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Sample Informed Consent Form
 
Note: Some elements may not be applicable depending on the nature and risks involved in the research
 


Title of Research Project

The consent form should be:

  • Printed on CHEO letterhead (the logos of other participating institutions can also appear on the letterhead).
  • Include the names of the Primary CHEO Site Investigators, and CHEO Co-investigators, their Division or PSU and contact information as well as the name of the study Sponsor (if any).
  • Clearly indicate that individuals are being asked to participate in a research study.
  • Broken down into subsections: Why is the study being done? How many people will take part in the study? What is the Current Standard of Treatment for this disease? What are the risks of the study and how are the risks different from standard of care? etc.
  • Include visual schemata (tables and flowcharts) to organize complex information such as the schedule of study visits & drug toxicities.
  • The footer of the consent form should include the current consent form version date and page numbers (e.g. Page 1 of 13).
  • Written in the second person, in language understandable to someone who has not yet completed high school (i.e.; approximately Grades 6 to 9). Contain simple declarative statements throughout. Jargon should be avoided as much as possible and acronyms explained. This online medical dictionary can be used to simplify medical terms.
  • The following steps can be used to obtain a global estimate of the readability of consent materials in Microsoft Word:
  • Create a document of the consent form in which you have previously removed any technical terms that are unavoidable (e.g., names of drugs, the condition under study), and the investigator’s name.
  • Go to "Tools", "Spelling & Grammar", and then to "Options". Select "Show Readability Statistics". The grade level will then be displayed upon completion of spell checking your document.
Why is this study being done?
The informed consent document should outline the scientific/clinical rationale for the proposed study, and the potential additional risks and benefits (compared to “standard” therapy) that might occur as a consequence of participating in the trial.

This description should include the following elements:
  • Current disease/diagnosis
  • “Standard” therapy for the disease that would be used on a child not participating in the trial
a. Success rate for current therapy
b. Side effects/toxicity of current therapy
  • Research therapy: Why it might be better than current therapy
a. Higher cure rate than standard therapy and/or
b. Fewer side effects/toxicity than current therapy
  • Additional risks/benefits/discomforts (compared to standard therapy) that will/might arise as a consequence of participating in this trial.
a. Risks: Known or unknown (totally new therapy, or new use of an established treatment).
b. Benefits: Higher cure rate/less toxicity/earlier pick up (more intensive monitoring), unknown.
c. Discomforts:
i. Additional tests: discomfort (blood tests), risks (general anaesthetics), etc.
ii. Extra time taken for additional tests.

Two examples follow:
‘You are being invited to join this study because your child has CNS tumour, which cannot be fully resected. Standard therapy for young children with ‘non-resectable tumours of the central nervous system’ has traditionally involved chemotherapy. The problem with this therapy is that … The purpose of this study is to see if the novel intervention can get rid of the cancer while avoiding some of these side effects. It is not know if this new therapy will be as effective. It is also not know if this new therapy will produce other side effects that we currently don’t know about… The difference between standard treatment and study participation in this case involves the use of the novel intervention, which is not always used across hospitals and is not proven to be better. We do not know if the novel intervention is better (or worse) than standard therapy in terms of success rate or side effects. The purpose of this study is to find this out…’

OR

‘Your child is being asked to participate in a study of the effects of the drug Z, because he has been diagnosed with Condition Y. The treatments for Condition Y can have a negative effect on children’s bones. Currently there is no standard practice for treating these types of health issues. It is believed that drug Z might work to …(specify). The drug is currently used to Condition Y in children and adults. In addition, drug Z has been used to treat…(specify). Health Canada has given approval to test the safety and effectiveness of drug Z in this research study. To date, research has not shown a clear benefit from the drug. This is why we are conducting this study.

If you agree to participate in this study, you would be randomly assigned to one of two study groups: one group would receive drug Z and the group would receive a placebo (a sugar tablet containing no active medication). This would then allow us to compare those participants who receive the medication to those who do not. If you agree to participate in the study, you would not know whether or not you would be receiving the active drug Z or inactive/placebo medication. Neither you nor your doctor can choose the group to which you would be assigned. You would have an equal chance (one in two) of receiving either the active medication or the inactive/placebo’.

How many people will take part in this study?
  • The number of participants to take part in the research should be specified both at CHEO, nationally and/or internationally.
What is the Current Standard of Treatment for This Disease?
  1. Routine vs. supplementary procedures should be clearly delineated. Whenever possible, supplementary procedures should be appended to routine tests.
  2. A lay explanation of randomization should also be included. It is often wise to explain that the treating physician is typically blinded to the participant assignment, and cannot influence this process. You will be 'randomized' into one of the study groups described below. Randomization means that you are put into a group by chance. Neither you nor your doctor can choose the group you will be in. You will have an equal (one in X) chance of being placed in any group. The purpose of randomization is to ensure that those receiving the [study medication] and those receiving [specify] are identical in every other respect. That way, we can know for certain that any differences that we observe between the two groups are due to the study medication and nothing else.  It is often useful to include a table summarizing the study procedures, for example.

