Clinical Trials Committee – Standard Consent Form

This is the required information for submitting an informed consent form/protocol submission.

 The following information is provided as a guide for investigators when developing an informed consent form and is not all-inclusive. Please refer to Informed Consent Form Template – Standard Research Studies (Nov 2016) and the Check Lists for Submission of a Research Study for a list of required information.
 When submitting a revised informed consent form, please ensure the ICF document is in additions/deletions format and include continuous line numbers throughout the tracked document.

Initial Mandatory Requirement

Is this statement included and verbatim?

Background/Rationale

Include a description of the following, when applicable:

  1. Information for subjects – why should this disease/condition be studied?
  2. General information – what impact does this disease/condition have on subjects?
  3. What potential does the study drug/procedure have for subjects?
  4. Why is the study drug dose or type of procedure being proposed?

Purpose/Objective

Is the primary study objective stated (in lay terms) according to the protocol?

Study Design

  1. Have randomization and blinding been explained?
  2. If the study is single-blind, is this addressed?
  3. If the study is double-blinded, are the details of when and how a code may be broken explained?
  4. If deception is necessary for the research, debriefing is required. Is a description included of the final consent process following debriefing?

Use of Placebo Section

Placebo controlled trials must adhere (and demonstrate adherence) to the principles outlined in the Tri-Council Policy Statement (TCPS 2) 11.2.

  1. Is this a placebo-controlled study?
  2. Does the information provided include treatments currently used for this disorder and discussion of effectiveness of the treatment?
  3. Does this section explain why a placebo is necessary?
  4. Is there an explanation of risks to the subject during any period standard treatment is withheld?
  5. Does information include measures taken to reduce the risk to subjects?

Study Procedures

  1. Is there a detailed description of what participation will involve for the subject (e.g. regular routines, nature of tests and procedures, amount of time spent at clinic visits)? Does this include time spent at home (e.g. filling in diaries, travel to and from site and labs, any other forms that need to be completed at home?)
  2. Are procedures identified which are not part of typical clinical care?

Risks and Discomforts

  1. Is there a description of discomforts and inconveniences associated with participation?
  2. Are known or suspected short- and long-term risks included?
  3. Are risks categorized in percentages? If risks are not in percentages please advise why.
  4. Are risks presented in tables for easy reference?

Reproductive Risks

  1. Are the risks regarding reproduction, lactation and fetal development explained?
  2. Are the acceptable methods of contraception listed?
  3. If required, is there a statement indicating that permission will be requested to follow a pregnancy according to the protocol?
  4. If the pregnancy is to be followed, is the reason(s) for following it stated (e.g. explicit safety reasons)?

Benefits

  1. Is this section free from inducements for the subject to participate (e.g. close physician monitoring, free provision of services and/or medications)?
  2. Does the consent form present a fair and honest view of the potential benefits?
 This section should not: 1. Over-emphasize the benefits of participation. 2. Present unproven benefits as potential benefit. 3. Emphasize compensation or other benefits in a way that could induce participation.
 This section should: 1. Indicate that randomization to the control group could mean the subject will not receive the active study treatment. 2. Indicate that non-participation will not have any negative consequences for the subject, including access to standard care.

Alternatives to Participation

  1. Are the alternatives to participating in the study listed?
  2. Are trade names of commonly used medications listed?
  3. Is there discussion of the risks and benefits of the alternatives or a statement indicating that the physician will discuss the risks and benefits of the alternative treatments with the subject?
  4. Is it clearly stated if the drug is available without participating in this study?

Confidentiality

  1. Is there an explanation of who will have access to the information collected? If access or disclosure of the patient’s health/registration information is required from the custodian (i.e. the patient’s primary caregiver), does the consent meet requirements of the Alberta Health Information Act section 34(2)?
  2. Is the Health Research Ethics Board of Alberta – Clinical Trials Committee (HREBA – CTC) included as having access to the information?
  3. Is the Health Research Ethics Board of Alberta – Clinical Trials Committee (HREBA – CTC) spelled out in full and correct?
  4. Is the mandatory wording present and correct if notifying the primary care physician of the subject’s participation is optional?
 The confidentiality clause should inform subjects that:
  • Personal health information will be collected as part of the study – include a description of what is considered “personal health information.”
  • Personal health information will be confidential. (In some circumstances the sponsor and/or investigator are required by law to release the personal health information on subjects.)
  • Confidential information will be protected. (Describe how: e.g. using code numbers or other methods.)
  • Study records will be kept separate from a subject’s medical records.
  • Use of collected information is limited to the purpose(s) of the study.
  • Personal health information will be checked occasionally against a subject’s medical records by representatives of the sponsor. Therefore, representatives of the drug company paying for the research will be able to view subject medical records.
  • Others may need to view a subject’s records, including representatives from the Health Research Ethics Board of Alberta – Clinical Trials Committee (HREBA – CTC), the Health Products and Food Branch of Health Canada (if applicable), the United States Food and Drug Administration (if applicable), and/or other foreign regulatory agencies.
  • Groups/persons outside Canada that/who view a subject’s medical records may be regulated by privacy laws less strict than those in Canada.
  • Study records must be kept for 25 years.
  • Subjects have the right to check their health records and ask for corrections to be made.
  • By signing the consent form, subjects give the investigator and sponsor permission to collect, use and disclose medical records as outlined in this section.
  • If providing notification of participation to the subject’s primary care physician is optional, the following statement must be included:

