IRB & Informed Consent
The Institutional Review Board (IRB)
What is an IRB?
An institution Review Board, or IRB is a committee made up of diverse people with an interest in protecting human research subjects. It can include doctors, lawyers, nurses, pharmacists, and members of the local community.
What is the purpose of IRB review?
The role of an IRB is to approve the initiation of, and periodically review the progress of, biomedical research involving human subjects. The IRB helps to ensure that clinical research trials are ethical i.e., rights and welfare of human subjects are protected, and that the research is scientifically sound. The IRB considers whether risks to those who will participate are minimized (or eliminated, if possible). The IRB also considers whether the investigator and the study staff have the necessary training and/or experience to conduct clinical trials appropriately.
A clinical trial must have approval from an IRB before anyone can sign up to take part in it. When a researcher is interested in conducting a research study that will involve human subjects, including a clinical trial, the researcher must submit the study to the IRB for review. The IRB’s job is to review all aspects of the new study to make sure the rights and welfare of human subjects are protected.
Why do we need an IRB?
Before IRBs, there was no unified way to protect the welfare of human subjects or to regulate research. This means that researchers could conduct research studies under different sets of rules, and this made it difficult to protect those involved. The current system requires the IRB to review all research involving human subjects before it begins, and provides guidelines for all IRBs to use to make sure the research is appropriate for human subjects to participate in.
Who’s watching over the conduct of the research?
The IRB is responsible for the ongoing review of all the clinical trials it approves. Any changes in the research plan needs to be reviewed and approved by the IRB before the investigator can carry them out. At least once each year, the IRB must review the research project again, taking into account any changes that have occurred, new safety information that has been reported, and the progress of the study. Information about any side effects that occur or any safety issues that arise is also reported to the IRB and the FDA. The BRANY IRB also conducts regular quality assurance reviews of the clinical trial site where the clinical trial is occurring to make sure that the investigator and study staff are conducting the clinical trial appropriately.
The Informed Consent Process
What is the informed consent process?
The informed consent process is how the investigator communicates the details about a clinical trial or other research study to the potential subject. The IRB reviews the informed consent process to help to make sure that the study details are communicated in language that is readily understandable to the person who may volunteer to be a research subject.
The informed consent process includes:
- Background information about why the study is being done
- A description of the research
- What will be expected of subjects who agree to participate
- How long subject participation in the study will last
- What procedures the subject will have to follow
- What the experimental procedures are
- What the reasonably foreseeable risks or discomforts are
- What the expected benefits of the research are (if there is any expected benefit – there may not be)
- What the alternatives to participation in the research study are
- How confidentiality of records identifying the subject will be maintained
- An explanation of whether any compensation and whether any medical treatment are available if injury occurs
- Whom to contact if there are any problems
- Whom to contact if there are any questions about the research and the research subjects’ rights
- Assurance that participation is voluntary, and that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue at any time without penalty or loss of benefits to which the subject is otherwise entitled.