Documentation of the
Informed Consent Process
USC Office for the Protection of Research Subjects (OPRS)
Session Overview
Highlights:
• Purpose of Informed Consent (IC)
• IC Process and Documentation
• Witness and Dates on IC
• HIPAA Authorization
• Significant New Information and Findings (SNIFs)
• IC Errors or Omissions
• Double-Checking IC Documentation
• IC Audit Findings
• Resources / Contacts
Purpose of Informed Consent
Consent (“autonomy” from the Belmont Report)
• Protects human subjects
• Ensures subject understand the study and are
informed about its risks, benefits and
procedures
• Provides subject an opportunity to ask
questions
• Allows subjects to voluntary decide
whether or not to participate in
research
Informed Consent is a Process
This presentation is focused on IC
documentation, however:
• Remember that Informed Consent is not just a
form…it’s a process that involves ongoing exchange
of information
• Subjects must be informed about changes or new
information about the study that may affect their
willingness to participate
Informed Consent Process
• Use the current IRB-approved, stamped consent
for the study
• Provide subject or Legally Authorized
Representative (LAR) a consent Form in his/her
language (or use Short Form Process)
• Ensure subjects/LARs have sufficient time to
consider participation, free of coercion or undue
influence
• Provide subject/LAR an opportunity
to ask questions about the study
Informed Consent
Documentation
• Subject/LAR must sign and date the form
• Person Obtaining Consent must sign and date
the form
• Provide a copy of the signed consent to the
subject/LAR
• Document in the subject’s chart or medical
record that consent was obtained and file the
Consent Form in subject’s records
• Document use of a translator on
subject’s chart, if applicable
Short Form Process
• When non-English speaking subjects are anticipated in
a study, the consent form should be translated in the
subjects’ language
• Use the Short Form Process for the unexpected
enrollment of subjects when a consent is not
available in the subject’s language
• A witness and translator must be present during the
consent process (translator may serve as witness)
• CA Subject Bill of Rights in the subject /LAR’s
language (if applicable) *Tip: see pg 1 of consent
• Short Form and Subject Bill of Rights templates are
available in thirteen languages on the HSIRB
website at: http://www.usc.edu/admin/oprs/hsirb/forms
Short Form Process
• Subject /LAR is presented with a copy of the
Short Form and Bill of Rights (if applicable) in a
language he/she understands
• Translator orally translates the current, IRB
approved study consent in the subject’s/LAR’s
language in the presence of a witness
• Ensure subjects/LARs have sufficient time to
consider participation, free of coercion or undue
influence
• Provide subject/LAR an opportunity to ask
questions about the study
Short Form Process
Documentation
• Subject/LAR dates and signs the Short Form and
Subject Bill of Rights, if applicable
• Witness dates and signs the Short Form and
Consent
• Person Obtaining Consent dates and signs the
Consent
• Subject /LAR receives a copy of the signed Short
Form, Bill of Rights (if applicable) and Consent
• Document that consent was obtained from the
subject/LAR in the subject’s chart or medical
record and file Short Form, Bill of Rights (if
applicable) and Consent in subject’s chart
Conditional IC Process
• Certain conditions (e.g., illiteracy, blindness) may
impede documentation of subject consent
• Conditional consent process can be utilized
• A witness must be present during the consent
process
• Ensure subjects/LARs have sufficient time to
consider participation, free of coercion or undue
influence
• Provide subject/LAR an opportunity to ask
questions about the study
Conditional IC Process
Documentation
• Subject makes a “mark” on the consent form, if
possible
• Witness signs and dates consent form
• Person Obtaining Consent signs and dates
consent form
• On consent form, note the method used for
communicating with subject and the means by
which subject communicated agreement
• Subject receives a copy of the signed consent
• Document that consent was obtained from the
subject in the subject’s chart or medical record
and file Consent
Consent Witness
• Not required unless using the Short Form or the
Conditional Process
• Additional considerations may be imposed by:
• FDA and ICH GCP: “impartial witness” when the
subject or LAR is illiterate
• Study sponsor
• Institutional
• Refer to the study protocol, investigator, sponsor
or IRB to determine requirements for your study
IC Documentation
*if consent includes California Subject Bill of Rights, subject must sign Bill of Rights (1st page) and consent (last page)
** Bill of Rights, if applicable (check if English version of consent includes Bill of Rights on 1st page)
Tip sheet available at:
http://www.usc.edu/admin/oprs/private/docs/hsirb/forms/Consent_and_Short_Forms_Final.pdf
Dates on Informed Consent
• Signature dates of person obtaining consent and
subject or LAR do not have to match (e.g.,
investigator may sign and date consent during process and
subject may sign and date consent after discussion with
relatives)
• Subject or LAR must sign and date consent
before any study procedures are conducted (FDAregulated studies: if subject signs consent on the day study
procedures begin, subject chart should document that consent
was obtained prior to study procedures)
• Check sponsor guidelines
• Do not “back date” consent!
