CTSA Alternative IRB models Working Group Update

1
CTSA Alternative IRB models Working Group Update

• Mike Joyner Mayo Clinic
• Tesheia Johnson Yale Univ

November 20, 2007
2
CTSA Alternative IRB Pilot WG

• Workgroup constituted to
• Identify circumstances where alternative IRB
  models would speed the multi-CTSA implementation
  of clinical research protocols
• Propose piloting of relevant alternative IRB
  models to the CTSA Consortium Oversight Committee

3
CTSA Alternative IRB Pilot WG

• Phone discussions, culminating in a conference on
  8/15
• Identify useful alternative IRB models to CTSA
  leadership and workgroups
• Appropriate clinical study at multiple CTSAs
  needed to promote a pilot of an Alternative IRB
  model?
• Local agreements between CTSA sites and other
  entities could serve as models
• Standard topic-specific language could expedite
  approval
• Data needed for process analysis
• CTSA members to present issues at public meetings
  SACHRP/OHRP
• Several regional reciprocity agreements (e.g. VA
  and State reciprocity agreements) could serve as
  models for CTSAs

4
CTSA IRB Issues

• Lack of uniformity of the review process among a
  multitude of IRBs
• The development and implementation of alternative
  models for IRB review
• The establishment of ethically acceptable
  policies for data sharing, privacy and integrity
  of public databases
• The encouragement of community engagement and
  participation, including protocol design and
  consent procedures in non-traditional research
  settings
• Input from OHRP et al essential, regulatory
  coordination will be the ultimate key

5
SACHRP CTSA Panel

• Secretary's Advisory Committee on Human Research
  Protections (SACHRP) on October 30, 2007 charged
  a CTSA Panel to
• discuss the challenges and opportunities in Human
  Subjects Research that emerge as Clinical and
  Translational Science Awardees transform the
  field of clinical and translational science

6
SACHRP CTSA Panel

• The presentations covered the main areas
• Overview of the CTSA Program by an NCRR CTSA
  Investigator - Anthony Hayward and Karen Marder
• Investigators perspective of the implementation
  of the NIH vision - Carl June
• CTSA Administrators perspective of challenges to
  CTSAs - Tesheia Johnson
• CTSA IRB Administrators perspective of
  opportunities afforded by the CTSA Consortium -
  Anthony Perez

7
SACHRP CTSA Panel

• Outcome of the CTSA Panel discussion
• SACHRP recommends the HHS Secretary encourage
  the Director of NIH to support the CTSA
  consortium in its efforts to develop and evaluate
  alternative models for IRB review and human
  subjects protection training.
• SACHRP would very much like to hear updates about
  the progress of the CTSA in exploring the ideas
  of alternative IRB review and training in human
  subjects protections.

8
This is a Process and Not an Event!

• Identify who will respond to the CTSA PI request
  for expediting protocol handling prior to
  implementation
• NCRR has identified Drs. Rosenblum and McCloskey
  to coordinate a taskforce for this
• Provide metrics to taskforce, which will report
  to CCOC in April 08
• Ask Tony Perez from UC Davis CTSA to share his
  experience with implementing IRB reciprocities
• Who else needs to be at the table?

9
CTSA Wiki

• CTSA IRB WG Page
• http//ncrrctsa.ncrr.nih.gov/wiki//x/JAB5