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  Minot State / IRB / Basic Elements of Informed Consent
Institutional Review Board

Basic Elements of 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.
    For questions about research involving human subjects, the potential participant or legal
    representative should contact the IRB Chairperson, irbchair@minotstateu.edu; you may
    also provide the specific contact information for the current IRB chair including his/her
    MSU phone number (available on the IRB website).
  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.
  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.
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