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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.
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
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.
The Institutional Review Board of Thomas Edison State University is charged with the responsibility and authority to approve, require modification in, halt unapproved or non-compliant research, periodically monitor the progress of long-term records, or disapprove all research activities involving humans that fall within its jurisdiction.
The IRB is responsible for establishing and administering institutional policies and procedures through which the University conforms to federal, state and local regulations that govern the protection of human subjects participating in research (human research subjects).
The IRB determines if a study meets the federal definition of research: "a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."
All research involving the collection of information, data or specimens/samples from or about human subjects or information, data, specimens/samples gathered from humans at some prior time either by the researchers themselves or someone else, must be reviewed and approved prior to such studies being undertaken.
The purpose of the IRB review is to assure, both in advance and by periodic monitoring, that appropriate steps are taken to protect the rights and welfare of human research subjects.
To accomplish this process, the IRB uses a group deliberation process to review and approve research protocols and related material (e.g., informed consent documents, investigator brochures, questionnaires). The focus of the process is to ensure that: