Research with Human Subjects, Research with Animal Subjects, and Work with Hazardous Substances and Equipment Research with Human Subjects-Institutional Review Board (IRB) Research with Animal Subjects-IACUC Work with Hazardous Substances and Equipment

Research with Human Subjects—Institutional Review Board (IRB)

Human subjects training information: http://www.columbia.edu/cu/irb/

How to apply for IRB approval: http://www.columbia.edu/cu/irb/

RASCAL: https://www.rascal.columbia.edu/

IRB Scope and Purpose

The main purpose of the IRB is to protect the rights and welfare of human subjects who take part in research. Therefore, IRB reviews all human subject research conducted by Columbia faculty, staff, and students, regardless of the location of the research activity, source of funding, and whether the research is exempt under the Code of Federal Regulations for Protection of Human Subjects (45 CFR 46). The IRB is also required to review research that is conducted by researchers who are not affiliated with the University when their research proposes to make use of University facilities or recruit University students, staff or faculty as research participants.

Morningside Campus

IRB Basic Training on the Protection of Human Participants

Columbia’s Morningside Institutional Review Board (IRB) with the assistance of the Ad Hoc IRB Committee has created a Web-based basic training program for the use of human participants involved in any University research project. This electronic basic training course has been mandated by Federal regulations and is required before approval can be granted for the use of human participants in any University research project. The online training course TC0015. Morningside Human Subjects Training Course is available on Columbia’s Research Administration Systems’ RASCAL Web site at: https://www.rascal.columbia.edu/. It is administered under the Compliance section’s testing center and contains information about topics such as laws and regulations, guidelines, responsibilities, resources, etc. Completion of this course and a passing grade of at least 80 percent on the corresponding exam fulfill the training requirement.

Students As Researchers

Research as defined in the 45 CFR 46 and conducted by graduate (and undergraduate) students at the Morningside campus is subject to federal regulations which require that all research protocols involving human subjects be reviewed by an Institutional Review Board for the protection of Human Subjects in Research (IRB) with the following exceptions for certain types of course-related studies. Research and clinical practica (usually in the form of course-related research or evaluation projects and/or directed studies) are designed to provide students an opportunity to practice various research methods such as interview, observation and survey techniques, measurement of behavior (e.g., reaction time, speech, problem solving) as well as data analysis. Typically such projects are quite limited in scope, do not lead to general knowledge, and are not undertaken with that goal in mind, and so do not require IRB review.

Any research conducted by graduate and undergraduate students that (1) does not fall under the definition of a research or clinical practicum, (2) that uses human beings as subjects, and (3) that is intended to contribute to general knowledge must be reviewed and approved by the IRB. This includes, but is not limited to, all independent research projects, master’s theses, and doctoral dissertations. Student research projects may be submitted to the IRB for consideration as exempt research if they meet federal exemption criteria such as research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior in which data is collected anonymously (i.e., with no names, Social Security numbers, or any other codes that can be linked to a list of names) or otherwise qualifying under exemption category 2 of the federal regulations. The course instructor must submit exemption requests to the IRB. See the following link for a complete listing of the federal exemption categories: http://www.columbia.edu/cu/irb/.

Responsibility of Student Advisers for All Student Research Projects

Morningside Campus

Faculty advisers as well as student researchers must be certified to conduct research with human subjects, even if they are not currently conducting research with human subjects. The current way of receiving certification is to complete the Computer-Based Training (CBT) course TC0015. Morningside Human Subjects Training Course, available on the RASCAL Web site: https://www.rascal.columbia.edu/.

It is the responsibility of faculty advisers to determine when a graduate student project does not meet the definition of a practicum and must be reviewed by the IRB. However, the adviser must be certified as described above to be authorized to make this decision. It is the responsibility of faculty advisers to ensure that research practica and exempt research activities are conducted according to the ethical standards of the relevant discipline. When student research activities are not practica, it is the responsibility of faculty advisers to assist students in preparing review materials for the IRB and to ensure that the research is conducted in accordance with CU’s agreement with the federal government and with applicable CU policy.

Columbia University Medical Center