When studies are conducted for new drugs or different ingredients that are used within foods, this group will oversee the studies. They will ensure that the guidelines of the studies are being followed as they should. All of the results and information from the study will then be reviewed by this group.

The purpose of this group is to carefully watch and review studies that involve humans to ensure that their rights are protected and that they are safe. Studies are important to be performed in order to see how medicines or other products work, but it is important that human life is protected. All human subjects need to be fully informed of what the study is, what it all involves, and any other information that is important. It is the responsibility of the Institutional Review Board to ensure that this happens as well. Special care is taken by this group when the subjects are more vulnerable such as with children or pregnant women.

The Institutional Review Board, as designated by the Food and Drug Administration (FDA) and the Department of Health and Human Services’ Office for Human Research Protections ( OHRP), is to review and monitor research programs that involve biomedical study of human subjects. IRBs perform this function to protect the safety and rights of human research subjects.I found some more information here. IRBs review all aspects of a program before an institution is approved to conduct its research. Types of information that IRBs review include various procedures that will be followed, methods for data collection and drafts of consent forms. In addition, if a research program involves risks, an IRB will review these risks and why an institution feels the risks are reasonable for the type of study. IRBs then approve or deny programs or request program revisions. Once programs are approved, IRBs continue to safeguard human participants by periodically reviewing and re-evaluating the programs.

In the United States, most medical research on humans is subject to an institutional review board. There is a broad exemption for research on educational strategies and testing. Research on data that already exists and cannot be connected to individual subjects is also exempt. Evaluation of food quality and taste, when the food is already approved by the FDA, usually does not require review.

The FDA requires that an IRB consist of at least five members. The members must have enough diversity and relevant experience among them to exercise informed judgement concerning the research. A specific diversity requirement is that an IRB contain at least on scientist and one non-scientist.

Many IRBs have been criticized for conflicts of interest. The Western Institutional Review Board, a for-profit company, claimed to review a majority of new drugs submitted to the FDA as of 2005.

A few interesting facts about IRBs that many people are unaware of:

IRBs not only safeguard a human subject’s body and mind, but also his privacy and rights.
IRBs must be diverse. They should attempt to have a balanced representation of men and women members from different professions. Every IRB must also include one person who has a scientific background and one person who doesn’t.
IRB members are not allowed to evaluate their own programs because of conscious or subconscious bias. They are also not allowed to evaluate programs from institutions they’re connected to.
IRBs are not always created through an institution. Commercial IRBs exist that independently evaluate programs for a fee.
IRBs require that the parents or guardians of a child consent in writing to allow him to enter a research program. A child is not required to agree or consent, but most IRBs ask program leaders to make certain that teens receive detailed information about a study including risks, if applicable, before agreeing.

You can learn more about IRBs by checking out the FDA’s “Institutional Review Boards Frequently Asked Questions Information Sheet.”

-A risk/benefit analysis–requires that the risk of harm or injury associated with the trial be minimal.
-Informed consent–requires the participant be aware of the nature of the trial, be aware they are taking part in a trial, and aware of any risks.
-Privacy–maintains privacy and confidentiality of participants.
-Monitoring and observation–ensures collected data befits the research.
-Continued review–IRB determines that ethical requirements are continuing to be met.

Thankfully, the IRB’s mission is to keep study participants safe and aware. This, in turn, allows researchers to continue to study subjects and find possible cures for disease, ethically.
What’s 1 more click? Your boss isn’t watching… High Ethics: VA Research