Human Subjects Institutional Review Board @ Keuka College
NOTICE: Conducting In-Person Human Subjects Research During the COVID-19 Pandemic
According to the IRB's policy (enacted in 2019, prior to the COVID-19 pandemic): Researchers that are members of the Keuka College organization (faculty, students, department heads, etc.) or from another institution with its own IRB (e.g. hospital, college or university) may request to conduct research at or about Keuka College. For research at or about Keuka College, the researcher will need to provide the reviewing IRB a site permission letter from a Keuka College agent who is authorized to grant such permissions.
At Keuka College, the following persons are authorized to grant such permission:
- Dr. Kenneth Sanders, Assistant Provost and Director of Institutional Research
email: ksanders@keuka.edu
- Dr. Bradley Fuster, Vice President and Provost
email: bfuster@keuka.edu
The IRB provides a template useful to both researchers seeking permission and for KC administrators looking to grant access to research at/on Keuka College. See the Site Permission Letter template for conducting research at Keuka College. Site Permission Letters with signatures must be included in the proposal packet.
The IRB does not review research proposals to evaluate their compliance with COVID-19 related protocols or policies. It is the responsibility of the researcher to obtain permission to conduct research from an authorized official of any organization where research is intended to take place and to provide the IRB with a signed letter authorizing such permission.
On this website, you will find:
About the IRB @ KC
The Human Subjects IRB (hereinafter referred to as "Human Subjects IRB" or "IRB") at Keuka College is a committee of members of the college community who review and oversee research by faculty, students and staff that involves human subjects. The IRB reviews all human subject research protocols in accordance with federal regulation, state law, and university policy. The review process is designed to protect the welfare and rights of human subjects by ensuring:
Equitable subject selection
Adequate informed consent
Assessment and minimization of risks
Privacy and confidentiality
Contact a member of the Human Subjects IRB Committee
If you have problems accessing content on this website, please first ensure you are logged in using your Keuka College email account. If you still have difficulties, please email the IRB Chair @ voconnor@keuka.edu
What is "human subjects research?"
To define "human subjects research" we must consult the Code of Federal Regulations Subpart A of 45 CFR part 46, often referred to as "the Common Rule." There, we can find definitions that guide our determination if a project does, or does not, involve human subjects research.
See below for definitions of "human subject" and "research" according to the Common Rule.
If your project meets the definition of "human subjects research" according to the Common Code, then it is under the purview of the IRB. The IRB must approve your research or determine it is exempt prior to the start of any research activities.
Need assistance determining if your project is "human subjects research"? Submit a Request for Determination of IRB Purview to the IRB chairperson.
A key component of an Institutional Review Board (IRB) review is considering scientific merit as a function of protecting the rights and welfare of human subjects.
Research that either 1) is not involving human subjects or 2) qualifies for Exempt level of review AND does not involve protected populations will not be reviewed for scientific merit.
ALL other research - regardless of the level of experience of the researcher/principal investigator - will undergo a review process that is intended to ensure that the research is of sound design and methodology.
According to the Common Rule (effective July 19, 2018):
Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Notice! At any point in the research process, if any individuals involved in the research project in any way obtains, uses, or generates private information or identifiable specimens then the project does involve human subjects. If you are uncertain if your project involves human subjects, you are advised to err on the side of caution and consult with a member of the IRB committee before you begin your research.
(46.102[e])
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.
For purposes of this part, the following activities are deemed not to be research:
(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
(46.102[l])
Who can submit their research to the Keuka College IRB for review?
Current full-time and part-time faculty, staff, and administrators who are qualified to conduct research involving human subjects.
Current students who are conducting research under the supervision of a qualified faculty or staff member.
For graduate student research, a qualified faculty or staff member must be the co-Principal Investigator (co-PI) or the co-investigator. The Keuka College IRB defines co-PIs as individuals who share equal authority and responsibility for the study. The Keuka College IRB defines a co-investigator as an individual who makes significant contributions to the study, but does not have the full authority or responsibility of the PI.
For undergraduate student research, a qualified faculty or staff member must be the co-Principal Investigator or the Principal Investigator. In all cases, the supervising faculty or staff member is responsible for ensuring the student prepares a coherent and complete research proposal and adheres to the approved protocol and standards outlined in the Common Rule (rev. 2018).
In some cases, adjunct faculty may request that Keuka College IRB review their proposed research on human subjects. When the adjunct faculty is acting as an “employee or agent” of Keuka College in the conduct of their research, then Keuka College would be “engaged in” the research, and our IRB should be a reviewing body of record.
If any of these conditions apply to the proposed research, then the adjunct faculty is required to submit their research to the Keuka College IRB for review:
If you are conducting your research on behalf of Keuka College. (If you are doing research as part of your responsibilities for any other institution, including one that you personally own, it is not “on behalf of” Keuka.)
If you are exercising institutional authority or responsibility in the conduct of your research. (If you are conducting research as part of your role as an adjunct faculty member, this would be the case.)
If you are conducting your research as part of performing institutionally designated activities. (If you are conducting research because you have been instructed by your department that this is expected of adjuncts, this would be the case.)
If none of these apply, then our IRB would not be an appropriate reviewing body. Our IRB reserves the right to determine applicability of our oversight on a case-by-case basis. When in doubt, please ask.
