Policies & Procedures
As part of the University Hospitals 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 Clinical Research Center (UHCRC); (b) separate e-mail correspondence sent by the UHCRC to all members of the research community; and (c) through the IRB News and Updates page on our site.
Effective July of 2016, the UH Clinical Research Center has begun transitioning the existing UH IRB Policies to UH Institutional Policies. This decision reflects the scope of IRB Policies being applied to all entities across the UH system which are engaged in research. The transition will occur over the next few months and the revised policies may be found under the heading ‘IRB’ on the UH Policies and Procedures page.
Please find below the current policies that are available on the UH Policies and Procedures page. Although the formatting may be different, the information within the policy has not changed with the exception of hyperlinks no longer being embedded in the policies.
In the future we will develop a revised webpage to include the additional references and resources such as links to federal regulations and respective agencies.
- IRB-1 – Investigator Responsibilities (rev 2.2017)
- IRB-2 – Certification in Human Subjects Protections (rev 2.2017)
- IRB-3 – Department Review of Protocols (rev 2.2017)
- IRB-6 – Exempt Human Research (rev 8.2016)
- IRB-7 – Protocol Submission Requirements (rev 2.2017)
- IRB-9 – Protocol Amendments (rev 9.2016)
IRB Administrative Policies
- IRB Policy, Appeals Process (rev 10.2015)
- IRB Policy, Purpose and Scope (rev 1.2017)
- IRB Policy, Membership (rev 1.2017)
- IRB Policy, Board Meetings and Administrative Policies (rev 8.2014)
- IRB Policy, Ethics Consultation (rev 1.2016)
- IRB Policy, Records (rev 8.2014)
- IRB Policy, Administrative Hold, Suspension, or Termination of IRB Approval (rev 1.2017)
- IRB Policy, Non-Compliance involving Human Subjects Research (rev 4.2014)
- IRB Policy, Monitoring (rev 2.2014)
- UH Administrative Policy, R-40 - Research Misconduct (rev 2.2017)
- IRB Policy, Reporting to Regulatory Agencies, Department Heads and Institutional Officials (rev 1.2017)
- IRB Policy, Quality Improvement Activities (10.2013)
- IRB Policy, Responsibilities of IRB Chair and Vice Chair (rev 2.2014)
- IRB Policy, Use of Explorys, inc. “Population Explorer” (PopEx) module to Conduct Research (rev 12.2013)
- IRB Policy, Executive Committee (rev 4.2014)
- IRB Policy, Human Research Protection Program (HRPP) Continuous Quality Improvement Processes (rev. 10.2014)
- IRB Policy, Research Involving Human Data or Specimens (rev. 10.2015)
Vulnerable Subject Populations
Actions for Approved Protocols
Appendices – Important information from other resources