In addition to describing the situation, the researcher needs to explain to what degree the event was attributable to the research. A reportable event will be reviewed immediately by a sub-group of the HRC, and a determination will be made whether the event is serious, unexpected, or both serious and unexpected. If in the latter category, additional reporting to federal agencies or sponsors may be required. It is the researcher's responsibility to Protect the involved human subjects, first and foremost. It is allowable to make immediate procedural changes without first getting HRC approval if the change is necessary to protect a human subject.
Forms are on the web.
A phone call or e-mail to the HRC administrator may be prudent. Depending on the nature of the event, the researcher may consider voluntary halting project activity until project alterations can be made to avoid the event happening again. Comply with HRC requests for information, either in writing or in person, and revised protocol procedures to avoid repeat events. Because the primary purpose of the regulations and the reason for IRBs to exist at all is to protect human research participants, it is clear that reporting problems is an important aspect of a researcher's responsibilities. When in doubt, call the RCO to ask, or err on the side of caution and submit a reportable event form.