Institutional Review Board (IRB) for Research Involving Human Participants

Welcome

The Institutional Review Board (IRB) is responsible for reviewing all research involving human participants prior to initiation of that research. Research designates an activity in which hypotheses are tested with the intention of contributing to generalizable knowledge.  Data collected for public presentation or publication are assumed to be contributing to generalizable knowledge.  In addition, any project involving human participants as research subjects must be reviewed and approved by the IRB prior to receiving funding from Saint Mary's College.

In compliance with federal guidelines (Title 45 CFR Part 46), the IRB is composed of at least five members with varying backgrounds in order that the IRB be sufficiently qualified through the experience, expertise, and diversity of its members to promote adequate review of research activities conducted at an institution.  The purpose of the IRB is 1) to insure the protection of human participants used in the projects, 2) to provide guidance in the design of experiments to insure that the information being sought will be obtained in an ethical manner, and 3) to provide a process that assures society that the experimental protocols have been reviewed and approved ethically by knowledgeable individuals who are not directly involved in the research.


Applying for IRB Review

IRB applications should be submitted in paper form by campus mail to Colleen Fitzpatrick, IRB Chair, 107 Moreau Center for the Arts.

 

Sample Review Form

Here is a copy of the form IRB committee members will use to review your proposal. As a way to insure that you are providing all of the required information concerning your project, you can use this checklist to do a preliminary review of your own. Any item on the checklist that isn't covered in the proposal will delay the approval process.

 

There are seven criteria that an IRB must consider before approving any project which utilizes human volunteers:

  1. Are the risks reasonable in relation to the benefits?
    Consideration of this criterion ensures that the generally accepted canons of good scientific research are fulfilled and that there is evidence of scientific propriety.  The IRB should consider the entire protocol from the participant's point of view and decide if the information gained is worthwhile.

  2. Are the risks minimized?
    The IRB must determine whether every possible precaution been taken to minimize pain, discomfort, or harm.  Are there adequate safeguards to the participant against anticipated risks?

  3. Is the selection of participants equitable?
    The IRB must insure that care has been taken to avoid discrimination or the overselection of vulnerable participants.  Who are the participants and do they come from a specific population?  Selection of particularly vulnerable participants requires specific consideration of  the protection of those participants.

  4. Has informed consent been obtained?
    Informed consent means that the participant has full disclosure of the procedures involved as well as the risks and benefits of these procedures. Does the participant understand what will be done, why it is being done, what risks are involved, the kind and possibility of discomfort, and the anticipated duration of the procedures?  All of the circumstances of being a participant must be understood by a competent individual, either the participant or the legally authorized representative of the participant. Incomplete disclosure is justified only when 1) complete disclosure would invalidate the research, 2) risks to subjects are no more than minimal, and 3) debriefing is eventually carried out. The decision to participate must be the individual's own decision on the basis of his or her values and should be free of coercion.  The IRB attempts to insure that the rights of the participant as a person are respected.

  5. Has informed consent been adequately documented?
    One of the major goals of the IRB is to insure that participants are provided with a form explaining the purpose of the research and supplying a description of procedures sufficient to obtain informed consent.  Individuals should  be informed that they have the right to refuse to  participate and that they also have the right to withdraw from the procedures at any time without being penalized.  (See specific requirements for informed consent.)

  6. Are the privacy and confidentiality of the participant protected?
    Any information obtained from the participant must be kept confidential and those individuals who have access to the information must be specified.  The privacy of the individuals and their capacity to control their way of life must be respected.

  7. Are the data monitored and the risk-assessment reevaluated during the course of the study?
    The IRB expects each investigator to be aware of the preceding seven criteria not only while designing research projects, but also while data collection is progressing.  The results should be assessed for effectiveness -- is the information sought being obtained?  The risks involved in obtaining the information should be reevaluated.  Is the information worth the risk to the participant?  The IRB requests notification at the conclusion of data collection, and also in the event of any unexpected negative consequences (e.g., unforeseen discomforts or harmful repercussions of the research)

Please contact Colleen Fitzpatrick, IRB Chair, at cfitzpat@saintmarys.edu with any IRB-related questions.

 


AttachmentSize
IRB Checklist44.5 KB
IRB Basic form49 KB
IRB Expedited form55 KB