Institutional Review Board

Under FDA regulations, an institutional review board (IRB) is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval) or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (such as informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

Summary of Logan Health IRB

I. Institutional Authority[1]
Logan Health, has established and maintains a Logan Health IRB that operates in accordance with applicable federal and state laws, Logan Health Policies regarding research[2], and the Logan Health IRB Handbook.

II. Purpose[3]
The purpose of the Logan Health IRB is to ensure the protection of human subjects/participants in research.

III. Principles
The Logan Health IRB is guided by the ethical principles set forth in the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research report entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the “Belmont Report”), applicable federal and state laws and guidance, local standards and expectations, and this Handbook. These principles include:

1. Respect for Persons – Respect for persons incorporates at least two ethical convictions: first, individuals should be treated as autonomous agents; and second, those persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.
2. Beneficence – Persons are treated in an ethical manner, not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. The term “beneficence” is often understood to cover acts of kindness or charity that go beyond strict obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do no harm, and (2) maximize possible benefits and minimize possible harms.
3. Justice – An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally. There are several widely accepted formulations of just ways to distribute burdens and benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed. These formulations are:

• To each person an equal share;
• To each person according to individual need;
• To each person according to individual effort;
• To each person according to societal contribution; and,
• To each person according to merit.

[1] 21 CFR 56.109(a); 45 CFR 46.109(a)
[2] Institutional Review Board Policy (A107); Research (A201); and Disclosure of PHI for Research (A960)
[3] 21 CFR 56.101(a) and 56.102(g); 45 CFR 46.101(a) and 46.102(g)

IRB Member Training

1. Each Logan Health IRB member shall have on file in the Logan Health IRB administrative offices a certification of completion of the U.S. Department of Health and Human Services (HHS) Belmont Report training program. If the member is professionally certified as an Logan Health IRB professional, clinical investigator, or as a clinical coordinator, he/she will not be required to complete the HHS Belmont Report training program as long as the certification is current.
2. New Logan Health IRB members will attend a mandatory orientation to become familiar with the Logan Health IRB, duties of members and the history of the creation of the Logan Health IRB.

Contact the IRB

Institutional Review Board Coordinator
Logan Health Medical Center
310 Sunnyview Lane
Kalispell, MT 59901
(406) 758-7495
[email protected]