Consent Form for Optional Component of a Study (template)
The following consent form is provided for illustrative purposes only and must be adapted to accurately reflect the proposed project.
This consent form includes an optional component involving a study designed to gather human biological material (i.e., blood, saliva, skin or other samples) during the course of a main research project, and the possible storage of these samples in a bank.
This consent form was developed on the basis of various consent forms used in optional studies, genetic research and sample banking in Canada, specifically but not exclusively, the Genetics Research and DNA Banking Form developed by Geneviève Cardinal, Mylène Deschênes, Bartha Maria Knoppers and Kathleen Cranley Glass of the Réseau de médecine génétique appliquée.
The consent form is consistent with the major principles of the:
· Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition (2010) (TCPS 2);
· International Ethical Guidelines for Biomedical Research Involving Human Subjects of the Council for International organizations of Medical Sciences (CIOMS, 2003);
· The Universal Declaration on the Human Genome and Human Rights (UNESCO, 1999);
· The International Declaration on Human Genetic Data (UNESCO, 2003);
· The Universal Declaration on Bioethics and Human Rights (UNESCO, 2005).
· Guidelines on Human Biobanks and Genetic Research Databases (OECD, 2009).
The consent form is a tool intended to facilitate the overall consent procedure in which "consent" means "free, informed and ongoing consent" and the terms “free” and “voluntary” are interchangeable.” (Ref.: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 3).
Instructions:
· Ensure that the consent form distributed to participants is consistent with the research protocol and, as applicable, the clinical expert’s notice (experimenter’s guide or researcher’s brochure).
· Omit italicized sections from the final version.
· Check that the level of language used is appropriate: grade 8 level is recommended.
· Express all scientific terms in plain language. Ex.: "DNA: A molecule that contains all of the genetic information required to direct cell activity in our body. DNA provides a series of instructions that determine the hereditary traits of an individual, such as eye colour or blood type.”
· Avoid using abbreviations or acronyms, etc.
· Use terms consistently.
· At the bottom of the page, add "Consent Form - version # dated --/--/---- "; and the numbers, dates and version of the research protocol of the principal study pertaining to this consent form.
· Number the pages 1/N, 2/N, 3/N … N/N.
· Include the Hôpital Montfort logo and the logo of organizations participating in the research, as applicable.
· Correct all typos and grammatical or syntactic errors.
· Carefully check that the French and English versions of the document are an exact match for content, style and intent.
Please begin with the following information:
CONSENT: The title of this form must specify that this portion of the study is completely optional, and identify the type of study in question (example: tissue banking, genetic testing, pharmacogenomics, population study, etc.) and which participant target group it concerns (parents, children, brothers, sisters, control group, etc.).
1. GENERAL INFORMATION
Project Name: Enter the project’s official name.
Principal Researcher’s Name (and supervisor’s name, as applicable): Specify his/her affiliation(s) (department, faculty or institute) and contact information (work and non-personal telephone numbers and email addresses).
Names and Contact Information of Co-researchers: Specify their affiliation(s) (department, faculty or institute) and contact information (work and non-personal telephone numbers and email addresses). State the name of the principal researcher affiliated with Hôpital Montfort.
Emergency Contact: As applicable (in the event that the sample involves another procedure not specified in the main study), give the name and contact information for the person to call in the event of an emergency.
Funding Source: Specify the name of the organization funding or sponsoring this portion of the research. If none exists, specify accordingly. This portion of the study is funded by (sponsor’s name, funding organization, pharmaceutical company, other). State whether the principal researcher is receiving financial compensation for recruiting participants. State whether participants can ask to receive relevant information.
Conflicts of Interest: Specify whether or not there are any apparent or potential conflicts of interest and disclose any likelihood of marketing the results, as applicable. If none exists, specify accordingly (ex.: specify whether the principal researcher and/or the institution have a financial interest in the company funding the project).
2. INTRODUCTION
To ensure that participants feel free to knowingly agree or decline to participate in the research project, you can introduce the document with a paragraph such as: Before agreeing to participate in this research project, please take the time to read and carefully consider the following information. This document explains the purpose of the research project, its procedures, benefits, risks and drawbacks. Please ask the person who gave you this document any questions you consider relevant.
3. INVITATION TO PARTICIPATE
I am being asked to participate in the above-named research project conducted by (researcher’s name and affiliation) or conducted by (student’s name) of (name of department, faculty or institute) under the supervision of (professor’s name) of the (name of department, faculty or institute).
Call attention to the voluntary nature of the participation: I am free to participate in this optional study or not. My decision to participate or withdraw from the study will not affect the quality of service provided to me now or in the future in any way.
4. PURPOSE
The purpose of the study is to (state why the research is being performed and explain its objectives).
5. OPTIONAL COMPONENT OF MAIN STUDY
Point out that participants may take part in the main study with no obligation to participate in this optional component of the study.
6. INCLUSION/EXCLUSION CRITERIA
This section can be used to describe the inclusion and exclusion criteria applicable to this portion of the study, even if only to state once again that it is open to everyone participating in the main study.
7. PARTICIPATION
My participation will essentially consist of (describing the intervention (example: provide a saliva, blood or other sample, etc.); the number of procedures, the length of each procedure); (Sessions) are planned (place, date, time and length of each session). I will also be asked to (example: to complete questionnaires). Specify the length of each meeting with the participant).
- State the amount of substance to be sampled (blood, saliva, cerebrospinal fluid or others) in ml (with the tablespoon equivalent in brackets);
- Describe how the sample will be taken and whether the sampling procedure is invasive (review again in the risk description section).
- State whether you will have access to medical records (ex., the research team will consult your medical record to gather information relevant to the research project).
