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The IRB and you

The IRB and you. Helen Harton (Baker 357) Professor of Psychology IRB Chair. What is an iRB and why do we need it?. Past problems: Nuremberg Code, Belmont Report, OHRP

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The IRB and you

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  1. The IRB and you Helen Harton (Baker 357) Professor of Psychology IRB Chair

  2. What is an iRB and why do we need it? • Past problems: Nuremberg Code, Belmont Report, OHRP • Review most research done at an institution or by those affiliated with that institution (required for all organizations that receive any federal funds) • Made up of members with expertise from across the university, plus at least one outside person and at least one nonscientific person: http://www.uni.edu/osp/irb-members

  3. What types of studies do NOT need approval? • Studies that are for internal use only (will not be publically presented in any way) • Class projects that will not be presented to anyone outside the classroom or published AND are minimal risk and not with children or other protected groups • Studies that do not involve living, human participants (or their personal data) • Studies that involve the use of existing data that are publically available and de-identified • Studies that involve passive, unidentified observation in a public place • If you have ANY questions about whether your study needs review, ask the IRB administrator (anita.gordon@uni.edu) or me.

  4. What are some particular risks or issues you’re likely to run into? • How will you recruit people? Are there any potential issues with perceived coercion or risks to them in the recruitment process? • What about issues of confidentiality, during data collection, storage, and reporting? • What if someone becomes upset during the study? Do you have a game plan to deal with that? • Could the study put you or the participants in physical danger or submit you to other types of risks? • Are you a mandatory reporter/are there things you’d have to report?

  5. When I know what study I want to do, what then? • Get IRB training. http://www.uni.edu/osp/irb-training • Complete an IRB application. http://www.uni.edu/osp/irb-forms • Standard form • Survey form • Existing data form • Attach a consent document or process, being careful to address all the issues (http://www.uni.edu/osp/sites/default/files/IRB%20Informed%20Consent%20Checklist.pdf) and put it in language that your potential participants will understand

  6. Attach materials and/or sample questions. • Really think through all the steps to your study—how will people contact you (attach flyers), how will you recruit them (attach script), where will you interview them (if not a public place, you’ll need location permission) • Think through whether you need any ‘letters of cooperation’ from agencies or locations and get those send on letterhead or via email (with title) to the IRB.

  7. Special populations • If you want to do research with “special populations,” you may have other issues to think about: • Prisoners (how will you make sure they are truly volunteering, how will you protect privacy, how will you protect yourself if necessary) • Children (you’ll need to get parental consent as well as child “assent”) • Those who can’t give consent themselves (e.g., the mentally ill, those with dementia)

  8. What happens after I submit the form? • Submit it to the IRB, either by hand delivering or by email to anita.gordon@uni.edu (has to have cc for your faculty supervisor on the project) • Then it goes out to a reviewer, who will get back to you within a couple of weeks, either with an emailed approval (in which case you can begin your study), with further questions (more likely), or with notification that your study will go to “full board.” • You’ll then respond back as quickly as possible (being careful to really answer their questions) and hopefully get an approval at that point.

  9. Types of approvals • Exempt from continuing review—Still need to get pre-approval from the IRB for any modifications, but you don’t need to do a closure or continuing review form. • Expedited—Same as above, except you need to fill out a continuing review form annually and “close” your study when you have completed all collection and analyses. • Full board—This is for studies with more than minimal risk. These are reviewed by the entire board, which meets once per month. You’ll be invited to attend. Review will take longer, so plan ahead.

  10. Issues where you might get held up • Standard form/survey form (let’s look through it) • Existing data form (be sure to get permission if necessary for using the data, figure out whether the data are truly de-identified) • REMINDER—if you go to another institution and want to continue the project, you’ll likely need approval of their IRB as well (at that time). • Projects continue until you’re done with analyses as well!

  11. Questions? • Also go over program of study/electives • Classes for fall: • Everyone: • 1 credit of readings • Wed. 12-3 Research Design • Clinical also advanced child T 8:30-11, elective • Social also psychometTTh 2, personal TTh 12:30, advances F 12 • Possible electives: Personality, Health Psych, Stats, Psychmet, cog, motiv/emo, s/p, drugs, other depts • Assignments for next week: • Completed IRB form • Read about writing! • For this week: IRB training cert

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