Use of Human Subjects in Research
All research conducted at Eastern Oregon University involving the use of human subjects is guided by the Code of Federal Regulations (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html).
In summary, criteria for research involving human subjects assumes:
- Risks to subjects are minimized.
- Risks to subjects are reasonable in relation to anticipated benefits.
- Selection of subjects is equitable.
- Informed consent will be sought from each prospective subject or the subject’s legally authorized representative.
- Informed consent will be appropriately documented.
- The research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
THE HUMAN SUBJECTS COMMITTEE
Eastern Oregon University, like every other institution receiving federal grants, has a committee charged with reviewing all research conducted at the University for conformity to 45cfr46. At present, the Institutional Review Board (IRB) is the designated review body.
Eastern Oregon University is responsible for the protection of the rights and welfare of human subjects used in research by, or under the supervision of, faculty and staff members of the University, when such
research is carried out as part of their duties as teacher, investigator, thesis advisor or student, or other academic activity. This responsibility is delegated to the IRB to the extent that the Committee shall determine for all activity, as planned and conducted, whether the rights and welfare of all subjects will be adequately protected.
To meet this responsibility, the Committee will review proposed research projects conducted by faculty members, University staff, or students, whether funded or not, when use of the facilities, services, or personnel of the University, and human subjects are involved. The membership of the Committee consists of full-time faculty members of Eastern Oregon University (in cases involving federal funding this committee will be expanded as required by 45cfr46). Members are appointed by and serve at the discretion of the Provost. The Committee meets at the call of its chairperson to consider questions of policy and individual research proposals which require review.
CRITERIA FOR REVIEW AND APPROVAL
The task of the IRB is to work with individuals conducting research to assure that all research involving human subjects meets the criteria defined in 45cfr46.
Research involving human subjects whether non-funded or funded from any source will be reviewed and must meet the criteria. If you have questions about whether a project needs IRB review contact the Chair, or refer to HHS policy 45cfr46 Part 46 FR 8392 for exemptions.
Research supervised by EOU faculty and conducted by students as part of class projects, course requirements, and/or demonstrations may be exempt from a full IRB review process and undergo an expedited review by the Chair as per HHS 46.110. In these cases a full IRB review may be requested by either the Chair or by the supervising faculty.
PROCEDURE FOR APPLICATION
Be aware that whether or not your research is federally funded, and whether or not you think it may be exempt from review, you need IRB approval to proceed if your research involves data that will be collected from human subjects. Application forms for the use of human subjects in research are available from the RAG website or from the IRB Chair.
You will receive written communication from the IRB indicating either approval of your proposal, or setting conditions which must be met before the proposal will be approved. DATA COLLECTION INVOLVING
HUMAN SUBJECTS MAY NOT BEGIN BEFORE APPROVAL IS RECEIVED.
Even after approval, it will be necessary to notify the IRB of any changes in your research plans. If the duration of your study is longer than a year, you will be required to submit a brief progress report annually.