Is it “Research” ?

1. Is it “Research” ? If Yes, What Then? Marianne McGrath, Ph.D., Chair Institutional Review Board (IRB)

2. What’s an IRB? • Because UM-Flint is an institution that receives federal funding, we are required to have our research reviewed by an Institutional Review Board (IRB) • All research in the UM system, federally funded or not, must be reviewed by one or more UM IRBs • The main purpose of an IRB is to ensure the ethical treatment of human participants in research

3. How is “Research” Defined? • The federal government defines research as, “systematic data collection efforts intended to develop or contribute to generalizable knowledge.” Examples: • Presenting the Project/Results at a Conference • Writing a Paper That Describes the Project/Results and Submitting it For Publication (and it may or may not be published; the intention was to publish it)

4. Examples of Non-Research Projects • Classroom activities where the results are limited to class discussion/use • Program/Department evaluations where the results will be used only for modification and improvement of that department • Any Faculty/Staff/Student Project involving human “information” that is not intended to be shared in any public domain • …All this being said, it’s still vital to consider:

5. The Participants Whenever possible, information should be coded with numbers to protect privacy and confidentiality The benefits of participating should outweigh any risks…and the risks should be minimal If identifiable data are collected (videotapes, etc) it’s best to consult the IRB for participant agreement forms, etc. If vulnerable participants are involved (pregnant women, children, individuals with cognitive impairments, prisoners) it’s best to consult the IRB for suggestions about ensuring safe & ethical treatment.

6. And if Your Project is Research • {You may present all or parts of it at a conference, or you may decide to try and publish it at some point in time.} • You must submit an application to the IRB. • Our application/review process is known as eResearch

7. eResearch Michigan Program for Research Information Management and Education (MPRIME) Principal Investigator (PI) /Study Team Training

8. eResearch Overview • What is it? • eResearch is a Web-based system for submission, routing, approval, and management of research information. • Initially, the system will be used for research involving human volunteers. • The system will help the University address its obligation to conduct human research in accord with relevant regulations. • eResearch is a component of the University plan for Human Research Participant Protection Program (HRPPP) and is coordinated with the Accreditation activities.

9. Benefits • The application will be prepared by means of a “smart form.” Built-in logic will guide PIs and SCs to relevant questions, based on their responses. • Validation of entered data will improve quality and may reduce number of changes required after submission. • Review and approval will be conducted online. • Email notifications will include hyperlinks to specific applications; the content of the correspondence will be maintained on the database for future reference. • Changes will be logged and time stamped.

10. To Submit an Application . . . • The PI (principal investigator) needs to: • Review information entered by the study team (can print full application to review) • Submit application electronically • Re-submit if changes are required by an ancillary committee, or an IRB Committee. • The PI will also need to electronically submit any adverse events, amendments, and scheduled continuing reviews.

11. New Application: Sections

12. A Couple of Very Important Points: 1.Research is classified into different “types,” depending on level of risk to participant: • Exempt • Expedited • Full Board Review

13. The Other Point! • 2. Researchers cannot make this determination/classification—the IRB must, according to federal regulations.

14. eResearch Training • Practice Lab and Hands-on Training • These are scheduled throughout the year • Learning Course • Self-paced online tutorial available • Go to eResearch.umich.edu and explore the options!

15. In Addition to These Options • Marianne McGrath is available to answer questions: mmcgrath@umflint.edu 762-3425

16. You May Be Asking… • Why eResearch—why change from our former procedures and “paper form” to eResearch and other procedural changes? • The main reason: Mary Sue Coleman, President of University of Michigan, wants our Human Research Participant Protection Program (HRPPP)—of which IRBs are a vital part, to be accredited. The eResearch application incorporates accreditation standards much more thoroughly than our old form.

17. Why is Accreditation Important? • Improves protection programs (IRB functions, and other aspects of the HRPPP) • Assists in achieving compliance • Facilitates research integrity and quality • Instills confidence in sponsors • Builds public trust (increased media attention to violations of ethical treatment, lawsuits, and/or shut-downs at Johns Hopkins, Iowa, Vermont, etc.)

18. Who will Accreditation Affect? • Generally, the entire UM system • Specifically, researchers/principal investigators with research projects currently approved and those that have expired in the last three years • Site visitors from the Association for Accreditation of Human Research Protection Programs (AAHRPP) will come to our campus and IRB members and researchers/PIs will be interviewed

19. How do researchers/PIs prepare for Accreditation/Site Visits? • Complete online training modules for understanding the ethical treatment of human participants in research and other issues—become PEERRS certified: • PEERRS helps you better understand aspects of human research such as informed consent, risk-benefit ratio, etc. • You’ll then better understand the eResearch application form http://www.research.umich.edu/training/peerrs.html You’ll need your “kerberos” password for this and eResearch websites

20. Preparation for Accreditation (continued) • Learn eResearch as soon as possible • Practice in eResearch “sandbox” • Go to eresearch.umich.edu and click “Sandbox” on the left side of the screen, then “Login to Sandbox” • And the “real” eResearch is available today— • Go to eresearch.umich.edu and click on Login

21. Becoming a Well-Informed Researcher (continued) • To learn more about non-biomedical research and IRB review, visit http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm • Read the Belmont Report http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm • To learn more about Accreditation http://www.aahrpp.org/www.aspx

22. UM-Flint IRB Web Site Please visit the UM-Flint IRB web site for all questions, concerns, and information regarding protection of human subjects in research http://humansubjects.umflint.edu

23. Summary & Questions • Protect and respect human participants and their information, in all projects, research and otherwise • If your project is “research”, understand the responsibilities of being a researcher/PI or study team member • Help UM achieve the goal of accreditation of its Human Research Participant Program—including IRBs and research projects • Questions/Concerns?