Research Involving Human Subjects

May 02, 2018

Scope: Who is Covered by this Policy?

Employees

 

Policy

Miami University is guided by ethical principles regarding all research involving humans as subjects. These principles have been 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 in Research (The Belmont Report).” In addition, requirements set forth in the common federal policy for the protection of human subjects will be met for all research funded by the Federal Government.

To this end, the Board of Trustees has approved an “Assurance of Compliance” with federal regulations for the protection of human subjects. The Institutional Review Board for Human Subjects Research (IRB) is designated as the Institutional Review Board for Miami University. The Office of Reseearch and Innovation ("ORI") provides administrative support for this Board.

To assure the protection of human subjects and to comply with Federal law, Miami University requires that, prior to initiation, all research projects involving human subjects must be reviewed and approved, or certified as exempt, by the University Institutional Review Board for Human Subjects Research (IRB) or a divisional or departmental committee to which the IRB has delegated review authority, if the research:

  1. is sponsored by Miami University; or
  2. is conducted by or under the direction of faculty, staff, or students of Miami University in connection with their institutional responsibilities; or
  3. is conducted by or under the direction of faculty, staff, or students of Miami University using any property or facility of the University; or
  4. involves the use of Miami University’s nonpublic information to identify or contact human research subjects or prospective subjects.

This policy applies to graduate and undergraduate student research projects which are intended for dissemination beyond the classroom. Student projects designed to provide research training to students and not intended for dissemination beyond the classroom are not covered by this policy.

The IRB has developed “Guidelines for Research Involving Human Subjects”. These Guidelines are applicable to all research with human subjects. It is the responsibility of the faculty or staff member to be familiar with these rules, to see that they are followed by students and other coworkers, and to forward research projects either to the IRB, or as otherwise provided.

Questions may be directed to the chair of the Institutional Review Board for Human Subjects Research, or to the ORI.

Related Form(s)

Not applicable.

Additional Resources and Procedures

Not applicable.

FAQ

Not applicable.

Policy Administration

Next Review Date

7/1/2023

Responsible Officers

  • Vice President for Research and Innovation
  • Office of the Provost

Legal Reference

  • The Common Rule 45 C.F.R. 46.101-46.124
  • NSF and NIH Research Compliance

Compliance Policy

Yes

Recent Revision History

 

Reference ID(s)

  • MUPIM 15.8
  • OAC 3339-15-08

Reviewers

  • University Senate
  • Vice President for Research and Innovation
  • Office of the Provost