Informed Consent Guidance

Informed Consent is a process in which researchers provide information to potential participants regarding the details of a research study prior to their enrollment in the study.  Please refer toe the Investigator’s Manual -  Policies and Procedures for a complete guidance.

Obtaining an informed consent involves:

• Providing information to the subject
• Ensuring the subject understands by answering questions the subject may have
• Obtaining voluntary agreement of the subject to participate in the study

The potential participant in a research study must participate willingly, having been adequately informed about the research. If the potential participant in a research study is part of a vulnerable population (i.e. pregnant women, cognitively impaired individuals, illiterate, children, or prisoners) special protections are required.

Special safeguards for Vulnerable Population

Special considerations must be in place to protect the rights and welfare of potential participants likely to be vulnerable to coercion or undue influence. The safeguards employed for vulnerable subjects include, among many other strategies, include the following as applicable, assessing the decision-making capacity of potential subjects, securing the involvement of a legally authorized representative, requiring parental permission from a parent/ legally authorized representative and in some studies from both parent, in addition to the child’s assent, and ensuring that incentives are not coercive.

The Informed Consent Document

The informed consent document is one aspect of the informed consent process, however it is very important. The Informed consent must

• Be written in lay terminology and at a Grade 6-8 readability level. If you are using MS Word to develop the consent document, check the readability via Flesch-Kincaid Grade Level during spell check.
• Be in a language that is understandable to the subject.
• Not contain any medical or scientific terminology. Please refer to the Glossary of Medical Lay Terminology for assistance in preparing the informed consent document
• Not contain any abbreviations and acronyms
• Be written in the second person: ie: You
• Be free of exculpatory language

Please refer to the checklist below as a guide while you are preparing your informed consent document. To assist the investigators in preparing the informed consent document, the ILAU RB has generated an Informed Consent Template that address the elements noted below.

Basic elements are required (Per regulations) for all informed Consent forms

• A statement that the study involves research
• An explanation of the purposes of the research
• The expected duration of the subject’s participation
• A description of the procedures to be followed
• Identification of any procedures which are experimental
• A description of any reasonably foreseeable risks or discomforts to the subject
• A description of any benefits to the subject or to others which may reasonably be expected from the research. If none, state so
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
• A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
• For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained
• A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled
• An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject
  • ( ) Research Qs
  • ( ) Rights Qs
  • ( ) Injury Qs

Additional elements as appropriate

• A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant),
• Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent
• Any additional costs to the subject that may result from participation in the research
• The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject
• A statement that significant new findings developed during the course of the research, which may relate to the subject’s willingness to continue participation, will be provided to the subject
• The approximate number of subjects involved in the study