Consent Form Checklist for Drug Trials
CONSENT FORM CHECKLIST FOR DRUG TRIALS
General Instructions:
Start with the KUMC consent form templates, posted at: Make adjustments as applicable to your study.
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.
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.
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.
Feel free to contact the IRB Office (913-588-1240) for a pre-review of your consent form.
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 thatare 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 drugbeing 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., sopatients 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:
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.”
- 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 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-timetext 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 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.
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.
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 sub-study, 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:
WILL IT COST ANYTHING TO BE IN THE STUDY?
If applicable, use language approved by the Research Institute and Hospital Billing
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
Discuss the institution’s financial assistance program
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 thatreimbursements 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).
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 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.