Guidance Document for Writing the
‘Participant InformedConsent Form’
The Ottawa Health Science Network Research Ethics Board (OHSN-REB) is required by national and international practice and regulation to determine whether it is ethically acceptable to invite potential research participants to take partin the proposed research project. REBs carefully review all aspects of the proposed research, including the Participant Informed Consent Form (ICF) which is an essential component of the ethical acceptability of the invitation to participate in the research.
Template ICFs are often provided by the sponsors (either industry or another academic institution). These templates must meet the OHSN-REB standardsoutlined in this guidance document and the ICF template. For sponsored trials, the sponsor must approve the document before the study is submitted for ethics review. Please consult with your sponsor for exact processes. Be sure to contact the OHSN-REB office if you encounter difficulty with a sponsor approving a particular section of the ICF.
This guidance document seeks to assist researchers and their staff by outlining what information to include in each section of the ICF. This document is structured with the same sections as the ICF template, and according to TCPS2 guidelines, specifically Article 3.2: “Researchers shall provide to prospective participants, or authorized third parties, full disclosure of all information necessary for making an informed decision to participate in a research project”, as well as, GCP guidelines, specifically section 4.8: “Informed Consent of Trial Subjects”. This guidance document and the consent template have been designed primarily towardspatients as participants in clinical trials.
If, after reading this guidance document and theICFtemplate, you still have questions, please contact the Protocol Officer responsible for your therapeutic area. To find out who your Protocol Officer is, please click on this link.
General Guidelines
•The ICF should aim to not exceed 8-10 pages, in most cases. Use brief, simple statements rather than long detailed explanations.
•Make sure information in the ICF is consistent with the research protocol and theREB application form. The OHSN-REB specifically reviews these documents for consistency.
•The principal investigators should refer to themselves as ‘study doctor(s)’ or ‘investigator(s)’ for clinical trials to avoid confusion with the participant’s family or treating physician.
•Write the ICF as though you are verbally explaining the study to a prospective participant using simple layperson’s language, aiming at a grade 8 reading level,as measured by Simple Measure Of Gobbledygook (SMOG)orFlesch-Kincaidevaluations. The SMOG calculator is available on copied from the protocol or application is not acceptable.
If reading level is high but ICF contains some absolutely necessary technical termsyou can check the true reading level using the following process:
- Check the reading level with the technical terms in place.
- Remove the technical terms and recheck the reading level.
- If the reading level lowers with technical terms removed, then high level is due to required technical terms.
- Enter the lower reading level into the appropriate section of the REB application.
•Acronyms may cause confusion and should be kept to a minimum. If required, define acronyms the first time they appear in the document.
•Use second person (“you/your”) throughout the information sections, and use first person (“I”) for the consent signature page.
•Be consistent with technical terms by using the same one throughout the document.
•Define or explain all required technical terms the first time they appear in the document, avoiding the frequent use of parentheses. If the consent form contains multiple technical terms, consider adding a glossary at the end of the consent form.
•Avoid using terms like study drug or medicine if study involves a placebo arm. A placebo is not a drug, medicine or therapy and should be referred to as study product, study agent or study tablets/capsules/infusion/device.
•Avoid bolding text aside from section headers.
•Use a consistent font style and size throughout the document; a minimum of 11 is required, 12 is preferable. Remember your audience when choosing font size (e.g. if recruiting ophthalmology patients, consent may require larger print).
•Section headers should not float at the bottom of the page without any text. If only the header appears, it should be moved to the top of the next page.
•The first page and the final signature page shouldbe on OHSN-REB letterheadif you are recruiting across sites (e.g. at both TOH and UOHI). If you are recruiting from only one institution (e.g. TOH only) you may use the new OHSN-REB letterhead or your institution’s letterhead.
•The other pages should contain “Page X of Y” and the version date of the document in the footer.
Consent Form Sections
Title of Study: Add complete study title
Local Site Principal Investigator (PI): Dr. John Smith, 613-798-5555, extension #12345
This must be the local investigator’s name and contact information and not the multicentre principal investigator.
Sponsor [or Funding Agency]:
The name of the company(ies) or institution(s) sponsoring and/or granting agency(ies) funding the research must be provided.
In addition, if the study is funded by a granting agency, but is receiving support from another company or agency (e.g., the drug is supplied by the manufacturer), this should also be stated. Potential participants are entitled to know all the companies or agencies which are involved in the study.
Funds coming from unrestricted donations must also be disclosed in the consent form.
Why am I being given this form?
Inform participants why they are being approached. For example, is it because they have a particular disease, or undergoing a certain type of test/procedure/surgery?
•Be as specific as possible but use everyday language. Do not use technical language or list the inclusion/exclusion criteria.
Why is this study being done?
