Human Subject Protection Program

1. Human Subject Protection Program IRB Update - Nursing Fall 2010 Mariette Marsh, MPA, CIP Assistant Director, HSPP marshm@email.arizona.edu 520-626-7575 (Direct) or 520-626-6721 (Main)

2. Project Numbers Total # Projects (as of Sept 2010, +/- 1%) • Full committee = 529(23%) • Expedited projects = 1049 (46%) • Exempt studies (last three years) = 692(30%) • Facilitated reviews = 98(.04%) • Unknown = 134 (.06%) TOTAL = 2270 VA Exempt/Exp/Full Committee = 151 of total (.07%) 2

3. IRB1 Chair: Peter Lichtenthal, MD Vice Chair: James Goodwin, PhD HSPP Organizational Chart IRB2 Chair: Elaine Jones, PhD Co-Chair: Thomas Park, PhD Organizational Official Vice President for Research Leslie Tolbert, PhD IRB3 Chair: Leslie Boyer, MD Vice Chair: James Goodwin, PhD Assistant Vice President for Research Compliance and Policy Elizabeth Boyd, PhD IRB4 Co-Chair: Linda Garland, MD Co-Chair: Ida (Ki) Moore, DNSc Co-Chair: Brenda Wittman, MD Director Human Subjects Protection Program Sheryl Wurl, PhD Assistant Director Process Improvement and Compliance Wendy Tate, PSM, CIP Assistant Director Education and Outreach Mariette Marsh, MPA, CIP IRB2 Coordinator: Simona Janisch Associate: Leslie Lee Associate: Danielle Griffin Associate: Andi Encinas IRB1 Coordinator: Rick Reed Associate: Joseph Yee IRB3 Coordinator: Anthony Pena IRB4 Coordinator: Lori Botello Associate: Danielle Gartner 3

4. IRB Committees 4

5. What comes before the IRB? • Human Research determination • Determine if project meets definition of “research” • Determine if project involves human subjects or identifiable information obtained from a human subject 5

6. Is it Research? Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. • Is the activity an investigation? (Investigation: A searching inquiry for ascertaining facts; detailed or careful examination.) • Is the investigation systematic? (Systematic: Having or involving a system, method, or plan.) • Is the systematic investigation designed to develop or contribute to knowledge? (Designed: evaluate whether the activities taking place will develop or contribute to knowledge. Develop: to elaborate or expand in detail. Contribute: to be an important factor in; help to cause. Knowledge: truths, facts, information.) • Is the knowledge generalizable? (Generalizable: Publication does not automatically mean universal applicability.) 6

7. Definition of Human Subjects Human Subject means a living individual about whom an investigator conducting research (whether a professional or a student) obtains • Data through intervention or interaction with the individual OR • Identifiable private information 7

8. What may not be human research? • Quality improvement activities • Case Studies and Oral Histories (discussed later) • Program evaluations • Secondary analysis of existing data not collected specifically for the proposed project AND not identifiable 8

9. If the project is not Human Subjects Research This process is currently under construction. Instruct the investigator to submit an application for an official determination. Effective October 1, 2010: • Complete the “FORM: Human Research Determination.” • If it is determined that the project is not human research, obtain all required signatures, and submit to HSPP for review. • Unit reviewers may require additional documentation prior to making a determination • If the PI is a graduate student, a copy of the form may be requested by the Graduate College. http://orcr.vpr.arizona.edu/irb/forms 9

10. Role of Department/Unit Reviewer Purpose: Review all research proposals that involve human research to ensure that they meet the acceptable standard of scientific rigor and merit prior to IRB review. Procedure: • Ensure the scientific rigor and merit is based on the acceptable standard of practice for field of study. • Require changes based on acceptable standards of practice from investigator before sending to IRB. 10

11. Reviewer content Objectives • Is the purpose clearly stated? • Are outcomes pre-determined? Background and rationale • Is adequate justification for conducting the study provided? • Are results of similar or pilot data available? • Is current literature cited? 11

12. Reviewer Content cont. Design • Is design adequate to determine stated objectives? • Are questions leading? Eligibility criteria • What are the specific inclusion or exclusion requirements? Outcome characteristics • Are the endpoints specified? 12

13. Verification of Training Form (VOTF) CITI training is required for everyone involved with human research (http://orcr.vpr.arizona.edu/irb/UA_Research) • Training is good for only two (2) years. • Residents or Student Researchers must have a Faculty Advisor/Mentor listed on their application. • Advisors also must have updated training. • An undergraduate level module is available. 13

