Policy and Procedures

Purpose

The purpose of the Holyoke Community College Institutional Review Board (IRB) is to safeguard the rights and welfare of humans who participate in research studies conducted by or with students, faculty, or staff members. The United States Department of Health and Human Services defines a human subject 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)]." Research, also defined in 45 CFR 46.102 (d), "means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Holyoke Community College has adopted the policies and procedures as outlined here in compliance with federal regulations and for the purpose of protecting members of its community and the integrity of human subject research.


IRB Composition

The Holyoke Community College IRB will consist of at least five and no more than nine persons "with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by the institution" (45 CFR 46.107). Collectively, the Board will include:

• An individual not affiliated with the college
• The Chief Research Officer or appropriate substitute
• 3 faculty members
• A non-scientist
• A scientist
• An individual who is an expert in working with vulnerable subjects (e.g., children, prisoners, mentally disabled persons, or economically or educationally disadvantaged persons.

The IRB may invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that of the IRB members.


 



Application Procedure and Forms

The "IRB Application for Research Involving Human Subjects," the "Application for Continuing Review or Study Closure," the "Application for Protocol Modification," and the "Registration of Classroom Research Activities" forms are available at the HCC Website. The HCC Website also provides two sample informed consent forms along with guidelines which specify the type of information that should be included in a consent form or in an information sheet. A sample research project information sheet (to be submitted when a waiver for a signed consent form is granted) is also available at the HCC Website. If you have questions or need guidance in the preparation of these materials, please contact one of the committee members.

 

Holyoke Community College
303 Homestead Ave. Holyoke, MA 01040
(413) 538-7000