Changes for Fall '08

Following is an outline of Office for the Protection of Human and Animal Subjects changes for fall.

1. Letter of Permission Required before Protocol Review Begins:

This semester the IRB office will not start protocol review until the signed letter of permission from the research site has been turned in. Last year, several researchers were denied permission by schools or agencies at the last minute, after a lot of office time had already been spent on their projects.

Please note: the letter of permission to recruit participants and/or conduct research should be on letterhead stationery if the organization has it, and should be signed by the principal, director, or the person who has authority to grant permission.

2. New Quality Assurance Program: Research Site Visits

The main purpose of a site visit is to confirm that a protocol is being carried out as approved by the IRB. It is also an opportunity to educate researchers, if needed, on the ethical principles that should underlie human subjects research.

The IRB may recommend a site visit for research studies that are sensitive or highly complex, or that involve vulnerable populations. A site visit may also occur if a serious adverse event has occurred or a complaint has been registered, or there is history of investigator non-compliance.

Complete details of the program, including investigator check lists, will be posted on the website prior to program initiation in mid-fall semester.

3. Staff Guidance on Review:

At Graduate Council meeting last year, the Associate Dean of Education asked us to suggest ways for students to alter research projects so their protocols would not require full committee review. Many students include procedures that may not be necessary to answer the research question. If a student is open to it, we will suggest ways to make the protocol reviewable in the office, which is usually a faster process for those with tight deadlines.

The IRB office is now clear on which projects do not require human subjects review, including oral history, class projects, needs assessments, and content expert interviews. We encourage researchers to consult with us since the issues are sometimes complicated. The office will document the no-review-needed determination in writing and students should attach a copy to their culminating experience proposals.

4. Our Forms and Templates page on the web site has added forms for reporting adverse events and protocol deviations or violations.

5. New Chairs for each IRB and the UACUC

Grace Hardie, Associate Professor of Nursing, will chair IRB 1, and Ellen Hines, Associate Professor of Geography, will chair IRB 2. Lynne Dowdy, Biology, will chair the University Animal Care and Use Committee.

Last Updated: September 2008