General Requirements for Informed Consent

  1. No researcher may involve a human being as a participant in research covered by this policy unless the principal investigator has obtained the legally effective informed consent of the participant or the participant's legally authorized representative.
  2. The prospective participant or the representative must be given sufficient opportunity to consider whether or not to participate under conditions which minimize the possibility of coercion or undue influence.
  3. The information that is given to the participant or the representative shall be in language understandable to the participant or the representative.
  4. No informed consent, whether oral or written, may include any exculpatory language through which the participant or the representative is made to waive or appear to waive any of the participant's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

The regulations require that the following information must be conveyed to each participant:

  1. a statement that the study involves research and an explanation of the purposes of the research;
  2. the expected duration of the participant's involvement;
  3. a description of the procedures to be followed and identification of any procedures that are experimental;
  4. a description of any reasonably foreseeable risks or discomforts to the participant;
  5. a description of any benefits to the participant or to others which may reasonably be expected from the research;
  6. a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;
  7. a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained;
  8. instructions on whom to contact in the event of a research-related injury to the participant;
  9. an explanation as to whether any compensation and medical treatments are available if an injury occurs; specifically, what the compensations are and if/when further information may be obtained;
  10. instructions on whom to contact for answers to pertinent research questions and research participants' rights; and
  11. statements that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.

When determined to be appropriate by the Institutional Review Board (IRB), participants must be provided with one or more of the following additional elements of information during the informed consent process:

  1. a statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) which are currently unforeseeable;
  2. anticipated circumstances under which the participant's involvement may be terminated by the investigator without regard to the participant's consent;
  3. any additional costs to the participant that may result from participation in the research;
  4. the consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation;
  5. a statement that significant new findings developed during the course of the research which may affect the participant's willingness to continue participation will be provided to the participant; 
  6. the approximate number of participants involved in the study; and
  7. when seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following statement will be provided to each clinical trial participant in informed consent documents and processes, "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time." (This requirement is specific to FDA and found at 21 CFR 50.25(c) and will notify the clinical trial participant that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act.)