Preventing Problems in Human Subjects Research: Tips from the IRB

1. Preventing Problems in Human Subjects Research:Tips from the IRB Joan Doherty, JD & Dominic Chiarelli, JD featuring Stephanie Hamilton, BSN, Damon Jacobson, & Laura Stueckle, MPH March 28, 2013

2. Why are we here? • Increase outreach by the Human Subjects Protection Program (HSPP) • Gather user input for future resources • Discuss best practices • Encourage collaboration

3. Topics • Consent Conferences • Modification Requests • Incident Reports • Asking IRB Questions

4. CONSENT CONFERENCES • Know the study-specific IRB requirements for obtaining consent, parental permission, assent, and HIPAA authorization • Confirm the documentation requirements • Use the right versions of the forms • Tips for obtaining consent remotely • Don’t make changes during conferences!

5. Know the IRB requirements… Consent & Parental Permission • Signatures required or a waiver of documentation? • Do both parents/guardians need to give consent? • Are children and their parents participants? Assent • Is assent necessary? • If required, must it be written, or is verbal sufficient? • Do the documentation requirements vary with age? HIPAA Authorization • Is protected health information (PHI) being used/created? • If HIPAA applies, are signatures required or waived? • Are there multiple forms? Hint: new template is simpler.

6. Confirming IRB Requirements • Where to look? • See IRB correspondence (especially renewals) • Work back from the most recent letters to the oldest • Tips for keeping track • Local Implementation Plan (LIP) section 5.2 • Create a cheat sheet (checklist, flow chart, etc)

7. Sample LIP Section 5.2

8. Use the Right Versions Note: Researchers are now required to use consent & assent forms with the IRB approval stamps (HIPAAs are not stamped). Question: What if a modification request to revise the consent form is pending with the IRB when I need to approach a family? • General answer: You can use the currently approved versions until a member of the study team receives the approved revisions. • Consider whether the changes may affect a participant’s willingness to take part or continue; if so, may need to re-approach. • Sponsor/coordinating center may advise. • Version Control • Help study staff use the right versions at enrollment • Create SharePoint folders and limit access to team members • Create a single PDF with ALL of the current forms • Organized folders make modifications easier • IRB stamped consents in *pdf format • Word versions to revise • Archive previous versions of approved *pdf consents • Update as soon as approvals are received

9. Remote Consent: Points to Consider Documentation? All the elements? Assent? • Participant must be able to review all forms during the discussion • Are signatures required? • Wait until signatures are received before proceeding • How to prove the conference happened? That they agreed? • Unless the IRB waives some or all of the elements of consent, you must provide all of the required elements • How will you ensure that all elements are presented every time? • Information sheet? • Phone script? • Cover letter? • Don’t forget to consider whether assent will be required, and how it will be obtained over the phone. • If assent is required, talk to the child only after the parent gives their permission. • Cognitive impairments?

10. Don’t Change a Thing (until the IRB agrees) • Do not add or remove content to the consent form during the discussion • Note: It’s also a problem to do less than what the IRB approved • Example: eliminating safety monitoring visits/labs • IRB must approve changes first • Only exception is when changes are “necessary to eliminate apparent immediate hazards to the subject,” (usually not the case).

11. SUBMITTING MODIFICATIONS • IRB has to approve ALL changes, no matter how small • Test: Are your documents identical to the versions the IRB has on file? • Common problem: Implementing changes without prior IRB approval. • making tweaks to consent form or protocol • involving personnel in the research before they have been formally added to the research team • exceeding the approved enrollment totals (e.g., chart reviews)

12. Modifications: Submission Tips • Think about ALL of the study documents that may be affected by the proposed changes, and revise if needed. • Example: changing eligibility criteria can mean revisions to the protocol, LIP, consent/assent forms, recruitment materials, etc. • Attach all the revised documents. • Track all changes • Required for submission. • Create clean copies • Although changes can be easily accepted in Word, this is not possible with our current PDF review system • Reduces processing errors by HSPP staff

13. Completing the Modification Form • Consider: Will the proposed change add a new study population? • May need to revise several of the existing documents, or create new consent and/or HIPAA forms. • Example: study involves administering an investigational drug to child participants; now the team wants to add questionnaires that ask about the parent’s quality of life  parent is a participant. • Most important question: Explain whether these changes add new risks or increase the current risks of study participation • Not asking whether the change will alter the regulatory risk category (e.g., from 45 CFR 46.404 to 45 CFR 46.405). • Address whether the new procedures may alter the risk/benefit assessment (e.g., increasing blood volumes, new risks)

14. REPORTING INCIDENTS • When is an incident report needed? • See IRB Policy 30 for definitions and timing information • Report with status report: if NOT serious non-compliance, continuing non-compliance, or an unanticipated problem (can opt to report sooner). • Report as soon as possible:if it MAY be serious/continuing NC or an unanticipated problem. • Discuss the issue(s) with the Principal Investigator • Consult with the sponsor/coordinating center, if applicable • If unsure, submit a question to the HSPP office

15. Incident Report Form Tips Violation/Problem Participant Impact Corrective Actions • Please be as specific as possible about the requirement that was not complied with (e.g., cite to the section of the protocol, IRB application, etc.) • Explain why it happened • If you notified the sponsor/coordinating center already, please mention this. • Important to be clear about the impact on the enrolled participant(s). • Clarify the status of the affected participant(s), whether they are continuing or have completed the study (e.g., less likely to require re-contact if the one enrolled participant is deceased). • Most important part! • Usually should not implement corrective actions until the IRB has approved the plan; in some cases the teams propose things that the IRB decides are unnecessary • Does the plan address the root cause? Will it prevent future recurrences?

16. Asking IRB Questions Simple Send a question to IRB@seattlechildrens.org Complex  Submit a Consultation Request Form