HIPAA – Privacy Rule
• Protected Health Information (PHI) is any
identifiable health information relating to a
subject’s physical or mental condition or
payment for health care (18 elements)
• If your study accesses (or creates) PHI, subjects
(or LARs) must sign a HIPAA form in addition to
informed consent
• Changes to the HIPAA form cannot be made
unless the Office of Compliance has approved
these changes
HIPAA Waivers
The IRB may grant the following waivers:
• Partial HIPAA waiver - for screening, recruiting
and identifying participants (very common)
• Full HIPAA waiver – if use or disclosure of PHI
involves no more than minimal risk to subject,
the research could not practicably be conducted
without the waiver and the research could not
practicably be conducted without access to and
use of PHI (rare)
Remember: without a HIPAA authorization or
waiver, researchers cannot utilize PHI data!
Significant New
Findings/Information (SNIFs)
• Except when necessary to eliminate apparent
immediate hazards to subjects, the IRB must review
and approve SNIF
• Subjects must be informed about SNIFs that may
affect their willingness to continue participation
• SNIF must be presented to subject in his/her
language
• Don’t forget to make arrangements for non-English speaking
subjects (e.g., originally consented with a translated consent or
short form)
• HSIRB can provide Spanish translation of SNIF
IC Errors or Omissions
• If an error is made on the consent:
• Strikethrough the mistake with a single line, write the correct
information next to it and initial and date the correction (i.e.,
original entry must be visible)
• If an entry was inadvertently omitted:
• Initial and date any entry made after the consent process
(should be done by person making entry)
• Include explanation in the subject’s record or Note to File
IC Version vs. Approval /
Expiration Dates
IC Approval Date and Expiration Date
• Located on right margin of each consent form page.
Includes IRB study number and valid date range. Ensure
that subjects are provided a current, IRB-approved consent.
IC Version (HSC) or Date of Preparation (UPC)
• Located on the footer of the consent form. This reflects the
date the consent was last updated, NOT the approval or
expiration dates.
Double-Check IC
Documentation
Remember to check:
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Consent expiration date
Consent version date
Fill-in sections of consent
Names, dates and signatures
HIPAA Authorization
Copies of consent/HIPAA provided to subject/LAR
Copies of consent, Short Forms, Bill of Rights and
HIPAA were filed in subject’s medical record, as
applicable
• Documentation that subject/LAR agreed to participate in
study in subject’s chart or medical record
Approved Documents in
iStar
To access Approved Documents (consent forms,
HIPAA forms, recruitment materials, etc)
• Click on “Approved Documents” link or “Documents” tab
Additional Considerations
• Study personnel must complete educational
requirements based on study (e.g. Human Subjects
Training, HIPAA, GCP)
• New study personnel must be trained on study
procedures including the consent process
• Regular communication ensures study team is aware
of changes in the study and consent documents
• If there is a lapse in IRB approval for the study, the
study team cannot proceed with study procedures
(unless IRB has authorized)
IC Audit Findings
Most common:
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Use of expired consent
Use of older version of consent
Missing entries on consent
Signature date errors
Other:
• Study staff fill-in subject or LAR sections of consent
• Consents are not handwritten (e.g., dates stamped)
• Use of one consent for multiple subjects
Resources
Informed Consent templates and Short Forms:
http://www.usc.edu/admin/oprs/hsirb/forms/
OPRS Informed Consent in Human Subjects
Brochure:
http://www.usc.edu/admin/oprs/private/docs/oprs/broc
hures/IFC_Booklet.pdf
HSIRB Website:
