Carthage College Institutional Review Board ( IRB )

1. Carthage College Institutional Review Board (IRB) Understanding the Review Process

2. Charge of the IRB • To ensure the safety and well-being of human participants (and animal subjects) in research • Applies to research done at Carthage College or done by Carthage Investigators • Ethics, Risks and Safeguards, Liability, Confidentiality, Anonymity, Security, and Research Integrity

3. The IRB Review Process • You file a proposal with the Institutional Review Board Office that explains the research and its use of participants • Exempt, Standard or Full Review • The IRB may request or demand changes to improve safety, confidentiality; resubmit • The IRB may request or recommend clarifications on methods or improvements to the study; address concerns or justify… • The IRB ultimately approves the study

4. Categories of Review (Human Participants) • Exempt • Claim of no potential risks to participants • Belief that no written consent form necessary • Verbal consent is adequate and in study design • Request for Exemption is filed with the IRB Office • IRB Chair reviews the research proposal and will grant exemption if it meets the criteria

5. Categories of Review • Standard Review • Minimal risk (not minors, no deception, not sensitive) • Requires filing the full Human Participants proposal form • Study participants voluntarily sign a written consent form: • 1 reviewer + IRB Chair

6. Categories of Review • Full Review • Required when the research design involves minors or other sensitive populations • Parental and minor consent forms • If physical/emotional “risk” is involved to participants; sensitive, personal subjects • If any deception is used • Requires the Full Proposal Form • 3 reviewers + IRB Chair

7. Members of the IRB • Cynthia Allen (Health/Physical Education) • Thomas Carr (Biology) • Scott Hegrenes (Biology, Chair) • Dan Miller (Neuroscience & Psychology) • Mark Miller (Business Administration) • Isabel Rivero-Vila (Modern Languages) • Wayne Thompson (Sociology) • Matt Zorn (Geography) • With support from • Deborah Usinger (Administrative Assistant)

8. Where can I get the forms? • Faculty Principal Investigator can access the Faculty page: http://www.carthage.edu/provost/faculty/ committees/institutional-review-board/ • Faculty can search for IRB on Carthage homepage • See Deborah Usinger , Clausen 213 • IRB Administrative Assistant proposals are processed, distributed

9. Are you Exempt from an IRB Review? • Does the study meet the criteria for exempt? • Do you believe your study poses no risks to participants and no written Informed Consent is needed? • If YES, file the Request for Exemption • The IRB will determine whether your proposal qualifies as exempt • What are the exempt criteria?

10. Informed Consent • Any person who agrees to participate needs disclosure… • Survey – if you ask somebody to take an anonymous survey, they need to know the subject matter (politics, religion, embryonic stem cells, facebook, etc.) • Survey Monkey and online data gathering • The willingness to participate IS their consent in a no-risk Exempt survey • Anonymous, no signed forms

11. Written Informed Consent • A Formal Legal Document, • signed, duplicates (participant, researcher) • Openly identifies the potential risks facing the participants • no surprises, can withdraw at any time • Wording must be clear, unambiguous • If using minors, need parental consent • If using adults, include the declaration… • I am 18 years of age or older…

12. How do I start the IRB Review process? • You fill out the forms and submit paperwork to Deborah Usinger, CC213 • Work with your Faculty Principal Investigator and Department Chair for signatures • IRB Chair responds via email (within a few weeks) • If your research proposal is clear, well-planned, ethical – you are given approval • Potential problems may be uncovered: incomplete proposal, wrong form, methods unclear, subject recruitment not feasible, unsupported claims, poor science… • Clear up the issues – you get approved!

13. What is in a Complete Proposal? ready for IRB review • Include any survey or questionnaire • Reviewed as part of the proposal • Include any “specific instructions” • Ex. a script of what is read to each participant • Signatures/Approval of Administrators • Principal Investigator, Dept Chair, School Administrators (off-campus) • A Reasonable Start Date! • IRB approval lasts for 1 year, extensions, addendum are possible

14. IRB Snafus are Lurking! • The process can be frustrating! • The IRB wants to know details! • So many checklists on the form! • Get it done right the first time • IRB is the advocate for participants’ rights & safety – as you write your proposal think about what the IRB needs to know in order to do our job effectively

15. Does my study need the Full Form or the Exempt Form? • It depends… • Exempt studies need to meet certain criteria to qualify for exempt… • If there is any risk or deception – use the full form • Informed Consent Statement Signed • This is our guide…

16. (Federal Standards for) Criterion 1 for Exemption • Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: • research on regular and special education instructional strategies, or • research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

17. Criterion 2 for Exemption • Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: • subjects can be identified • subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation.

18. Criterion 3 for Exemption • Research described in criterion 2 that is not exempt if: • The human subjects are elected or appointed public officials or candidates for public office; or • federal statutes(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

19. Criterion 4 for Exemption • Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. • Data needs to be coded, anonymous, cannot be traced back to or linked to any individual

20. Criterion 5 for Exemption • Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: • Public benefit or service programs; • Procedures for obtaining benefits or services under those programs; • Possible changes in or alternatives to those programs or procedures; or • Possible changes in methods or levels of payment for benefits or services under those programs.

21. Criterion 6 for Exemption • Taste and food quality evaluation and consumer acceptance studies, • if wholesome foods without additives are consumed or • if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency of the Food Safety and Inspection Service of the U.S. Department of Agriculture.