Assent | IRB | Randomization |
Blinding or Masking | Placebo | |
Informed Consent | Protocol |
Most research done in the United States must have what's called "independent review." This means that a group of experts in research on people, who are separate from the research, reviews it. In the US they are usually called Institutional Review Boards (IRB). Outside the US, they can be called Research Ethics Boards or Ethics Committees. They review research studies to decide whether or not to allow the studies to be done at the hospital, doctor's office, clinic or other place for which the IRB is responsible. IRBs are made up of different types of people: doctors, nurses, ethicists, community people, attorneys, patients, pharmacists and others.
The IRB's role is to help ensure that the study is well designed, that the risks are as low as possible and that the rights of study participants are protected. When IRBs review studies in children they take extra care and follow special rules.You can usually tell if an IRB has reviewed the study by a stamp on the consent form. If the consent form doesn't contain this information, ask your research team if the IRB has reviewed and approved the study.