Instructions for Researchers  Criteria for Approval  Informed Consent Education and Training in Subject Protections

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Institutional Review Board for the Protection of Human Subjects in Research (IRB)

        The Institutional Review Board (IRB), alternately referred to as The Committee for the Protection of Human Subjects, is a standing institutional review board established in compliance with federal policy for the protection of human subjects of research.

IRB Purpose

The basic principles that govern the IRB in assuring that the rights and welfare of subjects are protected are contained in Ethical Principles and Guidelines for the Protection of Human Subjects of Research (“The Belmont Report”).  The IRB adheres to the federal guidelines for protection of human subjects in research promulgated by the Department of Health and Human Services (DHHS), found at 45 CFR 46 and referred to as the “Common Rule.”  The purpose of the IRB is to ensure:

  • that no research activity sponsored or conducted by the University of Dayton unduly endangers the safety, comfort, or privacy of human subjects;

  • that procedures are followed to protect the rights and privacy of subjects during and after the research; and

  • that each subject has given informed consent to participation in the research.

 

        It should also be noted that the IRB serves another important function, which is to protect the researcher and the University from ethical and/or legal liability.

 

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Current members

        Dr. Mary Connolly (Interim Chair) Interdisciplinary Studies; Dr. Andy Foley, Student Health Center; Keri Brown Kirschman, Department of Psychology; Matt Willenbrink, Technology Partnerships; and  Charlie Russo, School of Education

        Please send all proposals (electronic and hard copy) to:

Andrea Hill

Student Assistant, IRB

Kettering Labs Room 542

Dayton, OH 45469-0104

(937) 229-2919

hillands@notes.udayton.edu

 

        All questions about policy, specific reviews, advisory opinions, and other technical matters should be directed to:

 

Dr. Mary Connolly,  Interim Chair

Science Center Room 240C

300 College Park Ave.

Dayton, OH  45469-2320

mary.connolly@notes.udayton.edu

Phone: (937) 229-3493

Fax: (937) 229-2291

 

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Guiding Principles

        The following principles apply to all research, including student projects, involving human subjects at the University of Dayton to ensure that adequate safeguards are provided:

  1. At all times subjects’ legal rights will be respected and their rights to privacy, dignity, and comfort will also be considered in approving proposed research.

  2. Risks to subject(s) must be reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.

  3.  Adequate provision(s) must be made for all facilities, procedures, and professional attention necessary for the protection of the individual as a research subject.

  4. Adequate provision(s) should be made for recruiting a subject population that is representative of the population base in terms of gender and minority representation unless scientifically justified.

  5. Research involving human subject(s) must be supervised by qualified persons, including qualified clinicians for all study-related healthcare decisions, and by at least one faculty member in the case of student-led research.

  6. Participation of a human subject in research must be voluntary and the right to withdraw at any time must be provided.  Information provided to gain subject consent must be adequate, appropriate and presented in lay language appropriate to the subject population.

  7. All research programs that involve human subjects must be reviewed by and must receive approval from the IRB prior to their initiation or prior to initiating any changes to the protocol. Continuing research programs are subject to annual review at minimum. Terms of review will be decided by the IRB Chair on a case by case basis.

The IRB cannot review research for which funding has already been approved, or that has already been performed.

      

       Page last updated 7/29/2008

Instructions for Researchers  Criteria for Approval  Informed Consent Education and Training in Subject Protections