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Informed Consent
Document Editing: Best
Practices
Lisa Shilling-Wright, MA, CIP
Team Leader, Scientific Editing
Presentation Topics
• Why the Informed Consent Document
(ICD) is edited
• The process of the Scientific Editors at
MD Anderson
• Specifics of the Boilerplates used by the
Scientific Editors
Health Literacy
“The degree to which individuals have the
capacity to obtain, process, and understand
basic health information and services
needed to make appropriate health
decisions.”
US Department of Health and Human Services 2000
Health Literacy Statistics
• 36% of adults read at or below the 7th
grade reading level
• 56% of adults over age 65 read at or
below the 7th grade reading level
• When broken down by ethnicity:
28% of Caucasian, 58% of African
American, and 66% of Hispanic adults
read at or below the 7th grade reading
level
2003 Health Activities Literacy Survey
Office For Human Research
Protections (OHRP) Policy
The informed consent process involves three key
features:
(1) disclosing to potential research subjects
information needed to make an informed decision;
(2) facilitating the understanding of what has been
disclosed; and
(3) promoting the voluntary nature of the decision to
participate in the research.
Informed consent must be legally effective and
prospectively obtained.
MD Anderson Policy
The Institutional Review Board (IRB) of The
University of Texas MD Anderson Cancer Center
requires that informed consent documents (ICDs)
for human subjects research are presented to the
research subject at the 6th-8th grade reading level.
Institutional Review Boards
(IRBs)
• Committees of doctors, researchers, and
community members
• Responsible for protecting research participants
(safety, ethics review)
• Review new proposed research studies and
revisions of ongoing studies, including the ICD
Scientific Editing at
MD Anderson
• Scientific Editing is a subset of the Office of
Protocol Research (OPR)
• Scientific Editors assist in the creation of
ICD templates for all types of research ICDs
used in the institution
• Scientific Editors edit all ICDs for clinical,
psychosocial, laboratory, and data review
trials during initial submission and revisions
Scientific Editing at
MD Anderson
The Scientific Editors work collaboratively
with the Principal Investigators (PIs),
research faculty and staff, and IRBs to
develop the ICD.
Workflow of Initial
ICD Editing Process
Researcher
submits ICD draft
to editor for
review
Editor makes
changes and
sends back to
researcher
with questions
to answer
Editor finalizes
draft
IRB reviews
and may make
contingencies
Researcher
may send it to
research
sponsor as
well
The IRBapproved ICD
is made
available to
researcher
Editor receives
updated draft
with questions
answered
Researcher uses
ICD in clinic to
enroll participants
Types of Boilerplates used by the
Scientific Editors
• Plain Language Boilerplate
• Drug Definition Database
• Adverse Event Glossary
• Adverse Event Database
• Template Boilerplate
Creating the Boilerplates
• New procedure/drug is included in an ICD
submitted to the Scientific Editors
• Scientific Editor researches the new item(s)
• Scientific Editor rewrites the technical
language into lay language
• New description is sent back to the PI for
review
If the PI Approves
the Description
• The description is reviewed at an IRB
meeting
• The Scientific Editor makes any IRBsuggested changes to the description, if
necessary
• Description is added to the boilerplate
template
If the PI Does Not Approve
the Description
• The PI revises the language
• The Scientific Editor approves the revision
and sends it to the IRB for review
• If the Scientific Editor does not agree, it is
sent to the IRB with an editor note
• The IRB determines the final language to be
used
• The description is added to the boilerplate
Plain Language Boilerplate
The editorial staff of OPR has developed a
database of standard phrases and
definitions that can be used during the
creation of an original ICD.
This database of terminology, or what is
referred to as the Plain Language
Boilerplate, includes commonly recurring
medical words, phrases, and procedures,
as well as procedural definitions and drug
definitions. All of which are written at a 6th 8th grade reading level.
Plain Language Boilerplate
Examples
Vital Signs:
Vital signs (blood pressure, heart rate, temperature, and
breathing rate)
Electrocardiogram:
You will have an electrocardiogram (ECG -- a test that
measures the electrical activity of the heart).
Placebo:
A placebo is a substance that looks like the study drug
but has no active ingredients.
Pharmacokinetic Testing:
PK testing measures the amount of study drug in the
body at different time points.
