Education Research and Social & Behavioral Science IRB

1. Education Research and Social & Behavioral Science IRB

2. BACKGROUND • Nuremberg Code • Infamous Cases 1950’s through 1970’s • 1971 - DHEW Guidelines Pamphlet • 1979 - Belmont Report • 1981 - 45 CFR 46

3. FWA • Agreement between UW and DHHS which allows for the conduct of HS research • OHRP/Common Rule • UW will be guided by the ethical principals of the Belmont Report regardless of source of funding

4. UW IRB WILL REVIEW IF: • Research is sponsored (i.e. funded) by UW • Conducted by, or under the direction of, any UW employee • Uses UW property or facilities • Requires non-public UW information to identify or contact subject

5. DEFINITIONS • Research 46.102(d) • A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge • Human Subject 46.102(f) • A living individual about whom an investigator obtains data through intervention or private information

6. RISK • For a study to be considered “minimal risk”, the risks associated with participating in the study must be equal to or less than the level of risk a participant will encounter in their daily lives • Acknowledgement of risk is acceptable and expected. What the IRB wants to see is the ways you will mitigate those risks (for example, encrypting data, pseudonyms, etc.)

7. STUDENT RESEARCH • All students conducting human subject research must obtain IRB approval • Senior Thesis • Hilldale Awards • Independent Study • Master’s Thesis • Doctoral Dissertation

8. STUDENT RESEARCH • Class Projects • May be research if Federal definition is met • If the results are for course credit/class assignment and will not be disseminated beyond the University, IRB approval is probably not required • Course assignments that are not research must be carried out ethically to protect individuals involved

9. INFORMED CONSENT • Informed consent is a process with its basis in ethical principals – it’s not just a signature • Written, signed consent is the default • Oral Consent • Literacy concerns • Cultural Norms • Protection of Participants • Waiver of Documentation of Consent • The only link to participants is the signed consent document

10. INFORMED CONSENT • Assent • Waiver of Consent • Waiver of Parental Consent • HIPAA Authorization • If the researcher works for or is a member of a HIPAA protected entity • PHI is being collected • Passive consent

11. ELEMENTS OF INFORMED CONSENT • 1) Statement that the study involves research • Identify it as a UW-Madison research project • 2) Description of any risks • Can be emotional • Risk of a breach of confidentiality • 3) Description of any benefits to the subject • There are typically NO direct benefits to participating in research • 4) Disclosure of alternative procedures

12. ELEMENTS OF INFORMED CONSENT • 5) Confidentiality of records • Use of pseudonyms • Data encryption • Password protected laptop • Use of audio or video recording • 6) If more than minimal risk – steps the research will take to mitigate those risks • 7) Contact information for answers to pertinent questions • 8) Statement that participation is voluntary • Participants can withdraw at any time, skip any questions they do not wish to answer

13. ELEMENTS OF INFORMED CONSENT • Compensation – Compensation is NOT a benefit • Parking pass • Gift cards • Drawings, raffles • Extra credit • If cash is offered, is the amount coercive?

14. Use the IRB Consent Wizard • The IRB wizard is a tool to help ensure all federally required elements of consent are included: https://rcr.gradsch.wisc.edu/cfwizard/start.asp?wisc The majority of modifications requested by the IRB are due to consent form errors. Use the wizard to avoid these errors.

15. WAIVERS OF INFORMED CONSENT • Waiver of documentation of informed consent • Only document linking subject to research and principal risk is breach of confidentiality • Minimal risk and involves no procedures for which written consent is normally required outside of research

16. WAIVERS OF INFORMED CONSENT • Waiver of Informed Consent • Minimal Risk • No adverse affect to rights & welfare of subjects • Research could not practicably be carried out without waiver • If possible, provide subjects with additional information after participation

17. EXEMPT RESERACH • Falls within one of the six categories listed at 45 CFR 46.101(b)(1-6) • Minimal Risk • Is human subject research, but is “exempt” from the regulations • IRB - not the PI - determines exemption • Does not require full IRB review

18. EXEMPT CATEGORIES • Conducted in established or commonly accepted educational settings, using normal educational practices • Educational tests, survey or interview procedures or observation of public behavior unless information is identifiable and sensitive

19. EXEMPT CATEGORIES • Educational tests, survey or interview procedures or public observation not exempt under the previous item if subjects are elected or appointed public officials or Federal statutes require confidentiality • Collection or study of existing data or documents if they are publicly available or anonymous

20. EXPEDITED REVIEW • Minimal risk • Falls within one of the categories found at 45 CFR 46.110 • All the regulations apply (unlike exempt) • The full IRB does not review the protocol

21. CATEGORIES ELIGIBLE FOR EXPEDITED REVIEW • Research on individual or group characteristics or behavior or employing a survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies

22. CHILDREN AS SUBJECTS • In most cases, children may participate only if the research involves no more than minimal risk • Consent of parent or guardian • Assent of the child • Age appropriate language • Written assent age 11 and up • Oral assent age 10 and under

23. INTERNATIONAL RESEARCH • Guidelines for International Research • Cultural, political or economic conditions that would increase risk to participants • Local IRB or ethics committee • Local contact for questions • Consent forms in native language of participants • Because traveling internationally increases the risk of a confidentiality breach, you will need to encrypt your data.

24. INTERNATIONAL RESEARCH • Consider the most appropriate method for obtaining informed consent • Take into account the literacy level of participants, cultural norms and confidentiality concerns. • All key personnel must complete CITI training, even if they are from outside the U.S. • In many cases it won’t be possible to expedite international protocols.

25. INTERNET RESEARCH • Surveys administered via the internet • How sensitive is the data • Security • Confidentiality • Consent Issues • FaceBook • Blogs • Chat rooms • Expectation of privacy by the subject • Minors

26. COLLABORATION WITH OTHER INSTITUTIONS • Must be a UW PI • PI’s must be tenure or tenure track faculty • Must provide evidence of approval from the other IRB • Must obtain approval from a UW IRB • All key personnel must complete human subject training

27. OTHER CONSIDERATIONS • Conflict of Interest • Status Relationships • Classroom or clinic environment • Community-based research • Issues of engagement of the community partner • Going into homes? • Sensitive Population • Non-English speaking participants