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3.03 Protection Of Human Subjects In...
College Hall 106
Last Revised:15 Oct 2004
Refer Questions to:Chair or Coordinator, Institutional Review Board
This policy applies to faculty, teachers, staff, and students in all offices and divisions of Gallaudet University. It also applies to off-campus researchers who use Gallaudet faculty, teachers, staff, or students as subjects in their research projects.
Gallaudet University follows current policy of the U.S. Department of Health and Human Services with regard to protecting the rights of human subjects involved in research and takes all reasonable steps to ensure their full protection when participating in research projects conducted on campus.
For this purpose, the University utilizes an Institutional Review Board (IRB) whose members review plans of research investigations involving human subjects. The University uses scientific competence and humanistic regard for individual rights and welfare as its criteria in selecting members for the IRB. The IRB is empowered to use consultants to supplement its own resources.
All research projects involving human subjects by Gallaudet University faculty, teachers, staff, or students must be submitted to the IRB for review prior to initiating the project. Additionally, research projects performed by off-campus researchers which involve Gallaudet University resources must be submitted to the IRB for review prior to initiating the research project. Off-campus researchers are required to have a Gallaudet faculty, teacher, or staff sponsor.
Prior to initiation of the investigations and to ensure adequate safeguards, the IRB determines for each activity that:
The University provides for IRB reviews to be conducted with objectivity and in a manner to ensure the exercise of independent judgment of its members. Members are excluded from reviews of projects or activities in which they have an active role or when a conflict of interest may exist. The University encourages continuing constructive communication between the IRB and research project directors as a means of safeguarding the rights and welfare of subjects.
The IRB maintains appropriate records of IRB reviews of applications and active projects, of documentation of informed consent, and of other documentation that may pertain to the selection, participation, and protection of subjects and to reviews of circumstances that adversely affect the rights or welfare of individual subjects.
Through administrative overview, the IRB periodically evaluates practices and procedures designed to protect the rights and welfare of subjects to ensure that they are being effectively applied and are consistent with the assurance given to the U. S. Department of Health and Human Services.
The University expects each individual conducting research to comply with this policy to the best of his/her ability. However, recognizing that self-regulation may not result in uniform practices with respect to human rights and welfare, the University charges the IRB with insuring compliance with this policy.
Approved by:Gallaudet University Administration
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