Research@UIC > Protocol Review > AAHRPP

AAHRPP

Education | Policy Updates | Contact

UIC OPRS has developed this site to deliver the latest information on the UIC OPRS research compliance program to investigators and coordinators, IRB members, and OPRS staff. The site features include tools, educational modules, and contact information to provide a practical summary of requirements tailored to the specific audience. This site includes 21 educational modules, each of which the relevant parties will have the opportunity to attend in person. For your convenience, you may also schedule your educational session/s on this site.

The launch of this site coincides with an upcoming site visit by the Association for the Accreditation of Human Research Protection Programs (www.AAHRPP.org), during which many IRB Members, investigators, research coordinators, and OPRS staff will be interviewed. Please note that the UIC AAHRPP application and the accreditation agency's response have been posted to secure internal websites for IRB members and OPRS Staff. Please check your email account for the link to these sites.

Education

• IRB Members
• OPRS Staff
• Investigators and Research Coordinators
• Community Members
• General Training Sessions
• Informed Consent Process

    IRB Members

1. Conflict of Interest – IRB Members (Boards 1, 2, 3) - PDF | PPT
   • Learn key conflict of interest definitions
   • Learn how your activities fit within the definitions
   • The steps to take when you have a conflict
2. Conflict of Interest – JBVAMC (Collaborative IRB - PDF | PPT
   • Learn the unique conflict of interest process when the JBVAMC is a performance or recruitment site
   • Learn key conflict of interest definitions
   • Steps to take when you have a conflict
3. HSPP Overview – IRB Members (Boards 1, 2, 3) - PDF | PPT
   • Overview of the UIC human subjects protection program (HSPP)
   • IRB member role in the HSPP
   • Review of various scientific and scholarly review committees and their practical implications for IRB members
4. HSPP Overview – Collaborative IRB (JBVAMC) - PDF | PPT
   • Overview of the
   • Demonstration of a protocol review and application of regulations
   • Tutorial on the purpose and use of the review guide
5. Essentials for IRB Members (Presentation will be available on 10/1/09)
   • Overview of IRB member determinations and responsibilities for initial and continuing review
   • What must be reported to the IRB and when
   • Demonstration of a protocol review and application of regulations
6. Collaborative IRB Essentials (Presentation will be available on 10/19/09)
   • Identification and application of unique VA Research requirements
   • Recent developments in VA Handbook requirements and other applicable materials
7. IRB Approval Criteria - PDF | PPT
   • Overview of core determinations that the IRB makes
   • Learn the basic and additional OHRP elements of informed consent
8. Flagging the Medical Record – Collaborative IRB - PDF | PPT
• Explanation of the term “flagging”
• Learn when and why to require that the medical record be flagged
• Learn how responsibilities are delegated and why

    OPRS Staff

1. Conflict of Interest – OPRS Staff (Presentation will be available on 10/18/09)
   • Overview of relevant office procedures related to investigator and research coordinator conflicts of interest
   • Mapping of communication between Conflict of Interest Office and OPRS
   • Detailed description of OPRS staff response to a variety of job functions
2. HSPP Overview – OPRS Staff (Presentation will be available on 10/18/09)
   • Recent federal enforcement actions
   • Overview of UIC human research protection program
   • Practical compliance issues in the administration of the program
   • Identification and coordination of other components of the program
3. HSPP Overview – Collaborative IRB Staff (Presentation will be available on 10/19/09)
   • Unique compliance concerns for VA Research
   • Overview of human subjects protection program specific to the Collaborative IRB
   • Identification and coordination of other components of the program and applicable subcommittees
4. Essentials for OPRS Staff (Presentation will be available on 10/18/09)
   • Overview of key documents that must be present before the submission is presented to the IRB member
   • Overview of OPRS staff responsibilities at pre-review
   • Frequent compliance questions and answers
5. Essentials for Collaborative IRB Staff (JBVAMC R&D Staff/ UIC Collaborative IRB Staff) (Presentation will be available on 10/19/09)
   • Overview of key documents that must be present before the submission is presented to the Collaborative IRB member
   • Overview of OPRS staff responsibilities at pre-review
   • Frequent compliance questions and answers
6. Prompt Reporting Requirements (JBVAMC, Collaborative IRB Members and Staff) - PDF | PPT
   