State the purpose of the study in lay terms and provide the background information and rationale for performing the study (e.g., results of previous studies, etc, as relevant to the participant)
•State whether the study is a continuation of a previous study, increased dosage, new combination, or changing administration of a drug, new patient population, etc.
•Indicate if the study drug, device or procedure is experimental; has been approved by Health Canada, FDA or other regulatory authorities; and the testing that has been completed.
•List the number of centres participating (for multi-centre trials), the total number of participants to be recruited from all centres, and the number to be recruitedat this site.
How is the study designed?
Design should include the following information (if applicable to your study): number of arms, comparators, placebos/active controls, randomization, blinding, etc.
What is expected of me?
Provide a clear description of how participating in the study will affect the patient/participant, and what will be expected of them.
•Make a distinction between research-related procedures and standard-of-care procedures. If the study includes procedures that the participant would undergo in the course of standard diagnosis or treatment, then these procedures do not need to be explained/described in-depth. The ICF should focus on describing research-related procedures and only discuss standard-of-care where necessary.
•Explain if the participant’s current therapies or treatments will be altered or discontinued.
•If a drug is to be given, indicate the dosage, the route of administration, and the duration of administration.
•Describe all tests (blood, x-rays, etc), measures, procedures, interventions, treatments or questionnaires that the participant will be expected to undergo, chronologically if possible.
•Consider the use of subheadings to help organize this section and increase readability (e.g. Screening, Baseline Visit, Randomization, and Follow-up).
•Indicate the frequency of each procedure and the length of time taken to complete it.
•The use of tables is recommended to describe procedures, particularly if they willbe repeated at several visits (see ICF template for an example). The table should be printed on one page.
•Indicate where he/she will take part in the study, whether it will be at the hospital, at home, how many visits their participation may involve, how long each visit will take, and whether any follow-up will be required for the study, etc
•For studies recruiting staff; indicate on whose time the study will take place (e.g. paid or leisure?)
Will my samples or research data be used in future research?
If tissue/blood banking is required, the consent must clearly state the specific, defined reasons the banking is required, and the defined, finite duration for which the samples will be stored.
It is strongly recommended that a separate consent form be used for future uses of data or samples, unless it is a mandatory part of the main study.
•If future use of the research data beyond the current study is anticipated, this should be explained (for example, subsequent use of videos, DNA banking, and creation of a permanent cell line).
•The purpose of future research on this data should be explained to ensure that specific consent from the participant is obtained.
•Set out options for the participant regarding the possible uses of samples, ensuring that the consent you request is as specific as possible. Consent which is not sufficiently specific is not considered to be valid consent. Thus, the goal is to ensure that consent obtained for studies in the future on collected samples will satisfy the research ethics board reviewing the future study.
•Explain who owns the data/samples, when or if the research data/samples are to be destroyed or if they will be sold.
•Explain if REB approval will be sought for future research on the data (justification will be required if REB approval will not be sought).
•For genetic/DNA research which is optional, a separate consent form is required.
How long will I be involved in the study?
Inform the participant how long the study is expected to continue (entire study not just individual participation), and the length of the participant’s expected study participation. Also indicate if the participant may be withdrawn from a study without their consent (see templatefor some examples).
Participant is also informed of foreseeable circumstances and/or reasons under which his/her participation in the trial may be terminated (ICH-GCP 4.8.10(r)).
What are the potential risks of discomforts I may experience?
List all potential risks or discomforts of each drug/product/test/procedure that are research related. You do not typically need to include the risks or discomforts for procedures performed as standard of care.
•For studies involving drug therapies indicate all risks listed in the investigator’s brochure, being sure to define medical terms.
•If study involves an active comparator, the risks from both the study drug and active comparator should be included.
•Quantify the side effects and risks in percentages or group them in categories whenever possible. Side effects should be in order of serious to non-serious.
•Always write out terms such as “less than” or “greater than” as some people may not understand symbols such as “<” or “>”.
•Address the reversibility, time to onset (e.g. immediate, delayed, late), and duration of side effects as applicable.
•If the likelihood of a risk is uncertain (e.g. not enough safety data) then be sure to inform participants of this and provide best idea. Perhaps quantify based on similar drug profiles (e.g. does novel therapy share a similar profile with other drugs in its class?)
•If the study involves a cocktail of different drugs, and this information is available, you shoulddescribe the risks associated with the cocktail instead of individually. (e.g. risks of taking drug A + B + C together instead of risks of drug A alone, risks of drug B alone, etc.) Taking drugs in combination may change the safety profile.
•Complex risks/technical side effects should be described with a level of detail that helps imagine the potential impact on one’s life (e.g. Drug X may cause low BP. People with Low BP may feel weak or tired, etc). The intent is not to have every side effect described with this level of detail, but to help make the description of complex/technical side effects more understandable to patients (e.g. ‘elevated liver function results’, what does this actually mean to participant? Does it mean their liver will work better or does this mean the liver is permanently damaged?)
