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 Template for Standard Research Studies and the Checklists 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

Researchers must address three components in informed choice:  competence, information disclosure and voluntariness (Refer to the Tri-Council Policy Statement Ethical Conduct for Research Involving Humans).

  • The investigator should supply the following information in ordinary language, avoiding jargon and supplying explanations (in lay terms) for crucial terms, preferably at a grade 8 reading level.
  • The form must be in the 2nd person and should be phrased in a tone that is respectful to participants (e.g. participants should be asked to return for a final visit, participants who become pregnant during the study should be asked permission to follow the pregnancy.)
  • A footer must be included which contains the following information: version date, a place for participant initials, and page numbers.
  • This is a template, so if any item is obviously irrelevant, it need not be included.
  • This document must be placed on your letterhead.
  • Please ensure the headings in your document are in the order presented here.

Note: The protocol will not be reviewed unless all mandatory and verbatim requirements are met.  Once these sections are added to your Informed Consent, please ensure that any redundant/duplicate clauses are deleted.

The first page of the informed consent form must begin with the following, mandatory and verbatim:

Research Project and Title: ___________
Primary Investigator: __________
Co-Investigators: __________
Sponsor: __________
This consent form, a copy of which has been given to you, is only part of the process of informed consent. It should give you the basic idea of what the research is about and what your participation will involve.  If you would like more detail about something mentioned here, or information not included here, you should feel free to ask.  Please take the time to read this carefully and to understand any accompanying information.

Background/Rationale

This section should include a description of the disease/condition being investigated, current standard therapy, possible deficiencies in the standard therapy and the rationale for the investigational treatment (why the study drug/procedure has potential for participants).

Purpose/Objective

This section should, in lay terms, reflect the primary objective(s) of the study, as contained in the protocol.

Study Design

This section should explain such aspects of research design as randomization and blinding.  In the case of double-blinds, include details of when and how a code may be broken.  If deception is necessary for the research, debriefing is required and a description of the final consent process after debriefing should be included. Include how many participants will be enrolled worldwide and at your site.

Use of Placebo Section

The Tri-Council Policy Statement states, “when a clinical trial including a placebo control is undertaken, the researcher and the REB must ensure that participants or authorized third parties are fully informed about any therapy that will be withdrawn or withheld for the purposes of (1) the research, (2) the anticipated consequences of the withdrawing or withholding of the therapy, and (3) the reasons why the investigators deem a placebo-controlled trial to be necessary.

The following issues should be addressed in the Informed Consent document in a section entitled “Use of Placebo”: This section should address:

  • treatments that are currently used in the treatment of the disorder, including a discussion of their effectiveness,
  • why a placebo is necessary,
  • the risks to the participant during the period that standard treatment will be withheld,
  • measures that will be taken to reduce the risk to participants.

Please use the following wording (if the placebo is used for blinding purposes only, use only the first two paragraphs):

USE OF PLACEBO

What is a placebo?

A placebo is an inactive substance; it has no medication (drug) in it.  It looks the same as the real medication.

Why is a placebo used in this study?

In a research study it is important to obtain accurate information.  Many people who have X disorder (explain the issues about the disorder that are relevant to the justification for the use of placebo).  A placebo is used in order to “blind” the study so neither you nor the study doctor will know whether you are on active drug.  This is done so that you and your study doctor will not be influenced by expectations of the effects of the drug (or list any other reasons).

What will I give up if I receive placebo?

As previously mentioned, there are a number of treatments available for the treatment of X disorder. If you choose to participate in this study there is a _ in _ chance you will receive placebo.  This will lengthen the time before you receive a treatment that may be effective.  During this time you may experience worsening of your condition, including increased symptoms such as (list symptoms).  If your symptoms worsen and make you uncomfortable, you can withdraw from the study.  You can do this at any time during the study.

Study Procedures

This section should provide a detailed description of what participation will entail for the research participant (visit schedule, regular routines, nature of tests and procedures, amount of time spent at clinic visits, etc.). Include time spent at home, if applicable (e.g. filling in diaries/questionnaire, travel to and from research site and labs, etc.) Identification of those procedures which would not be part of usual clinical care should be included.

