Human Research Protections Office (HRPO)

Unanticipated Problems Involving Risk to Research Participants or Others

During the UMB HRPP AAHRPP re-accreditation site visit June 23-25, 2008, the AAHRPP site visitors reported a lack of knowledge or familiarity with the terminology Unanticipated Problems Involving Risk to Research Participants or Others and the inability to distinguish between Unanticipated Problems and Adverse Events.   Their findings were consistent across all UMB personnel: investigators, research staff, IRB members, HRPP leaders and representatives.  UMB HRPP SOP I.3.J and III.2.B .

Due to the nature and implications of these events, all individuals involved with Human Subject Research are requested to participate in at least one educational offering by September 30, 2008 and to maintain your certificate of completion.

The following education options are available:

1.      Complete the on-line module.  Certificates can be printed upon completion:

http://medschool.umaryland.edu/HIPAA/quiz/index.asp

                   a.   On-line Pre-registration is suggested, although not required:

         http://medschool.umaryland.edu/ors/livetraining/

3.      Identify an individual on your research team to attend a “Train the Trainer” session to  receive specialized training to provide education to your team members (additional information will be forthcoming).

a.    If you are interested, please send an email to: HRPOEducation@som.umaryland.edu

4.      Request an HRPO staff member to come to your site to speak with your research team   members on this topic.  

a.      Send an email to: HRPOEducation@som.umaryland.edu indicating possible days, times, location, contact information and anticipated number of attendees

For more information, contact the HRPO at 410-706-5037 or HRPOEducation@som.umaryland.edu

Unanticipated Problems Training/Access Courses

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