IV. Principles and Policy for the Protection of Human Subjects of Research (Formerly Appendix R)

A. Statement of Ethical Principles
B. Institutional Policy
C. Implementation of Policy

East Carolina University acknowledges and accepts its responsibilities for protecting the rights and welfare of individuals who act as subjects for research conducted by its faculty and staff. The protection of human research subjects was dealt with in a president's (chancellor's) policy memorandum dated May 22, 1970. This earlier memorandum is hereby amplified and superseded.

A. Statement of Ethical Principles

1. East Carolina University has adopted as a guiding statement of ethical principles the three comprehensive principles and three applied requirements as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research dated April 18, 1979, and entitled The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Respect for persons, beneficence, and justice are the three basic principles; consent, favorable risk/benefit assessment, and selection of subjects, are the three requirements.

2. In addition, East Carolina University, through its University and Medical Center Institutional Review Board (UMCIRB), has adopted as further guiding principles the following existing code:

· World Medical Association Declaration of Helsinki: Recommendations guiding Medical Doctors in

Biomedical Research Involving Human Subjects, and subsequent revisions

3. In addition, East Carolina University acknowledges and accepts the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46) for all applicable DHHS-funded research and, except for the requirements for reporting information to DHHS, and all other human research regardless of source of funding.

B. Institutional Policy

It is the policy of East Carolina University that all activities involving human subjects of research at/or sponsored by the university or its faculty and staff shall be submitted, reviewed, and approved by an appropriately established institutional review board -the UMCIRB. The UMCIRB has the sole authority to adjudicate as to the need for exemption from review, as defined by 45 CFR 46.101(b). These categories for exemption are summarized in the Standard Operating Procedure Manual which is published by the UMCIRB.

East Carolina University has established and maintains in accordance with 45 CFR 46 a university-wide IRB entitled the University and Medical Center Institutional Review Board. This committee (UMCIRB) works in two different functional ways:

1. as a policy-recommending or "policy-making" and appellate body subservient to the chancellor for the

protection of the rights of human subjects or research conducted at or sponsored by the university and

2. as a research-review body for human research projects in order to apply determined policies towards the protection of human subjects of research.

The UMCIRB serves presently as the IRB with the responsibility and authority to review all human research activities at/or sponsored by the university which are regulated by 45 CFR 46 or by the FDA or are sponsored byextramural agencies and also all other activities involving human subjects of research at/or sponsored by the university.

East Carolina University requires all principal investigators and their research teams to comply fully with the appropriate federal regulations, institutional policies, and the UMCIRB Standard Operating Procedure Manual.

C. Implementation of Policy

In all activities including human research subjects, the chairperson of the pertinent department or head of the academic unit is responsible for ensuring that the principal investigator's research activities are performed according to the institutional statement of principles that includes existing ethical codes and the UMCIRB Standard Operating Procedures as guidelines for protecting the rights and welfare of human research subjects The IRB shall have theauthority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects according to 45 CFR 46.113. The IRB will provide a report to the investigator, institutional officials, and sponsoring agency. Principal investigators of research studies involving human research subjects must submit a complete protocol, current UMCIRB processing form, informed consent document, and any other study related materials. The appropriate forms, instructions and details related to submission can be obtained through the UMCIRB office. A copy of all research study materials including signed informed consent and study related correspondence must be maintained by the principal investigator for at least 3 years or longer if required by the research sponsoring agency.

Investigators are responsible for reporting the progress of UMCIRB-approved research to the Office of the UMCIRB, through the use of a renewal or continuation Internal Processing Form, no less often than once per year as set forth in 45 CFR 46.109. In addition, research investigators are responsible for reporting promptly to their department chair and to the UMCIRB office, any significant injuries to human subjects or any unanticipated problems which involve risks to the research subjects or others.

Approved: 27 September 1984

East Carolina University Chancellor

Amended: 27 June 2001

East Carolina University Chancellor