 

Day 1

Day 2

Day 3

Day 4

Blood work

o             

o             

o             

o             

Blood pressure

 

o             

 

o             

ECG

 

o             

 

o             


What are the participant's responsibilities?

  • A description of the expectation(s) of the participant should be included. 

What is the length of time for participation?

  • A fair estimate of the length of time the participant will be in the study for treatment and, if applicable, follow-up.
 What are the risks of the study and how are the risks different from treatment?
  • A sentence indicating that participants may experience side effects; some of the side effects may be expected, but there may be side effects that are not expected.
  • A fair description of any risks and inconveniences (including time commitment) to participating in the study should be included.
  • For Clinical Trials, outline in an attachment, the study procedures and clearly identify how these differ (if at all) from standard care.
  • Whenever possible, the drug toxicities should be summarized in table form. It is often easier for participants to retain this information if it is organized on the basis of probability. The incidence of side effects should be stated as natural frequencies rather than percentages, e.g., '14 in 100 patients suffer from infection’. There is evidence to indicate that lay people inexperienced with probabilities better understand risks expressed as natural frequencies rather than percentages.' If preferred, both forms could be used to express the incidence of adverse events, i.e; 12 in 100 or (12%) of patients.

Likely

Less Likely

Rare but serious

Rash

Hair loss

Allergic reactions


  • The participant should be advised what action to take to manage toxicities. He / she should also be provided with a clear course of action to take if the symptoms worsen.
  • The radiation exposure associated with the study procedures should be stipulated in the consent form. These values should be referenced to every day life (‘The x-ray of your pelvis x-ray would expose you to the same amount of radiation to which you would be exposed in everyday life over a period of approximately… days’).
  • Any supportive care should be specifically described.
  • Participants should be advised that the risks and inconveniences of the study are believed to be equivalent across the different study arms (clinical equipoise), e.g., ‘The purpose of this study is to compare two or more treatments. Based on our current knowledge, we do not know if any (either) of the treatments being studied are significantly better than the other(s) in terms of either effectiveness or side effects. The study would be stopped if we learned that this was not in fact, true.
  • Any costs of participating in the study should be outlined. Participants should be aware of what, if any, study-related expenses will be covered by the Sponsor or Investigator.
  • The injury clause as outlined in the standard phrasing: In the event that you or your child suffer injury as a direct result of participating in this study, normal legal rules on compensation will apply. Medical care will be provided to you or your child.  By signing this consent form you are in no way waiving your legal rights or releasing the investigator and the sponsor from their legal and professional responsibilities.
Are there benefits to taking part in the study?
  • Individuals should be told if any direct benefit will come to them as a result of participating in the study. You may or may not benefit from participating in this study; however, our hope is to change clinical practice or to take better care of our patients in the future.
If I chose, how would I withdraw from the study?
  • Participants should be told how they can withdraw from the study.
  • They should also be told under what circumstances their participation could be discontinued without their permission.
  • Individuals should be assured that their decision to participate or not in the study will not influence the care they receive at CHEO.
  • Participants should be provided with information on their right to request the withdrawal of information or specimens, and any limits of the feasibility of that withdrawal.
What other treatment options are there if I do not participate in the study?
  • When applicable, palliative support should be discussed and offered. One alternative to pursuing further treatment is called palliative or comfort care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the disease. It would not treat the condition directly, but instead tries to improve the child’s quality of life. Comfort care tries to keep your child as active and comfortable as possible while the disease progresses.
What about Confidentiality and Privacy?
  • Your personal information will be kept strictly confidential except as required or permitted by law.
  • For Phase I, II, or III clinical drug trials: Representatives of the sponsoring company and/or Health Canada, as well as representatives from the CHEO Research Ethics Board have access to your child’s personal information.
  • For clinical drug trials funded by NIH (U.S): Representatives of the sponsoring company or government regulators such as the Food and Drug Administration (U.S.) and Health Canada as well as representatives from the CHEO Research Ethics Board have access to your child’s personal information.
  • A statement indicating that if the results are published, the participant's identity will remain confidential.
  • Individuals should also be told how clinically relevant information will be handled by the researchers (e.g., abnormal laboratory results; suspicions of child abuse, suicidality, or intent to harm others).
  • For studies subject to the U.S. Food and Drug Regulations, the following statement must be included verbatim "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the website will include a summary of the results. You can search this Web site at any time."
In closing, participants should be told that:
  • They will be provided with any additional information that may influence their willingness to continue to participate in the research study.
  • They will be provided with a summary of the results at the conclusion of the study.
  • They will be given a copy of the consent form.
  • The roles and responsibilities of the REB as outlined in the standard phrasing: The CHEO Research Ethics Board (REB) has reviewed and approved this research project. The REB is a committee of the hospital that includes individuals from different professional backgrounds. The Board reviews all research that takes place at the hospital. Its goal is to ensure the protection of the rights and welfare of people participating in research. The Board’s work is not intended to replace a parent or child’s judgment about what decisions and choices are best for them. You may contact the Chair of the Research Ethics Board, for information regarding patient’s rights in research studies at (613) 737-7600 (3272), although this person cannot provide any health-related information about the study.
A space should be provided to print & sign one’s name & date the signature.

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