Biosafety – Sharing Data for Compliance

When we were building the Biosafety Protocols module of TOPAZ Elements many years ago, we spent time talking to some of the NIH officials who, at the time, were working to implement the audit program for institutions receiving NIH funding.  The primary messages were clear and simple;

  • The IBC should have it’s own protocol form, not “piggy back” on the IACUC or IRB form.
  • The committees should communicate!
  • It should be easy to search for protocols based on some very simple criteria – BSL level and Guideline Section at minimum

As a result, we were carful to ensure that the Elements implementation of the Biosafety Protocols module accommodated these requirements.  It is its own module, with its own forms and lists.  The PI is able to tie together the Biosafety protocol with its sibling animal or human protocols as part of the request, and the committee can then check on status, protocol content and even meeting dates for their colleague committees.  And the very powerful searching capabilities built into Elements (for example, in the Protocol Histories screen) make it easy to select protocols based on the requests of auditors, by BSL level, Guideline Section or many other parameters.

Like the other Protocol modules, the system retains all the comments, review assignments, meeting minutes and status selections for all versions of the protocol, with reports that are specifically designed for handing to your NIH or other auditors.

It is true that several TOPAZ customers use other vendors’ solutions for their IBC or IRB protocols modules, and we support this through a variety of integration strategies, but in following this path, you lose both the compliance benefits described above, and the usability benefits that come from having a consistent look and feel for the PIs, administrators and committee members.  Applying a consistent “3 Is” approach to the software selection across your committees can bring some significant benefits