If you have a personal physician, it is important that s/he know that you are entered into a research study and may be taking a drug that could affect your health. With your permission, we will notify your personal physician that you are enrolled in this study.

I consent to my primary care physician being notified of my participation in this study.
[x] YES [x] NO
Subject’s Initials_________

 If the investigator is the subject’s primary care physician, this statement is not required.
  • If there is an optional genetic component to the protocol, please provide a separate genetic consent form.
  • If the genetic component is mandatory, include the following paragraph in the main informed consent form:

 “There may be risks to your eligibility for employment, life insurance, mortgage insurance or private health insurance if the results of genetic testing were to be inadvertently disclosed to certain parties. Safeguards have been established to ensure that such disclosure will not occur. For example, we have taken steps to ensure that a coded number, rather than your name, will be used to identify your sample and that your name will not be disclosed in association with the sample at any time. In addition, the results of genetic testing will not be placed upon your medical record. Despite these efforts, we cannot guarantee you with 100% certainty that your genetic information could never be linked to you.”

 Rationale: the risk of individual harm arising from participating in genetic research is unclear. Inclusion of the preceding paragraph may offer some clarity but should only be inserted IF it reflects what you and the sponsor are actually doing. Otherwise, the paragraph could be modified, as needed, to reflect the reality.

Cost to Patients

  1. Is there a statement indicating the Alberta Healthcare Insurance Plan (AHCIP) (spell out in document) will not be billed for visits, treatments or procedures related to the study?
  2. Is there a description of any financial costs the subject may incur and whether these costs may be reimbursed?
  3. Is there a statement advising who will be responsible for the cost of remedies to treat nuisance side effects?
  4. If this drug is not approved for marketing in Canada, is the mandatory statement included?
  5. If subjects receive fees for participating in this research protocol, a statement must be included in this section that states the nature of the reimbursement. If the amount is specifically stated in the budget, it must also be included in the consent form document.
 The statement should also include: 1. How the subject may apply to receive reimbursement. 2. Maximum amount of reimbursement. 3. What sort of costs will be covered by reimbursement e.g. travel, daycare, over-the-counter medicines, etc.

Compensation

  • Is the mandatory statement included/verbatim?
 All Informed Consent Forms must include a statement regarding the sponsor’s policy on compensation for subjects who are injured as a result of their participation in the research.

The statement must:

  • Be in plain language
  • Accurately describe the sponsor’s compensation policy. For example, health care costs are covered, but loss of wages or future earning capacity are not.
  • Explain that a subject’s private health insurer (e.g. prescription drug, dental coverage) may not cover medical costs if the subject is injured due to participation in a research study. Subjects will need to familiarize themselves with their policy(ies) to determine what is covered.
  • Explain who will determine whether an injury is study-related.
  • Clearly explain how conflicts among the decision-makers are to be resolved, where the policy is to have the study doctor and the sponsor (or sponsor’s representative) make this determination. The CTC suggests an independent party make the final decision when there is a disagreement between the sponsor and the study doctor.
  • Explain that subjects are entitled to sue if they do not receive compensation voluntarily from the sponsor. 
     The legal costs of a claim can be significant and are the subject’s responsibility.

Withdrawal from Study

Does this section describe the process for subjects who are screen failures, withdrawals or complete the study? More specifically:

  • Are the reasons clearly stated if a subject withdraws and final procedures are to be performed for safety reasons?
  • If not for safety reasons, is there a statement that procedures are not mandatory and the subject can refuse?
  • He or she may withdraw from the study and must notify the investigator in writing.
  • Collected information will not be destroyed, even after withdrawal from the study?
 His/her previously collected personal information may continue to be used following withdrawal from the study? For example:
  • The information will be used or disclosed if necessary to preserve the scientific integrity of the study
  • Study data already integrated into the database will not be withdrawn
  • Anonymized information will continue to be used.

Ethical Review

  • If this mandatory statement is included, is it verbatim?

Signature Page

  • Does this section conform to the mandatory wording?

Document Footer

  • Does this section contain version date, page numbers and space for the subject’s initials?