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Administration and Operations Manual

3.03 Protection of Human Subjects in Research Projects

Last Revised: 15 Oct 2004
Refer Questions To: Chair or Coordinator, Institutional Review Board

Scope

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.

Policy

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 rights and welfare of subjects are adequately protected.
  • Any risks to subjects are outweighed by potential benefits.
  • The informed consent of subjects is obtained by methods that are adequate and appropriate.

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

Procedures

  1. No research project involving human subjects may be initiated until the IRB has reviewed the aspects of the project plan and has approved the proposed approach to mitigate any foreseeable problems. The IRB determines the following:
    1. What rights, or aspects of well-being, of individual subjects might be at risk in the research? An individual is considered "at risk" if he/she may be exposed to the possibility of harm (physical, psychological, sociological, or other) as a consequence of any activity which goes beyond the application of established and acceptable methods.
    2. Whether the potential risks to an individual are outweighed by the potential benefits or by the importance of the knowledge to be gained.
    3. Whether the methods to be used to gain informed consent are adequate and appropriate.
  2. An application for review must be submitted to the Gallaudet IRB well in advance of the anticipated start date of the research.
  3. Informed consent must be obtained prior to the initiation of the research activity. The informed consent documents an agreement between the researcher and the subject, or his/her authorized representative. The written document includes:
    1. A fair explanation of the procedures to be followed, including an identification of those which are experimental.
    2. A description of the benefits to be expected, if any.
    3. A description of any reasonably foreseeable discomforts and/or risks.
    4. An explanation as to whether any recourse is available if injury occurs, and if so, what it entails.
    5. A description of compensation for participation, if any.
    6. A statement describing the extent, if any, to which records identifying the subject are maintained confidentially.
    7. An offer to answer any questions concerning the procedures and information on how to contact the researcher(s) and IRB.
    8. An instruction that participation is voluntary and the subject is free to withdraw his/her consent and to discontinue participation in the project or activity at any time.
  4. The IRB or its representative will monitor the progress of each approved project at least once each year in relation to risk and protection procedures. In the event that proper safeguards and consent procedures are found lacking, the IRB will take whatever action it considers appropriate, up to and including a recommendation that the project be terminated.
  5. The principal investigator of an approved project must report to the IRB any changes in research design that may affect the rights or welfare of human subjects involved and may not carry out such changes until the IRB has approved them.
  6. Any IRB member involved in a project under review may not vote on any action to be taken with respect to the project.
  7. All decisions of the IRB and any pertinent related information are incorporated in the IRB records.
  8. For research conducted by off-campus researchers:
    1. The Gallaudet faculty, teacher, or staff sponsor should be from an academic or research discipline related to the proposed research.
    2. All projects must have prior approval from the home institution's IRB.
    3. The Gallaudet sponsor must agree to accept responsibility for the scientific merit of the project. The sponsor must completely review the research methodology with the investigator. Special attention should be given to the adequacy of informed consent for deaf subjects, taking into consideration such factors as proficiency of the investigator in sign language or the use of certified interpreters, the reading level of written materials, and respect for the values of the deaf community.
    4. Applications must be signed by the Gallaudet sponsor.
    5. The Gallaudet sponsor may be asked to attend an IRB meeting to answer any questions regarding the use of human subjects in the research project.
    6. The Gallaudet sponsor is responsible for monitoring the research during all phases of data collection to ensure that the investigator respects all regulations regarding the use of human subjects.
    7. The Gallaudet sponsor should maintain a file containing copies of the research proposal, IRB approval letters from the home institution and Gallaudet, as well as copies of final reports or publications that result from the research.
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