The Saint Mary-of-the-Woods College (SMWC) Institutional Review Board (IRB) is responsible for creating and implementing policies and procedures for the protection of human subjects involved in research. The policies and procedures are based on the Code of Federal Regulations established by the Department of Health and Human Services, Title 45-Public welfare, Part 46, Subpart A at 45 CFR 46, “Federal Policy for the Protection of Human Subjects” (the Common Rule), (January 19, 2017).

The Final Rule aims to better manage the types of research conducted and supported by all the Common Rule departments and agencies (specifically including behavioral and social science research). Facilitating the conduct of minimal risk research is one of the main purposes, as well as reflecting modernization of research. The Final Rule recognizes evolving technologies (including mobile technologies, the Internet, and the growth in computing power) have impacted modern research activities and new kinds of research have developed.

Most parts of the new Final Rule take effect on January 19th, 2019 (due to the six-month delay from the Interim Final Rule), while revisions to cooperative research and the use of single Institutional Review Boards (sIRBs) will take effect January 20th, 2020 (HHS 2018). There are many individuals within organizations that play important roles in the protection of human subjects.

The purpose of the IRB is to safeguard and protect from harm those persons who volunteer to be subjects in research conducted at or sponsored by SMWC faculty, staff, or students. The IRB ensures that: risks to subjects are minimized, risks are reasonable in relation to anticipated benefits, subject selection is equitable, informed consent is documented, and data are kept confidential and safe. Any research involving human subjects must be submitted to, reviewed by, and approved by the IRB before data collection begins.


Beginning January 1, 2012, all researchers will be required to complete a Basic Course in the Protection of Human Subjects. This course is delivered by the Collaborative Institutional Training Initiative (CITI).

 

Policy and Procedures for the Protection of Human Subjects, Revised 2018