Risks and Discomforts

This section should include a description of the likelihood of any discomforts and inconveniences associated with participation and of known or suspected short- and long-term risks.  This information should be categorized with a qualifier such as percentages (e.g. less than 1%, 1-5%, 5-10%, etc.) or label (very common – greater than 10%, common, uncommon and rare).  On occasion, this information may be more easily read by the participant if presented in a tabular format.

If there is a mandatory genetic portion to the study, please include the following paragraph:

“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.

Reproductive Risks

This section should explain risks regarding reproduction, lactation and fetal development.  If the participant or participant’s sexual partner must use contraception during the course of the study (required either by the protocol and/or site policy), the acceptable methods must be listed and for how long the participant must use contraception.  Should a pregnancy occur and if required by the protocol and/or site policy, a statement should be included indicating that permission to follow the pregnancy will be requested and the reason(s) for following the pregnancy.

Benefits

This section should explain the probability and nature of direct and indirect benefits to the participants and to others. Although not mandatory, the following statement is recommended, “Although participation in this study may be of no benefit to you personally, it is hoped that what is learned here will be of future benefit to others suffering from disease X.”  Items such as close physician monitoring and the free provision of medications and services may be seen by some participants as inducements to participate and therefore, must not be listed as a benefit.

 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.

Alternatives to Participation

This section should identify alternatives to enrollment in the research (e.g. standard of care).  If the study drug is available without participating in the study, please clearly state this. The trade name(s) of commonly used medications should be listed.  A discussion of the risks and benefits of the alternatives or a statement indicating that the study doctor will discuss the risks and benefits of the alternatives with the participant must be included.

Confidentiality

This section should include an explanation of who will have access to information collected and to the identity of the participant, including a description of how confidentiality will be protected.  The Health Research Ethics Board of Alberta –Clinical Trials Committee must be included as having access to the information.

Please include the following in this section:

  1. That personal health information will be collected as part of the study.
  2. List what is included in “personal health information”.
  3. That information will be kept confidential.
  4. How confidentiality will be protected (i.e. use of code numbers, etc.)
  5. That study records will be kept separate from medical records.
  6. That in some circumstances, sponsor and / or investigator may be required by law to release personal health information about participants (e.g. must report positive HIV, Hepatitis results to local health authority).
  7. The purpose for which the information collected will be used (should be limited to the purposes of the study).
  8. Whether permission is being sought to disclose the participant’s participation to their family physician.
  9. The health information collected will be checked from time to time against medical records by representatives from the sponsor, and that this implies that representatives of the drug company paying for this research will be able to view your medical records.
  10. That other persons may also need to view participant’s records, including representatives from the 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.
  11. That where the groups / persons who need to see participants’ medical records are outside Canada, the privacy laws in these other places may be less strict than those in place in Canada.
  12. That study records must be kept for 25 years.
  13. That participants have a right to check health records and ask for corrections to be made.
  14. That by signing the consent form they give investigator and sponsor permission to collect, use and disclose medical records as outlined in this section.

This section must also indicate whether or not the participant’s primary care physician will be notified of their participation in the study and if any information about the participant will be sought.

If providing notification of participation to the participant’s primary care physician is optional, the following must be included:

We believe it is extremely important that your personal physician know, if you have one, 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.

____ YES                    ____   NO

Participant’s Initials_________

If you need to request personal health information from the participant’s from another custodian (e.g. primary care physician, specialist), a consent for the release of this information (referred to in Section 34(1) of the Health Information Act) must be provided and must include the requirements outlined in Section 34(2) of the HIA.  Please refer to the Consent to Disclose Health/Registration Information form.

Cost to Patients

This section should provide a description of any financial costs that the participant may incur as a condition of, or because of, participation in the research and whether these costs will be reimbursed.  There must also be a statement that the Alberta Health Care Insurance Plan will not be billed for any visits, treatments or procedures related to the conduct of this study.

Where treatment is involved, participants must be advised of who will be responsible for the cost of any remedies (prescription or non-prescription) that may be required to treat possible side effects.

