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Informed Consent

The following information is provided to assist investigators in understanding informed consent requirements and processes. Informed consent documentation must be attached to each human subjects research submission through ORahs (Office of Research Application for the use of Human Subjects).

  1. Required Procedures for Obtaining Consent from Human Subjects Used in Research
    1. 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.
    2. Investigators must provide a description of the consent process to be used on the "Consent" tab in ORahs. This should include a description of the procedures to be used in obtaining informed consent sufficient to assure the HSC that the above conditions will be met.  If applicable (e.g. research with minors), descriptions of minor assent and parental permission processes must also be included on the ORahs "Consent" tab.
  2. Waiver of the Requirement for Obtaining Informed Consent
    1. 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 concurs 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.
    2. Investigators wishing to obtain a waiver of the informed consent requirement must complete the request for waiver of elements on the "Consent" tab in ORahs. This should include evidence that the research could not be practicably carried out without the waiver.
  3. Basic Elements of Informed Consent
    1. 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. 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.
    2. 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.
  4. Waiver of Requirement for Basic Elements
    1. 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.
      3. Investigators wishing to obtain a waiver of the informed consent requirement must complete the request for waiver of elements on the "Consent" tab in ORahs. This should include evidence that the research could not be practicably carried out without the waiver.
  5. Documentation of Informed Consent
    1. 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.  Remember that informed consent is a process and not just a document. Prospective subjects must be allowed the opportunity to discuss and review any questions they may have about participation in the research.
    2. The methods which may be used to document informed consent are:
      1. The "long form"
        1. This is the standard form used in human subjects research.
        2. This form includes all the required elements of informed consent.
        3. 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" This form may be used in specific circumstances as discussed below. The creation of a "short form" informed consent form is done in addition to the standard "long form" documentation. 45 CFR 46.117(b)(2):
        1. "Permits oral presentation of informed consent information in conjunction with a short form written consent document (stating that the elements of consent have been presented orally) and a written summary of what is presented orally. A witness to the oral presentation is required, and the subject must be given copies of the short form document and the summary.
        2. When this procedure is used with subjects who do not speak English, (i) the oral presentation and the short form written document [see OHRP sample at http://www.hhs.gov/ohrp/policy/ic-non-e.html#sample] should be in a language understandable to the subject; (ii) the IRB-approved English language informed consent document may serve as the summary; and (iii) the witness should be fluent in both English and the language of the subject.
        3. At the time of consent, (i) the short form document should be signed by the subject (or the subject's legally authorized representative); (ii) the summary (i.e., the English language informed consent document) should be signed by the person obtaining consent as authorized under the protocol; and (iii) the short form document and the summary should be signed by the witness. When the person obtaining consent is assisted by a translator, the translator may serve as the witness.
        4.  The IRB must receive all foreign language versions of the short form document as a condition of approval under the provisions of §46.117(b)(2). Expedited review of these versions is acceptable if the protocol, the full English language informed consent document, and the English version of the short form document have already been approved by the convened IRB."
      3. 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.
  6. Waiver of Documentation
    1. 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.
    2. In cases where the documentation is waived, the HSC may require the investigator to provide the subjects with a written statement regarding the research.
    3. Investigators seeking waiver of documentation requirements should include in
    4. Investigators wishing to obtain a waiver of documentation must complete the request for waiver  on the "Consent" tab in ORahs. This should include evidence that the research qualifies based on either A1 or A2.
  7. Consent Form Documentation and ORahs
    1. Non-exempt research:  All research related written informed consent/assent/parental permission documentation as well as oral scripts must be provided with the investigator's ORahs submission under the "Consent Forms" tab.  Various consent and debriefing templates are provided for investigator use. Oral scripts may be entered into ORahs by modifying the "Custom Consent" template.
    2. Exempt research: All research related written consent/assent/parental permission documentation as well as oral scripts associated must be attached to the investigator's ORahs submission under the "Attachments" tab.
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Updated: March 26, 2014.