Download CONSENT FORM

Human Research Protection Program
CONSENT FORM CHECKLIST FOR DRUG TRIALS
General Instructions:
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Start with the KUMC consent form templates, posted at:
http://wichita.kumc.edu/research/research-compliance/informed-consent/consenttemplates.html Make adjustments as applicable to your study.
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The attached checklist serves as a guide to ensure the federal regulations and institutional
requirements are met. Minor variations are acceptable, provided the required topics are
covered and the document is clear, concise and reader-friendly.

Please use a Question-Answer format to enhance reader comprehension.
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Focus on readability: use simple terms, short sentences, short paragraphs; use active
voice more than passive voice.
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Lay language is among the most important considerations in the consent document.
Replace technical terms with plain language. Resources for readability and lay terminology
are posted on our website at: http://wichita.kumc.edu/research/researchcompliance/informed-consent/consent-writing-tips.html

Consider improving comprehension with drawings, simple diagrams and charts instead of
lengthy sections of text.
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Present information only one time; redundancy needlessly lengthens a document.
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Write the consent form in second-person voice, i.e. “You are being asked…”
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Avoid coercive statements such as “You understand that” or “You have been told that…”
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Medical terms should be defined the first time they are used.
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Spell out acronyms the first time they are used.

It is not required to describe standard of care procedures that would occur regardless of
study participation. Focus on activities that will occur solely because of research
participation.
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Discuss optional aspects (such as sub-studies or optional genetic analysis) in a separate
consent form or in a separate section that is placed after the main consent signature lines.
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Use at least 12 point font. Arial 12-point font is requested.
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Feel free to contact the IRB Office (316-293-2610) for a pre-review of your consent form.
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Please note: When the consent form is IRB-approved, the electronic system will
automatically affix a footer to the approved consent document. The footer will contain the
IRB number for the project, valid approval dates, and the Federalwide Assurance number
(FWA00003411).
INTRODUCTION/OVERVIEW
The document should begin with a high-level overview of a clinical trial (e.g., statements
that the person is being invited to join a research study, definition of a clinical trial,
participation is voluntary, the difference between standard medical care and research,
encouragement to ask questions, ability to decline or withdraw without consequences.)
A statement that the study will take place at KUMC, the PI name, expected enrollment
study-wide and expected enrollment at KUMC.
In this section, or in the section about study purpose, discuss the study population and
why the person is being invited to participate
In the introduction or in a separate section below, state that researchers will tell
participants about any new information that may affect their willingness to continue in the
study.
Comments:
WHY IS THIS STUDY BEING DONE?
A description of the study population, if not mentioned above.
The typical problems or symptoms that are being addressed by the study
Currently available treatments and/or knowledge about the condition
A statement of the unmet need that provides study rationale
Comments:
WHAT IS BEING TESTED IN THIS STUDY?
Description of the drug being studied
A lay description of how the drug works.
A lay description of how the drug is different from currently available treatments (This
description is particularly important in communicating why the drug might be more
effective, reduce symptoms, improve survival, etc., so patients understand why they
might want to consider participation in the study.)
FDA status of the study drugs; if investigational, a statement that investigational products
are still being tested; include any conditions for which the drug is approved.
Include the route of administration: oral, intravenous, sub-cutaneous, etc.
Comments:
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HOW LONG WILL I BE IN THE STUDY?
Explain the total length of time the subject will be in the study, including any long-term
follow-up. If not described elsewhere, use this section to provide an overview of the time
involved in screening, treatment and follow-up.
Comments:
WHAT WILL I BE ASKED TO DO?
Include a general statement about reading and signing this consent form before any study
procedures take place.
As applicable, provide an overview of Screening, Treatment and Follow-up. To support
readability, this overview should explain the sequence of events in simple, logical order.
State the number of study visits, if not addressed earlier.
If subjects will be randomized:

Present the list of study groups in bulleted format for better readability

Describe the number of groups and the randomization ratio, such as “You will
have a 3 in 4 chance of receiving study drug and a 1 in 4 chance of being
assigned to the placebo.”
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Tell subjects how the group assignments will be made. Use language such as,
“A computer will decide which group you are in. Group assignments are
random, like flipping a coin or rolling the dice.” Alternatively, describe the
subject characteristics or other factors that dictate group assignment.

