Institutional Review Board
Stem Cell Treatment Safety Assured with IRBs
Adult stem cell procedures are very safe and effective treatments for chronic medical conditions, degenerative diseases and cosmetic enhancement. An exciting area of medicine, it seems that almost every day, stem cell research is discovering new ways to use a person's own adult stem cells to improve health and physical appearance, but how do we know that stem cells are safe and effective to use? The answer is Institutional Review Boards (IRBs).
IRBs exist to ensure that the health and rights of patients involved in research studies are protected, using accepted and proven medical and ethical standards. Without the standards of IRBs, advances in medicine would not be possible.
What Is an IRB and What Does it Do?
An IRB is a group of professionals who review and approve a study, such as a stem cell research study, that will involve human subjects. Any study that an IRB reviews must provide extremely in depth information so that the IRB can perform its responsibilities, which include:
- Ensuring that a stem cell research study minimizes or eliminates risks to human participants.
- Ensuring that the investigators involved in a stem cell research study have adequate training and experience to carry out the proposed study.
- Proposing changes to a study that will ensure that the research is ethical, safe, and confidential, and approving any changes suggested by the study investigators.
- Confirming that a study meets or exceeds medical standards and protocols for human research.
Because of these weighty responsibilities, IRBs are formed by educated, experienced individuals from various fields. IRBmembers can be physicians, scientists, professional researchers, lawyers, or other career professionals. An IRB reviews a study from its initial concept all the way to the end, when the study is concluded.
Who Regulates IRBs?
The Food and Drug Administration (FDA) regulates IRBs. The FDA requires that any study that involves the use of pharmaceutical drugs, biological products, or medical devices be reviewed and approved by an IRB. The FDA provides guidelines for IRBs that include:
- How human participants can be recruited, and what information they must be given.
- How to determine if a relationship, for instance, a friendship, between an IRB member, a sponsor of a stem cell research study, or a researcher will impact the impartiality of the study.
- What records about its members and activities an IRB must keep, make public, keep confidential, or share with others connected to a stem cell research study.
- The right of the FDA to make a scheduled or unscheduled inspection of an IRB and any studies it is currently reviewing, or has approved in the past.
These regulations guarantee that IRBs are acting in the best interest of the research and its human participants, and are not influenced by other factors.
Why is an IRB Necessary?
Even if IRBs were not required by law, they would be a good idea. IRBs make sure that stem cell research studies meet medical standards that ensure human subjects will not be exposed to unnecessary risk, and will not be exposed to any risk without their knowledge. These standards ensure that a stem cell research study is professional and that the results are reliable and can be built on by other researchers or moved towards use by the medical field. In this way, an IRB forms a reliable first step in the long process towards approval of novel medical treatments and advanced cosmetic surgery using stem cell research.