Laura M. Argys Associate Dean for Research and Creative Activities College of Liberal Arts and Sciences University of Colorado Denver

1. Establish and convene an Institutional Review Board 2. Develop and follow written procedures 3. Review protocols for exempt status, under expedited review or under full board review. 4. IRB may approve protocols, require modifications, or disallow the research. 5. Review ongoing protocols at least annually. 6. Maintain records of IRB activities.

Minimizing risk to subjects Assuring subject privacy/confidentiality/consent Complying with federal and state regulations Avoiding delays to research faculty Using employee time effectively on IRB

1. Have the right people on the IRB Diversify the faculty on the IRB Race/ethnicity/gender disciplines/types of research Biomedical/Clinical trials Focus groups/conducting surveys Ethnography/qualitative research Behavioral experiments Educational research Use of secondary data Include research active faculty Experience with vulnerable populations Scientific/non-scientific concerns

2. Provide resources for a successful IRB Provide dedicated staff to Manage paper submissions To take minutes Point of contact Provide a remote or physical presence Provide sufficient time to the chair of the IRB

3. Promote responsible Human Subjects research Establish the expectations that all appropriate researchers undergo human subjects review Provide education on human subjects research For researchers For students Training on submission procedures

4. Maintain a knowledgeable IRB Maintain continuity of IRB members Provide Human Subjects and HIPAA training Make experts available to the IRB International experts Disciplinary experts

5. Ensure compliance Have a quick process for evaluation of exempt status Provide expedited review by designated committee member Make the full board process efficient

6. Effective communication between the IRB and researchers Ask the questions that will elicit the information needed by the committee. Embed explanations in the application materials Build logical skip patterns into the application Ensure that the committee has the expertise to understand what can be expected of the researcher.

7. Make the process interactive Provide opportunities for Principal Investigators to meet with committee members: To answer questions that arise during the committee review To get clarification regarding modification requests

8. Save time: Conduct business between meetings Provide advice and consultation for applications in preparation Evaluate exempt research Conduct expedited reviews Consult on modifications

9. Create focused review panels Biomedical panels Behavioral and Social Science Panels Education Research Panels

10. Improve record keeping: Adopt/devise an electronic record system Provide faculty access to records of all of their protocols. Provide notification of scheduled reviews Provide feedback from committee