What Needs HSC Review?

1. What Needs HSC Review? Staying compliant with Federal research regulations

2. Two Central Questions • Is it research? • Does it involve human subjects? If both answers are “yes,” then it needs HSC review

3. Defining “Research” • From 45 CFR 46: • Research is a systematic investigation • Primary goal: Develop or contribute to generalizable knowledge

4. Human Subjects • Your project involves human subjects if: • Person is living AND EITHER • Data gathered through interaction with that person OR • The project uses identifiable private information

5. Human Subjects Research at ISU • ALL research involving human subjects must be reviewed by the Human Subjects Committee when: • The researcher is affiliated with ISU (e.g., faculty, staff, student, administrator) OR • The research targets ISU’s students, faculty, staff, etc.

6. It Just Doesn’t Matter … • Where your research takes place • If you’re affiliated with ISU, your research needs HSC review even if it is conducted in another country • How (or whether) your research is funded • Whether your research is part of a course or assignment

7. Role of Publication • Publication (or intent to publish) is NOT a reliable indicator of whether a project counts as research • Not all research is published • Some things that are published are not research

8. NOT Research – Examples • Outcomes assessment • E.g., Instructor evaluations, exit interviews • Quality assurance/Quality improvement • E.g., Gathering performance data to identify problems, measure effects of changes • Case report • None of these generalizes beyond a particular program or patient – not research

9. NOT Research – More Examples • Medical practice/Innovative therapy • Intended only to benefit a particular patient, but uses nonvalidated procedures • Public health practice • E.g., Monitoring infectious diseases, program evaluation, needs assessment • Resource utilization review • E.g., Review of resources used in medical treatment

10. Research on Existing Data Sets • If data are about living people, then HSC review is required • If no identifiers are used, project may qualify for a Certificate of Exemption

11. Pilot Studies • These require HSC review! • A pilot study is still a study • May involve risks for participants • Raises issues of voluntary, informed consent

12. Multi-Site Studies • If ISU is one of many sites in a large study, the local researchers need HSC review • If project is minimal risk, the HSC may accept the review conducted by the project’s home IRB

13. Oral History Projects • May involve issues of confidentiality, risk of retribution, voluntariness, etc. • Researchers should consult with the HSC before beginning their projects

14. Teaching Research Methods • No HSC review is required provided: • Purpose is to teach research methods • Students gather data only from one another • No sensitive subject matter; minimal risk • Data are destroyed at the end of the course

15. Research as Coursework • HSC review is required! • Could have students submit projects individually to HSC • Instructor could file a single “blanket proposal” • Students’ projects must be very similar