Institutional Review Board Risk Benefit Ratio

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

An Institutional review board (IRB) is an appropriately constituted group that has been designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in or disapprove research. It serves an important role in the protection of the rights and welfare of human research subjects.

The first article is entitled “of mice but not men: problems of randomized clinical trials,” is written by Samuel Hellman and Deborah S. Hellman discusses the issues of randomized medical testing and experiments on patients. The article describes the role of the personal physician and how the physician can take an ethical or unethical path of treating his/her patients. The relationship between the patient and physician is greatly emphasized because according to the article trust is very valuable in medicine especially when a patient’s life is at risk. A Kantian and a Utilitarian view of randomized clinical trials are debated but the authors clearly steers towards a Kantian point of view.

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).

They may include the endangering of the life of the patient and adverse side effects of the treatment. In most cases, for this type of research, risk assessment in terms of statistics come in handy where the possibilities are explained to the participant and well recorded in liability forms (Millum & Menikoff, 2010). If a program has research projects and does not follow the IRB review, the repercussions may include: bearing the burden of

One. The Belmont Report has failed to distinguish different sources including the kinds of vulnerability or to map particular protections to particular vulnerabilities (Rogers & Lange, 2013). This can be a problem because different kinds of vulnerability justify different responses. Nickel (2006) claims that there are two overlapping senses of vulnerability at work with the Belmont Report and in following human research ethics guidelines (p.2141). The first relates to the capacity to give informed consent, which the Belmont Report connects to the principle of respect for autonomy (Nickel, 2006). The second is the sense of vulnerability, as explained by Nickel, which relates to the Belmont Reports principles of justice meaning fairness (Nickel, 2006). The concern here is that vulnerable groups may be overrepresented in research for example, when the group lacks understanding or power to refuse participation (Rogers & Lange, 2013). This is explicit in the Belmont Report. Within the study, it was also explained that vulnerable groups may be excluded from research and thereby be excluded from the benefits of participation in clinical trials and subsequent access to treatments for which research evidence exists (Nickel, 2006). Research ethics guidelines that simply list groups likely to be vulnerable run a risk of stereotyping, and of the consequent harms of unjustified exclusion of research (Rogers & Lange, 2013, p. 2141).

There are several ethical issues regarding research on drug addiction. Goodwin and Goodwin (2013) suggest to ensure a study does not have any ethical issues it must be reviewed by the Institute Review Board (IRB). To gain IRB approval the rationale for this study, the procedures, possible risks to the participants and how these risks will be avoided as well as the consent form and materials to be used must be submitted.

Utilitarianism is the concept that balances the many benefits as well as the discomforts of society. Nonetheless, utilitarianism could be put to the test with clinical research because it is not completely clear about how to balance people’s pain, discomfort, or inconveniences of such test and examinations. However, the ethical dilemmas from the past have changed, as a new set of ethical principles for the protection of human subjects of research are being reinforced for physicians to follow when doing research experimentation on individuals. Besides, these ethical

Benefit risk evaluations are carried out in the modern regulations systems since 1960 following thalidomide disaster. However, it has been in the past decades that both industry and regulatory authorities have started to focus on actual methodology for conducting such benefit risk asssessments. On the regulatory side, European Medicines Agency (EMA) was one of the first agencies to discuss benefit risk assessment methodology. The evolution of requirements for assessing the benefits and risk of a medicinal products has resulted in changes in regulatory review process [1].

TGA and advisory committee deliberations are occurring in an evolving drug development environment. New technologies offer the potential for therapeutic advances at the same time as concerns about medicines safety have resulted in calls for increasing amounts of data on new medicines. Public critics of the process have noted lack of approval of medicines perceived as beneficial, whereas others seemingly demand that only drugs without any risk of harm be approved. These tensions increase the importance of the advisory committee process and the responsibilities placed on committee members.

Whenever a fair process is utilized, the citizens will commonly acknowledge the discrepancy in what they obtain in contrast to others. There is a common sense maxim that “there should be a reasonable balance between human activity and its consequences. “ The standard of the double effect, for example, holds how an action can have both bad and good effects is tolerable if four circumstances are achieved. Effectual proportional ethical review depends on the probability of classifying ethical issues and possibilities essential in “an application without it going through a full research ethics committee.” If unlikely or tedious and difficult task, then unquestionable application will not be managed promptly or, more troublingly, several debatable applications will “slip through without being scrutinized to an appropriate level.

Informed consent is another consideration that the researcher must use. Providing facts, possible implications, future actions, or consequences (capacity) must be clear so that the participant(s) fully understand their

The current DURC policy has several limitations in providing oversight due to its applicability only to institutions that receive federal funding and a defined list of agents, toxins and experiment categories. The policy burdens Institutional Review Entities (IRE) by placing on them the added responsibility for review and mitigation of DURC that is already performed by federal agencies. These added oversights could stifle potentially beneficial DURC projects.

The most common and classical issues relate to human subjects, invasion of privacy, confidentiality of records and interviews, accessibility of data, and immunity from prosecutions (Wolfgang, 1981). Unethical methods in research can be traced back to World War II, when human subjects were tortured and killed in the name of research. In other studies, people were used as guinea pigs for drug testing, infected with diseases, exposed to cold temperatures and high altitudes (Higgins, 2009). The Nuremberg Code was the first set of standards to address the unethical research on human participants and provided provisions for their well being. The code states that (1) voluntary informed consent is essential without coercion, (2) expected outcome should justify the experiments, (3) experiment should be conducted by qualified scientists, (4), experiment should be conducted in a way that avoids all unnecessary physical and mental suffering or injury, and (5) there should be no expectation of death or disabling injury from the experiment (Schuster, 1997). The Nuremberg Code has served as a model for the United States federal regulations of informed consent of the research subject but also peer review of research protocols by a committee on the institution review board of the research institution (Schuster,

How a subject perceives the risks associated with a clinical trial is a critical piece of informed consent and has been shown to impact patients’ willingness to participate in clinical research (Kim, Tanner, Friedman, Foster, & Bergeron, 2015; Monson, Parlour, Simcock, Fallowfield, & Jenkins, 2011). There are multiple items which can impact a patient’s perception of risk including disease state, gender, ethnicity, age, and factual and subjective knowledge of clinical research.