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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 the Informed Consent Template – Standard Research Studies and the Checklists ...
- Reportable Events
a change to the informed consent form; AND/OR; immediate...
- Templates and Forms
Templates and Forms - Standard Informed Consent Requirements...
- Genetic Informed Consent Requirements
Please refer to the Genetic Informed Consent Form Template...
- Fees
Fees - Standard Informed Consent Requirements | HREBA
- Suspensions / Terminations
Suspensions / Terminations - Standard Informed Consent...
- Review Types
A clean and tracked changes version would of the ICF would...
- Items Required for Review
Please modify the study’s informed consent form to the...
- Frequently Asked Questions
Frequently Asked Questions - Standard Informed Consent...
- Reportable Events
The informed consent process may become more complicated during pregnancy because of the presence of the fetus and the obstetrician–gynecologist's dual concern for maternal and fetal well-being. However, the ethical obligation to obtain informed consent using shared decision making does not change based on pregnancy or parenting status 4 39.
1 day ago · The guidance harmonization is part of other regulatory changes that are expected in early 2025 concerning single IRB reviews of proposed research, Riddle explains, so sponsors, contract research organizations, and sites with templates for their informed consents are advised to be ready for making updates as even bigger changes are coming down the pike.
- Foreword
- Table of Contents
- 1. Introduction
- 2. Guidance for Implementation
- 3. Risk Managemet and Pharmacovigilance Planning
- 4. Effective Date
- 5. Contact Information
- Appendix A: Considerations in using contraceptives in clinical trials
- Appendix B: ICH Guidelines
Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.
Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.
As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.
This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.
•1. Introduction
•1.1. Policy objective
•1.2. Principles
•1.3. Policy statements
•1.4. Scope and application
•1.5. Background
1.1 Policy Objectives
This document provides guidance on the study and analysis of sex differences in clinical trials of therapeutic products in order to generate evidence to advise on the optimal use of therapeutic products in both women and men. For many years, it was accepted that women did not differ from men except where their reproductive organs were concerned. Thus it was assumed that, data obtained from research involving male subjects could simply be extrapolated to women, and therefore, there was no need to include female subjects in studies (clinical trials). However, scientific evidence shows that there are often many clinically meaningful differences. As such, this guidance addresses considerations pertaining to the appropriate inclusion of women in all stages of clinical trials and research with the aim of identifying and analyzing sex-related differences that may affect the safety and efficacy of a therapeutic product. This guidance document reflects the Government of Canada's Health Portfolio Sex and Gender-based Analysis (SGBA) Policy which supports the development of sound science and the implementation of rigorous and effective research that expands the understanding of health determinants in both sexes in order to provide knowledge which can result in improvements in health and health careFootnote 1. While this guidance recognizes the importance of the elements of a diversity framework, such as ethnicity, socioeconomic status, disability, sexual orientation, migration status, age and physical status (early menopause etc.), it focuses on sexFootnote 2 related differences in clinical trials. This guidance document supersedes the Health Canada Guidance Document on Inclusion of Women in Clinical Trials issued in 1997.
1.2 Principles
This guideline supports the conduct of studies in accordance with generally accepted Good Clinical Practices (GCPs) that are designed to ensure the protection of the rights, safety and well-being of clinical trial subjects. This includes the GCPs referred to in Division 5, Part C of the Food and Drug Regulations, Part 4 of the Natural Health Products Regulations, and described in the International Conference on Harmonisation (ICH) Guidance (E6) on Good Clinical Practice and in ISO14155, Clinical Investigation of Medical Devices for Human Subjects. This Guidance is also consistent with the International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002) of the Council for International Organizations of Medical Sciences (CIOMS) and with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2010) where it states that "Women shall not be inappropriately excluded from research solely on the basis of gender or sex"(Article 4.2).
1.3 Policy Statements
Prior to receiving market authorization in Canada, therapeutic products should be evaluated in subjects who are representative of the full range of personsFootnote 3 likely to receive the product. In general, clinical trials should enrol subjects representative of the population(s) expected to use the therapeutic product. Specifically: It is recommended that a representative number of womenFootnote 4 be included in clinical trials for therapeutic products that are intended to be used specifically by women or by heterogeneous populations that include women. It is recommended that women, including those of child-bearing potential and postmenopausal women, be included at the earliest possible stages of clinical trial researchFootnote 5 so that potential sex-related differences are identified and taken into consideration when planning Phase III pivotal trials. Although it may be reasonable to exclude certain potential subjects at early stages due to characteristics that may render evaluation of therapy more difficult (e.g. women and/or men on concomitant therapies), inclusion of such subjects is encouraged as early as possible in phases of clinical development so that therapeutic product interactions (e.g. drug-drug; natural health product-drug; natural health product- natural health product and product-disease) can be identified and assessed.
Where sponsors intend a therapeutic product to be used by both women and men, it is recommended that sponsors include both sexes in: (a) nonclinical studies; and: (b) in clinical trials to allow detection of potential sex-related differences in efficacy and in safety.
