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

Why are we here?

• Increase outreach by the Human Subjects Protection Program (HSPP)

• Gather user input for future resources

• Discuss best practices

• Encourage collaboration

Topics

• Consent Conferences

• Modification Requests

• Incident Reports

• Asking IRB Questions

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!

Know the IRB requirements…

Signatures required or a waiver of documentation? Do both parents/guardians need to give consent? Are children and their parents participants?

Consent &Parental Permission

Is assent necessary? If required, must it be written, or is verbal sufficient? Do the documentation requirements vary with age?

Assent

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.

HIPAA Authorization

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)

Sample LIP Section 5.2

IRB Requirement Child Patient Adult Patient Parent

Consent, Written (18+) 1 Parent Permission

X X

Consent w/ Documentation Waiver

Consent Waiver

Assent Not Required Ages 4-6

Verbal Assent (under 18)

Written Assent (under 18) Ages 7-17

HIPAA Authorization (18+) 1 Parent Authorization

X N/A

HIPAA Waiver N/A

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

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?

Remote Consent: Points to Consider

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?

Documentation? All the elements? Assent?

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).

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)

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

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)

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

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.

Incident Report Form Tips

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?

Violation/Problem Participant Impact Corrective Actions

Asking IRB Questions

Simple Send a question to IRB@seattlechildrens.org

Complex Submit a

Consultation Request Form