2. Investigator Initiated Research Best Practices for IRB: SBER Corey Zolondek, Ph.D. IRB Operations Manager Wayne State University

3. Overview Is IRB Review Required? Is the study exempt? Recruitment Criteria for approval Research and non-research activities Student research Study locations outside of your institution International research

4. Is IRB review required? Is the study systematic and designed to contribute to generalizable knowledge? – Quality Improvement – Journalism – Oral histories documenting specific events – Research training as a classroom activity

5. Is IRB review required? Is the study about living individuals? – Aggregate data – Organizational practices

6. Is IRB review required? Does the study involve an intervention, interaction, or private identifiable data? Is the study FDA-regulated?

7. Is the study exempt? Regular classroom activities Surveys Interviews Observing public behavior Existing records

8. Recruitment Avoid coercion or undue influence in recruitment – Recruitment of children and other vulnerable groups – Recruitment of students or employees – Secondary/”Snowball” methods Avoid emphasizing compensation Mention all details likely to influence decisions to join

9. Criteria for approval: Risks to subjects are minimized Physical, psychological, social, legal, economic Scientific justification for any methods with potential risk (especially if risks are greater than daily life) Plans to minimize each identified potential risk – Counseling – List of resources – Data protection – Option to end participation immediately

10. Criteria for approval: Risks are reasonable in relation to anticipated benefits Adequate scientific justification of proposed research methods Benefits are not overstated The study is likely to yield valid results

11. Criteria for approval: Selection of subjects is equitable Scientific justification for targeting a group Scientific justification for excluding a group Adequate justification if using convenience sampling

12. Criteria for approval: Informed consent will be sought from each prospective subject People with knowledge of the study are obtaining consent Appropriate amount of time to consider enrolling Parents are aware of child’s participation Adequate consent process if targeting populations with low English literacy rates

13. Criteria for approval: Informed consent will be appropriately documented Follow regulations requiring written consent (e.g. HIPAA, FERPA) Waive documentation if written consent is not required

14. Criteria for approval: When appropriate, there is an adequate plan for monitoring data to ensure safety of subjects May be needed for behavioral interventions, especially if participants are children

15. Criteria for approval: There are adequate provisions to protect the privacy of subjects and maintain confidentiality of data Security of data – Persons with access – Physical security (e.g. locks, doors) – Encryption/passwords – Use of master lists Location of participant interactions and interventions Only collecting data required to address hypotheses

16. Research and non-research activities are clearly defined School-based research Behavioral interventions Participant observation

17. Student research IRBs should ensure researchers have adequate expertise and resources to conduct a study Faculty mentoring and supervision is needed for students – Include in correspondence

18. Study locations outside of your institution Letters of support from unaffiliated institutions where research recruitment and/or procedures are done (i.e. schools, businesses, community groups, etc.) Unaffiliated institutions understand that research will be conducted Plans to train study personnel from an unaffiliated institution

19. International research Export Control Local context – Ethics review in international location – Investigators’ familiarity with international location – Local customs/laws – Spoken and written language used by investigators

20. Questions? Corey Zolondek, Ph.D. IRB Operations Manager Wayne State University zolondek@wayne.edu