For studies recruiting students/trainees:
Indicate if there is an impact on evaluations if they participate or not and what their results are. It is also relevant to indicate how the risk will be mitigated.
Placebo Risks:
If study involves placebo please list the risks of being placed in placebo arm, if any.
Delay in Treatment Risks:
If study involves a delay in treatment pleaselist the risks to participants because of this delay.
Radiation Risks:
If your study involves procedures that will expose participants to radiation, please fill out the appropriate forms and include an appropriate statement about the risk.
Is there a concern with pregnancy or breastfeeding?
onlyinclude the applicable language for the study, e.g.if pregnancy is an exclusion criterion orif the study poses risks to those who are pregnant, become pregnant or are nursing mothers (as per TCPS2 Art. 4.3 and ICH GCP s. 4.8.10 (g)).
Are there any potential benefits for me?
Identify the specific direct/indirect benefits to subjects if he/she participates in the study.
•Do not include monetary/expense reimbursements in this section; this should be indicated in the “Will I be paid for my participation or will there be any additional costs to me?” section.
•Ensure statements are not coercivebut realistically provide an appreciation of the scientific knowledge anticipated.
Items such as close physician monitoring and the free provision of services may be seen by some participants as inducements to participate and therefore, must not be listed as a benefit.
Do I have to participate? What alternatives do I have?
Choose the appropriate paragraph in the consent template to match your study population.
If I agree now, can I change my mind and withdraw later?
•Explain that participant may withdraw from the study at any time without an impact on their care, or future employment, education, etc.
•Participant is also informed of foreseeable circumstances and/or reasons under which his/her participation in the trial may be terminated (ICH-GCP 4.8.10(r)).
•Participants should also be given the choice of having their data withdrawn from the study completely, or be provided with the reasons why this option might not be possible. State if withdrawal is impossible. For example, surgical procedure may not be reversible.
•Be sure to tailor section to your protocol (e.g. if study is not regulated remove mention of regulators; if no FDA involvement remove mention; if no sponsor remove mention, etc).
What compensation will I receive if I am injured or become ill in this study?
Indicate that treatment in the event of injury or illness will be covered by the sponsor and/or Institution.
Choose the appropriate paragraph in the consent template and delete the other.
Will I be paid for my participation or will there be any additional costs to me?
Participants should be provided with a parking voucher, or be informed if they are to be reimbursed for expenses such as parking, meals, babysitting, etc. Receipts must be submitted for these reimbursements to ensure that the reimbursement is not considered taxable income. A handwritten receipt will suffice if it is signed by the research participant if an official receipt is not available (i.e. bus fare).
Describe any monetary compensation and/or expense reimbursements for the study.
•Explain that the study product (drug(s)/device) will be provided at no cost to them for the duration of the study.
•Indicate if participant will be reimbursed for direct study related costs, such as parking, meals, babysitting, transportation, accommodation, etc.
•Indicate if participant will be compensated for his/her time in a study.
•If the Investigators will receive payment for enrolling participants (rare) into the trial, this must be disclosed (specific fee to him/her, not as part of per patient budget).
If the study is paying for participation, in excess of reimbursement of expenses, you must include the required text provided in the consent template.
Commercialization possibilities: Explain if there is a plan for the investigational product to be marketed following the study (e.g.: new drug, device, software, etc.) and who would gain from market approval.
How is my personal information being protected?
Describe how participant’s personal health information (PHI) and/or Personal Identifying Information (PII) will be protected, stored, and at the appropriate time, destroyed.
•Explain, as stipulated in the ICF template language, that all information that leaves UOHI and/or TOH is stripped of all personal identifiers and only identified with an independent study number. Initials and date of birth (DOB) are considered personal identifiers. If DOB is required, only the year and month may be used.
•Indicate how the Master List will be maintained and safeguarded, electronically and in hard copystored securely and separately from coded study data.)
•Electronic records must be stored on the Institutional secure server, not on a computer’s C drive. Files must be password protected. No portable devices may contain PHI/PII.
•Explain who will have access to the records; the list should include sponsor (if applicable), Ottawa Health Science Network Research Ethics Board (OHSN-REB), representatives of [Ottawa Hospital Research Institute (OHRI) or University of Ottawa Heart Institute (UOHI)] (customize to your institution). In addition, include Health Canada and/or FDA only for trials regulated by them. If this study is taking place at other locations such as Bruyere, Montfort, CHEO, etc. then indicate their REBs may also review study files for audit purposes.
•Include the appropriate number of years for storage depending on the nature of the study. For interventional studies regulated by Health Canada, files must be kept for a minimum of 25 years. For non-regulated studies, files must be kept for 10 years. Secure storage must be maintained for this period.