The Role of the Institutional Review Board and the Protection of Human Subjects

Grady, C. (2010). Do IRBs protect human research participants? JAMA, 304(10), 1122-1123. Retrieved from http://jama.jamanetwork.com/article.aspx?articleid=186530

In the famous Belmont Report, several guidelines regarding informed consent, assessment of risk and benefits, and selection of subjects in addition to ethical practice and procedure in the area of human research are outlined. The Belmont Report attempts to summarize the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Belmont Report, 1979). In particular I would like to discuss the standards for informed consent, assessment of risk and benefits, and selection of test subjects drawn out by the Belmont Report. These three areas of interest are said to be the applications of the general

Protecting individuals from harm ensures that researchers think the possible effects of their research on the candidates. For example, candidates rights and feelings should be well thought-out when planning the project and collecting the data from the individuals. Research should not cause harm or offence, but this should be considered in the context of the

Institutional Review Board. On September 30, 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research submitted its report entitled “The

This book really leads me to consider some important and essential issues in scientific research. In my point of view, the first theme of the book is the morality and ethical issue. As we all know, under the today’s regulation and laws, the right

Ethical standards also require that researchers should make sure when they are conducting any research on a participant, the participant is put into danger. As

Overall, the IRB exists to prevent unethical research from being conducted on humans. The goal is to prevent the past from repeating itself such as the Tuskegee study and the Henrietta Lack’s

A review of the proposed participants of the study will ensure high-risk groups (if any) will be considered as per the National Statement on Ethical Conduct in Human Research (‘National Statement’; NHMRC, 2007). While some of these high-risk

The publishing of the book, Immortal Life of Henrietta Lacks, not only brought light to an incredible story but also to the incredible need for change in legislation and governing bodies within the research system. Since its release in 2010, there have been various policy introductions coming from the United States Department of Health and Human Services. Among one of the greatest is titled, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.”

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.

Science, medicine, and psychology are powerful tools capable of increasing human understanding of the world, curing diseases, or assisting individuals in living more fulfilling lives. The potential for good is drastic; however, a potential for hurt exists as well. Although history is full of stories documenting the positives of research, events of scientific research hurting individuals still haunt history. These events, including the Holocaust and the Tuskegee experiments, demonstrate instances where scientific research on human beings is clearly unethical and damaging. Due to horrific events such as these, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published the Ethical Principles and Guidelines for the Protection of Human Subjects of Research, or Belmont Report, in 1979.

An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. IRB upholds the highest standards in the ethical conduct of research, including the protection of human participants. The purpose of the IRB is to ensure that all human subject research be conducted in accordance with all federal, institutional, and ethical guidelines. All human subject research, regardless of funding source, must be reviewed and approved by the IRB before

The HHS regulations describe categories of human subjects research that may be exempt from requirements described in the HHS regulations including IRB oversight.

There is much debate in the ethics involved in anthropological research and how much the research boards should get involved, because such involvement limits the amount of freedom a researcher has to conduct their experiment. The International Review Board and the Review Ethics Boards should have a common set of regulations to protect the rights of research subjects as well as ensure the subjects receive the maximum amount of benefits while minimizing harm. However, while it is critical to ensure that these regulations are being enforced and the researcher’s actions are being monitored, the interpretations of these regulations should not be so harsh as to unnecessarily limit and sabotage the entire researcher’s purpose if the experiment would

In research, the principle of respect for persons (i.e. autonomy) is concerned with an individual’s capacity to act according to their own will and life plans. Simply put, respect for persons states that a person should be free from external control, thereby choosing to participate in research voluntarily. Now, in regard to pediatric research, children are considered as a vulnerable population due to their diminished autonomy. What is meant by diminished autonomy is that for one reason or another, an individual is controlled by others. In this case, children are, in sense, controlled by their parents. Now, this is an essential part of