1. Alyssa Speier, MS, CIP QA/QI Education Specialist Stanley Estime, MSCI QA/QI Specialist Interview, Survey, and Focus Group Research: IRB Processes and Challenges

2. 22 Agenda Questions to think about before you prepare your IRB Submission. Informed Consent Recruitment Payment Confidentiality and Privacy Tips from IRB Reviewers Useful Tools Case Study

3. Questions to think about before you prepare your IRB Submission Are you conducting a “systematic investigation?” Is the project generalizable? Are you collecting identifiers? Is the information that you are collecting sensitive? 3

4. Are you conducting a “systematic investigation?” Systematic – having or involving a system, method, or plan? – One or two interviews would not be systematic. – e.g., hearing an oral history Investigation – a searching inquiry for ascertaining facts; detailed or careful examination – Including research development, testing and evaluation If not a systematic investigation, not considered “research” by the federal regulations; therefore, “Not Human Subjects Research” – Does not require IRB review unless formal determination requested 4

5. Is the project generalizable? Is the systematic investigation designed to develop or contribute to generalizable knowledge? – Designed: done with purpose and intent. – Develop: to elaborate or expand in detail. – Contribute: to be an important factor in; help to cause. – Knowledge: truths, facts, information. Generalizable: universally applicable – Quality Improvement/Assurance is not generalizable outside of department/organization/institution, etc. – E.g., course evaluation to learn how to improve course. If not, project would not be considered “research” per the Federal Regulations; IRB to determine “Not Human Subjects Research” – Therefore would not require IRB review unless formal determination requested 5

6. Are you recording identifiers during your interactions/interventions? Interactions: – Emails and Letters – Surveys (online or hard copy) – Telephone calls – Face-to-face – Observation Identifiers: – Names, SS#, Address, phone #, Email address, etc. On-line surveys are always considered identifiable (re: IP Address) Even if you assign Participant ID numbers, if there is a link to the person’s identity in existence, you are collecting identifiable data – Voice and video recordings Regardless of how quickly they will be transcribed 6

7. Are you collecting private “sensitive” data? Would disclosure of data collected be harmful to participant's: – Financial standing – Employability – Insurability – Reputation – Or place participants at risk of criminal or civil liability The IRB often looks to researchers and local IRB to weigh in on this, as they are familiar with the study population and local culture – Is the information being collected sensitive to the specific target population? 7

8. 8 Will Your Human Subjects Research be Exempt? *Research with prisoners is never exempt **Interview, survey, focus groups with children must be expedited Identifiable Data?Sensitive Data? Exempt! Expedited! Yes No Yes No Full Board! Greater than minimal risk

9. Informed Consent There needs to be a consent process if you are interacting with participants For Exemptions – No long-form consent document required; however for exemptions, process to obtain consent must be in place that discloses: That the project is “research” That participation is “voluntary” A brief description of the study procedures – mention if it is being audio or video recorded Investigator name and contact information – Local Investigator – No form and no signature required, but must submit to the IRB before implementing – Script with the above is fine 9

10. Informed Consent (continued) Expedited Review, full consent process and form – Use ORARC consent templates to ensure all required elements included – Required elements listed in Criteria for Approval and Additional Considerations reviewer checklist Section 7 – See ORARC Assent Template for minors (used in addition to parental permission form) – Waiver of documentation (signature) of consent may be appropriate 10

11. Recruitment – Where, when, how? – Avoid Coercion or undue influence – No “finders fees” or “bonus payments” Advertisements – Is limited to the information prospective subjects need to determine their eligibility and interest – Does not accentuate the payment on advertisements – See Advertisements Reviewer Worksheet 11

12. Payment Selecting compensation – Amount and method appropriate for the population (not coercive) $, Gift Card, Voucher, token of appreciation, etc.? Described in the Informed Consent Document – Credit for payment accrues as the study progresses and not contingent on completing study – See Payments Reviewer Worksheet 12

13. Confidentiality and Privacy Confidentiality –refers to participants’ data – How data will be kept (electronic and hard copy)? – Who has access? How long? – Where will it be stored? – IDs assigned and used on data collection forms? Privacy –refers to a person’s desire to control access of others to themselves. Plain clothes/car Mailings without reference to study on envelope? Where is consent/study procedures taking place? Stress keeping private in FG Assigning Alias’s in FG? 13

14. Tips from the IRB Reviewers Submit the survey, interview, or focus group tool with your submission – This is what they base their determination on – Include version dates on all tools, recruitment, and consent materials Make sure to fill out section 6.4 of protocol summary, 6.4“Procedures involved in the Human Research” – Explain how you are conducting your surveys, interviews, focus groups, etc. Submit changes prior to implementation in the field 14

15. Useful Tools ORARC Investigator Manual ORARC Reviewer Worksheets Study Management Tools 15

16. Case Study A HSPH student investigator is conducting a research study on bullying in school age children grades 6-12. Research procedures will include observing children’s playground/recess activities. In addition, teachers, principals, and the superintendents at the various schools will be asked to participate in focus group discussions on how bullying is handled in schools. 16

17. Case Study A separate one-on-one, in-person interview will be conducted with these individuals as well. Students will be given a survey to take home which addresses bullying practices at their schools. Parents will be asked to assist them with completing the information in the survey. 17

18. Scenario #1 What are some of the issues in this scenario? Do you think this study can be exempted from IRB review? Which participants should consent be obtained from? 18

19. Scenario #2 What are some of the issues in this scenario and how would you resolve them? Is there any situation in this scenario that may require reporting to the IRB? 19

20. 20 Questions? Quality Improvement Program Staff Stanley Estime, sestime@hsph.harvard.edu, 617-432-2164sestime@hsph.harvard.edu Alyssa Speier, aspeier@hsph.harvard.edu, 617-432-2140aspeier@hsph.harvard.edu Leslie Howes, lhowes@hsph.harvard.edu, 617-432-2153lhowes@hsph.harvard.edu IRB Operations Staff Paul Hryvniak, phryvnia@hsph.harvard.edu, 617-432-2160phryvnia@hsph.harvard.edu Cecelia Grano De Oro, bgranode@hsph.harvard.edu, 617-432-2142bgranode@hsph.harvard.edu Susan Burnside, burnside@hsph.harvard.edu, 617-432-2143burnside@hsph.harvard.edu Julie Kaberry, jkaberry@hsph.harvard.edu, 617-432-2149jkaberry@hsph.harvard.edu Resources OHRA Website QIP’s Service Request Form

21. 21 REDCap Research Electronic Data Capture: https://redcap.sph.harvard.edu/redcap/ https://redcap.sph.harvard.edu/redcap/ – Free, secure, web-based applications: Data Management and Survey Tool – Requires IRB approval prior to granting access (Data security determination must be assigned) Submit Initial Application explaining REDCap use in Protocol Summary Submit Modification/Clarification for existing protocols – REDCap education sessions coming soon Contact sestime@hsph.harvard.edu for questionssestime@hsph.harvard.edu