Mission:  The mission of the Human Research Ethics Program (HREP) is to protect the rights and welfare of human subjects enrolled in research under the auspices of the New Jersey Department of Health & Senior Services (Department).  This mission is grounded in the ethical principles of Respect for Persons, Beneficence, Justice and Stewardship.  HREP is also responsible for promoting the Responsible Conduct of Research.

HREP will accomplish its mission by:

1. Developing policies, procedures, forms and guidance on the protection of human research subjects, monitoring for compliance as necessary.



2. Serving as the primary contact to Federal agencies with human subjects research oversight authority.



3. Serving as the Department's primary resource for the protection of human research subjects, assisting investigators in the development and conduct of ethically responsible research.



4. Developing and implementing educational programs, projects and initiatives on the protection of human research subjects.



5. Providing program personnel to serve as the Department's Research Integrity Officer as required by the Federal regulations on research misconduct at 42 CFR Part 93.



6. Promptly reporting to the Commissioner, Senior Policy Advisor to the Commissioner, Institutional Review Board (IRB), Office of Legal & Regulatory Affairs or appropriate regulatory agencies: i) research activities that have been implemented or modified without IRB approval, ii) research activities that have been conducted in violation of IRB decisions, determinations, directives or requirements (i.e., "serious or continuing noncompliance"), iii) research activities that have been conducted in violation of Department policies or procedures, iv) research activities that have been conducted in violation of Federal or New Jersey laws, regulations or guidance, v) incidents in which confidentiality has been breached, vi) incidents in which there has been a serious or unanticipated adverse event to a research subject, vii) incidents in which there has been a conflict of interests that may compromise the integrity of the research, viii) incidents in which there has been a problem involving risks to subjects or others or ix) incidents in which there has been a suspension or termination of IRB approval.



7. Providing guidance and support to Department Divisions/Programs for the drafting of regulations, statutes, contracts, grants, and agreements that have a component related to the protection of human research subjects.



8. Reviewing and commenting on proposed human subjects research-related rules, regulations and statutes.



9. Providing guidance for the protection of human research subjects to Department personnel.



10. Conducting Ethics & Regulatory Assessments of human subjects research projects proposed under the authority of the Department's Federalwide Assurance (FWA).



11. Providing support to Department Divisions/Programs responsible for data repositories and registries for the protection of research subjects' identifiable private information.



12. As mandated by the Department's FWA, maintain oversight authority for the protection of human research subjects. Such oversight includes, but may not be limited to, monitoring for compliance and implementing and overseeing corrective actions to address non-compliance based on findings from site-visits, inspections, investigations and audits of human subjects research activities.



13. As mandated by the Department's FWA, in consultation with the Commissioner and the Senior Policy Advisor to the Commissioner, i) subject IRB-approved research to further review and approval or disapproval (HREP cannot approve research if it has not been approved by the IRB), ii) prohibit, suspend or terminate research activities, iii) prohibit investigators or support personnel from engaging in research under Department auspices or iv) take additional actions as necessary to protect the rights or welfare of research subjects.



14. Making official determinations of non-research, non-human subjects research and exempt human subjects research.



15. Making determinations for approval of death certificate requests for research purposes in accordance with New Jersey state law.

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