GUIDELINES FOR IRB REVIEW (Abbreviated Form)

Any and all information gathered from living humans for scholarly study is subject to review by the Institutional Review Board (IRB) if conducted at, supported by, or otherwise associated with Iowa Wesleyan University. This policy is aimed at finding out (1) whether there is anything about the research using living humans that is likely to harm the participants either grossly or subtly, (2) if so, whether risk of such harm is at the absolute minimum level for the research area, (3) whether anticipated benefits are sufficient to justify exposing the participants to any risk that may be involved. Also many funding sources and publication vehicles require objective review of any research involving living humans as participants.

GENERAL POLICIES

  1. Research that exposes human participants to the risk of unreasonable harm shall not be conducted.
  2. The IRB shall be authorized to review and to approve or disapprove, or state conditions for, the conduct of any research involving a human participant or participants, in accordance with the policies stated herein and sound research design and equitable selection of participants.
  3. Committee members shall not participate in the approval of research projects in which they have a conflicting interest.
  4. Informed Consent. The principal investigator shall document that he or she has explained to participants, prior to their participation, the objectives of the research, the expected duration of the participant’s involvement, the procedures to be followed, the potential risks and benefits, any compensation, and who to contact with questions or concerns.
  5. Investigators shall respect the privacy of participants, advising participants in advance of any limits to confidentiality.
  6. Participants shall not be induced to participate by means that might affect their ability to decide freely whether to participate.
  7. It shall be made clear to participants that participation is voluntary and they are free to quit the research at any time without penalty.
  8. If research is to be conducted with participants likely to be vulnerable to coercion or undue influence (such as children, prisoners, pregnant women, mentally ill persons, intellectually disabled persons, or economically or educationally disadvantaged persons), additional safeguards may be required by the IRB to protect the rights and welfare of these participants.
  9. Teachers who assign or supervise research conducted by students are responsible for ensuring that the student is qualified to safeguard adequately the well-being of the participants.

Membership.  The IRB shall consist of seven members appointed from the faculty, staff, student body, and community.  See full guidelines for requirements of committee membership.

IRB REVIEW PROCEDURES

There are four tracks for review:

  1. Full prior review. This kind of review would be done for, but not limited to, the following: grant research; at the request of the investigator; when necessary for potential publication;where there is potential for risk or harm; when participants are unable to give free and informed consent; where the use of deception is necessary to conduct the research; and when the research was submitted for expedited review, but in the process a full review was deemed necessary.PROCEDURE: The investigator(s) shall submit to the IRB the completed forms (plus any additional materials reasonably requested by the IRB) 10 days prior to a regularly scheduled IRB meeting where the full review will take place. The outcome of the IRB review shall be reported in writing to the principal investigator and the VPAA.
  1. Expedited prior review. This procedure would be used when there is no or very minimal risk to the participants.  An expedited review must be done for faculty and student (such as for senior paper, independent research, a course project, and the like) research involving living human participants. Such a review may be done if a faculty member requests one for any classroom research project or demonstration using human participants.If a researcher makes changes to the project that significantly alter the circumstances under which it was approved, the IRB must be informed and the research re-approved before continuing the research.  If these changes to a previously approved research study are minor, an expedited review can be used during the period (up to one year) for which approval is authorized.  An expedited review may also be used to review a re-authorization of a previously approved research project after the one year approval has expired.The IRB makes the final determination of whether a project meets criteria for expedited review.
  1. Requested review. This would happen prior to or during any type of research involving human participants if requested by any Iowa Wesleyan University faculty member, IW student, IW staff, or research participant.
  1. Preliminary review. This kind of review would be done at times when a full review is called for but is not possible (such as during the summer).

IMPORTANT NOTE: Basic classroom experiments and demonstrations (e.g., taking a blood pressure reading) that clearly involve virtually no risk to participants are not subject to review.

IRB review approval shall be good for one year, unless otherwise indicated by the IRB.  Any research projects continuing beyond one year must re-submit an updated proposal to the IRB for approval.  Any proposed changes relevant to participants in a research activity approved by the IRB requires further review by the IRB before such changes can be initiated, except when necessary to eliminate apparent immediate hazards to the participant.

Investigators must immediately suspend the research and report to the IRB and the VPAA with all due haste any adverse change in health or behavior of any human participant that may be attributed to the research. The research must not resume without approval by IRB.

Note: This is an abbreviated form of the IRB Guidelines.  Refer to the full Guidelines for IRB Review for further information.

 

 

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