When applicable, tell subjects that neither they nor the investigator will know
which group they are in; however, this information would be available in the
case of an emergency.
Discuss dosing details: route, dosage, frequency and duration of therapy
Inform subjects if there are significant differences between standard care and study
participation. Discuss any aspects of standard care that will not be provided or will be
withheld during the study.
Inform subjects if there is a washout period.
Inform subjects about any procedures that are experimental.
If standard procedures are described, explain that subjects will continue to receive their
usual medical care (such as physical exams, routine lab tests, regular scans, etc.) on a
regular schedule. Any discussion of standard procedures should be very brief.
If applicable, state that information from their usual medical care will be collected for
research purposes.
For clinical trials with multiple study visits, use a table to demonstrate the study visits and
the research-related procedures that will occur. The use of a table avoids lengthy and
repetitive descriptions of individual study visits. The table should be written in lay terms
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and condensed from the typical schedule of events that appears in the study protocol.
The purpose of the table is to provide an overview so that the potential subject
understands the implication of participation. Avoid details of standard care procedures or
tests. When multiple questionnaires are used, do not list the questionnaires by their
professional name; instead, summarize the topics that are covered, e.g., ‘quality of life
questionnaires.’
Indicate the length of each study visit as one of the lines on the table.
Consider having multiple tables if there are different procedures for different arms of the
study.
Following the table, present a one-time text description of the individual research-related
procedures shown in the table. The text descriptions should correspond with the line
items on the table. Describe what will happen and when. Use simple terms and short
sentences. Do not include risks of the procedure in this description.
For studies that involve blood draws, explain the various purposes for the samples
(routine labs, pregnancy test, biomarkers, etc.)
When applicable, state the total amount of blood drawn during the study. Express the
amount of blood in teaspoons or tablespoons (rather than milliliters).
If applicable, describe testing for communicable diseases (hepatitis, HIV, tuberculosis).
State that positive results will be reported to the Kansas Department of Health, as
required by law.
If the study involves a drug screen for illicit drugs, explain whether or not they can still
participate in the study with a positive test. State whether or not the results will be put in
the subject’s medical record.
If subjects will be asked about serious depression or suicidality, discuss the steps that will
be taken if a concern is noted, e.g., referral to a specialist for further care
If the study involves an optional sub-study, make brief reference to the optional aspects
and state that subjects who are interested in participating will sign a separate consent
form or indicate their willingness at the end of the consent form.
Describe what will happen to the subject when the study is over, such as opportunity to
continue getting the drug in an open-label study, being transferred to standard medical
care, etc.
If the study involves the ongoing collection of data from medical records (either during or
after active participation), inform the subject what information will be collected from their
records.
If the analysis of samples is a key objective of the study, discuss what will happen to the
samples after the study is over.
Comments:
WHAT ARE THE POSSIBLE RISKS OR DISCOMFORTS?
Begin with general statements about the possibility of risks, monitoring that will occur, the
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fact that some side effects or risks may not yet be known, etc.
Describe the risks for each drug. If both investigational and approved drugs are involved,
present the risks of the investigational drug first.
Categorize risks by their predicted frequency, using categories such as Common, Less
Common, Rare but Serious.
Provide an approximate percentage for each category. Use “greater than” and “less
than” rather than “>” or “<”. For example, categories might be: Common - more than
20%; Less Common – less than 20%; Rare but Serious – fewer than 2%. The IRB does
not prescribe a particular classification of percentages since data on risks may vary.
Present the risks in a bulleted format for better readability.
Use lay terminology when describing the risks. The lay term should always be included.
If preferred, you may also include the medical terminology in parentheses, e.g., decrease
in red blood cells (anemia).
When appropriate, explain the ramifications of a particular risk, e.g., what it would mean
to the subject if a particular lab value was elevated or if surgery would be required to
address the problem.
Note any side effects that would be permanent, life-threatening or fatal.
Risks that only pertain to other populations should not be included.
Include risks of previous animal studies only if very few human studies have been done
or the results from the animal studies have direct implication for human participants.
For drugs that have black box warnings: describe a ‘black box warning’ in lay terms.
Explain that it is the strongest warning given by the FDA. Use lay terms to describe the
key risk(s) and what steps would be taken to address the problem. It may be helpful to
asterisk the risks related to the warning. If the black box warning applies only to eligibility
criteria that would be identified in screening, this additional paragraph is not required.
If subjects will be withdrawn from standard care, state that there are risks that the study
drug would not be as effective as standard care. Discuss the ramifications of the lack of
efficacy.
Address risks of approved drugs/devices or standard therapies as follows:

Per federal guidance, the risks of research in a study include those risks of therapies that some
participating subjects would face that are or could be different from the risks of therapies they would
have faced without participating in the research study.

If subjects will be receiving a particular therapy regardless of study participation, or if receipt of the
therapy is an inclusion criterion for the study, then the risks of that particular therapy are not considered
research risks and should not be included in the consent form. For example, if the study only includes
persons who have already been prescribed a particular drug or are already being scheduled for a
particular surgery, then the risks of the drug or surgery are not research risks

