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…
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.
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
Consent, Written (18+)
Child Patient
1 Parent
Permission
Adult Patient
Parent
X
X
X
N/A
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
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
Remote Consent: Points to Consider
Documentation?
All the elements?
Assent?
 Participant must be
 Unless the IRB
 Don’t forget to
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?




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?
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?
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 noncompliance, 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
Incident Report Form Tips
Violation/Problem
Participant Impact
Corrective Actions
 Please be as specific
 Important to be clear
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.
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?
Asking IRB Questions
Simple  Send a question to
IRB@seattlechildrens.org
Complex  Submit a
Consultation Request Form