In some instances, further confirmatory studies in a single sex may be appropriate, in particular when a product is intended for use in one sex exclusively. Evaluation of the effects of phases of the menstrual cycle on therapeutic product response in females should also be considered.
Health Canada adopted the International Conference on Harmonization guideline, E2E Pharmacovigilance Planning 18 (ICH E2E). ICH E2E identifies topics that should be incorporated into the safety specifications and risk management plan/pharmacovigilance plan to clarify where further evidence/data may be needed post-authorization of a therapeutic product. Sex-based differences or considerations should be addressed within these topics. This could include information related to differences between men and women in their response to therapeutic products, as well as reproduction/developmental toxicology or the use of products by special populations including pregnant and breastfeeding women.
Further, any gaps in knowledge related to sex-based potential differences or considerations and any further post-authorization evaluation requested by the regulator should be made public at the time of approval.
This guidance document is effective as of May 29, 2013.
Questions concerning inclusion of women in clinical trials and analysis of sex differences should be directed to:
Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Health Products and Food Branch
Health Canada
200 Tunney's Pasture Driveway
Preamble
In conducting clinical trials, contraceptive guidance is frequently necessary and may involve complex considerations to address the needs and circumstances of a diversity of subjects and their partners. Compliance may be enhanced when both male and female subjects and their sexual partners have a clear understanding about the importance of contraception and about methods that should be used consistently and correctly. In addition to pregnancy testing prior to and during a clinical trial, "subject education should be sufficient to ensure compliance with measures designed to prevent pregnancy during the period of drug exposure (which could exceed the length of the study)Footnote 21. Much knowledge regarding contraception is publicly available (see suggested resources section below). This Appendix is intended to be an additional resource to clarify some considerations in using contraceptives in clinical trials. Note: No one method of contraception is 100% effective. It is recommended that a statement to this effect be included in all Informed Consent Forms requiring contraceptive guidance. The Informed Consent Forms should also provide a list of the contraceptive methods recommended. In addition, Informed Consent Forms should clearly state if there is a possibility that the investigational product may lessen the effectiveness of a hormonal contraceptive agent.
I. Relevant Populations
I. a. Studies that include Women Contraception should be considered in women of childbearing potential Women of childbearing potential are females who have experienced menarche and do not meet the criteria for women Not of childbearing potential .Women Not of childbearing potential are females who are permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical causeFootnote 22. I. b. Studies that include Men Abstinence or contraception may be recommended where there is evidence (or good reason to believe) that the investigational product binds to the sperm and may have teratogenic effect. I. c. Studies that include Paediatric Subjects Studies in paediatric populations where it is possible that subjects (both male and female) are sexually active and have reached puberty, should contain guidance on contraception. Guidance should be provided in a manner and format appropriate to the age of the subjects.
II. Contraceptive Methods
II. a. Highly effective Highly effective methods of contraception, when used consistently and correctly, result in low failure ratesFootnote 23. These may include: hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation. Highly effective methods of contraception might not always be achievable in the clinical trial setting and, therefore, the most effective alternative can be achieved using methods in combination. II. b. Effective methods Effective methods may include: barrier methods of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge). Note: No barrier method by itself achieves a highly effective standard of contraception. The proper use of diaphragm or cervical cap includes use of spermicide and is considered one barrier method. The cervical cap and contraceptive sponge are less effective in parous women. The use of spermicide alone is not considered a suitable barrier method for contraception. When used consistently and correctly, "double barrier" methodsFootnote 24 of contraception (e.g. male condom with diaphragm, male condom with cervical cap) can be used as an effective alternative to the highly effective contraception methods described above. The consistent and correct use of a male condom in association with spermicide may be considered an acceptable barrier method in some clinical trial settings.
Additional International Guidance for Nonclinical Studies
WHO Guidelines on Nonclinical Evaluation of Vaccines.World Health Organization,WHO Technical Report Series, No. 927, 2005
May 8, 2023 · During pregnancy, informed consent can be described as the process of decision-making between a patient and the health care provider regarding the clinical management of the pregnancy. The goals of the informed consent process are to empower the patient with information about benefits and risks that are needed for an informed choice about ...
Feb 25, 2022 · Background. Informed consent is an integral part of good healthcare practice in which autonomous patient-centred choice-making is central [1, 2].In the United Kingdom, echoing a decision taken by the Australian Courts in the 1990’s [], the decision in Montgomery and subsequent cases [5–9] reflects increasing legal endorsement of the importance of consultation dialogues which foster patient ...
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Feb 1, 2021 · Background How to best support pregnant women in making truly autonomous decisions which accord with current consent law is poorly understood and problematic for them and their healthcare professionals. This observational study examined a range of ante-natal consultations where consent for an intervention took place to determine key themes during the encounter. Methods Qualitative research in ...