- State whether the data gathered will be matched to other information (ex., demographic data bank, tumor registry, etc.).
- State how the samples will be used. Example: The samples gathered will be used for the purposes of this research project only; or: Our research team plans to conserve these samples for future research.
Future Research
Our research team plans to conserve the samples gathered for future research. We would ask you to check the box that corresponds to your wishes. (Ask participants to check the appropriate boxes below):
For coded samples:
If the researcher plans to use my coded sample for future research, I would like the researcher to contact me again to ask for my consent: Yes No
If the researcher is unable to reach me (in the event that my contact information has changed), I consent to allow my coded sample to be used for future research on the following topic X: Yes No
For anonymous samples:
Since my sample will have been rendered anonymous, I realize that the researcher will be unable to contact me again after the research project ends. I consent to allow the researcher to conserve and use my anonymous sample for future research on the following topic.
The following paragraph applies exclusively in the event of anticipated lost capacity. See TCPS 2, art. 3.11.
Furthermore, the participant’s instructions regarding future research should be specified here as clearly as possible, if any, i.e., “an individual’s preference for participation in future research in the event that the individual loses capacity. Research directives are written instructions to be used by the authorized third party as information about a prospective participant’s preferences when the third party is asked to provide substitute consent.” (Ref.: TCPS 2, chapter 3, Article 3.11).
Alternatives to Participation
(Note: Although the only possible alternative is not to participate, this section must be included in the document as specified, for example, in: 45 CFR 46.116(a)).
State the options available to participants if they refuse to participate in your project (it is usually enough to state that the participant’s only alternative is to refrain from participating in this part of the study; in such cases, it is important to mention that the decision not to participate will have no impact on participation in the main study).
8. BENEFITS
My participation in this research will (explain the nature of any benefits to):
· the participant (if there are no direct benefits to the participant, inform the participant accordingly);
· others; and
· the advancement of knowledge.
9. RISKS
I understand that since my participation in this research (example: requires me to provide personal information), there is some possibility that it will result in (describe possible risks of emotional, psychological, physical, social, financial or other discomfort).
For research performed on samples already taken: Since the research is being performed on samples previously taken, I will not be exposed to any specific sampling-related physical risk.
For a study free of any apparent risk, you may simply mention the following: No known risks are involved in participation in this research.
Support Measures
In the event of an unexpected discovery or the risk of psychological effects, please provide and indicate the support measures you will offer to the participant.
Depending on the nature of the research project, also inform participants that they will receive a list of resources where they can obtain access to genetic counselling under a new heading, as follows:
Genetic Counselling Services: The researcher will provide a list of resources for access to genetic counselling.
10. MARKETING OPPORTUNITIES / WAIVER
An analysis of my sample could contribute to creating commercial products from which I may not derive any financial benefit.
11. DATA AND SAMPLE CONSERVATION
Data Conservation
The data gathered (please specify the data gathered, i.e., in paper or electronic format; examples: questionnaires, other) will be kept in a secure manner (describe how and where data will be stored, who will have access to it and how long it will be conserved. NB: If data is transferred or shared between several sites, specify the data conservation methods used at each site).
State who will have access to the compiled data.
Include any clause that discusses intellectual property rights to samples and data.
Human biological material sample identification and conservation: length of time and location
Specify whether the samples will be identified, coded or rendered anonymous (or anonymized) and how long they will be conserved. (Refer to Chapter 12 of the TCPS 2 for definitions of these categories).
State who (individual/legal entity (lab, biobank or other) will have custody of the samples while in storage (ex., principal investigator, his/her representative, etc.) as well as access to them and for what uses.
For anonymized samples: Samples will have been rendered anonymous, which means that following each sampling, all identifiers that could be used to trace you will be deleted. As applicable, state whether any: Information will be appended to the sample such as (your age, your gender or certain basic clinical, pathological or demographic data, etc.) although they may not be able to reveal your identity or trace you.
For identified samples: Samples will be identified, meaning that samples will include a direct identifier (your name, health insurance number or others) and the researcher or the researcher’s team will therefore be able to trace you using the sample.
For coded samples: Samples will be coded, meaning that following sampling, a code will be assigned to the sample that the researcher or the researcher’s team will use to trace you. However, only he researcher or a person delegated by the researcher will be able to perform the decoding.
State who will have the code key, where it will be kept, the measures taken to protect confidentiality and the persons having access.
Specify the sample conservation time limit:
Samples will be kept at (researcher A’s laboratory, at the premises of research institute/centre X, or in bank Y) under the responsibility of (researcher or bank manager)
a. For a specific period. All samples will be destroyed by (specify the destruction method) after (X amount of time)
b. For X months or years after the research project ends. After this period, all samples will be destroyed;
OR:
Samples (ex., DNA) will be kept in immortalized cell lines, i.e., for an indefinite period in (the laboratory of Researcher A, at the premises of research institute/centre X or bank Y) under the responsibility of the (principal investigator or bank manager).
12. CONFIDENTIALITY AND ANONYMITY
I have the researcher’s assurance that any information I share with him/her will be kept strictly confidential. I expect that the content will be used only for (specify the purpose for which the gathered data will be used) and with respect for confidentiality (explain how confidentiality will be protected). However, there is some possibility that research records identifying me (in the case of questionnaires concerning identifying data) will be examined in the presence of the researcher by a representative of the organization sponsoring or funding the research (state the name of the organization, the pharmaceutical company, the ICRS or other), Health Canada, the U.S. Food and Drug Administration (if relevant) and the Research Ethics Board for research control purposes. However, I have been given assurances that no record identifying me, by name or initials, for example, will be permitted to leave the researcher’s office. (If confidentiality cannot be protected by reason of a legal obligation, please state so explicitly and give the reason.)