Institutional Review Board

Researchers are responsible for following the procedures outlined in the Research Project Procedures and Guidelines.

Does your research plan need an IRB review?

Research investigators, department heads, and thesis/dissertation or faculty advisors are responsible for insuring that ALL research involving human subjects is submitted to the IRB for review. Definitions from the federal rules for human subject research 45 CFR 46.102(f):

• Human Subjects: a living individual about whom an investigator (whether faculty or student) conducting research obtains
  
  1. data through intervention or interaction with the individual, or
  2. identifiable private information
• Research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge

All research involving human subjects will be reviewed if:

1. the research is sponsored by the University, or
2. the research is conducted by or under the direction of any employee, student 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, student or agent of the University using any property or facility of the University, or
4. the research involves the use of the University's nonpublic information to identify or contact human research subjects or prospective subjects.

Some projects may be reviewed by the Chair alone and whether or not a full Board review will be necessary can usually be ascertained by contacting Dr. Elizabeth Hill, Chair of the IRB.

What needs to be submitted for the IRB review?

Project proposals being submitted for IRB review should be sent to the Chair and must include:

1. A completed Project Summary Form
2. A copy of the exact Informed Consent Form that will be used with the study volunteers along with the advertisements for study volunteers. See guidelines for these advertisements. Consent forms must include all items identified in the model and must be readily understandable by the average lay person. If the volunteers are children the language must be age appropriate. Consent forms provided by a funding agency must be amended to conform to the above referenced policy statements or will be returned for amendments prior to IRB review.
3. A copy of the complete research project, including questionnaires and interviews when applicable.
4. A copy of your CITI training completion certificate.  CITI provides an on line course on human subjets protection in research.  Click here for further instructions. 
5. A copy of the Investigators Brochure (supplied by the Drug Company), when applicable.
6. A letter of approval authorizing the use of their site, signed by an appropriate official, if research volunteers are to be used at sites other than UDM or UDM affiliated hospitals (i.e., schools, shelters, social agencies, nursing homes).
7. If the project uses a vulnerable population (patients, prisoners, or children), please provide documentation of an ethics review within that institution, such as an internal ethics committee, a similar oversight group or a medical director.

Documents to be reviewed by the IRB must be submitted to the Chair, IRB, at least three (3) weeks prior to the next regularly scheduled Board meeting (see schedule below).

What needs to be submitted throughout your study?

For ongoing review (yearly), submit the Review Report.

At project completion, submit the Final Summary.

The IRB shall notify the research investigator in writing of the IRB's decisions, conditions and requirements and provide the research investigator reasons for the IRB's decision to disapprove a research project and an opportunity for the research investigator to respond. Reasons for disapproval shall also be transmitted to the Academic Affairs Office by the IRB. Upon approval, the investigator will be sent an approval letter signed by the IRB Chairperson. The letter will state the length of the IRB approval, and approval expiration date.

Meeting Schedule

The Institutional Review Board generally meets on a regular basis six times a year. Documents to be reviewed by the IRB must be submitted to the Chair, IRB, at least three (3) weeks prior to the next regularly scheduled Board meeting. Location of the meetings is the Fisher Administration Bldg. 5th floor conference room.