Research & Economic Development

Office of the Vice Chancellor

General Requirement for Informed Consent 

  1. No researcher may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative.
  2. The prospective subject 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 subject or the representative shall be in language understandable to the subject or the representative.
  4. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject'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 subject:

  1. 45 CFR 46.116(b)

    Basic elements of informed consentExcept as provided in paragraph (d), (e), or (f) of this section, in seeking informed consent the following information shall be provided to each subject or the legally authorized representative:

    1. 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 that are experimental;
    2. A description of any reasonably foreseeable risks or discomforts to the subject;
    3. A description of any benefits to the subject or to others that may reasonably be expected from the research;
    4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
    5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
    6. 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;
    7. 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;
    8. 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; and
    9. One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
      1. A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
      2. A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

     

    45 CFR 46.116(c)

    Additional elements of informed consentExcept as provided in paragraph (d), (e), or (f) of this section, one or more of the following elements of information, when appropriate, shall also be provided to each subject or the legally authorized representative:

    1. 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;
    2. Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject's or the legally authorized representative’s consent;
    3. Any additional costs to the subject that may result from participation in the research;
    4. The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;
    5. 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 to the subject;
    6. The approximate number of subjects involved in the study;
    7. A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
    8. A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
    9. For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).