INSTITUTIONAL REVIEW BOARD
Protecting research subjects
Any person volunteering to participate in a research study is entitled to informed consent, privacy, and confidentiality with respect to the research protocol and data collected. Human research oversight and compliance at Bellarmine University is administered by the Institutional Review Board (IRB). The IRB is composed of full-time faculty members appointed by and reporting to the Provost. Guidelines for IRB operations are outlined in Title 45 Part 46 of the Code of Federal Regulations and by the Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services http://www.hhs.gov/ohrp/
The United States Office for Human Research Protections has a page of training videos that can be useful to both members of an IRB and for persons submitting studies for review. The videos can be watched here.
Members of the IRB
(For General Questions Call the IRB Secretary below between Hours of 8:00 am -4:30 pm on Mondays and Tuesdays & Thursday 8:00 -11:30 am)
Camilla Hardin IRB Recording Secretary Pasteur 154 email@example.com 272-8032
What does the IRB review?
Prior to its implementation, all research involving human subjects conducted by Bellarmine University faculty or students requires IRB review. Moreover, the design and conduct of any human research study is the responsibility of an identified faculty Principal Investigator (PI). Key terms relating to IRB review are as follows.
Systematic investigation, including testing and evaluation, designed to develop or contribute to generalizable knowledge.
Living individual from whom an investigator obtains data through personal intervention or interaction, or from whom identifiable private information is gathered.
Experiments where there is exposure to some type of stimulus or environmental intervention involving physical procedures to gather data, for example, obtaining biological specimens or evaluating human performance, and studies where data are generated by questionnaires, interviews, surveys, or existing records.
Identifiable private information
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).
Full-time Bellarmine faculty member responsible for the design and conduct of research involving human subjects. If a PI is uncertain if his or her study constitutes research in the sense of requiring IRB review, a committee member may be contacted to discuss the matter.
Do student and classroom-related projects need IRB review?
Student or classroom-related projects may involve collecting data from human subjects using experimental or quasi-experimental interventions. Guidelines regarding IRB review of such projects are as follows.
1. Secondary data analysis: Student or class-related projects designed and conducted as educational exercises using data that are either publicly available or data that have been de-identified and impossible to link to personal identities. (No IRB submission required).
2. Secondary data analysis: Student or class-related projects designed and conducted as educational exercises using datasets that include private information and codes that link to identifiers, but the students do not have access to the identifiers. The class instructor and department are responsible for providing the necessary training in respecting the confidentiality of the data (No IRB submission required).
3. Primary data analysis: Student or class-related projects using methods such as interview, questionnaire, mail, email, web survey, telephone, etc. (IRB review may or may not be required).
a. When subjects in a class or student project are drawn only from students enrolled within the class or from the department where the project originates, IRB review is not required. In these cases, the instructor and department are responsible for providing the necessary training in respecting the privacy of the individuals and the confidentiality of any resulting information, along with training in the relevant professional ethics.
b. Class projects involving subjects (students or otherwise) from outside a given department require IRB review. The instructor will send a brief description of the planned protocol(s) to the IRB, preferably within the first month of the semester in which the project is to be conducted. Describe the topic and a brief theoretical basis for the proposed class project(s) and who the respondents will be. Student submissions are not accepted. The instructor(s) and the Department Chair will sign and date the project description.
Course instructor(s) of students from outside the department from where a class project originates must agree in writing ahead of time to allow their students to participate. For example, if the intent is to ask students enrolled in IDC 100 to participate as subjects in a research methods class, the IDC instructor(s) must agree before the class project can commence.
If a class or student project entails the use of campus residence halls or commons areas as venues to recruit subjects, the sponsoring instructor is responsible for having the student investigator(s) coordinate scheduling with the Dean of Students prior to data collection. The Deanís contact information is:
Dr. Helen Grace-Ryan, Dean of Students Bellarmine University
Horrigan Hall 225C / Contact: E-mail - firstname.lastname@example.org Telephone - 272-8426
Instructors and departments are encouraged to contact any IRB member, as needed, to discuss ways to handle topics such as privacy, confidentiality, and informed consent when class projects are part of the course syllabus. Strategies can be shared relating to managing risks of deductive disclosure, coercion-free recruiting, informed consent, and special considerations for projects that include potentially vulnerable individuals. These issues may remain even when IRB review is not required, in which case instructors, departments and schools play an even greater role in providing the appropriate guidance and oversight.
