NUTS & BOLTS of Human Subjects Research at IUB

1. NUTS & BOLTS of Human Subjects Research at IUB Why, When, Who The application process

2. Why • Protect Human Subjects • Assurance with Federal Government • Protect University and researchers

3. When (must you apply for approval) • Any research involving data collected from Human Subjects • What is a Human Subject? • What is Research? • Classroom research – http://www.indiana.edu/~resrisk/sturespo.html • In-house program evaluations

4. Who • Vice President for Research • Associate Dean Ann Gellis • The Committee • Staff

5. Forms • http://www.indiana.edu/~resrisk/instruct.html • Choose: on-line exempt (3 versions), or WordPerfect, MSWord, PDF • Choose the form - New, Continuation, Amendment

6. Level of Review • Full Committee - most risk • Expedited - minimal risk; specific categories • Exempt - low risk; specific categories

7. Exempt & Expedited every week deadline is Monday at 5:00 p.m. review is usually on Wednesday p.m. Full Committee - once a month meeting is usually 3rd Thursday deadline is the Monday 2 weeks before the meeting Deadlines

8. Use of MCCSC students • http://www.indiana.edu/~fieldexp/request.html • Joanna Evans, Educ 1046, 856-8541, joanevan@indiana.edu

9. HIPAA • Health Information Portability & Accountability Act • Covered Entities • Researchers

10. Review Response • Who are the Reviewers? • When will I hear back? • What if my study isn’t approved? • What kind of information will I be told? • When will it get reviewed again?

11. Use of technical jargon information is inconsistent between application & consent form failure to provide information requested Failure to provide information in correct place failure to proof read for typos failure to include all instruments, recruitment materials, signatures Common Mistakes

12. Use of small type that is hard to read Consent form/Information Sheet does not follow required format Use of outdated language in consent form/information sheet Use of language that will not be understood by subjects More Common Mistakes

13. Researcher Responsibilities • Have an approved advisor • Pass the HS Protection test • Respond to Committee in timely manner • Keep copies for at least 3 years • Obtain approval for changes • Notify Committee ASAP of any problems

14. Interesting Numbers • 695 items processed in 90/91 • 1948 items processed in 02/03 • of those 1948, 860 were new studies • of those 860, 564 were student projects • of those 860 new studies, 276 were from the School of Education. HPER had 74 and Psychology had 79

15. More Numbers • Those 860 new studies came from 51 IUB schools/departments and 2 researchers from outside IU • items per week range from 11 to 48 • average that get approved each week - 24%

16. Web sites with information • http://www.indiana.edu/~resrisk/hmpg.html • http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm • http://grants.nih.gov/grants/policy/hs_educ_faq.htm • IU test site: http://www.iupui.edu/~resgrad/Human%20Subjects/HumanSubjectsCourse.html

17. Office Staff • Cybil Cole, Director Human Subjects Risk Compliance • Senta Baker, Research Compliance Coordinator • Sherry Babcock, Senior Office Assistant • Carmichael Center L03, 530 E. Kirkwood • 855-3067 • iub_hsc@indiana.edu