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Informed Consent

As indicated in federal regulations for protection of human subjects (45 CFR part 46), investigators must obtain informed consent of the human subject or the subject’s legally authorized representation.

For protocols at expedited or full board review levels, documented informed consent will consist of a written consent form approved and stamp dated by the IRB and then signed and dated by the subject or the subject’s legally authorized representative. A copy shall be given to the person signing the form. The signed consent forms shall be kept in the investigator’s secured and protected files. (Participant signed consent forms should be maintained by the investigator for 3 years.)

Informed consent is more than just getting participants to sign a form. It is a process that involves giving participants enough information so that they understand the research and its risks. The goal of the informed consent process is to provide sufficient information so that participants can make informed decisions about whether or not to originally participate in a study or to continue participation.

The process starts when investigators enroll participants in a study and is ongoing throughout the research project. Obtaining consent involves informing participants about their rights, the purpose of the project, the procedures that will occur during the study, and the potential risks and benefits of participation. 

The informed consent document must be written in language easily understood by the participants (no higher than an 8th grade reading level). Additionally, participants must be given sufficient time to consider whether or not they will agree to participate. Within the process of informed consent, investigators must minimize the possibility of coercion or undue influence.

 

  • What factors should be included when getting informed consent?
  • What if my participants do not speak English?
  • Are there situations when I do not need to get consent?
  • What is "implied" consent?
  • What is the difference between a consent form and an assent form?   

 


Elements of Informed Consent – See https://www.hhs.gov/ohrp/regulations-and-policy/guidance/checklists/index.html

  • 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
  • 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
  • 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.
  • Research, Rights or Injury: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
  • 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

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), which are currently unforeseeable
  • 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