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IRB Review of Student Internships in the School of Public Health

IRB Review of Student Internships in the School of Public Health. IRB Health Sciences & Behavioral Sciences University of Michigan 2009-2010. Goal of this Audiocast.

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IRB Review of Student Internships in the School of Public Health

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  1. IRB Review of Student Internships in the School of Public Health IRB Health Sciences & Behavioral Sciences University of Michigan 2009-2010

  2. Goal of this Audiocast Describe the situations in which internships conducted by MPH students in the School of Public Health might require IRB oversight There may be other types of internships not described here. Please contact the IRB-HSBS at 936-0933 if you have questions about your internship. 10/12/2009 2

  3. No IRB Review Required • Internship does not involve research with human subjects (see last slide for definition) • Example: Your internship involves taking soil and air measurements. You are not collecting any information about people. 10/12/2009 3

  4. No IRB Review Required • Internship with agency or industry • Collecting data for non-research purposes • Internship activities part of regular work scope of the organization • Example: MDCH regularly collects and analyzes data about the prevalence of HIV/AIDS. Your internship consists of entering this data into a spreadsheet and running basic descriptive statistics. 10/12/2009 4

  5. No IRB Review Required • Working with a UM investigator on research already approved by UM IRB • Internship consists of approved research activities • Example: Dr. Smith is a UM professor working in Egypt to conduct an IRB-approved study of colon cancer. Your internship consists of assisting Dr. Smith with data collection and analysis as approved by the IRB. 10/12/2009 5

  6. No IRB Review Required • Working with non-UM researcher on a study approved by a non-UM IRB • Internship consists of approved research activities • Copy of non-UM IRB approval & letter from research in student file • Example: Dr. Campbell is a physician at a hospital in Jamaica and is leading a study of diabetes approved by a local IRB. Your internship involves assisting Dr. Campbell in collecting data as described in the approved protocol. 10/12/2009 6

  7. IRB Review Required • Internship consists of student conducting own, independently-devised research project with human subjects • Intent to present/publish findings • Example: Your internship consists of a research study of UM graduate student health behaviors. You will collect and analyze the data, then present and publish your findings. 10/12/2009 7

  8. IRB Review Required • Analysis of previously-collected data or specimens to answer student’s own research questions • Intent to present/publish findings • Example: Data about dengue fever are collected by an NGO in South America as part of its humanitarian efforts. You obtain a dataset from this NGO and analyze it to answer your own research questions. You plan to present and publish your findings. 10/12/2009 8

  9. IRB Review Required • Working with researcher on an IRB-approved study • Internship activities will consist of entirely new research elements • If UM investigator, the UM investigator should amend the IRB application to add the student to study team; the student need not submit an IRB application • If non-UM investigator, UM IRB review is required or UM may rely on the non-UM IRB to protect human subjects. 10/12/2009 9

  10. IRB Process Information • If your internship activities require IRB review • If you aren’t certain, contact the IRB-HSBS • Allow as much time as possible, at minimum 2-4 weeks (or longer) • For work beginning in May, aim to submit your IRB application by March or April • VERY IMPORTANT: You cannot do your work until you have obtained IRB approval, even if you are already on-site 10/12/2009 10

  11. Resources 10/12/2009 IRB Health Sciences & Behavioral Sciences (IRB-HSBS) • irbhsbs@umich.edu • 936-0933 • www.irb.umich.edu eResearch • www.eresearch.umich.edu • HELP features, tutorial, Sandbox in eResearch Informed consent templates & samples • www.irb.umich.edu/Consent/consent.html Office for Human Research Protections (OHRP) • www.hhs.gov/ohrp Contact IRB-HSBS with your questions!

  12. Research with Human Subjects • Research means a systematic investigation designed to develop or contribute to generalizable knowledge. Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. 10/12/2009 12

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