Research is not always predictable; in fact some of the best discoveries have happened when things don’t go according to plan. However, there are instances in which you need to report unexpected events, particularly if the results are adverse. The purpose of reporting unexpected adverse events is not punitive but rather an opportunity for the principal investigator to revise the protocol to prevent further issues and for the Board to understand where they can better assist researchers in the future.
The following three categories define undesirable research events. These definitions are important to understanding what needs to be reported to the IRB-SBS and OHRP.
Noncompliance and more specifically, a "protocol violation," results from any change or departure from the study design or procedures of a research project that is not approved by the IRB-SBS prior to its implementation. Also, a protocol violation is thought to be any departure from established code of ethical conduct from the researcher's professional organization, or from applicable local, state, national and/or international regulations, policies and procedures. For example, a data recording procedure is not followed properly and confidential data about a participant is accidentally published on a website, or a laptop is stolen with participants’ social security numbers and home addresses, putting the participants at risk for identity theft. The act may be an unexpected problem or misfortune, a careless act or mistake, or a deliberate act against what the Board recommended.
In addition, failure to properly maintain a protocol is also considered a noncompliance event. For example, letting a protocol lapse without submitting a continuation request or modifying a protocol and failing to notify our office of the change are considered noncompliance events. Repeated disregard for maintaining a protocol is a serious noncompliance event. It is important that you keep accurate records and an updated protocol in order to maintain compliance with the IRB-SBS and federal regulations. If the study is complete, don't let it lapse but close the study instead.
OHRP recognizes that adverse events are a normal part of conducting a study and while they should be recorded and monitored as part of the data collection process, they don’t necessarily need to be reviewed by the IRB and OHRP. OHRP does define three categories where reporting an adverse event is necessary:
Essentially, if the resulting event changes the level of risk that was previously approved by the Board, the Board and researcher needs to revisit the protocol’s procedures and recommend appropriate changes to accommodate the new level of risk. These changes could include changes to the protocol, consent forms, and other documents used in the study. If the protocol received an expedited review or was exempted in the initial review (because the protocol was considered minimal risk at the time), a change in risk may require that the protocol receive full board review for any future reviews. In addition, the Board has the authority to terminate or suspend approval for a study if they feel that the risk to participants is too great for the study to continue.
Noncompliance events that change the probability of harm to a participant must be reported to the IRB, even if a participant was not harmed as a result of the problem.
If you are completing the protocol for the first time and it has no previously approved word document version, you should mark “no” to the first question and continue with the rest of the protocol.