PRINCETON UNIVERSITY

QUESTIONNAIRE A
INSTITUTIONAL REVIEW BOARD FOR HUMAN SUBJECTS
Summary Policy Statement

The Institutional Review Board for Human Subjects (IRB) is charged by the University Research Board with the task of protecting the interests and rights of human subjects involved in Princeton research. It strives to fulfill the charter in a way that minimizes interference with the autonomy, research objectives, and specific timetables of individual researchers yet complies with the law and University policies in this area.

All research at Princeton involving humans as subjects is guided by the ethical principles set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (entitled: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the "Belmont Report"), regardless of whether the research is subject to Federal regulation or with whom conducted or source of support (i.e., sponsorship).

The IRB will review, and has the authority to approve, require modification in, or disapprove all research activities, including proposed changes in previously approved human subject research. For approved research, the IRB also determines which activities require continuing review more frequently than every twelve months or need verification that no changes have occurred if there was a previous IRB review and approval.

Before human subjects are involved in research, the IRB determines if the research falls under exempt or nonexempt criteria. In the case of nonexempt research, the IRB gives consideration to:

1. the risks to the subjects
2. the anticipated benefits to the subjects and others
3. the importance of the knowledge that may reasonably be expected to result
4. the informed consent process to be employed

Through the submission of proposals to the IRB for either exempt or nonexempt research involving human subjects, research investigators acknowledge and accept their responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable laws, regulations, and policies.

It is the responsibility of the Office of Research Integrity and Assurance (ORIA) to provide support to the IRB and to exercise administrative oversight for this process of review and certification, and to insure that all research complies with the University's assurances for protecting the rights and welfare of human subjects. The appropriate Questionnaire A (for nonexempt research), Questionnaire B (for exempt research), or Annual Review forms are submitted to ORPA for these purposes. Please email irb@princeton.edu if you have any questions.