   • Overview of definitions
   • Identify the procedure relevant to your role

    Investigators and Research Coordinators

1. Conflict of Interest – Investigators and Research Coordinators (Presentation will be available on 10/1/09)
   • Recent developments in conflict of interest and its importance
   • What needs to be reported to IRBs
2. Conflict of Interest – Investigators and Research Coordinators (JBVAMC) (Presentation will be available on 10/19/09)
   • Recent developments in conflict of interest and its importance
   • What needs to be reported to IRBs
   • Identify what institution and office you need to report your conflict given your institution
   • Learn what conflict of interest policies you follow given your institution
3. HSPP Overview – Investigators (Research Coordinators) (Presentation will be available on 10/1/09)
   • Recent enforcement actions against investigators
   • Overview of the relationship between the various HSPP components
   • Expedited vs. exempt research
   • Unanticipated problems defined and placed in practical scenarios
   • Helpful submission timelines and pointers
   • Consequences of lapses in IRB approval
   • Adverse event reporting and definitions
4. HSPP Overview – Investigators (Research Coordinators) (JBVAMC) (Presentation will be available on 10/1/09)
   • Recent enforcement actions against investigators
   • Overview of the relationship between the various HSPP components
   • Expedited vs. exempt research
   • Unanticipated problems defined and placed in practical scenarios
   • Helpful submission timelines and pointers
   • Consequences of lapses in IRB approval
   • Adverse event reporting and definitions
5. Investigator Responsibilities (Research Coordinators) (Presentation will be available on 10/1/09)
   • A step by step tutorial on submitting materials to OPRS
   • What is the IRB approval criteria and how to meet this criteria
   • The essential documents investigators must have on file at all times
   • What are the document retention time lines that apply to you
   • Orientation to the UIC OPRS website resources
   • Overview of the informed consent process
6. Investigator Responsibilities (JBVAMC) (Presentation will be available on 10/1/09)
   • A step by step tutorial on submitting materials to the Collaborative IRB
   • What is the IRB approval criteria and how to meet this criteria
   • The essential documents investigators must have on file at all times
   • What are the document retention time lines that apply to you
   • Orientation to the UIC OPRS website resources
   • Overview of the informed consent process
7. Sponsor-Investigator Responsibilities (Presentation will be available on 10/1/09)
   • Overview of recent enforcement actions involving sponsor-investigators
   • What is the IRB approval criteria and how to meet this criteria
   • Why sponsor-investigators have a dual role
   • Additional informed consent process considerations for sponsored research
8. Prompt Reporting – Investigators (JBVAMC) (Presentation will be available on 10/1/09)
   • Overview of definitions
   • Identify when an event needs to be reported
   • Learn the reporting process

    Community Members

1. Community IRB Member Responsibilities (Boards 1, 2, 3 and Collaborative IRB)
   (Presentation will be available on 10/19/09)
   • Defining the Community Member’s role on the IRB
   • The importance of bringing sensitivity to the needs and concerns of the community to the IRB

    General Training Sessions

1. Lapses in IRB Approval (IRB Members, OPRS Staff, Investigators and Research Staff) (Presentation will be available on 9/16/09)
   • Consequences of a lapse of IRB approval
   • Learn how to avoid lapses of IRB approval
2. Prompt Reporting Requirements (IRB Members, OPRS Staff) - PDF | PPT
   • Learn what type of events need to be promptly reported to the IRB
   • Learn how to submit reportable events.

    Informed Consent Process

1. Informed Consent Process (Presentation will be available on 10/19/09)
   • Find the appropriate flexibility in the regulations
   • Learn tips on obtaining effective informed consent
   • Learn about proper delegation of the informed consent process

Policy Updates

Here is the link for the policy updates:
http://tigger.uic.edu/depts/ovcr/research/protocolreview/irb/policies/updates.pdf

Contact

Andra Popa, Assistant Director
E-mail: apopa@uic.edu
Phone: 312.413.1632

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