Human Research Subjects

Checklist of General Requirements for Informed Consent

General Requirements for informed consent:

  1. An explanation of the purpose(s) of the research; the expected duration of the subject's participation, and a description of the procedures to be followed, including identification of any procedures which are experimental.
  2. A description of any reasonable foreseeable risks or discomforts to the subject.
  3. A description of any benefits to the subject(s) or others which may result from the research.
  4. A statement describing the extent, if any, to which confidentiality of records and/or anonymity of subjects will be maintained.
  5. If appropriate, an explanation as to whether any medical treatments will be available if injury occurs, and if so, what they consist of, or where further information may be obtained.
  6. If appropriate, a statement that Northern Illinois University policy does not provide for compensation for treatment of injuries that may occur as a result of participation in research activities.  Also include that the above shall not be construed as a waiver of any legal rights or redress which the participant may have.
  7. An explanation of whom to contact for answers to pertinent questions about the research (list researcher's name and phone number and, if student research, faculty advisor's name and phone number) and subject' rights (NIU Office of Research Compliance, 815-753-8588), and whom to contact in the event of a research-related injury to the subject.
  8. A statement that participation is voluntary, and refusal to participate or discontinuation of participation will involve no penalty or loss of benefits.
  9. If minors are involved, a specific section for the parent/guardian to indicate refusal to allow participation.
  10. If minors capable of giving assent are involved, a provision for obtaining assent from the minor.  Guidelines are also available from the ORC (click here) for information on obtaining assent).

Additional Elements to be used when appropriate

  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) which 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 costs to the subject(s) that may result from participation.
  4. The consequences of withdrawal from the research.
  5. A statement that any meaningful findings which result from 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 research.
  7. NIU policy requires that projects involving the use of videotaping or audiotaping must make specific mention of these in the consent documents.  The subject must have the choice of whether to participate in the video or audiotaping procedures.  This consent is separate and distinct from consent to participate in the project, therefore, separate signature and date lines are required.

Questions? Call the Office of Research Compliance at (815) 753-8588