Our Clinical Research 101 series takes an in-depth look at key steps and tips for navigating the clinical research process. The fourteenth installment in our Clinical Research 101 series is by Project Manager Laura Zunino, BSc, CCRP.
Ms. Zunino is a Project Manager with CHÉOS and the CIHR Canadian HIV Trials Network (CTN). She has extensive experience working with patients and healthcare professionals and specializes in the end-to-end management and monitoring of investigator-initiated and industry-sponsored clinical research.
Clinical Research 101 Series
What is informed consent?
According to the International Conference on Harmonization – Good Clinical Practice (ICH-GCP), informed consent is “a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.”
The proper documentation of participant consent is a core component of the ethical conduct of research. Research involving human participants must be reviewed and approved by an independent ethics committee to ensure that appropriate consent procedures are in place and that the rights, safety, and well-being of potential participants are protected. Investigators and their study teams are tasked with creating comprehensible and readable consent forms and obtaining informed consent (except in certain circumstances) from study participants before performing assessments or administering investigational treatments.
What is the informed consent process and why is it so important?
The endeavor of obtaining “informed consent” should not be viewed as simply an act of acquiring a participant’s signature on a form but instead as a fundamental and ongoing process that facilitates a participant’s understanding of a treatment or intervention and its risks/benefits throughout the study as well as sufficient understanding of the study itself. This process empowers potential participants to make informed decisions about their participation in a research study based on their perception of what is best for their situation.
An important part of this process is providing potential study participants adequate time to review the information in a consent form with whomever they wish (family members, general practitioner, close friends, etc.) before deciding whether a given study is suitable for them. Furthermore, they should be given the opportunity to ask any questions and have them answered to their satisfaction. Only once this process has taken place, and the patient has agreed to participate voluntarily and without coercion, should they sign the consent form along with any study team member, witness, or qualified translator involved in the informed consent process.
Are there any tips to creating better consent forms?
According to Health Canada, informed consent documents must generally contain: introductory information, summary of procedures and participant time commitment, access to research information, risks/benefits, compensation/expenses, and confidentiality/publication of results. When drafting a consent form, special consideration should be given to the complexity, length, and language of the document which should be comprehensible to potential research participants (and/or their legal guardians or substitute decision makers).
As guidelines have evolved over the years, consent forms have developed into overly complex and lengthy documents that many potential participants may struggle with comprehending.
Aside from using lay language, there are several methods that can be utilized to increase the readability and comprehensibility of informed consent forms. Suggestions by Pandiya (2010) and Grady et al. (2017) on increasing comprehension include:
- Using a shortened consent form with essential information and appendices attached for more information
- Using bullet points and diagrams to outline complex concepts
- Using readability scores available in most common programs, such as Microsoft Word (a readability score of less than Grade 6 is generally recommended)
- Leveraging digital and electronic technology such as e-consent forms containing multimedia that provide an overview of the study and participant involvement, pop-up definitions of unfamiliar terms, and built-in quizzes to assess comprehension.
Additionally, peer review by non-healthcare workers (particularly by individuals in the population being studied) can provide meaningful recommendations for consent documents before they are finalized and submitted for ethics approval.
Links to references and resources:
- Health Canada and Public Health Agency of Canada. Requirements for Informed Consent Documents. [document]
- WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, 2013. [document]
- International Council for Harmonisation (ICH). Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6 (R2), 2016. [document]
- Gupta UC. Informed consent in clinical research: Revisiting few concepts and areas. Perspect Clin Res. 2013;4(1):26–32.
- Pandiya A. Readability and comprehensibility of informed consent forms for clinical trials. Perspect Clin Res. 2010;1(3):98–100.
- Grady C et al. Informed Consent. N Engl J Med. 2017; 376:856-67.
- Rebers S et al. Exceptions to the rule of informed consent for research with an intervention. BMC Med Ethics. 2016;17:9.
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