Important! - Effective October 15, 2012
has been selected to replace RAM2.0. All "research projects" must be submitted to the IRB Committee via
. Researchers and all key personnel must register with
to access the applications & required forms that are located in the IRBNet Document Library. For additional information go to IRBNet Information & Login.
NOTE: The new OU informed consent templates (adult,
parental permission and assent) are available in the document library of
IRBNet and MUST be used for all human subjects research projects that require documentation of written informed consent.
All research
conducted by Oakland University's researchers, faculty, student or staff involving the participation of human subjects must be submitted for review by the Institutional Review Board (IRB) for the Protection of Human Subjects.
The IRB is guided by the ethical principles found in the report of the National Commission for the Protection of the Human Subjects of Biomedical and Behavioral Research entitled Ethical Principles and Guidelines for the Protection of Human Subjects in Research
When reviewing a proposal, the board considers:
- The risks to the subjects.
- The anticipated benefits.
- The importance of the knowledge that may result.
- The informed consent process to be employed.
The board is particularly stringent when considering applications for the research involving fetuses, pregnant women, prisoners, children, the cognitively impaired or other potentially vulnerable groups.
Does My Research Project Require IRB Review?
Mandatory CITI Training
All researchers, faculty, students or staff conducting research involving the use of human subjects, or accessing their private identifiable records, must have completed the mandatory CITI training before IRB approval is granted and the research project is initiated.
OU Human Subjects Cooperative Research Procedures
All human subjects research must be reviewed by the OU IRB prior to implementation. However, investigators involved in projects with other institutions may use joint review arrangements, rely upon the review of another qualified Institutional Review Board (IRB), or make similar arrangements for avoiding duplication of effort. Investigators should be familiar with the OU Human Subjects Cooperative Research Procedures and contact the Office of Research Administration at Barbara Kooiman or (248) 370-2762 or review OU Human Subjects Cooperative Research Procedures for more information.
Applicants
All researchers conducting research involving human subjects need to be familiar with Oakland University IRB Guidelines.
- The IRB will only review applications for research conducted by Oakland University faculty or others formally sponsored by OU faculty.
- It is the faculty member’s responsibility to inform student researchers to read the OU Guidelines before initiating research projects.
- Investigators are responsible for conducting the research as described in the approved or exempted application and for submitting a revision to the application describing any departures from the original
before revisions are implemented. No data should be collected while the revised application is being reviewed. Data collected during this time may not be used.
- Research projects might be subject to intramural inspection or audit.
- Standards for Privacy of Individually Identifiable Health Information.