Note:    The CTC does not allow participants to be paid for participation, however, reimbursement of out-of-pocket expenses is considered appropriate.  This reimbursement should be based on a reasonable assessment of such costs and be justifiable by the principal investigator if called upon to do so by the HREBA – Clinical Trials Committee.

If participants are to receive fees for participating in this research protocol, then a statement must be included in this section that states the nature of this reimbursement.  If the amount is specifically stated in the budget then this amount must be included in the consent form document. Please remember the reimbursement for expenses being paid at the end of study participation is not acceptable; the Committee considers the full amount as a single payment at the end as an inducement to stay in the study. Offer reimbursements at quarterly intervals at the minimum

The Statement should include:

  1. How the participant may apply to receive reimbursement
  2. Maximum amount of reimbursement
  3. Type of costs covered by reimbursement (i.e. travel, daycare, over the counter medicines)

If the study drug is not yet approved for use in Canada, this section must conclude with the following statement, where appropriate (e.g. in Phase I, II and some Phase III studies, where the prescribing indications for drug usage may be changing from investigational to approved for use):

We will assist you in ensuring that appropriate treatment for your condition continues once the study has been completed and/or the drug is no longer available through the study.  There is no guarantee that the drug will be available to you at that time.  If the drug has been approved for marketing, you or your health insurance may have to pay for it.

Compensation

A statement regarding possible compensation if the participant is injured as a result of the research is mandatory.

This statement must contain plain language; accurately describe the sponsor’s policy; be appropriate for the study population.

Explain who will determine whether an injury is study-related.  Where the policy is to have the study doctor and the sponsor (or sponsor’s representative) make this determination, it must be clear how conflicts among the decision-makers are to be resolved. The Committee suggests that where there is a disagreement between the sponsor and study doctor as to whether an injury is study-related, an independent third party should make the final decision.

The Health Research Ethics Board of Alberta – Clinical Trials Committee (HREBA-CTC) requires that research participants have a clear understanding of who will decide whether an injury to them is study related.  This is not negotiable and needs to be clearly stated in the consent form.  The HREBA-CTC is not concerned about who decides, the only concern is that the responsibility is defined and a process is declared should there be a disagreement if multiple parties are named.  Please insert a statement that indicates who decides if an injury is study related.  If an injury is determined by both the study doctor and sponsor, please clarify that if there is a disagreement, who will make the final determination (study doctor, sponsor or independent third party).

This section must conclude with the following statement: (mandatory and verbatim)

You still have all your legal rights.  Nothing said here about treatment or compensation in any way alters your right to claim damages.

Withdrawal from Study

Information must be included regarding the provision of ongoing care for participants who are screen failures; withdrawals for any reason; or participants who complete the study (e.g. participant will not be penalized or lose any benefits or medical care to which they are entitled).

If participants withdraw or are withdrawn from the study and procedures are to be performed at a final visit, the participant should be asked to return for this.  If the final procedures are to be performed for safety reasons, the reasons must be stated.  If not for safety reasons, a clear statement must be included indicating that the procedures are not mandatory and that the participant may refuse to participate in this further evaluation.

Please include that even if they withdraw from the study;

  • the information already gathered will not be destroyed
  • there may be some continued use of the personal information collected about them. For example, the information will be used or disclosed if necessary to preserve the scientific integrity of the study; that study data already integrated into the database will not be withdrawn; that anonymized information will continue to be used

Ethical Review

If the investigator wishes to refer to the HREBA– Clinical Trials Committee role, the following statement may be included:  “The Health Research Ethics Board of Alberta – Clinical Trials Committee has reviewed this protocol and has found it to be ethically acceptable.”

Signature Page

Although the investigator can delegate the provision of information for the consent, the investigator retains ultimate legal and ethical responsibility for ensuring the participant:

  1. is provided with all appropriate information (for each individual participant);
  2. understands the information;
  3. has had all questions adequately addressed; and
  4. has the capacity to consent.

The last page of the informed consent form must end with the ICF Mandatory Verbatim Signature Page (click here).

Inclusion of Incompetent Participants

For inclusion only in studies where incompetent participants are recruited and who may become competent at a later date, the ICF Inclusion Signature Page (click here) is required.