1. The IRB Approval Process Michael Bingham, JD Assistant Director, University of Wisconsin-Madison Education IRB 608-262-9710 mbingham@education.wisc.edu

2. What Led Us to IRB Review? Nuremberg Code Nuremberg Code Infamous Cases 1950’s through 1970’s Infamous Cases 1950’s through 1970’s 1979 - Belmont Report 1979 - Belmont Report 1981 - 45 CFR 46 1981 - 45 CFR 46

3. Is The Study Really Human Subject Research? The first step is to determine if the study qualifies as “Human Subject Research.” The first step is to determine if the study qualifies as “Human Subject Research.” –Human Subject: 45 CFR 46.102(f) defines a human subject as “a living individual about whom an investigator (whether professional or a student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

4. Is The Study Really Human Subject Research?  “Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes.” (45 CFR 46.102(f))  “Interaction includes communication or interpersonal contact between investigator and subject.” (45 CFR 46.102(f))  “Private Information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public.” (45 CFR 46.102(f))

5. Is The Study Really Human Subject Research? –Research: 45 CFR 46.102(d) defines research as “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”  - Think of it this way: A major goal of the activity is to learn something for the purpose of benefiting people other than the research subjects. Would this project be conducted as proposed if they project investigator knew that he or she would never receive any form of academic recognition for the project, including publication or presentation of the project at an academic meeting?

6. Why Does the IRB Need to Review? If a study does not meet the elements of “Human Subject Research”, it does not need to be reviewed by the IRB. If a study does not meet the elements of “Human Subject Research”, it does not need to be reviewed by the IRB. If a study does meet the elements, the IRB must review and determine if all required criteria are satisfied. If a study does meet the elements, the IRB must review and determine if all required criteria are satisfied.

7. Student Research All students conducting human subject research must obtain IRB approval All students conducting human subject research must obtain IRB approval –Senior Thesis –Hilldale Awards –Independent Study –Master’s Thesis –Doctoral Dissertation

8. What Now? The IRB Staff will determine if a study qualifies as exempt, expedited, or requires full committee review. The IRB Staff will determine if a study qualifies as exempt, expedited, or requires full committee review. If exempt, one member of the IRB will review, request any modifications, and approve. If exempt, one member of the IRB will review, request any modifications, and approve. If expedited, a 3-person “sub-committee” will review, request any modifications, and approve. If expedited, a 3-person “sub-committee” will review, request any modifications, and approve. If full committee, the entire IRB will review, request any modifications, and approve. If full committee, the entire IRB will review, request any modifications, and approve.

9. Review Schedule Exempt protocols are reviewed usually within a few days after receipt Exempt protocols are reviewed usually within a few days after receipt The expedited sub-committee meets once a month. Protocols must be submitted 2 weeks prior to the meeting date. The expedited sub-committee meets once a month. Protocols must be submitted 2 weeks prior to the meeting date. The full board also meets once a month. Protocols must be submitted 2 weeks prior to the meeting date. The full board also meets once a month. Protocols must be submitted 2 weeks prior to the meeting date.

10. Exempt Research Falls within one of the six categories listed at 45 CFR 46.101(b)(1-6) Falls within one of the six categories listed at 45 CFR 46.101(b)(1-6) –Examples:  Research Conducted in Normal Educational Settings, involving Normal Educational Practices  Anonymous Educational Tests, Surveys, Interviews or Public Observations (Not applicable to studies that involve children as participants)  Collection Or Study of Existing Data: Only if the sources are publicly available or if the information will be recorded in such a way that the subjects cannot be identified.

11. Exempt Research Minimal Risk Minimal Risk Is human subject research, but Is human subject research, but Is “exempt” from the regulations Is “exempt” from the regulations IRB - not the PI - determines exemption IRB - not the PI - determines exemption Does not require full IRB review Does not require full IRB review

12. Expedited Research Department of Health and Human Services regulations permit certain types of research to be reviewed and approved by expedited review. Department of Health and Human Services regulations permit certain types of research to be reviewed and approved by expedited review. Expedited review is a type of review that is conducted by a rolling subcommittee of IRB members. The full IRB is then notified of all decisions. Expedited review is a type of review that is conducted by a rolling subcommittee of IRB members. The full IRB is then notified of all decisions.

13. Eligibility for Expedited Review There are two general categories that can qualify for expedited review: There are two general categories that can qualify for expedited review: 1) Research activities that present no more than minimal risk AND are listed in a NIH Guidance Document as an adjunct to the main regulations: 1) Research activities that present no more than minimal risk AND are listed in a NIH Guidance Document as an adjunct to the main regulations: –Category 5: Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes.

14. Expedited Review Cont. –Category 6: Collection of data from voice, video, digital or imaging recordings made for research purposes. –Category 7: Research on group characteristics (including, but not limited to, research on perception cognition, motivation, identity, language, communication, cultural beliefs or practices and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. 2) Minor changes in previously approved research during the period for which approval is granted. 2) Minor changes in previously approved research during the period for which approval is granted.

15. The IRB Is Required To Determine That Numerous Criteria Are Met There are 8 criteria that the IRB must determine are satisfied in order for the IRB to grant approval. There are 8 criteria that the IRB must determine are satisfied in order for the IRB to grant approval.

