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.
No comments:
Post a Comment