What Needs HSC Review? Staying compliant with Federal research regulations

Two Central Questions 1.Is it research? 2.Does it involve human subjects? If both answers are “yes,” then it needs HSC review

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

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

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.

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

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

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

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

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

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

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

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

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

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