The IRB performs critical oversight functions for research conducted on human subjects. The committee is formally designated to review and monitor biomedical and behavioral research that takes place on campus.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 (IRB) at the College of New Jersey is an appropriately constituted administrative body established to protect the rights and welfare of human subjects recruited to participate in research activities.
The Institutional Review Board of The College of New Jersey 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 College 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:
- The risks to human subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose the research participants to risk.
- The risks to human research subjects are reasonable in relation to the anticipated benefits (if any) to the individual, and the importance of the knowledge that may be expected to result.
- The selection of human subjects for research projects is equitable.
- Human research subjects are adequately informed of the risks and benefits of research participation and the procedures that will be involved in the research; and that informed consent is obtained from each prospective human research subject, or his/her legally authorized representative, in accordance with, and to the extent required by federal regulations and IRB policies.
- Informed consent of human research subjects is obtained in advance of research participation and appropriately documented in accordance with, and to the extent required by federal regulation and IRB policies.
- The research plan, when appropriate, makes adequate provision for monitoring the data collected to ensure the safety of the human research subject.
- There are adequate provisions to protect the privacy of human research subjects and to maintain the confidentiality of research data.