What is the Canisius College IRB?
The Institutional Review Board (IRB) is a Canisius College committee tasked with the supervision of all research that involves human subjects. The IRB requires that all research involving human subjects conducted by faculty, students or staff affiliated with Canisius College be reviewed and approved by the IRB prior to data collection.
The main emphasis of the IRB is to determine whether the risk to the participants is minimized and is reasonable when weighed against the benefits of the project for its participants. In addition, the IRB evaluates whether the selection of participants is equitable and particularly vulnerable populations are safeguarded with respect to their rights and safety.
Ultimately, investigators must be familiar with and behave according to the spirit and letter of federal and professional guidelines pertaining to human research. (The requirements summarized in Title 45, Part 46, of the Code of Federal Regulations and in the Belmont Report are available from the IRB Chair upon request.)
Why does Canisius College have an IRB Review Process?
Federal regulations that stipulate “each institution or agency which conducts or which proposes to conduct or authorize human research shall establish a human research review committee…No human research shall be conducted or authorized by such institution or agency unless…such committee has reviewed and approved the proposed human research project…” Canisius College faculty, students, and staff are subject to these regulations.
What is the definition of research?
The Office of Human Subjects Research (OHRP) defines research as "… a systematic investigation including research development, testing and evaluation designed to develop or contribute to generalizable knowledge". (http://ohsr.od.nih.gov/guidelines/45cfr46.html#l46102). If the intent does not fall within the above classification, IRB review and approval is not required.
What is the definition of a Human Subject?
OHRP defies a human subject as "… any living individual 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." Even mundane research conducted with paper-and-pencil questionnaires qualifies as human experimentation.
Does the IRB ever actually reject a project, or is this just a “rubber-stamp”?
Although it is uncommon, the Canisius College IRB is both permitted and when necessary, expected to disapprove research protocols involving excess risk to the human subjects or one that contains serious methodological errors. In most cases, the IRB tries to work with the researcher to modify their protocol in a way that provides appropriate levels of protection for the participants.
In the past, the research projects I assigned to my students did not require IRB review. Is that still the case?
Students’ research projects may be approved as “exempt” from IRB review, but they are no longer excused from participating in the review process. The chair of the IRB, or his/her designee, can determine if the project is qualifies for exemption. In order to make this determination, the student must submit a Human Research Review Request Form along with a brief summary of the research.
Why isn’t student research automatically exempt?
Whether the researcher is a student, faculty or staff member, their research may be exempt if it falls into one of the proper exemption categories (http://ohsr.od.nih.gov/guidelines/45cfr46.html#l46110). These are usually research projects conducted solely within the confines of the classroom and overseen by a faculty member. When a student’s project cannot be exempted by the IRB chair, this is usually because it involves studies of a potentially sensitive nature or includes human subjects from a protected population, such as prisoners or parolees, minors, those who are socioeconomically, educationally or linguistically impaired, the elderly, pregnant women, among others. These types of projects cannot be automatically exempted simply because they are student projects. Since they are being done as an assignment by a Canisius College employee, the College is ultimately responsible for the proper conduct of the research.
Why has this procedure changed?
There has been a nationwide crackdown by federal agencies, who are increasingly scrutinizing the oversight provided by University IRB’s and deeming the process as too lenient. Over the past six years, federal regulators have restricted or shut down research at more than 20 institutions for violations.
What kind of criteria do the reviewers apply when looking at a research proposal?
IRB reviewers look for methodological and written assurances that your research plan provides adequate protection for the rights and welfare of the human subjects involved. In particular, your reviewers focus on the areas of purpose, methodology, risks/benefits, handling of informed consent.
How does IRB approval benefit me?
Having your research protocol approved by the IRB tells your research participants that you have taken the appropriate steps to assure their protection. In the event this is called into question, you will have the College’s protection because you have followed the appropriate institutional procedures. IRB approval also makes it possible for the results of your research to be published in professional journals, many of which have set standards for treatment of human research subjects in accordance with federal guidelines.
The review process also offers our students with an excellent educational opportunity. Students should not perceive the process to be an institutional obstacle in their education, but rather be brought to understand that it is part of the normal and expected process. The CC IRB will gladly facilitate for the instructor by offering lecturers, teaching materials, and other educational resources.
How much time does the approval process take?
The average review process takes between 2-3 weeks, although it will vary depending on when the proposal is submitted. High volume times such as the beginning and end of the semester may result in slightly longer review periods. In addition, the faculty review will take additional time if your protocol is submitted during a holiday break or the summer semesters. If the IRB requests modifications, there will be a subsequent reevaluation of the protocol, which can take additional time. In submitting your protocol, you should plan to allow for sufficient lead time before the actual research must begin.
In a course where all students are expected to conduct research projects, the instructor is encouraged to batch mail his/her students’ proposals. This will expedite the process and ensure that all students conform to the timelines set by the instructor.
What can I (or my student) do to get a protocol approved quickly?
- Tailor your protocol to address only those issues of concern to the IRB
- Do not include a full literature review
- Adhere to a 10- page limit
- Cover in detail all issues relating to participant confidentiality and informed consent.
- If the protocol includes a letter of consent, make sure the contact information for the IRB Chair is included. The following phrase should be used on all consent letters or, when no letter used, either the cover letter or survey (for anonymous survey):
What detailed information is required for a full protocol submission?
The researcher should provide a detailed research protocol including the:
- Purpose of Objectives
- Research Methodology
- Data Analysis
Hard copy proposals may be mailed to the IRB Chair:
Michael Dolan
Department of Sports Medicine, Health & Human Performance
Canisius College
2001 Main Street
KAC 211
Buffalo, NY 14208
Phone: (716) 888-2964