|Note information for using human subjects in research|
All persons affiliated with the University who wish to conduct research involving human subjects on or off campus must first receive approval from the UND Institutional Review Board (IRB). Such research includes, for example, the use of educational tests, the administration of surveys and interviews; the observation of public behavior; the study of existing identifiable data, records or specimens; oral history research; as well as clinical studies involving drugs, medical devices, collection of blood samples, etc. The establishment of the IRB at institutions like UND is mandated by the federal government in order to protect human subjects.
Conducting human subjects research without IRB approval is unethical and contrary to the stated policies of UND and the Board of Higher Education. Failure to comply with IRB policies and procedures may result in project termination, interruption of research support, and, in some cases, a report to the federal agency funding the non-compliant research project. Therefore, we encourage you to protect yourselves by submitting your project to the IRB for review before the research begins. The IRB manual is no longer in effect. The board has approved new standard operating procedures which contain updated information about every aspect of the IRB. Information about IRB policies and procedures can be found on the IRB’s home page at http://www.und.nodak.edu/dept/rdc/regucomm/IRB/index.html.
The review process is initiated by submitting a research protocol to the IRB. Forms can be found on the IRB’s web site. The IRB forms are updated periodically in order to reflect changes in UND and federal policies, and only the current updated applications will be accepted. Therefore, it is important that a new IRB form be downloaded from the web site for each new proposal. If an outdated form is submitted, it will be sent back to the PI without being reviewed. Forms are also available by contacting the IRB secretary at the Research Development and Compliance (RD&C) office in 105 Twamley Hall.
There are three categories used in the review of research protocols. Most proposals fall in the "Exempt" or "Expedited" categories and can, as a result, be reviewed by one member of the Board. Approximately 14 days are required for the review of projects that fall in these categories. Reviewers may request additional information or refer the protocol to the full foard. In either case, the review may take longer. There are four exempt certification forms that may be used if the proposed research qualifies for exempt review under one of the categories listed on the forms. For all other research projects, the human subjects review form must be used.
"Full Board" review is required for projects with physical risks or potential for injury or harm to the subject’s dignity or well being. The Full Board meets on a monthly basis. If full board review is required and the project involves human subjects who are patients undergoing medical treatment as part of the research project, or involves imposing physical stress or intrusive medical procedures, the clinical medical subcommittee must also review the protocol and provide a recommendation to the IRB. This typically adds one additional week to the review process. A schedule of IRB meetings and deadline dates for the coming months follows.
The UND IRB requires all principal investigators and key personnel to complete human subject education before starting their research. Key personnel are defined as persons who will have contact with human subjects or who will have access to identifiable data. The UND IRB has two options for fulfilling the educational requirement. The first option is an internet-based set of modules sponsored by the Collaborative IRB Training Initiative (CITI) and the University of Miami. The CITI course consists of a group of modules encompassing the history of the IRB system, the regulations governing human subjects research, and topics specific to areas of particular importance, controversy or complexity. The researcher should choose the track that best fits his or her type of research, either biomedical research or social/behavioral research, and complete the basic course under that track. Registration for the course is accessible at http://www.citiprogram.org. The modules will need to be completed within 30 days of registering for the course. Specific UND requirements are listed on the UND institutional page available on the course site. The other educational option would be to attend an IRB basics workshop. Please contact the IRB coordinator if you would like more information.
The IRB has determined that PI’s and key personnel must complete IRB education at least once every three years. Either of the options listed above can be completed to fulfill this requirement, or researchers seeking recertification may take the refresher course on the CITI site. Registration for the refresher course is accessible at http://www.citiprogram.org.
The IRB coordinator and IRB members are available to make presentations to faculty/students/staff regarding IRB policies, procedures, etc. Also, the RD&C has several videos and books that may be checked out by faculty members. If you are interested in either of these options, please contact Jodi Everett, IRB administrative secretary, at 777-4279.
UND INSTITUTIONAL REVIEW BOARD MEETING AND DEADLINE DATES:
SEPTEMBER 2006 - MAY 2007
Meetings at 3 p.m. / Proposals requiring full board review deadline / Clinical proposals that require subcommittee and full board review deadline
Fri., Sept. 8, 2006 / Tues., Aug. 29, 2006 / Tues. Aug. 22, 2006
Fr., Oct. 6, 2006 / Tues., Sept. 26, 2006 / Tues., Sept. 19, 2006
Fri., Nov. 3, 2006 / Tues., Oct. 24, 2006 / Tues., Oct. 17, 2006
Fri., Dec. 1, 2006 / Tues., Nov. 21, 2006 / Tues., Nov. 14, 2006
Fri., Jan. 5, 2007 / Tues., Dec. 26, 2006 / Tues., Dec. 19, 2006
Fri., Feb. 2, 2006 / Tues., Jan. 23, 2007 / Tues., Jan. 16, 2007
Fri., March 2, 2007 / Tues., Feb. 20, 2007 / Tues., Feb. 13, 2007
Fri., Apr. 6, 2007 / Tues., March 27, 2007 / Tues., March 20, 2007
Fri., May 4, 2007 / Tues., Apr. 24, 2007 / Tues., Apr. 17, 2007
NOTE: All meetings will be held at 3 p.m. in 305 Twamley Hall. Changes in location, date, or time will be announced in the University Letter prior to the meeting.