2009 UPDATE: University Hospitals Case Medical Center IRB Policies, Procedures, Forms and Templates

As part of the UH Case Medical Center IRB's process of quality improvement and self-assessment, many of our current policies, procedures and forms/templates are being reviewed and revised accordingly. Many of the revisions are administrative in nature. However, in the coming months there will be some new processes and procedures presented to the research community. These are being done to ensure appropriate maintenance of the highest Human Research Protection Program (HRPP) standards under AAHRPP accreditation.

The research community will be made aware of any changes, revisions or clarifications through (a) "Collaboration Corner", the bi-monthly newsletter published by the UH Center for Clinical Research and Technology (CCRT); (b) separate e-mail correspondence sent by the CCRT to all members of the research community; and (c) through the "IRB News and Updates" page on the UH Case Medical Center's IRB's website.

IRB Administrative Policies

• IRB Policy, Purpose and Scope (rev 4.2007)
• IRB Policy, Membership (rev 4.2007)
• IRB Policy, Board Meetings and Administrative Policies(rev 2.2009)
• IRB Policy, Ethics Consultation (rev 4.2009)
• IRB Policy, Records (rev 10.2009)
• IRB Policy, Administrative Hold, Suspension, or Termination of IRB Approval (rev 5/2007, v. 6/2007)
• IRB Policy, Non-Compliance with Human Subject Regulations (rev 3.2007)
• IRB Policy, Monitoring Audits (rev 3.2007)
• IRB Policy, Executive Committee (rev 4.2009)
• UHCMC Administrative Policy, Research Misconduct (3.2009)
• IRB Policy, Reporting to Regulatory Agencies, Department Heads and Institutional Officials (3.2007)
• IRB Policy, Quality Improvement Activities (4.2009)

Investigator Issues

• IRB Policy, Investigator Responsibilities (rev 2.2009)
• IRB Policy, Certification in Human Subjects Protections (rev 7.2007)

New Protocols

• IRB policy, Case Report Submissions (8.2008)
• IRB Policy, Exempt Human Research (rev 3.2009)
• IRB Policy, Protocol Submission Requirements (rev 2.2009)
• IRB Policy, Department Review of Protocols (rev 5.2007)
• IRB Policy, Additional Required Reviews (rev 5.2007)
• IRB Policy, Expedited Review (rev 3.2007)
• IRB Policy, Chart Review and Discarded Tissue Studies (rev 5.2007)

Protocol Issues

• IRB Policy, Use of Placebos and Washout Periods in Research (rev 4.2009)
• IRB Policy, Recruitment of Subjects (rev 4.2007)
• IRB Policy, Remuneration of Subjects (rev 4.2009)
• IRB Policy, Investigational Devices Used in Research (2.2009)
• IRB Policy, Investigational Drugs or Biologics Used in Research (2.2009)

Consent Issues

• IRB Policy, Informed Consent (rev 5.2007)
• IRB Policy, Consent for Special Categories of Studies (rev 3.2007)
• IRB Policy, Re-consenting Subjects (rev 5.2007)

Vulnerable Subject Populations

• IRB Policy, Decisionally Impaired Research Subjects (rev 4.2007)
• IRB Policy, Assent from Children in Research Studies (rev 5.2007)
• IRB Policy, Pregnant Women, Human Fetuses and Neonates (rev 8.2009)
• IRB Policy, Prisoners as Research Subjects (rev 8.2009)
• IRB Policy, Other Vulnerable Populations (rev 2.2009)

Actions for Approved Protocols

• IRB Policy, IRB Policy, Event Reporting: Unanticipated Problems, Adverse Events and Protocol Deviations (rev 5.2007,v 7.2007)
• IRB Policy, Protocol Continuing Review (rev 5.2007)
• IRB Policy, Protocol Amendments (rev 5.2007)
• IRB Policy, Closure of an IRB Approved Protocol (rev 8.2005; v. 5.2007) (Note: replaces Protocol Termination)”

Miscellaneous

• IRB Policy, Emergency Use of Investigational Drug, Biologics, or Device (rev 5.2007)
IRB Policy, Humanitarian Use Devices (rev 8.2005)

• IRB Policy, International Research (rev 8.2005)
• IRB Policy, Research Involving Human Data or Specimens (rev 8/2005)
• Use of PHI in Research (HIPAA and the Privacy Rule) (rev 05.2008)
• UHCMC Administrative Policy, CP-7 Investigational Drugs (3.2009)

Appendices – Important information from other resources

• Appendix, William T. Dahms, M.D. Clinical Research Unit
• Appendix, Certificate of Confidentiality
• Appendix, HIPAA Regulations with an Impact on Research
• Appendix, Research Repositories, Databases and HIPAA Privacy Rule (NIH 04-5489, 1.2004)
• OHRP Guidance: Guidance on Coded Private Information or Biological Specimens (10.16.2008)