SBS IRB Policies and Procedures

SBS IRB Policies & Procedures Manual (02.24.2019)

Effective Dates & Applicability

The revised policy manual applies as follows:

• To ALL research initially approved on or after January 21, 2019
• To some research approved prior to January 21, 2019:
  • For federally funded research, the IRB may decide (on a case-by-case basis) to apply the Three Burden-Reducing Provisions as well as some or any of those revisions in the revised policy manual that do not conflict with the pre-2018 Common Rule. Projects approved utilizing the three burden-reducing provisions will comply with the revised Common Rule as required on January 21, 2019
  • For projects not otherwise subject to the Common Rule, the SBS IRB Office or SBS IRB may apply some or all of the revisions in the revised manual on a case-by-case basis

When the research invokes multiple regulatory frameworks (e.g., Common Rule, DOJ, HIPAA, Illinois laws, etc.), all will be considered and applied as required. For those projects not transitioned (or only partially transitioned) to the new policy, the previous version of this policy manual will continue to apply as applicable.

The manual will continue to be updated as OHRP provides additional guidance related to the revised Common Rule. Contact the SBS IRB Office with questions about previous versions of the SBS IRB Policy Manual.

Other Research-Related Policies and Procedures

Research-Related Policies and Procedures:

• University Research Administration Policies: https://ura.uchicago.edu/page/policies
• Conflict of Interest: https://ura.uchicago.edu/page/conflict-interest-conflict-commitment-coi-coc
• Principal Investigator (PI) Eligibility: https://ura.uchicago.edu/page/principal-investigator-eligibility
• Mandatory Reporting Requirements: https://provost.uchicago.edu/handbook/clause/mandatory-reporting-suspected-child-abuse-and-neglect
• Payments to Research Subjects: http://finserv.uchicago.edu/support/policies/1200/1218_HumanSubect.shtml

Data Access, Storage, and Transfer:

• University Research Data Retention Policy: https://adminet.uchicago.edu/admincompt/finpolic/2708.shtml
• Data and Material Transfer Agreements (Contracts, MTAs, DUAs, CTAs): https://ura.uchicago.edu/page/contracts
• UChicago Data Classification Guide: https://its.uchicago.edu/data-classification-guideline/
• UChicago Data Usage Guide: https://dataguide.uchicago.edu/
• Accessing and Utilizing University Data for Research: https://dsc.uchicago.edu/
• Secure Data Enclave (SDE): https://securedata.uchicago.edu/
• Center for Research Informatics (CRI): https://cri.uchicago.edu/

International Travel & Research:

• Travel Toolkit for International Research: http://www.traveltoolkit.uchicago.edu/
• Export Control: https://ura.uchicago.edu/page/export-controls
• International Human Subjects Research Standards: https://www.hhs.gov/ohrp/international/

Other UChicago IRB-Specific Forms, Policies, and Procedures:

• Biological Sciences Division (BSD) IRB: http://bsdirb.bsd.uchicago.edu/
• Social Service Administration (SSA) IRB: https://www.ssa.uchicago.edu/institutional-review-board