Informed Consent

I. Required Procedures for Obtaining Consent from Human Subjects Used in Research

  A. Federal regulations impose specific conditions under which informed consent must be obtained from research subjects. These conditions may not be waived unless the requirement for obtaining informed consent is waived. They are:

    1. The prospective subject or the subject's representative must be provided sufficient opportunity to consider whether or not to participate.

    2. The consent must be obtained under circumstances that minimize the possibility of coercion or undue influence.

    3. The information that is given to the subject or representative shall be in language understandable to the subject or the representative.

    4. The informed consent presentation, whether oral or written, may not 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 the liability for negligence.

  B. Investigators should include in the Application for Approval of Activity Involving the Use of Human Subjects (UCSB/ORDA Form 112f, Attachment A) a description of the procedures to be used in obtaining informed consent sufficient to assure the HSC that the above conditions will be met.

II. Waiver of the Requirement for Obtaining Informed Consent

  A. No investigator may involve a human being as a subject in research covered by these regulations without first obtaining the legally effective informed consent of the subject or the subject's legally authorized representative unless the HSC specifically waives the requirement to obtain informed consent.

The HSC may approve a waiver of the consent requirement only if the investigator documents and the HSC concur that the research could not practicably be carried out without the waiver, and

    1. the research is to be conducted for the purpose of demonstrating or evaluating: (a) Federal, state or local benefit or service programs which are not themselves research programs, (b) procedures for obtaining benefits or services under these programs, or

    2. (a) the research involved no more than minimal risk to the subjects, (b) the waiver will not adversely affect the rights and welfare of the subjects, and (c) whenever appropriate, the subjects will be given additional pertinent information after participation.

  B. Investigators wishing to obtain a waiver of or for the informed consent requirement should submit to the HSC with the Application for Approval of Activity Involving the Use of Human Subjects (UCSB/ORDA Form 112f, Attachment A) evidence that the research could not be practicably be carried out without the waiver, and that either A.1. or A.2. above applies to the research.

III. Basic Elements of Informed Consent

  A. In seeking informed consent from subjects or their representatives, an investigator must provide them with the following elements of information:

    1. A statement that the study involves research and an explanation of the purposes of the research;

    2. The expected duration of the subject's participation;

    3. A description of the procedures to be followed, and identification of any procedures which are experimental;

    4. A description of any reasonably foreseeable risks or discomforts to the subjects;

    5. A description of any benefits to the subject 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 subject;

    7. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

    8. For research involving more than minimal risk, an explanation as to whether any compensation and whether any medical treatments are available if injury occurs, and if so, what they consist of, or where further information may be obtained;

    9. An explanation of whom to contact for information about the research;

    10. An explanation of whom to contact for information about research subjects' rights;

    11. An explanation of whom to contact in the event of a research related injury.

    12. A statement that participation is voluntary, that 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.

  B. Whenever appropriate, one or more of the following elements of information must also be provided to the subjects:

    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 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 research which 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.

IV. Waiver of Requirement for Basic Elements

  A. The HSC may approve a consent procedure that waives inclusion of or alters some or all of the required elements of information only under the same conditions that apply to waiver of the requirement to obtain informed consent, i.e., if the investigator documents and the HSC concurs that the research could not be practicably carried out without the waiver or alteration, and

    1. the research is to be conducted for the purpose of demonstrating or evaluating (a) Federal, state, or local benefit or service programs which are not themselves research programs, (b) procedures for obtaining benefits or services under these programs, or (c) possible changes or alternatives to these programs; or

  2. (a) the research involved no more than minimal risk to the subjects, (b) the waiver will not adversely affect the rights and welfare of the subjects, and (c) whenever appropriate, the subjects will be given additional pertinent information after participation.

  B. Investigators wishing to obtain a waiver if the informed consent requirement should submit to the HSC with the Application for Approval of Activity Involving the Use of Human Subjects (UCSB/ORDA Form 112f, Attachment A) evidence that the research could not be practicably be carried out without the waiver, and that either A.1a. or A.1b. above applies to the research.

V. Documentation of Informed Consent

  A. Unless the documentation requirement is specifically waived by the HSC, informed consent must be documented by the use of a written consent form approved by the HSC and signed by the subject or the subject's legally authorized representative.

  B. The methods which may be used to document informed consent are:

    1. The "long form"

      a. This form includes all the required elements of informed consent.

      b. It may be read to the subjects or their representatives, but in any event, the investigator must give the subjects or their representatives adequate opportunity to read it before it is signed.

    2. The "short form"

      a. This form states that the required elements of informed consent have been presented orally.

      b. When this method is used, a written summary of what is to be said to the subjects or their representatives must be approved by the HSC.

      c. A witness must be present when the oral presentation is made.

      d. The witness must sign a copy of both the summary and the short form.

      e. The person actually obtaining consent must sign a copy of the summary.

    C. Whichever method is used, a copy of the consent form must be given to the subject or the subject's representative, and if the "short form" is used, a copy of the summary must also be given to the subject or representative.

VI. Waiver of Documentation

  A. The HSC may waive the requirement to obtain a signed consent form for some or all of the subjects if the investigator presents evidence and the HSC agrees either

    1. that (a) the only record linking the subject and the research would be the consent document, (b) the principal risk would be potential harm resulting from breach of confidentiality, and (c) each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern.

or

    2. that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

    B. In cases where the documentation is waived, the HSC may require the investigator to provide the subjects with a written statement regarding the research.

    C. Investigators seeking waiver of documentation requirements should include in the Application for Approval of Activity Involving Human Subjects (UCSB/ORDA Form 112f, Attachment A) the basis for such a request.

VII. Consent Forms

For additional important information on this subject, see headings I-IV.

  A. Long-Form Signed Consent. Either of the following methods may be used:

    1. Investigator-designed form.

      a. The form must include all applicable elements of information (see heading III) and is to be signed and dated by the subject or the subject's legal representative

      b. If the research falls within the definition of "medical experiment" contained in Section 24174 of the California Health and Safety Code, the "Human Subjects' Bill of Rights" (UCSB Form 112e)

    2. If the Investigator-designed form is used with Subject Information Sheet (112d) or the Bill of Rights (112e)

      a. Basic Elements 1, 7, 8, 9, 10, 11, and 12 are omitted from the investigator-designed form;

      b. A statement is added to the form to inform the subject that UCSB/ORDA Form 112d (or 112e as appropriate) is attached to and is a part of the consent form.

  B. Short-Form Signed Consent.

    1. This consent procedure consists of an oral presentation, which includes all applicable elements of information (heading III), and a short form to be signed and dated by the subject or the subject's representative. The short form states that the required elements of information have been presented orally to the subject or the subject's legal representative.

    2. A copy of the summary and of the short form must be attached to each copy of the application to the Human Subjects Committee for approval of the use of the subjects.

    3. A copy of UCSB/ORDA Form 112d or Form 112e, as appropriate, should be made available to the person signing the form.

  C. Regardless of which of the above methods is used,

    1. The presentation of consent information (whether written or oral) must be addressed to the person who will be giving consent (e.g., you are requested. . . , your child will be. . . , your signature indicates. . . .). The short form may be written in the first person.

    2. The investigator should consult information under headings I. and V. for further information about procedures.

VIII. Oral Consent

When documentation is waived by the Human Subjects Committee, the following procedure is used:

  A. Oral and/or written presentation of all applicable elements of information is given to the subject or the subject's legal representative.

  B. UCSB/ORDA Form 112d or 112e, as appropriate, is given to the subject or representative.

  C. The oral consent of the subject or representative is requested.