If a standard care drug, device or therapy is an aspect of what the research study is evaluating, then
those risks are research risks and they should be included. For example, if the study is comparing the
effectiveness of two or more approved therapies, or comparing investigational versus approved
therapies, the risks of the approved therapies would be considered research risks and should be
included in the consent form.
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Address placebo risks, if applicable:
o If standard care or approved therapy is withheld from subjects who receive a
placebo, discuss the risks of being assigned to the placebo group (i.e., worsening
of symptoms or disease progression).
o Discuss any rescue measures that would be used if the subject’s condition
worsens.
o If the study involves standard care plus a treatment arm or placebo, you may state
that the risks for the placebo group will be similar to the risks for standard care.
If there is a washout period, describe the risks of stopping the current treatment.
Address allergic risks and actions to take in the event of a serious allergic reaction. The
discussion of allergic risks should be placed after the listing of other drug risks and before
any procedural risks.
For studies involving comparative effectiveness research, it may be appropriate to
discuss the risks of randomization.
Follow the drug risks with a description of the procedural risks.
When the study involves DNA analysis for genetic mutations or where parentage,
predisposition to disease or other sensitive information might result, address the genetic
risks as well as the GINA protections. DNA analysis only relates to an optional substudy, the GINA protections should be stated with other details about the sub-study.
As directed by the KUMC Radiation Safety Committee, include any radiation risks
Comments:
PREGNANCY RISKS
Begin with a general lay-language statement that the drug may have risks for an unborn
child or nursing infant and that all the risks related to pregnancy may not yet be known.
Specify the required birth control, bulleting the options for better readability.
Include abstinence as a birth control option
As applicable, discuss measures to be taken by both men and women
If the sponsor wants to follow the outcome of a partner’s pregnancy, state this and
explain that a separate authorization form is required.
Comments:
ARE THERE BENEFITS TO BEING IN THE STUDY?
Address potential benefits to the subject
Address potential benefits to society from the knowledge that might be gained
Comments:
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WILL IT COST ANYTHING TO BE IN THE STUDY?
For clinical trials, use language approved by the Research Institute
State what research-related procedures are covered by the study
Discuss any planned billing to the subject’s insurance
When the trial involves a hospital procedure or hospital stay, specifically state who will be
covering those costs.
Discuss the risk of insurance not covering standard care costs for trial participants
Comments:
WILL I GET PAID TO PARTICIPATE IN THE STUDY?
Discuss any payment that will accrue; state the payment per visit and the anticipated total
amount if all visits are completed
Use the institution’s standard language about the ClinCard system
If reimbursements are planned, describe them separately so that it is clear that
reimbursements require receipts and that reimbursements are not taxable income
If samples are being collected, include a statement about ownership of samples and no
plans to share profits with participants.
Comments:
WILL THE RESEARCHERS GET PAID FOR DOING THE STUDY?
Use the institution’s standard language about the Research Institute getting paid
If the Conflict of Interest Committee requires a disclosure related to the study, include
required text in this section.
Comments:
WHAT HAPPENS IF I GET HURT OR SICK DURING THE STUDY?
Include a contact phone number for the investigator if a serious problem occurs
Include a 24-hour phone and instructions on whom to ask for if subjects are told to call
the switchboard (i.e., appropriate medical specialist on call).
For hospital-based studies, instruct the subject to tell the switchboard operator and the
attending physician that they are in a research study.
Include statements about who will pay for research-related injuries. These statements
must align with the contract being negotiated with the Research Institute.
Use the institution’s template language about reporting injury payments to Medicare
Include the institutional statement about contacting the HRPP if the subject has been
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harmed.
Comments:
DO I HAVE TO BE IN THE STUDY?
Include an assurance that research participation is voluntary and that subjects can still
receive services from the institution without being in the study.
If this assurance is explained in the summary/overview, it does not need to be repeated
in separate section.
Comments:
WHAT OTHER CHOICES DO I HAVE?
Discuss alternative treatments that would be available if the subject did not participate in
the trial.
If the test article or intervention is FDA-approved or otherwise available outside the study,
you must state: “You can have access to [test article/intervention] even if you are not in
this study.”
Comments:
HOW WILL MY PRIVACY BE PROTECTED?
Begin with general statements about protecting confidentiality and that absolute
confidentiality cannot be guaranteed.
Include all the required HIPAA elements of description of PHI, users of PHI, recipients of
PHI, purpose of disclosures, risk of re-disclosure, expiration date, requirement for
authorization, etc.
This section must include a statement that the sponsor, regulatory groups and the FDA
may inspect or copy their study information for audit purposes.
Comments:
CAN I STOP BEING IN THE STUDY?
Assurance that subjects can stop at any time without consequence
If applicable, discuss the risk of stopping the study drug suddenly
If applicable, discuss the request that the subject come in for an End-of-Treatment visit
for safety purposes.
Discuss the subject’s right to cancel permission for the use of their PHI
Include instructions to notify the study team of the cancellation in writing
If the sponsor wants to collect data about subjects who have withdrawn from active
participation, a separate Withdrawal consent is required
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Comments:
COULD MY PARTICIPATION BE STOPPED EARLY?
State that the study could be stopped by the investigator, sponsor or FDA without the
consent of the subject
State that the sponsor, investigator and KUMC are not obligated to provide the study
drug if the study is stopped.
Comments:
WHO CAN I TALK TO ABOUT THE STUDY?
Provide contact information for any questions, suggestions, concerns, or complaints
Include contact information for the KUMC IRB office
The standard clinicaltrials.gov statement should go here unless included elsewhere
Comments:
CONSENT
Use the KUMC signature block, as prescribed in the consent templates
Comments:
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