INSTITUTIONAL REVIEW BOARD
BELLARMINE UNIVERSITY
Protecting human subjects involved in research
Any faculty member or student conducting research involving human subjects is obliged to ensure his or her research plan takes each person’s safety into account. A research subject is also entitled to informed consent when participating in a study. Moreover, each subject is entitled to privacy protection and confidentiality with respect to the research data collected. For these reasons, human studies must undergo an institutional review process. At Bellarmine University, the Human Subjects Protection Committee (HSPC) serves as the administrative Institutional Review Board (IRB) committee that provides such review. This committee is composed of full-time faculty members appointed by the Provost as required under Title 45 Part 46 of the Code of Federal Regulations. HSPC review applies to any research conducted by University faculty or students, involving human subjects or analysis of data gathered from human subjects, regardless of funding status, prior to its implementation.
Members of the Committee
Dr. Jerome Walker, IRB Chair
Cardiopulmonary Science Program,
Bellarmine University
452-8415 (O) or jwalker@bellarmine.eduDr. Pamela Cartor
Psychology Department,
Bellarmine University
452-8195 (O) or pcartor@bellarmine.edu
Dr. Akhtar Mahmood
Department of Chemistry and Physics
Bellarmine University
47303599 (O) or amahmood@bellarmine.edu
Dr. Thomas Maloney
Department of Philosophy
University of Louisville
tsmalo01@gwise.loisville.eduDr. Sherill Cronin
Department of Nursing
Bellarmine University
sherillc@bellarmine.edu
Dr. Joseph Sinski
Department of Chemistry and Physics
Bellarmine University
452-8219 (O) or jsinski@bellarmine.eduDr. David Porta
Department of Biology
Bellarmine University
452-8009 (O) or dporta@bellarmine.eduDr. Frank Walker (Alternate for Medical Studies)
Louisville Metabolic and Atherosclerosis Research Center
Research Physician
frank.walker@insightbb.com
What should be reviewed by the HSPC?
The following list of definitions and guidelines pertains to the review process.
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Research is defined as a systematic investigation, including testing and evaluation, designed to develop or contribute to generalizable knowledge through public dissemination.
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Human Subjects are living individuals about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
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Identifiable private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).
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Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and psychological manipulations of the subject, or the subject’s purposes.
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Interaction - includes communication or interpersonal contact between investigator and subject.
When an investigator is uncertain if his or her study involving human subjects constitutes research in the sense of requiring HSPC review, a committee member may be contacted to discuss the matter.
What documentation is needed?
The review process involves the researcher submitting a “packet” to the IRB that includes: (1) cover documentation, (2) an investigator training certificate, (3) an abstract describing the proposed study’s purpose and methods (no more than 3 typewritten pages), and (4) a copy of a statement of informed consent. The necessary documents for the review process can be obtained at the links below.
Cover documentation is found in the following two links.
Investigator training certification involves completing an orientation to human studies and the informed consent process. This is required of the PI and, if applicable, each co-investigator. Online training is available at the links below. Complete the tutorial (which takes 45 minutes to 2 hours); take the post-test; and print the outcome for inclusion with the IRB packet. Ongoing studies require yearly investigator training certification renewal.
This one works:
http://phrp.nihtraining.com/users/login.php
The two below are having some server issues that we are in contact with the sites for:
http://www.research.umn.edu/consent/ or
http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp
Informed consent documentation for studies involving collecting information from subjects through the use of interviews or surveys is found here.
Application for Question/Interview/Survey Study
Following are consent guides for studies not involving interviews or surveys but other forms of data collection.
You might want to look at the Informed Consent Guide to help you with this form.
Subject Assent to a Medical Study (If Applicable)
Risk Benefit Analysis (If Applicable)
Conflict of Interest Form (If Applicable)
When the IRB packet is completed, submit one hard copy of the full proposal to Dr. Jerry Walker HSPC Chair and a second hard copy to Dr. Joseph Sinski by campus mail. Also, if we determine your proposal will go to full review, or if we need an outside expert to look at your proposal please be prepared to send us an electronic copy but only upon request.
HSPC Review Categories
Each human study research project submitted to the HSPC is placed into one of the following 3 categories of review. It should also be noted that a study’s review category is assigned by the HSPC and not the investigator(s).
Exempt Review-There is a body of social science and educational research that falls into the exempt category. This refers to studies where the only involvement of human subjects is either in a normal educational setting, or the research involves educational tests and methods, or uses surveys, interview procedures, or observations. It is important to note that a research study under the exempt category is reviewed by the HSPC. The meaning of exempt refers only to a study not requiring an annual report by the investigator.
Expedited Review-Such studies entail nonexempt research involving minimal risk to subjects or non-invasive research that is neither exempt from review nor requires full review (see below). Annual reports are required of ongoing studies expedited studies.
Full Review–This term pertains to research involving more than minimal risk to subjects, including invasive research, sensitive topics and information that could lead to criminal prosecution, research involving deception, vulnerable populations, and in those situations where federal funding is being sought. For example, full review studies would be research involving extreme deception, AIDS patients, the very young, the mentally incompetent, prisoners, the infirm, collecting body specimens, and sensitive information related to illegal drugs and child abuse. Annual reports are required of ongoing full review studies.
How long does it take to review a study?
The HSPC reviews human research studies are reviewed on an as-needed basis. The investigator submitting a completed research packet that is determined to require exempt or expedited review, may expect an IRB response within 10 working days of submission. The researcher may expect the HSPC to declare a study will require full review within 10 working days of submitting complete documentation. However, full review entails the entire HSPC membership meeting in group. The committee meets as often as once monthly from August to May. The investigator(s) may anticipate a response from the HSPC within 4 weeks from the time the committee meets. Every effort will be made to convene the full committee on a timely basis as the need arises for a research project’s full review.
Suspension or termination of HSPC approval
The HSPC has the authority to suspend or terminate approval of research that is not being conducted in accordance with the HSPC’s requirements, or that is not in accordance with the planned and approved protocol, or that has been associated with unexpected and serious risk to subjects. Any suspension or termination of approval shall include a statement of the rationale for the HSPC’s action and shall be reported promptly to the investigator, the appropriate university officials, and the appropriate department or program head.
Further information may be obtained from the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services. Visit http://www.hhs.gov/ohrp/
Other potentially useful during your study
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