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Study Title or Protocol #:

KUMC CONSENT TEMPLATE FOR FDA-REGULATED STUDIES

General Instructions: (Delete this page of instructions when your draft is complete.)

This consent template is appropriate for studies that involve FDA-regulated products. Studies that do not involve FDA-regulated products should start with “Consent Template #2.” Use the “Consent Template for Surrogate Decision-Makers” if you plan to enroll adults who are cognitively impaired.

Template statements in blue are instructional. There are yellow highlights for areas to fill in the blanks. Statements in black are sample language.

When using the template, delete the instructional information and any other statements that do not apply.

Focus on readability: use simple terms, short sentences, short paragraphs; use active voice more than passive voice.

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:

Consider improving comprehension with drawings, simple diagrams and charts instead of lengthy sections of text.

Present information only one time; redundancy needlessly lengthens a document.

Write the consent form in second-person voice, i.e. “You are being asked…”

Avoid coercive statements such as “You understand that” or “You have been told that…”

Medical terms should be defined the first time they are used.

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. If applicable, you may make a brief reference to ongoing standard care.

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.

Use at least 12 point font. Arial 12-point font is requested.

Make sure phone numbers are correct, and confirm that emergency contact phones are answered 24 hours.

Ask others to proofread your document. Check for typos, incomplete sentences, font size, paragraph alignment, spacing gaps or awkward page breaks.

When you are finished creating your draft, there should be no moreblue text, red text or yellow highlights.

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).

Feel free to contact the IRB Office (913-588-1240) for a pre-review of your consent form.

If this is a clinical trial, retain the hospital-required bar code in the

header of page 1 only. Once you delete these instructions, the bar code should remain on page 1.

RESEARCH CONSENT FORM

TITLE

Protocol #

Sponsor:

Investigator: [First, Last name],MD

University of Kansas Medical Center

913-588-xxxxx

This research study will take place at the University of Kansas Medical Center (KUMC) with [ ]as the researcher. About [ ] peoplewill be in the study at KUMC. A total of about [ ]people will be in the study at [ ] centers across the United States

Why is this study being done?

  • Brief description about the condition under study and the typical problems or symptoms that are being addressed by the study
  • Currently available treatments and/or knowledge about the condition
  • The problem with existing treatments (e.g., current treatments do not control symptoms, have too many side effects, lose efficacy over time, oral version or extended release is needed, etc.)
  • Concluding purpose statement, such as “This study will compare an experimental drug with standard treatments to see if it is better for[managing your symptoms].”

What isbeing tested in this study?

  • Description of the specific test article (drug, device or biologic) or intervention being studied
  • Lay language description of how the test article works
  • Lay language description of how the test article or intervention differs from currently available treatments and why it might help the study population(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 test article
  • If the product is FDA-regulated, include a statement about whether or not it has approval by the U.S. Food and Drug Administration for this condition. If not,
  • State that the use of the product does not have FDA approval and is considered investigational.
  • Explain that investigational products are still being studied to find out what a safe dose is, what the side effects are, and whether or not the product is effective in the disease or condition being studied.

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. For example:

We expect your participation to last about ______[weeks/months] (up to ______for screening, ______of taking the study drug, and ______of follow-up), and will include up to ____ office visits to the clinic.

What will I be asked to do?

As applicable, provide an overview of the components of the clinical trial, such as Screening, Treatment and Follow-up.

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.”
  • Tell subjects how the group assignments will be made. If random, use language such as, “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.
  • State the dosages, device or intervention types for each group.

Sample language:

You will be randomly assigned (like rolling the dice) to one of __ groups.

  • Group 1: (how often, dosage)
  • Group 2: (how often, dosage)
  • Group 3: Placebo, (how often, dosage)

You will have a 1 in __ chance (__ %) of receiving [study drug] and a 1 in __ chance (__ %) of receiving placebo. A placebo has no active ingredients but is made to look like the study drug. You and the study team will not know which treatment you are receiving. If there is an emergency, the study team can find out which group you are in. In the rest of this consent form, ______and placebo will both be called “the study drug.”

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 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.

Introduce the table with language such as the following:

Below is a table that lists all the procedures that will happen at each study visit. After table, you will find more details about the study procedures.

Following the table, describe the study procedures individually. As applicable, describe what will happen and when and where they will occur. Include the inpatient and outpatient assessments. Use simple terms and short sentences.

When applicable, state the total amount of blood drawn during the study, in teaspoons or tablespoons (rather than mLs).

For studies that involve blood draws, explain the various purposes for the samples (routine labs, pregnancy test, biomarkers, etc.)

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 the consequences of a positive test and 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 a 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, 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.

If requested by the sponsor, you may add an additional section about expectations for the study subject. The section should focus on special obligations that might impact the decision to participate. It should also use language such as “asked” rather than “required,” such as:

If you join the study you will be askedto....

What are the possible risks or discomforts?

You may have problems because of [the drug, device or intervention] used in this study or because of the procedures that will be performed during the study. These are called adverse events or side effects. Some may be only an inconvenience, but some may be harmful. There could be side effects of [test article] that are not yet known or the research may involve risks to you that are currently unforeseeable. It is important that you tell the study team immediately about any side effects or problems you have.

Describe the risks for each drug, device or procedure. If both investigational and approved products are involved, present the risks of the investigational product 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 “<”. Note that categories and percentages may vary per study and according to the risks of individual drugs or devices: for example, 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.

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.

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.

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.

As applicable, inform subjects about whether the side effect(s) can be treated.

Note any side effects that would be permanent, life-threatening or fatal.

If surgery would be needed to address a side effect or complication, describe.

If research subjects will be undergoing a standard clinical surgery or intervention, make reference to it and state that a separate hospital consent will describe those risks.

If subjects will be withdrawn from standard care, state that there are risks that the study drug/device would not be as effective as standard care. Discuss the ramifications of the lack of efficacy.

Address risks of FDA-approved drugs/device 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 medications, devices or surgical techniques, the risks of those drugs, devices or techniques would be considered research risks and should be included in the consent form.

Address placebo risks, if applicable:

  • 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).
  • Discuss any rescue measures that would be used if the subject’s condition worsens.
  • 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

Sample language for an outpatient study is as follows:

Allergic Reaction Risks

Sometimes, people have serious allergic reactions to drugs. A severe allergic reaction could be life-threatening and may result in death. Symptoms of allergic reactions include:

  • Swelling of the mouth, throat or eyes
  • Rash
  • Difficulty breathing
  • Coughing
  • Wheezing
  • Sudden drop of blood pressure
  • Seizures
  • Flushing
  • A fast pulse
  • Sweating

You should call 911 if you think you are having a severe allergic reaction. Please also contact the study team if you have any of these or other side effects during the study.

If there is a risk of combining study drug and other drugs, include statements such as the following:

Risks associated with taking [study drug] in combination with other drugs

For your safety, tell the investigator or a member of the study team about any drugs you are taking or planning to take, including herbal products, supplements or drugs without a prescription. The study team will tell you if there might be a problem with the drug combination.