Informed Consent ProcessInformed consent is the process of telling potential research particpants about the key elements of a research study and what their participation will involve. The informed consent process is one of the central components of the ethical conduct of research with human subjects. The consent process typically includes providing a written consent document containing the required information (i.e., elements of informed consent) and the presentation of that information to prospective participants. Show
In most cases, investigators are expected to obtain a signature from the participant on a written informed consent document (i.e., to document the consent to participate) unless the IRB has waived the consent requirement or documentation (signature) requirement.
Informed consent documentsAn informed consent document is typically used to provide subjects with the information they need to make a decision to volunteer for a research study. Federal regulations (45 CFR 46.116) provide the framework for the type of information (i.e., the "elements") that must be included as part of the consent process. New with the revised 2018 Common Rule is the requirement that the consent document begin with a "concise and focused" presentation of key information that will help potential participants understand why they might or might not want to be a part of a research study. Key Information ElementsThe image below displays the five elements identified in the preamble to the revised Final Rule as suggested key information. Note: Element number 5 (alternative procedures) applies primarily to clinical research. General Information & Tips for Preparing a Consent DocumentReading levelInformed consent documents should be written in plain language at a level appropriate to the subject population, generally at an 8th grade reading level. A best practice is to have a colleague or friend read the informed consent document for comprehension before submission with the IRB application. Always:
Writing tipsThe informed consent document should succinctly describe the research as it has been presented in the IRB application.
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Informed Consent TemplatesIRB-HSBS strongly recommends that investigators use one of the informed consent templates developed to include the required consent elements (per 45 CFR 46.116), as well as other required regulatory and institutional language. The templates listed below include the new consent elements outlined in the 2018 Common Rule. If you choose to create an informed consent document without utilizing an IRB-HSBS template, you must ensure that all required elements are included and that the recommended language (found in the templates) is utilized appropriately.What must be told to the research participants when obtaining written informed consent?Consent should be obtained before the participant enters the research (prospectively), and there must be no undue influence on participants to consent. The minimum requirements for consent to be informed are that the participant understands what the research is and what they are consenting to.
Which of the following must be included in the informed consent in research?Valid informed consent for research must include three major elements: (1) disclosure of information, (2) competency of the patient (or surrogate) to make a decision, and (3) voluntary nature of the decision. US federal regulations require a full, detailed explanation of the study and its potential risks.
What information is needed for informed consent?A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
What are the 4 principles of informed consent?There are 4 components of informed consent including decision capacity, documentation of consent, disclosure, and competency. Doctors will give you information about a particular treatment or test in order for you to decide whether or not you wish to undergo a treatment or test.
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