16. 1 – Risks to Participants Are Minimized Is the proposed research design scientifically sound? Is the proposed research design scientifically sound? Will this study unnecessarily expose participants to risk? Will this study unnecessarily expose participants to risk? Is the hypothesis clear? Is it clearly stated? Is the hypothesis clear? Is it clearly stated? Is the study design appropriate to prove the hypothesis? Is the study design appropriate to prove the hypothesis? Will the research contribute to generalizable knowledge and is it worth exposing participants to risk? Will the research contribute to generalizable knowledge and is it worth exposing participants to risk?

17. 2. Risks to Participants are Reasonable in Relationship to Anticipated Benefits? Are the risks to participants reasonable in relation to the anticipated benefits, if any, to participants, and the importance of knowledge that may reasonably be expected to result? Are the risks to participants reasonable in relation to the anticipated benefits, if any, to participants, and the importance of knowledge that may reasonably be expected to result? What is the level of risk? What is the level of risk? Is there any prospect of direct benefit to the participant? Is there any prospect of direct benefit to the participant?

18. 3. Participant Selection is Equitable Who will be enrolled (men, women, ethnic minorities, children, ill persons, healthy persons)? Who will be enrolled (men, women, ethnic minorities, children, ill persons, healthy persons)? Are the participants appropriate for this protocol? Are the participants appropriate for this protocol? What is the rationale for inclusion/exclusion, and is it appropriate? What is the rationale for inclusion/exclusion, and is it appropriate?

19. 4. Informed Consent Will Be Obtained Informed consent will be obtained from prospective participants or their legally authorized representatives, unless waived in compliance with 45 CFR 46.116 (c) and (d). Informed consent will be obtained from prospective participants or their legally authorized representatives, unless waived in compliance with 45 CFR 46.116 (c) and (d). Does the consent document include the eight required elements? Does the consent document include the eight required elements? –1) Statement that the study involves research. –2) Explanation of the purposes of the research –3) Expected duration of the subject’s participation in the research

20. Informed Consent Cont. –4) Description of the Procedures to be followed. –5) Identification of any procedures that are experimental (not typically applicable to Ed. Research) –6) Description of any foreseeable risks or discomforts to the subject –7) Description of any benefits to the subject or to others than may reasonably be expected from the research

21. Informed Consent Cont. –8) Statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. –9) Explanation of whom to contact for answers to pertinent questions about the research and research subject’s rights. –10) Statement that participation is voluntary, that refusal to participate involves no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

22. Informed Consent Cont. Is the consent document understandable to participants? Is the consent document understandable to participants? –The IRB recommends writing each adult consent document at an 8 th grade level. Child assent should be written at the level of the target group. Who will obtain informed consent (PI, other study staff member) and in what setting? Who will obtain informed consent (PI, other study staff member) and in what setting?

23. 5. Informed Consent Will Be Documented Informed consent must be appropriately documented unless waived in compliance with 45 CFR 46.117 (c). Informed consent must be appropriately documented unless waived in compliance with 45 CFR 46.117 (c). Remember, a consent document (which must included all required elements) must still be given to participants; they simply do not sign this document. Remember, a consent document (which must included all required elements) must still be given to participants; they simply do not sign this document.

24. 6. Research Plan Makes Adequate Provisions To Monitor Data If appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of participants. If appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of participants. Does the research design minimize risks to subjects? Does the research design minimize risks to subjects? Would use of a data & safety monitoring board or other research oversight process enhance subject safety? Would use of a data & safety monitoring board or other research oversight process enhance subject safety?

25. 7. Adequate Provisions to Protect Privacy and Confidentiality Are there adequate provisions to protect the privacy of participants and to maintain the confidentiality of data? Are there adequate provisions to protect the privacy of participants and to maintain the confidentiality of data? Will personally-identifiable research data be protected to the extent possible from access or use? Will personally-identifiable research data be protected to the extent possible from access or use? Are any special privacy & confidentiality issues properly addressed? Are any special privacy & confidentiality issues properly addressed?

26. 8. Additional Safeguards for Vulnerable Participants Where applicable, are additional safeguards, for participants likely to be vulnerable to coercion or undue influence, implemented? Where applicable, are additional safeguards, for participants likely to be vulnerable to coercion or undue influence, implemented? Are appropriate protections in place for vulnerable participants, e.g. pregnant women, fetuses, socially or economically disadvantaged, decisionally impaired persons? Are appropriate protections in place for vulnerable participants, e.g. pregnant women, fetuses, socially or economically disadvantaged, decisionally impaired persons?

27. Research Involving Minors The Education Research IRB reviews many studies involving minors. There are special protections that must be in place before a study involving children as research participants can be approved. The Education Research IRB reviews many studies involving minors. There are special protections that must be in place before a study involving children as research participants can be approved. Study must pose minimal risk Study must pose minimal risk Students aged 11 and over must “assent” to be in the study Students aged 11 and over must “assent” to be in the study –Assent is defined as a “child’s affirmative agreement to participate in research.” A child’s passive resignation to submit to an intervention or procedure must not be considered assent.

28. Research Involving Minors At least one parent/guardian must provide “consent” for the child to participate. At least one parent/guardian must provide “consent” for the child to participate.

29. Summation It is the duty of the IRB to determine that all required criteria are met. It is the duty of the IRB to determine that all required criteria are met. April 21, Session on Informed Consent – Please visit http://www.grad.wisc.edu/research/wksho p/index.html#HRPPSS for more details. April 21, Session on Informed Consent – Please visit http://www.grad.wisc.edu/research/wksho p/index.html#HRPPSS for more details. http://www.grad.wisc.edu/research/wksho p/index.html#HRPPSS http://www.grad.wisc.edu/research/wksho p/index.html#HRPPSS