The Approval Process
Before a proposed research study can even start enrolling people, the investigator must submit a detailed application to the IRB. The IRB carefully reviews the application with the following criteria in mind:
- The risks to participants are minimized as much as possible, through sound research design and the use of procedures that are not unnecessarily risky.
- The risks are reasonable in relation to the anticipated benefits and the importance of the knowledge that may result.
- Participants will be selected fairly.
- There is a plan in place for seeking and documenting participants' informed consent (see Simplification of Informed Consent Documents). The informed consent document is both legally and ethically sound.
- If necessary, provisions have been made for monitoring the data collected to ensure the safety of participants as the trial progresses.
- Provisions have been made to protect the privacy of participants and the confidentiality of data collected during the study.
Based on these considerations, the IRB either approves or refuses to approve the clinical trial and notifies the investigator and the institution of its decision in writing. In some cases, the IRB may specify certain changes the investigator must make in order to secure approval for the study. If the IRB grants approval, it also must decide how frequently the trial should be reviewed once it is under way.
Usually this is determined according to the degree of risk the trial involves. At the very least, its progress must be reviewed yearly. For certain trials, especially large multi-site Phase III trials, a Data Safety Monitoring Board may be appointed to keep track of the data in order to ensure participants' safety, to ensure that evaluation of interim results are made completely, and to ensure that the results and ethics of the trial are above reproach.