Importantly, non-IRB reviewed class projects cannot be published or presented at a conference or any forum outside of Bellarmine University. Retroactive IRB review is not permitted for any data resulting from this type of class project.
What documentation is needed to submit a study?
To submit a study to the IRB, the PI will send one hard copy of a completed packet to the IRB Recording Secretary at:
Camilla Hardin IRB Recording Secretary Pasteur 154 email@example.com 272-8032
Collate study packets in the following order.
(1) Cover documentation
Provide the information in the following two links.
(2) Investigator training certification
In order to become certified to perform human subjects research, you must complete one of the training tutorials below: These tutorials take 45 minutes to 2 hours; complete the post-test and print the outcome for inclusion with the IRB packet. Ongoing studies require yearly investigator training certification renewal.
(3) Study Protocol and related documentation
Submit a protocol and investigator CV, items a & b below, with all studies. Complete items c, d, & e below if they apply.
a. Study Protocol
Describe the studyís purpose and methods in no more than 3 typewritten pages. Append references and a full copy of any questionnaires, surveys, or other measurement instruments used in the study.
b. Vita of all investigators.
c. Risk Benefit Analysis
If in the Principal Investigatorís judgment a study involves greater than minimal risk, complete an Application for Risk Benefit Analysis Minimal Risk means the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during performance of routine physical or psychological examinations or tests.
d. Subject Recruitment
Submit a copy of any notice or advertisement that will be used in recruiting subjects into the study.
e. Conflict of Interest
If in the Principal Investigatorís judgment there is a real or perceived financial interest attached to the conduct or outcome of a sponsored study on the part of the PI or any Co-Investigator complete a Conflict of Interest Form
(4) Informed consent documentation
For studies where information is gathered from subjects using interviews or surveys, complete the Preamble to Consent Form
For studies with forms of data collection other than interviews or surveys, use the following consent guides, submit a Consent Form using the Consent Form Checklist You might want to look at the Informed Consent Guide to help you with this form.
IRB Review Categories
A member of the IRB will assign each incoming research study to 1 of 3 review categories.
There is a body of social science and educational research that may, for example, involve human subjects in a normal educational setting; educational tests and methods protocols; or certain survey, interview or observation protocols. When the IRB applies Exempt Review procedures to a study, the review period is 12 months and no annual report is required.
Studies that entail non-exempt research involving minimal risk to subjects or non-invasive research that is neither Exempt Review nor requires Full Review (see below). The PI will submit an annual Progress Report Form for each ongoing Expedited Review study.
Certain research involves more than minimal risk to subjects. Examples may include research involving extreme deception, the very young, the mentally incompetent, prisoners, the infirm, or protocols where body specimens are obtained, or sensitive information related to illegal drugs and child abuse. The entire IRB membership must meet for Full Review studies. The PI will submit an annual Progress Report Form for each ongoing Full Review study.
When a proposal is to undergo Full Review, or if an outside expert is needed to look at a proposal, the PI may be asked to submit an electronic copy of the packet to the IRB Recording Secretary, but only upon request.
How long does it take to review a study?
For most Exempt and Expedited Reviews, the PI may expect a response from the IRB within two weeks of submitting a complete packet. Review will not begin until the package is complete. If Full Review is required, monthly IRB meetings are scheduled as needed. Every effort will be made to convene the full committee on a timely basis in this event.
Suspension or termination of IRB approval
The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with its 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 IRB action and shall be reported promptly to the investigator, the appropriate university officials, and the appropriate department or program head.
Amending and terminating studies
An Amendment Request must be submitted to the IRB Recording Secretary firstname.lastname@example.org prior to implementing any revision to an IRB- reviewed protocol or informed consent. Protocol or consent amendments cannot be enacted until the PI is notified by the IRB.
A Termination Form is submitted to the Recording Secretary email@example.com when the data collection phase of a study is completed prior to the end of the review period. No additional submissions will be reviewed if there are outstanding termination forms due to the IRB.
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Last modified: Wednesday August 4th, 2010 by Sinski