Monday, January 28, 2008

What is an IRB?

I'm a bit bothered that I found a good definition of an IRB at a private IRB like Quorum Review. But I did, and I'm not about to steal their explanation of what an IRB is or does without crediting them. It would be quite unethical after all.

An institutional review board ("IRB"; known in Canada as a research ethics board, or "REB") is a group of individuals who are responsible for reviewing a study to make sure that the research participant's rights and welfare are protected. Most clinical research studies cannot begin without a review board’s approval. Board members generally include health care personnel such as doctors, nurses, and pharmacists. The Board also includes other members of the scientific community, non-scientists such as clergy or social workers, and community members (For Canadian research, a majority of REB members must be Canadian citizens).

Ethics Boards carries out their responsibilities to protect the rights and welfare of research participants by reviewing the protocol to make sure that risks to participants are minimized, that risks are acceptable in light of the possible benefits, that the informed consent document is accurate and complete in describing the study and its risks and benefits, and that the clinical research study is conducted in an ethical manner. If the Board believes that these conditions have been met, it may approve the study and allow it to begin.

Once the clinical research study begins, the Board is responsible for periodically reviewing the approved study to assure that the rights and welfare of research participants continue to be appropriately protected. Usually, the informed consent document will provide the research participant with a phone number to contact the clinical investigator or the IRB/REB if the participant has a question or concern about how the study is being conducted.

And there you have it. This is pretty much my world.

Sunday, January 27, 2008

What is Greater than Minimal Risk?

Greater than minimal risk is a term commonly uttered in the Institutional Review Board (IRB)world.

45 CFR 46.102(i):
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
The tricky part of this definition is what is considered "routine." What is routine for one person--a cancer patient, for example--may not be the same as a healthy individual with no illnesses. Or suppose someone is bipolar or schizophrenic. Her routine tests may be quite unroutine for others even if they are the same exact procedure.

What appears to be a simple definition can actually be something quite complicated.

Saturday, January 26, 2008

And so it begins

The first entry.