Boilerplate Consent Examples
While on this study, you are at risk for side effects. These
Side effects will vary from person to person. The more
Commonly occurring side effects are listed in this form,
as are rare but serious side effects. You should discuss
these with the study doctor. You may also want to ask
about uncommon side effects that have been observed in
small numbers of patients but are not listed in this form.
Many side effects go away shortly after treatment is
stopped, but in some cases side effects may be serious,
long-lasting or permanent, and may even result in
hospitalization and/or death.
Tell the study staff about any side effects you may have,
even if you do not think they are related to the study drug.
Before the Edit
Serum (approximately 3 tsp) for
pharmacogenomics. Pharmacogenomics is the
evaluation of individual genomic variations in
relation to the delivery and effectiveness of
drugs. Knowledge of individual genotypes and
phenotypes makes it possible for physicians to
customize drugs and drug delivery methods for
specific subgroups.
After the Edit
Blood (about 3 teaspoons) will be drawn for
pharmacogenomic (PGx) testing. PGx testing
looks at how someone's genes may influence if
and how well the study drug may affect the
disease.
Drug Definition Boilerplate
The Scientific Editors have created a database of lay
definitions of the mechanism of action of drugs used in
the institution.
Drug Definition Boilerplate
Before the edit:
– Erlotinib is an EGFR inhibitor. The drug follows
Iressa gefitinib, which was the first drug of this type.
Erlotinib specifically targets the epidermal growth
factor receptor (EGFR) tyrosine kinase, which is
highly expressed and occasionally mutated in
various forms of cancer. It binds in a reversible
fashion to the adenosine triphosphate (ATP) binding
site of the receptor. For the signal to be transmitted,
two members of the EGFR family need to come
together to form a homodimer. These then use the
molecule of ATP to autophosphorylate each other,
which causes a conformational change in their
intracellular structure, exposing a further binding
site for binding proteins that cause a signal cascade
to the nucleus. By inhibiting the ATP,
autophosphorylation is not possible and the signal
is stopped.
Drug Definition Boilerplate
After the edit:
– Erlotinib is designed to block the activity of a
protein found on the surface of many tumor cells
that may control tumor growth and survival. This
may stop tumors from growing.
Adverse Event (AE) Glossary
The Scientific Editors have created a glossary of over
1,750 side effects that have been translated from the
technical names of the side effects to lay definitions.
The glossary also includes a notation if a side effect is
serious or considered non-serious.
AE Glossary Examples
• alopecia=hair loss (partial or total)
• palmar-plantar erythrodysesthesia = handfoot syndrome (palms of hands/soles
of feet with pain, swelling, and blistering)
• bundle branch block = irregular heartbeat
• cholecystitis = gallbladder inflammation
(possible abdominal pain)
Adverse Event Database
The Scientific Editors collaborate with
researchers to edit new and revised ICDs to
lower the reading level of side effect language
related to study drugs. Once this language has
been reviewed and approved by the IRB, it is
added to the Adverse Event Database so that
future investigators studying these drugs can
use the same risk profiles. The database is
updated regularly with new information derived
from pre-clinical testing of investigational drugs,
clinical trials, and post-marketing reports.
ICD Template Boilerplate
The Scientific Editors, in collaboration with the MD
Anderson legal department and IRB, have created
boilerplate template language for each ICD
template (Clinical, Laboratory, Psychosocial, Data
Review, and Compassionate). The template
boilerplate ensures that the FDA required items
are included in each document at an appropriate
reading level.
ICD Template Boilerplate Examples
You will be informed of any new findings that
might affect your willingness to continue taking
part in the study.
MD Anderson may benefit from your
participation and/or what is learned in this study.
Benefits of the Boilerplates
• Creates consistency among ICDs within
the institution
• Speeds creating and editing ICDs for
faculty and research staff, as well as
Scientific Editors
• Enables the Scientific Editors to have IRB
approved language available to support
document changes
Conclusion
The Boilerplate databases are an
invaluable tool that fosters consistency
among ICDs across the institution, while
increasing the clarity of highly complex
information. This facilitates the disclosure
of relevant information to potential
research subjects, thus allowing them to
make a voluntary and informed decision
about whether or not they wish to
participate in the research.