http://www.usc.edu/admin/oprs/hsirb/w.usc.edu/admin/
provost/oprs/training/videos.html
Contacts
http://www.usc.edu/admin/provost/oprs
Health Sciences Campus
General Hospital, Suite 4700
1200 North State Street
Los Angeles, CA 90033
Tel: (323)223.2340
Fax: (323)224.8389
E-mail: irb@usc.edu
Office for the Protection of Research Subjects
3720 South Flower, Third Floor
Los Angeles, CA 90089-0706
Tel: (213)821.1154
Fax: (213)740.9299
E-mail: oprs@usc.edu
http://www.usc.edu/admin/provost/oprs/
http://www.usc.edu/admin/provost/oprs/hsirb/
University Park Campus
837 Downey Way
Stonier Hall, Room 224a
Los Angeles, CA 90089-1146
Tel: (213)821.5272
Fax: (213)821.5276
E-mail: upirb@usc.edu
http://www.usc.edu/admin/provost/oprs/upirb/
Office of Compliance
3500 Figueroa St.
University Gardens Building, Room 105
Los Angeles, CA 90007
Tel: (213)740.8258
Fax: (213)740.9657
E-mail: complian@usc.edu
http://www.usc.edu/admin/compliance/
Jennifer Hagemann, MS
Office for the Protection of Research Subjects
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Program started on May 2008
Human Subjects Protection Program
Accreditation (AAHRPP)
Not-for-cause audits
Criteria: random but…
 High volume of studies
 Vulnerable population
 New investigators to USC
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Format: 2-3 hours, review 2-6 studies, focus:
study documentation
Consent
72%
IRB Application Discrepancies
39%
Problem Areas
Lack of Documentation
30%
HIPPA Form
20%
Miscellaneous
13%
Lack of Communication with FDA
11%
Lack of Communication with IRB
11%
Personnel-Related Issues
9%
Protocol Non-Compliance
7%
0%
10% 20% 30% 40% 50% 60% 70% 80%
Findings by Percentage
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Consent + HIPAA form Issues: no documentation of consent; use of unapproved consent;
missing subject name, signature, or signature date; missing PI signature; use of wrong HIPAA
form; HIPAA form not signed by subjects; required fields not completed in HIPAA form
IRB Application Discrepancies: discrepancies between IRB application and study
procedures; unable to locate approved documents in iStar; study personnel different from
those in application; personnel obtaining consent is different from that in application
Lack of Documentation: no documentation of subjects meeting inclusion/exclusion criteria;
no regulatory binder or substantial documentation missing
Personnel-Related Issues: lack of GCP training; lack of personnel; lack of personnel
oversight
Lack of Communication with FDA: personnel listed on Form 1572 form differs from IRB
application; missing information in Form 1572; lack of annual progress report for investigatorinitiated studies
Lack of Communication with IRB: done in untimely manner; study closure report not
submitted; protocol deviations not reported to IRB
Protocol Non-Compliance: differences between protocol and study procedures;
inclusion/exclusion violations
Miscellaneous: potential for subject coercion; funding not distributed to proper channel,
investigator unaware of consent requirement for all subjects and study closure
responsibilities
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FDA: FDA-regulated research (drugs, biologics,
devices)
http://www.fda.gov/ICECI/EnforcementActions/Bioresearch
Monitoring/default.htm
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OHRP: human subjects research, normally those
funded by Health and Human Services (HHS)
http://www.hhs.gov/ohrp/compliance/index.html
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Study Sponsor: for-cause, non-compliance
IRB for-cause: non-compliance, whistleblower,
deficiencies in IRB submissions, lapses in IRB
approval
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Socio-Behavioral vs. Biomedical Research
Templates* (http://www.usc.edu/admin/oprs/research/rc)
 Study / Regulatory Binder*
 Participant files
▪ Source Documentation (e.g., physical exam, survey, ECG)
▪ Case Report Forms
▪ Notes to file
▪ Calendar / Subject Visit log*
▪ Consent documentation
 Logs: Enrollment*, Screening*, Training
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Train staff: initial and ongoing; maintain log
Meet regularly: discuss new developments,
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Maintain open communication lines: ensure
procedures, revised consents
team members know whom to contact when
unexpected or adverse events occur
 Standardize procedures: study procedures
should be consistent and systematic for all
participants (e.g., assessments, recruitment, consent)
 Participate in educational meetings: specific to
field (e.g., symposia) and institution (e.g., IRB
training)
Form Templates
 USC
http://www.usc.edu/admin/oprs/research/rc
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Partners
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UCSF
http://www.partners.org/phsqi/vrb/files/index.htm
http://hub.ucsf.edu/regulatory-binder
USC IRB and OPRS website
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http://www.usc.edu/admin/oprs/
Investigator Tips – HSC IRB
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USC Institutional Review Board (IRB)
•
Sandy Jean, MS
Overview
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Recruitment of Participants
Retention of Research Records
Confidentiality and Security of Research Records
What Happens After Your Study is Approved?
