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Institutional Review Board

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Contact Information

IRB Administration Office
[University Hospitals]
Lakeside 1400
11100 Euclid Avenue
Cleveland, OH 44106
MS: LKS 7061
(216) 844-1529
FAX: 216-844-1547

IRB Policies and Procedures

Updates to UHCMC IRB Policies, Procedures, Forms and Templates

As you are aware, many of the IRB Policies and Procedures and required submission documents have recently been revised as part of the ongoing quality improvement of the UHCMC Human Research Protection Program. The accompanying document entitled “Summary of New and Revised IRB Administrative and Investigator Policies and Procedures” lists the revised documents and provides a summary of the changes. Many of the revisions are minor clarifications to existing IRB requirements to ensure compliance with the federal regulations governing human subjects’ protections. However, there are several policies that have significant revisions, and for these the Office of Research Compliance will be providing you with additional education. Specific announcements regarding educational sessions will be communicated to you in forthcoming emails. If you have questions or concerns regarding any of the changes, the staff at the Center for Clinical Research will be available to assist you.

To facilitate the review of all new submissions submitted after June 30, 2007, please ensure that all submissions use the most recent version of all submission forms (e.g., protocol submission forms, consent templates, HIPAA Authorization language, etc.) available on-line (Forms & Templates).

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 5.2007)
IRB Policy, Ethics Consultation (rev 8.2005)
IRB Policy, Records (rev 3.2007)
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 8.2005)
IRB Policy, Scientific Misconduct (rev 8.2005)
IRB Policy, Reporting to Regulatory Agencies, Department Heads and Institutional Officials (3.2007)

IRB Investigator Policies and Procedures
Investigator Issues

IRB Policy, Investigator Responsibilities (rev 5.2007)
IRB Policy, Certification in Human Subjects Protections (rev 8.2005)

New Protocols

IRB policy, Case Report Submissions (8.2008)
IRB Policy, Exempt Human Research (rev 5.2007)
IRB Policy, Protocol Submission Requirements (rev 3.2007)
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 8.2005)
IRB Policy, Recruitment of Subjects (rev 4.2007)
IRB Policy, Remuneration of Subjects (rev 8.2005)

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 8.2005)
IRB Policy, Prisoners as Research Subjects (rev 8.2005)
IRB Policy, Other Vulnerable Populations (rev 8.2005)

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)

Appendices - Important information from other resources

Appendix, General Clinical Research Center
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)
Appendix, OHRP Guidance on Coded Private Information or Biological Specimens

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