Institutional Review Board
Basic Elements of Informed Consent
The following information shall be provided to each subject or the legally authorized
representative
- 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. - A description of any reasonably foreseeable risks or discomforts to the subject.
- A description of any benefits to the subject or to others that may reasonably be expected
from the research. - A disclosure of appropriate alternative procedures or courses of treatment, if any, that
might be advantageous to the subject. - A statement describing the extent, if any, to which confidentiality of records identifying
the subject will be maintained. - 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. - 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). - 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. - One of the following statements about any research that involves the collection of
identifiable private information or identifiable biospecimens:
- 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 - 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.
- A statement that identifiers might be removed from the identifiable private