APPENDIX B

INFORMED CONSENT

  1. Attributes of the Consent Process
    To meet the federal requirements for informed consent, the consent process must have all of the following attributes:
    • An investigator (or approved designee) will obtain the informed consent of the potential subject or the subject's legally authorized representative, unless the requirement for consent has been waived or altered by the IRB.
    • The circumstances of the consent process will provide the subject or legally authorized representative sufficient opportunity to consider whether to participate.
    • The circumstances of the consent process will minimize the possibility of coercion or undue influence.
    • The information provided during the consent process will be presented in language understandable to the subject or the subject’s legally authorized representative.
    • The information being communicated during the consent process is free of exculpatory language through which the subject or legally authorized representative is made to waive or appear to waive any of the subject’s legal rights or to release (or appear to release) the investigator, sponsor, or the university (or its agents) from liability for negligence.
       
  2. Elements of Informed Consent
    1. Required Elements
      The information provided during the consent process must be consistent with the federal requirements. Unless informed consent is waived or altered by the IRB (see “Waiver or Alteration of Informed Consent” below), the consent process must include the following basic elements:
      • A statement that the study involves research, explanation of the purposes of the research, expected duration of participation, description of the procedures to be followed, and identification of any procedures that 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 that may reasonably be expected from the research
      • 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
      • Explanation of whom to contact for answers to pertinent questions about the research and the subject’s 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 that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
      • For research involving greater than minimal risk, an explanation about whether:
        • Medical treatments are available if injury occurs and, if so, what they consist of or where further information can be obtained
        • Compensation is available if injury occurs and, if so, an explanation as to what it consists of or where further information can be obtained.
           
    2. Additional Elements
      One or more of the following elements will also be provided to potential participants during the consent process, when 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) that are currently unforeseeable
      • Anticipated circumstances under which 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
      • 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 that may relate to the subject’s willingness to continue participation will be provided
      • Approximate number of subjects involved in the study.

        Additional information beyond the basic and additional elements of consent (above) may also be required when the IRB determines that this information would meaningfully add to the protection of research participants.
         
  3. Consent Language
    1. Exculpatory Language
      The informed consent process may not contain any exculpatory language through which the subject is made to waive or appear to waive any of the subject’s legal rights or release (or appear to release) the investigator, sponsor, or the university (or its agents) from liability for negligence.
       
    2. Complex Language
      The information provided during the consent discussion must be presented in language understandable to the subject or the subject’s legally authorized representative. The consent discussion should not include complex, technical, or highly specialized language or medical jargon that would not be understandable to potential participants.
       
  4. Waiver or Alteration of Informed Consent
    In the limited circumstances described below, the IRB can approve a consent process that does not include, or alters, some or all of the elements of informed consent.
    1. Research on Public Benefit or Service Programs
      The IRB can waive or alter the requirements for informed consent for non-exempt research examining state or local public benefit or service programs or certain features of those programs if all of the following criteria are met:
      • The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine public benefit or service programs, procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs
      • The research could not practicably be carried out without the waiver or alteration
      • The research is not FDA-regulated.

        Note: Similar research conducted under federal authority or research conducted by (or subject to the approval of) a private entity would not qualify for this waiver.
         
    2. Minimal Risk Research
      The IRB can waive or alter the requirements for informed consent for non-exempt research that meets all of the following criteria:
      • The research involves no more than minimal risk to subjects
      • The waiver or alteration will not adversely affect the rights and welfare of subjects
      • The research could not practicably be carried out without the waiver or alteration
      • Whenever appropriate, subjects will be provided with additional pertinent information after participation
      • The research is not FDA-regulated.
         
    3. Research Designed to Study Conditions in Children
      The IRB can waive or alter the requirements for parental or guardian permission for certain non-exempt research involving children
       
    4. Planned Emergency Research
      The IRB can approve a waiver of the requirements for informed consent for non-exempt research in life-threatening situations in which it is not possible to obtain informed consent from subjects or their legally authorized representatives.