102 Roudebush Hall
The IRB for Miami University has the responsibility to oversee procedures for carrying out the University's commitment to protect human subjects in research. This oversight includes both internal and externally funded research. The IRB is authorized to approve, require modifications in (to secure approval), or disapprove all research activities using human subjects covered by this policy. Qualifying research can be administratively approved by the Miami Research Ethics and Integrity Office (termed Level 1 review process).
Human Subject: Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Some activities may appear to be human subjects research, but are not included in the definition. These include:
When activities may include these activities, it is wise to check with the Miami Research Ethics and Integrity Office before conducting the research.
This policy applies to all activities which, in whole or in part, involve research with human subjects if:
All researchers who interact with human subjects to collect data must complete a required educational program on ethics and procedures for the use of human subjects in research before the Institutional Review Board may approve a proposal.
The CITI on-line training course must be completed by the principal investigator (PI), co-principal investigators, and other key personnel who are responsible for the design and/or conduct of the study. The requirement applies to subcontractors, consultants, individual fellowship applicants, study coordinators, and persons who conduct invasive procedures, or conduct health or opinion surveys or interviews. Research assistants including graduate and undergraduate students who are collecting data from human subjects including providing explanations or answering questions about the research in relation to recruiting or use of data gathering instruments are also required to complete the training program.
Individuals providing technical services only such as setting up a room, handing out and collecting survey instruments without providing explanations or answering questions about the research or data-gathering instruments, typing data into a data base, transcribing audiotapes, or reviewing videotapes to code behavior, are not covered by this requirement; however, they should receive instruction on maintaining privacy and confidentiality of data.
A vital component of all human subjects ethics training are the ethical principles regarding all research involving humans as subjects. These principles have been set forth in the report published by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled, "Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research." Some of these principles include respect for persons, beneficence (including minimization of risks and maximization of benefits), and justice. This report is addressed in the CITI on-line training and may also be downloaded here: Belmont Report
Researchers who propose to conduct research involving humans as subjects shall prepare and submit an Application for Approval of Research Involving Human Subjects to the IRB. Applications must be approved prior to any subject recruitment or contact with subjects. Researchers must complete the required education program on research ethics for human subjects research prior to approval of an application (see section IV).
The objective of committee review is to ensure that the rights and welfare of the subjects are adequately protected and that all activities involving human subjects are in compliance with University policies and Federal regulations to assure that:
Researchers shall obtain approval for proposed human subjects research prior to recruiting subjects or collecting data from subjects. This applies to preliminary and pilot studies which are developing or testing instruments and procedures, as well as the full study.
Researchers shall explain to subjects, prior to their decision about whether or not to participate, the objectives of the research, the procedures to be followed and the potential risks and benefits. Researchers shall not use individuals as subjects unless satisfied that they, and/or others legally responsible for their well-being, fully understand the consequence of participation and freely consent to participate in the research. The IRB may waive these requirements for written informed consent only when persuaded that the research cannot otherwise be done, that its potential value outweighs the indignity to the subject, and that the subject runs no further risk or harm in participating. Researchers shall seek consent from subjects to participate only under circumstances that provide the prospective subject sufficient opportunity to consider and decide freely whether or not to participate. Subjects shall be given a copy of the informed consent materials to keep.
Researchers shall make clear to subjects that participation is voluntary and that they are free to withdraw from active participation in the research at any time. Subjects who indicate a desire to withdraw shall be allowed to do so promptly and without penalty or loss of benefits to which the subject is otherwise entitled. Any payment to subjects must be reasonable and prorated with partial payment in the event subjects discontinue participation during the course of the study.
Researchers shall respect the privacy of subjects. They shall protect confidential information given them, advising subjects in advance of any limits upon their ability to ensure that the information will remain confidential.
Researchers shall obtain approval from the IRB prior to making any changes in the research procedures. This approval shall be done in a timely manner.
In almost all cases, consent from parent(s) or legal guardian(s) is required for children under age 18. College students who are under age 18 must have parental or guardian consent to participate as research subjects. In addition to parental or guardian consent, children should also be asked for their assent to participate in the research project in language appropriate to the subject's age and maturity.
Surveys, interview procedures, or participant observations are not eligible for exempt status (Level 1 Review) when persons under age 18 are involved as subjects.
If you have any further questions about the IRB application materials, training requirements, review procedure or other issues, please contact the REI Office at 529-3600 or email us at humansubjects@MiamiOH.edu.
To report an adverse event involving research subjects or non-compliance with protocols: Contact Jennifer Sutton 513-529-0454 as soon as possible.
Multi-Agency Federal Wide Assurance: FWA 00000397 Expires 31 Aug 2027
MU IORG ID: 0000563 Expires 09/20/2025
MU IRB Registration ID: 00000895