Purpose of the Elms College Institutional Review Board (IRB)

The purpose of the Elms College Institutional Review Board is to:

1. Ensure the protection and rights of human research subjects
2. Review research involving human subjects
3. Review federal mandates and policies regarding ethical standards for research,
4. Update guidelines and procedures according to these federal guidelines
5. Disseminate policies and procedures for conducting ethical research to faculty and students.
6. Generate reports to faculty and administration regarding activities of the IRB committee.

What is an Institutional Review Board?

IRBs are boards, committees, or groups formally designated by an institution to conduct initial and continuing review of research involving human subjects.

All IRB committees are governed by Title 45 Part 46 of the Code of Federal Regulations (CFR) (http://ohsr.od.nih.gov/guidelines/45cfr46.html) and are regulated by the Food and Drug Administration and the National Institutes of Health's (NIH) Office for Human Research Protections (OHRP) within the U.S. Department of Health and Human Services (DHHS) (http://www.hhs.gov/ohrp). The DHHS requires institutions, who receive federal funding (ex.: federal financial aid to students), to have an IRB committee as do a number of other agencies.

The IRB must also follow the regulations, laws, and policies set down in the Belmont Report (http://ohsr.od.nih.gov/guidelines/belmont.html) and the Nuremberg Code (http://ohsr.od.nih.gov/guidelines/nuremberg.html).

The above codes as well as International Review Boards were developed in response to the various research abuses that occurred in the early twentieth century. The two most notorious cases were the experiments conducted by the Nazi physicians, as noted in the post-World War II Doctors' Trial, and the Tuskegee Syphilis Study, which was conducted between 1932 and 1972 by the U.S. Public Health Service.

Title 45 of the Code of Federal Regulations defines both Research and Human subjects. Research is defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities" (45 CFR 46.102(d)). Human Subjects is defined as "a 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. (45 CFR 46.102(f))

In compliance with the Title 45 Act institutions "engaged in research which is covered by this policy and which is conducted or supported by a federal department or agency shall provide written assurance satisfactory to the department or agency head that it will comply with the requirements set forth in this policy." (45CFR 46.103 (a))

According to the Department of Health and Human Services (2005) section 46.107, IRB membership should include at least 5 members "with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution."