Institutional Review Board

Any institution participating in research or sponsored programs must have an approval process in place for the use of human subjects.  Please allow up to four weeks for applications to be reviewed. Applications submitted within the first seven days of the month will be reviewed by the end of the month. If the IRB committee has any questions or concerns regarding the proposal, the approval process may take longer than usual.

What is research?

Per 45 CFR 46.102(l), “research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”

What is a human subject?

Per 45 CFR 46.102(e), [h]uman subject means a living individual about whom an investigator (whether professional or student) conducting research (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable specimens.”

What is minimal risk?

Per 45 CFR.102(j), "[m]inmal risk means that 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 the performance of routine physical or psychological examinations or tests."

Why does the IRB exist?

The IRB exists as a body to assure the protection of research subjects in accordance with federal regulations and the ethical principles set forth in the Belmont Report (i.e., respect for persons, beneficence, and justice).

What does the IRB do?

The function of the IRB is to review requests on research involving human participants and to conduct periodic reviews of human participant policies and procedures.

Per 45 CFR 46.111, the IRB “shall determine that all of the following requirements are satisfied: 1) [r]isks to subjects are minimized; 2) [r]isks to subjects are reasonable in relation to the anticipated benefits; 3) [s]election of subjects is equitable, 4) [i]nformed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by, 45 CFT 46.116; 5) [i]nformed consent will be appropriately documented or appropriately waived in accordance with 45 CFT 46.117; 6) [w]hen appropriate, the research plan makes adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

If the IRB determines that benefits of a proposed research study outweighs the risks, they review the consent process to ensure that all potential risks and benefits are clearly identified to prospective participants and that participation is voluntary.

After the review, the IRB may elect to approve, table, or reject the research application. The committee may require protocol revision(s) and resubmission. In the event of requested revisions, the proposal must be resubmitted for IRB review and approval.

I have questions...

If you have further questions about whether or not your research must be reviewed by the IRB, please consult the Human Subject Decision Charts:  2018 Requirements. If the decision charts do not address your question, please contact the IRB at irb@atu.edu for further guidance.

 

Collaborative Institutional Training (CITI)

The Collaborative Institutional Training (CITI) is an online training module teaching research methods. Researchers must complete the CITI training prior to beginning their project. IRB Applications will not be reviewed without inclduing proof of CITI course completion. 

CITI Training CourseCITI Course Enrollment Instructions

 

IRB Links 

 

Institutional Review Board

Appointments 2019-2020