2014 Webinar: Complex Protocols

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As research and clinical trials evolve, IRBs face challenges in reviewing increasingly complex protocols. Complications that may be presented by sponsors include additional optional components or sub-studies that are tied to the main study but are not part of the main study objectives and third party involvement in the conduct of the sub-study. Protocols from certain larger sponsors usually contain the information that the IRB needs to properly review the study and any additional components. However, some sponsors are less attuned to the intricacies of IRB review, and may fail to provide the level of information an IRB requires when reviewing these activities.

Without sufficient information in the protocol, IRBs cannot adequately assess the risks or evaluate whether the risks are minimized or reasonable. Furthermore, incomplete information makes it challenging to establish whether there are adequate provisions to protect the confidentiality of study data.  

This webinar helped IRBs determine whether protocols submitted for review contain incomplete information and will provide guidance on requesting additional information from the sponsor to better protect human subjects. 

Presenter Lori Roesch, CIM, CIP, discussed the following examples of complex protocol scenarios:

  • Studies with optional health economic or tissue banking activities
  • Studies with pregnancy surveillance data requested
  • Studies with a washout period as either part of the protocol or an eligibility criterion 

Audience: This introductory level webinar was of interest to IRB administrators, particularly those at small institutions or research programs with limited resources, as well as those new to the field. 


Lori Roesch, CIP, CIM, is the director of the research subject protection program (RSPP) at Aurora Health Care, Inc, which includes both a biomedical and social and behavioral IRBs. Aurora is an integrated not-for-profit health care provider serving communities throughout eastern Wisconsin and northern Illinois. With the expertise of 10 human protection professionals, the RSPP oversees more than 500 active research protocols which includes FDA regulated clinical trials involving drugs, devices, or biologics, cooperative group cancer clinical trials, investigator-initiated single and multisite research, as well as behavioral research. In June of 2004, Aurora’s HRPP was among the first sixteen programs in the country to achieve accreditation (through the Partnership for Human Research Protection, Inc.), and continues to maintain full accreditation with the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). Lori has been serving as an accreditation site visitor for AAHRPP since 2006 and serves as a consultant and mentor to other IRB programs and IRB professionals. Lori has been a PRIM&R member since 1999, serves as a PRIM&R mentor, and has recently been selected to serve on the Council for Certification of IRB Professionals.    

Certificates of Attendance

Certificates of attendance for the Complex Protocols: Digging Deeper to Better Protect Human Subjects webinar were made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

If you would like to receive a certificate of attendance for a previous PRIM&R educational program, please email info@primr.org or call 617.423.4112, ext.0.

CE Credit for Certified IRB Professional (CIP®) Recertification 
Webinar participants holding the CIP credential who wish to apply credits from Complex Protocols: Digging Deeper to Better Protect Human Subjects toward CIP recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 60-minute webinar counts as 1.0 CE credit hour.

For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from PRIM&R webinars have received such advance recognition, and may be counted towards these 15 hours.

Additional information about CIP recertification can be found here.