their ability to give informed consent may be affected by physical, mental or emotional responses to their situation” (Nordentoft & Kappel, p. 369). When planning a research project, a researcher or IRB should consider the vulnerable participant as there is often diminished capacity to participate in their care thereby bringing into question the validity of understanding informed consent and the ability to withdraw from participation at any time. The Institutional Review Board (IRB) serves to protect vulnerable populations such as children, prisoners, pregnant women, and the physically

One of the tasks typically performed by an institutional review board (IRB) is ensuring the protection of participants in research proposals through risk–benefit ratio. The risk–benefit ratio requires the IRB to determine if there are any physically, psychological or legal risks to the participants in a research proposal. If risk is found to be a factor (such as side effects from medicine); the IRB makes a decision based on the balance between the risk the participants will be exposed to and the amount of good that will result from the study. The IRB concludes that the research will not be conducted if the risk out weights the benefits. However, if the risk does not outweigh the benefits of the result; the IRB gives the

Historically speaking, the treatment of humans and animals has been poor in the name of research. Instances such as those occurring in Nuremburg and Tuskegee set forth a foundation for governance in research of human subjects. Respect of the individual’s autonomy and the beneficence must be demonstrated in the study.

Directing and implementing research this summer has increased my understanding of the time and effort it takes to effectively accomplish a desired study. This study has given me first-hand experience into the field of research, while increasing my interest in connecting research to a part of my future career. In social work and psychology, research is constantly incorporated to evaluate social norms, effective treatment plans, and case studies. Each research study is conducted differently, but seems to follow a similar pattern of tasks and goals in order to complete a study effectively. I found myself learning the most about the research process during the submission of my IRB. Even though I have taken advanced research classes at Grand Valley State University, I have not been required to submit an IRB for our study due to the minimal harm we had for the participants. For this study, Dr. Youker and myself spent over a month developing our proposal for the IRB and found ourselves constantly critiquing the requirements needed to ensure that our participants were safe during our study. The IRB process created a great amount of stress in my research process due to the constant editing, but it gave me an understanding for why ethics are in place to keep participants safe. This process allowed me to create guidelines that included exactly types of yoga participants would be participating, ways to prevent physical harm during classes, and reflect on the process needed to evaluate

One ethical principle is that of respect for persons who are involved in the research. According to the Belmont Report (1979) this principle should honor a person and their autonomous choices, however, the report observes that not all individuals are “capable of self-determination” (sec. Part B 1. Respect for Persons). This incapability requires that those persons be protected (Belmont Report, 1979). Wertheimer (2011) corroborates this in stating that group soft-paternalism is implicit that research should not capitalize on or abuse vulnerable populations, or those population groups who are not able to make rational self-determination. The presence of group soft-paternalism by Wertheimer (2011) in exploiting vulnerable groups also supports the Belmont Report (1979) ethical principle of justice. This principle ensures that persons selected for research are not merely being selected based on their vulnerability (Belmont Report, 1979, sec. Part B 3.

Class notes conclude, “1974 legislation requires IRB’s to “protect human subjects from research that is risky, harmful, or does

The IRB’s role is to protect human subjects and to hold researchers accountable for the way in which information is collected and utilized for research (Sontag, 2012). Research must undergo a formal review process, which for many researchers may appear to be onerous but necessary (Kennedy, 2005).