Is it “Research” ?If Yes, What Then?

Marianne McGrath, Ph.D., ChairInstitutional Review Board (IRB)

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

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Project/Results and Submitting it For Publication (and it may or may not be published; the intention was to publish it)

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:

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.

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

Michigan Program for Research Information Management and

Education (MPRIME)

Principal Investigator (PI) /

Study Team Training

eResearch

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.

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.

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.

New Application: SectionsRequired Information

1. General Project Info

2. Sponsor Information

3. Performance Sites

4. Project Abstract

5. Research Design

6. Benefits & Risk to Subjects

7. Special Considerations

8. Subject Populations

9. Exemption

10. Informed Consent

11. Subjects

12. Confidentiality

Special Consideration Details

13. Compensation

14. Experimental Health Care Treatments and Procedures

15. Drugs, Biologics, etc.

16. Devices

17. Placebo

18. Biological Specimens

19. Stem Cells

20. Genetic Analysis

21. Ionizing Radiation

22. Organ/Tissue/Cell Transfer

23. Gene Transfer

24. Secondary Data Analysis

25. Protected Health Information (HIPAA)

26. Epidemiology

27. Deception Research

28. Internet/Email

29. Survey Research

30. International

31. Watching/Listening to Audiovisual Materials

32. Data Safety Monitoring Plan

Vulnerable Subjects Details

33. Minors

34. Neonates

35. Pregnant Women and/or Fetuses

36. Lactating Women

37. Women of Child Bearing Potential

38. Prisoners

39. College Students

40. Impaired Adults

41. Subjects Vulnerable to Coercion

Committee Details

42. GCRC Resources

43. PRC Information

44. Supporting Documents

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

The Other Point!

• 2. Researchers cannot make this determination/classification—the IRB must, according to federal regulations.

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!

In Addition to These Options

• Marianne McGrath is available to answer questions: mmcgrath@umflint.edu 762-3425

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.

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.)

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

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

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

Becoming a Well-Informed Researcher (continued)

• To learn more about non-biomedical research and IRB review, visithttp://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

• Read the Belmont Reporthttp://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

• To learn more about Accreditationhttp://www.aahrpp.org/www.aspx

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

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?