Skip to Main Content

This site provides information using PDF, visit this link to download the Adobe Acrobat Reader DC software.

Chat with TESU

Institutional Review Board

The purpose of this document is to assist investigators planning to conduct research involving human subjects in designing their research and submitting it for approval.

Human subjects research must be reviewed if conducted by any staff, or students, or any other person under the auspices of the University.

About the IRB at Thomas Edison State University

The National Research Act Public Law 99-158, the most recent extension of that law The Health Research Extension Act of 1985, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research provide guidelines for research with human subjects to ensure their protection in the design and conduct of research. These federal regulations require that any institution requesting and receiving funds from a federal department or agency for research involving human subjects must assure that such research is reviewed and approved by the institution’s Institutional Review Board (IRB).

Any research or clinical investigation that involves human subjects conducted by Thomas Edison State University staff or students, whether funded or unfunded, shall be under the jurisdiction of the IRB. The IRB is responsible for determining and assuring that

  1. the welfare and rights of human subjects are adequately protected and informed consent given, if necessary
  2. human subjects are not placed at unreasonable physical, mental, or emotional risk as a result of research
  3. the necessity and importance of the research outweighs the risks to the subjects
  4. the researcher(s) is/are qualified to conduct research involving human subjects

Additional information provided in the manual includes: a definition of research involving human subjects that must have IRB review and approval and that which is exempt; types of IRB review and resulting actions; policies governing cooperative research; and extensive guidelines for conducting research involving special populations, such as pregnant women and fetuses, prisoners, and children. Guidance also is provided for preparing all documentation, including the submission form, research protocol, and informed consent form, along with samples of each, and the procedures to be followed in submitting such documentation to the IRB for review.

For all funded research involving human subjects, the individual submitting the funding proposal will be responsible for coordinating the submission of required documentation to the IRB for review. In the case of unfunded research involving human subjects, staff and students proposing research involving human subjects will submit all documentation to the IRB Chair who will be responsible for reviewing the research and determining if it warrants review by the IRB.

The IRB performs critical oversight functions for research conducted on human subjects. The committee is formally designated to review and monitor scientific and behavioral research that takes place under the auspices of Thomas Edison State University. It is charged with the responsibility and authority of approving, requiring modification in, halting unapproved or non-compliant research, periodically monitoring the progress of long-term records, or disapproving all research activities involving human subjects that fall within its jurisdiction.

Toni M. Terry, BA

"I am 67 years old, soon to be 68, and to be able to say I did this at this day in my life is just gratification for my own self."

Watch Toni »