RSP 201–05: Human Subjects in Research—Assurance of Compliance

To assure that all research and sponsored projects involving human subjects are conducted in an ethical manner and that ASU complies with government standards for research involving human subjects

45 Code of Federal Regulations § 46 (2005)

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, April 18, 1979

ASU has made a formal written assurance to the Office for Human Research Protections (OHRP) regarding the protection of human subjects in research. This assurance is filed with and approved by the OHRP and applies to all research involving human subjects, and all other activities which even in part involve such research, regardless of sponsorship, if one or more of the following apply:

1. the research is sponsored by the university

   or

2. the research is conducted by or under the direction of any employee or agent of the university in connection with his or her institutional responsibilities

   or

3. the research is conducted by or under the direction of any employee or agent of the university using any property or facility of this institution

   or

4. the research involves the use of the university’s nonpublic information to identify or contact human research subjects or prospective subjects.

Noncompliance with the assurance may result in the university losing eligibility for all federal funding.

All research involving human subjects must be reviewed and approved before data collection can begin. Research must be conducted in accordance with 45 Code of Federal Regulations § 46 (2005).

1. ASU is guided by the ethical principles regarding all research involving humans as subjects set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (entitled, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research), regardless of whether the research is federally sponsored or subject to federal regulation.
2. All ASU performance sites must conform to the ethical principles that are at least equivalent to those of the university or as determined by the Department of Health and Human Services (DHHS) secretary.

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