• Amendments
• Continuing Review
• Reportable Events
Recruitment
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Recruitment is the first step in consent process
Respect privacy during recruitment
IRB reviews and approves recruitment materials
Tips for recruitment advertisements
• DO:
– State that it is research
– State what is involved (very brief)
– Add department name, USC name or approved
logo, IRB number, version date
Recruitment
• DON’T:
– Overstate benefits of participation
– Emphasize payment for participation or free services
– Use the word “treatment” if your study involves
experimental procedures
Recruitment
• Cannot pay a bonus or finder’s fee for referrals to
your study (USC policy)
• Cannot coerce students or employees into
participating
• Avoid appearance of coercion:
• Post recruitment flyers in public areas rather than
directly approaching students or employees
• Have another investigator obtain consent from
participants who are your students or employees
Confidentiality
• Collect the minimum amount of personal info you
need to achieve your study objectives
• If possible, record data anonymously
• If not, record and label data with a random code
instead of an identifier
• The master list matching up code numbers with names
(or other identifiers) must be stored in a secure place,
separate from the coded data
Confidentiality
• Can data be shared with others?
• Only as described in the IRB application and as
disclosed to participants in the informed consent
• Handle your participants’ data the way you want
your own sensitive info handled
• HIPAA Privacy Rule
• Violation of HIPAA rules can lead to fines
and imprisonment
Security of Records
Paper:
• Store in locked file drawers, locked office/storage area
• Restrict access to research staff (as identified in the
IRB application)
• Restrict copying of study documents and data
Photos and Recordings:
• Alter identifying features as early as possible
• Transcribe and destroy recordings
Security of Records
Electronic:
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User name and password required to access data files
Restrict access to research staff
Restrict copying of electronic files
Mobile storage devices (laptops, stick drives) must be
password protected and encrypted
“USC requires all laptops and mobile storage devices that are
paid for with university funds and/or used for USC business
purposes to be encrypted. We strongly encourage you to avoid
storing any sensitive data on such equipment altogether.”
- USC Policy Memo dated April 22, 2009
Record Retention
How long should you keep research records?
• USC policy = 3 years after research is completed
• FDA-regulated products (drugs/devices) = 2 years
after product is approved / sponsor stops testing
• Sponsor may have additional requirements
• HIPAA forms = 6 years after research is completed
IRB Review after Approval
Reminder - Principal Investigator and Faculty
Advisor Responsibilities
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All staff are properly trained and licensed
Won’t change protocol without IRB approval first
Will use only current, stamped consent for enrollment
Faculty Advisors:
• Meet with student regularly to monitor study progress
• Arrange for another faculty member to accept responsibility
if unable to supervise the student personally
IRB Review after Approval
Now what?
Ongoing responsibilities to IRB:
• Amendments – whenever you want to make
changes to the study
• Continuing Review – annually
• Reportable Events – as needed
IRB Review after Approval
Amendments
• Submit amendment for IRB approval BEFORE *
implementing changes (add/change procedures,
eligibility criteria, informed consent or recruitment
materials; or sponsor requires changes)
• Open an amendment application in iStar:
– Describe changes in amendment application
– Edit study application
– Wait for IRB approval
* Unless change is needed to avoid immediate harm to participants
IRB Review after Approval
Significant New Information
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If you learn new info that could affect participants’
willingness to continue in the study, you must tell
them (as promised in the informed consent)
Usually involves new risks or new procedures
Prepare “Significant New Information/Findings”
form (template available)
Submit an amendment to IRB
After IRB approval, provide form and discuss with
participant
IRB Review after Approval
Continuing Review (CR)
Unless your research qualifies as “exempt” your IRB
approval will expire every year. You must submit an annual
CR to keep the study open. CR is a review of the research
activities over the past year.
• You will receive reminders about study expiration
• Open a CR application in iStar:
– Provide info requested (enrollment to date, participant
complaints or withdrawals, study progress)
– Submit to IRB at least 1 month before study expires
• If study expires, ALL research activities must stop
IRB Review after Approval
Study Closure
When all research activities done (including all data
analysis), submit “Final Report” to close study
• Open a CR application
• Select the “Final Report” option
• Provide info requested
• Study will be archived in iStar
IRB Review after Approval
Reportable Events
What problems must be reported to the IRB?
• Adverse Events
• Participant experiences a side effect that is unexpected,
serious, and related to the research
• Unanticipated Problems (place participants, research
staff, or others at greater risk of harm than was
previously known)
• Laptop containing data is stolen or lost
• Files with signed informed consents are lost during a move
IRB Review after Approval
• Protocol Deviations
• Enrollment of a participant who was ineligible
• Procedures missed or performed outside of window
• Expired or wrong consent form used to enroll participant
• Procedure:
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Open a Reportable Event application in iStar
Select type of event
Provide info requested
IRB will either acknowledge or request more info (including
a corrective action plan)
Questions?
training/videos.html