14. Key Personnel • Only Key Personnel need to be listed on the Verification of Training Form (VOTF) as defined by NIH at http://grants.nih.gov/Grants/glossary.htm#K • VOTF needs to be updated when key personnel change or at continuing review. • Additional staff that need to be listed include: • Any person consenting • Study coordinator(s) or contact person 14

15. Site Authorization • When research will be performed outside of the PI’s home department, a written site authorization is required (must be submitted to HSPP for file completion)  • When recruitment will be performed outside the PI's department, a written site authorization is required (to be maintained in PI’s files) • Posting a flyer/brochure • Using a facility to identify potential subjects 15

16. Common Pitfalls • Submitted too late to provide adequate time for review. • The most current template(s) were not used • Lack of a thorough, clear description of the research goal. • Insufficient detail about the study procedures. • Incomplete answers to all questions. If not applicable, state why. • The question asked is not the question answered. • Not all materials that a subject may see, hear, or be asked are submitted. 16

17. Certificate of Confidentiality (CoC) • May protect identifiable research information from forced disclosure. • To be used with projects that obtain sensitive data. • Does not matter whether project is funded. • CoC covers all data collected from start of project. CoCKiosk:http://grants.nih.gov/grants/policy/coc/ 17

18. Continuing Review Projects that are non-exempt must be re-approved by the IRB each year before the expiration date. • Paperwork must be submitted to the HSPP 45 days in advance of expiration of project. • Notices are sent 60 days in advance of expiration to email address on file. 18

19. Continuing Review cont. • If the project is not approved by the expiration date, the project will be administratively closed and a new application will be required. • Investigators will be restricted from submitting new human research until the completed continuing review form has been received. • If the data are no longer the project can be concluded. 19

20. Encryption • Review the guidelines for IT security at http://security.arizona.edu/files/ISG301.pdf • Contact your department/college’s IT unit to determine how best to encrypt and secure data. 20

21. Engagement in Research The University of Arizona is engaged in Human Research when UA employees or agents are interacting or intervening with Human Subjects for the purpose of conducting Research. Refer to the guidance at: http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html Additional agreements may be required. 21

22. Leaving Institution • PI is responsible for transferring oversight or concluding the project before leaving the institution. • Departments are responsible for keeping track of individuals leaving the institution and to ensure that the project is appropriately concluded. 22

23. Records Retention • A record is any information associated with a research project. • Records may be electronic, digital or paper. • Research records must be de-identified as promptly and thoroughly as possible. • If identifiers remain, adequate justification for needing identifiers should be the IRB application. 23

24. Records Retention cont. In accordance with the University of Arizona Common Records Retention and Disposition Schedule, maintain Human Research records, including signed and dated consent documents, for whichever of the following time periods are the longest: • The length of time required by law; or • As long as the sponsor requires (for sponsored research); or • 6 years after the completion of the research; or • 6 years after the age of majority, if the research involves children. http://web.arizona.edu/~records/common_retention_schedules.pdf 24

25. Native American/Alaskan Indian/Indigenous Populations • Requires consultation by: • American Indian Studies (social and behavioral) • Office for Multicultural Affairs (biomedical) • Includes use of secondary data that was not collected by the PI of the proposed project, even if the data are de-identified. • Tribal authorization generally required prior to conducting research. 25

26. New Information A new investigator manual, application, consent templates, and policies will be released electronically in early October. Only the forms posted on the HSPP website will be accepted after December 23, 2010. After December 23, 2010, all other forms will be sent back to PI without review. 26

27. Raffles • Investigators often consider offering potential participants in human research the opportunity to enter into a raffle or drawing for a prize as an inducement to participate in the study. • Raffles are considered gambling under the State of Arizona and cannot be used except in certain circumstances. See Handout “Raffles in Research” 27

28. Conflict of Interest (COI) • Reporting outside interests is an institutional requirement for all human research regardless of funding or status as a researcher. • Reporting is required with each new project and continuing review. If you have questions about COI, contact the COI coordinator, Mary Lovely, at 626-7879 or lovely@email.arizona.edu See handouts “Conflict of Interest” 28

29. Stay Connected Visit our website www.orcr.vpr.arizona.edu/irbto get the newest forms and updates Sign up for the HSPP Listserv to get the latest information and updates- it’s easy: http://orcr.vpr.arizona.edu/irb/UA_Research Mariette Marsh, MPA, CIP Assistant Director, HSPP marshm@email.arizona.edu 520-626-7575 (Direct) or 520-626-6721 (Main) 29