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

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

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

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

Although the proposal’s title briefly explains its purpose, there is a lot more written into this bill than one first realizes. Evolving just one year after the book, it proposes changes that would help better strengthen the basic protections for the valuable research dealing with human life in any way. The policy introduces new perspective on the expanded pool of research of the 21st century-one that may no longer fully protect the human

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.

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

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.

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

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

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

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

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

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

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

An experiment should undergo examination by the review boards to make sure that the researcher’s actions are ethical and it’s going to be common for many different interpretations of the regulations to occur however, it shouldn’t be judged so harshly that it’s unnecessary. For example, in the third case, the IRBs have interpreted the regulations so harshly that “they have treated speaking with someone as equivalent to experimenting on them and have almost killed fieldwork in the process.”. When interpreted to such an extreme degree, these rules that were meant to protect the rights of the test subjects has completely rendered the researcher unable to even perform the experiment in the first place.