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Informed Consent



  Standard Operating
  Procedures:

     IUB SOP
         The IUPUI SOPs were
         adopted by Indiana
         University Bloomington
         (IUB) on 08/18/08.
         The IUB Office of Research
         Administration is in the
         process of reviewing and
         revising these procedures,
         as necessary and will post
         them once they are
         approved.
         

  Informed Consent
  Categories:

    Minors

    Students

    Mentally Disabled

    Secondary Data Sources

    Deception

    Web-based Studies

    Info. Mining from the
       Internet (Facebook,
       MySpace, etc...)


In addition to concerning itself with risk, the IRB must consider the subject's consent to participate in the research project. An underlying ethical principle of the Federal regulations is that human subjects enter into research voluntarily and with adequate information. (See The Belmont Report, 1979)  Thus, consent must be informed and voluntarily given. A subject's consent is "informed" if he/she has a reasonable comprehension of that to which he/she is consenting. The investigator must use language appropriate to the subject's ability to comprehend. Generally, the consent form should be written at the 8th grade reading level. Nondisclosure of information to subjects must not be used simply to assure their participation in the research. It is desirable, but not mandatory, that the investigator, rather than an assistant, obtain the consent.

To ensure that subjects' consent is voluntary, the IRB considers whether any undue pressures will be brought to bear on potential subjects. Such pressure may be subtle as, for example, when a teacher asks his or her own students to become subjects of his or her research.  Excessive compensation or no payment for withdrawals is viewed by the IRB as pressure. See the compensation policy Payment to Research Subjects.

In order to obtain informed consent the investigator must provide a statement that includes the information listed on the Informed Consent Statement Checklist. A sample informed consent statement is included in the application forms to assist investigators in the preparation of the consent form. The sample reflects both requirements of the Federal regulations and customary language adopted by the IUB Human Subjects Office. Use of the sample will facilitate the review process. Each subject must be given a copy of the signed consent form.

The consent statement (or information sheet) that is approved by the IRB will be stamped with two dates, the approval date and the expiration date.  When the form has expired it must be submitted for reapproval by the IRB.  Exempt level documents will be stamped for the time period of the study.  Expedited and full committee documents will be stamped for the time period of the approval (no longer than one year).  The stamped version must be used to make the copies for the subjects. 

Who is to give consent? Any legally competent adult can give consent; but said adult cannot give valid consent if he/she is under the influence of alcohol or drugs, or if the consent is obtained under duress. This latter point is important in academic circumstances since students are often asked to volunteer as subjects. If possible, investigators should not use their current students. If current students must be used, it must be made clear to the subjects that the decision to participate will have no effect upon their grades. 

Investigators should be aware that the IRB will not approve a study involving a researcher's current students even if no adequate alternative design is available, unless the IRB is satisfied that voluntary consent can be obtained.  Also see Students as Subjects for Guidelines with respect to the inclusion of the investigator's own students in research.

The consent process for studies conducted in foreign countries, or with illiterate populations, may be altered so that consent may be given orally and documented on tape. Such tapes must be treated in the same manner as paper consent forms. 

 

Waiver of Consent

Any other alteration (waiver) to the consent process will normally be reviewed by the full committee. Justification for such a waiver must be documented according to the regulations below. If these criteria cannot be met, a waiver will not be approved.

Under CFR 46.116(d) "an IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

1)  The research involves no more than minimal risk to the subjects;
2)  The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3)  The research could not practicably be carried out without the waiver or alteration; and
4)  Whenever appropriate, the subjects will be provided with additional pertinent information after participation."

Further, under CFR 46.408(c), "in addition to the provisions for waiver contained in 46.116 of Subpart A, if the IRB determines that the study is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition."