Policies and Procedures
- 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 by staff conducting research, and students engaging in research in courses taken at Thomas Edison State University.
- 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 is responsible for developing policies which address the following areas: 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; and 4) the researcher(s) is/are qualified to conduct research involving human subjects.
- Any research or clinical investigation that potentially puts human subjects at risk, performed by staff or students at Thomas Edison State University, whether funded or unfunded, shall be under the jurisdiction of the IRB.
- The committee will be chaired by a College administrator appointed by the Provost. The term will be a renewable two year term.
- The membership will include representation from all 5 schools, the Watson Institute, and New Jersey State Library representing a blend of mentors and staff. The Provost Cabinet will recommend mentors and administrators. The Provost will appoint.
- Two community members will serve, who are not mentors.
- Community members will be appointed by the Provost
- The Assistant Provost will be a member.
- Administrators will be appointed by the Provost, with input from the Provost's Cabinet.
- Committee membership will be for a period of two years, and renewable for two years, on a rotational basis.
Each member has one vote.
- A quorum is constituted with a majority of the membership. A community member must be present to constitute a quorum.
- The IRB will meet monthly until the structure, policies and procedures for IRB review are established, approved, and published.
- The IRB will meet a minimum of bi-annually.
- On an ad-hoc basis meetings will be called, to review submitted IRB applications.
- The meeting format will be electronic, and/or face to face.
- The chair will report all activities to the Provost on a bi-annual basis.
Deliberation 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).
- 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, which warrants review by the IRB, 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 the need for further review.
- Deliberation 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).
Types of IRB Review: Depending on the level of risk of the research protocol and the participant population, IRBs may conduct either full board review or expedited review.
- For certain kinds of research involving no more than minimal risk and for minor changes in previously approved research, the IRB Chair and a designated voting member or group of voting members review the proposed research rather than the entire IRB. ii) It cannot be assumed that research poses minimal risk because it involves only interview or survey data collection. Sensitive questions may lead to distress that exposes participants to greater than minimal risk. Loss of confidentiality can cause harm to participants, their relatives, and others. The IRB determines the designation of Expedited Review.
Full Board Review
- When full board review is necessary, the research proposal is presented and discussed at a meeting at which a quorum of IRB members is present.
- For the research to be approved, it must receive the approval of a majority of those voting members present.
- IRB members may participate by means of electronic and/or telephonic communication and need not be present physically.
Research Exemptions from IRB Review
- Under Federal regulations [45 CFR 46.101 (b)], certain categories of activity are considered research but may be declared exempt from review by the IRB. This determination must be made by the IRB prior to the research being conducted.
- Certain low-risk research is exempt from the requirements in the Federal regulations concerning IRB review and approval. If a study falls into one of the exempt categories, researchers still have ethical responsibilities to protect participants' rights.
- The researcher should not make the final determination of exemption from the applicable Federal regulations or the provisions of the institution.
- Expedited Review
- Members of the IRB will have education on an annual basis. Through the CITI program (www.citiprogram.org) to register and complete the requisite modules.
- Thomas Edison State University has determined that all individuals involved in research which warrants review by the IRB with human subjects, including investigators (principal and co-) as well as members of the research team must complete the CITI: Course in the Protection of Human Subjects
- Links to the Universitys IRB will be imbedded in the appropriate courses.
Policies, Procedures, and Paperwork
- Develop Policies and Procedures and publish and communicate in appropriate College venues.
- Publish forms to submit an IRB application.
- Maintain electronic records relevant to research conducted under the auspices of the IRB.
- Operate within an established budget.