Staff | Purpose | Process | Learn More

Staff

The Carleton IRB committee is composed of people in the local academic community.

The 2009-20010 current members are:

Ken Abrams (Psychology)
Joe Chihade (Chemistry)
Lauren Feiler (Economics)
Nathan Grawe (Associate Dean of the College, Ex Officio)
Kari Nelson (Community Member)
Andrea Nixon (Director of Curricular and Research Support)
Kim Smith (Political Science and Environmental Studies, Chair)
Christopher Tassava (Corporate and Foundation Relations)

Purpose

The Institutional Review Board (IRB) is responsible for overseeing all research done at Carleton by faculty, students or staff that involves human subjects.

The goals of the IRB are to ensure that researchers understand and uphold the following two standards:

1. Human subjects should not be placed at undue risk;

2. Subjects should give uncoherced, informed consent of their participation in the research.

The IRB is not a college committee in the usual sense; it is subject to the regulations of a federal agency: the Office for Human Research Protections (OHRP) within the Department of Health & Human Services (DHHS).

The federal government requires that all research involving human subjects conducted by an institution that receives federal funding be reviewed in advance by an IRB at the institution. Even if a specific research project is not funded by the government, the IRB is still expected to review it because Carleton receives federal funding.

Like other institutions, Carleton has assured the DHHS that it will observe federal rules on this matter.

Applicable federal language:

"[E]ach institution holding an OPRR-approved Assurance is expected to maintain a unified system of protections applicable to all human subjects research covered under the Assurance." [OPRR guidance, "Knowledge of Local Research Context," 27 August 1998, udated 21 July 200. OPRR is the Office for Protection from Research Risks within the National Institutes of Health.]

"Each institution remains responsible for implementation, within its local research context, of appropriate oversight mechanisms in order to ensure compliance with the determinations of the reviewing IRB." [Ibid]

The Process

During the academic year, applications are processed on the Thursday after submission at 5:00 p.m. The IRB would like to see a fully-developed plan and accompanying documentation (e.g. a questionnaire or scripts when the subjects are likely to be interviewed). In the case where students are the researchers, the applications must be reviewed by a Research Advisor before they are processed by the IRB.

When an application is turned in, the chair asks a member of the board to be Primary Reviewer. This reviewer reads the application and the supporting materials. Then, he/she prepares an analysis and a recommendation for distribution to other IRB members. If they agree with the recomendation, the reviewer sends an e-mail message to the applicant explaining the finding. The normal findings are:

a. Many applications can be Exempt from IRB review because they either make use of existing records, involve standard educational/psychological tests, or for other resons listed in the federal regulations. However, it is up to the IRB (not the researcher) to determine whether a project is Exempt.

b. Most other applications can be dealt with on an Expedited basis because there is no more than minimal risk of harm to the human subjects and they fall into one of several categories or research listed in the federal regulations.

c. An occasional application will require a Full Review. This can entail a delay of several weeks because the IRB must hold a convened meeting. Projects that will misinform or mislead the human subjects so as not to taint their responses will always trigger a Full Review.

Most applications are dealt with in a week to ten days. The researcher should not wait until last minute to submit his/her application. Delays may result from unusual circumstances, during finals, or during breaks, but 90% of delays are due to inadequate or missing Consent Forms. We urge all applicants to submit a Consent Form. (In some cases, the IRB may determine that your research is Exempt, in which case you are not required to submit a Consent Form. However, it is in your interest to submit a Consent Form regardless in order to avoid any unnecessary delays.)

Doing research that involves human subjects is a privilege, not a right. The IRB has dealt with numerous applications and will work with applicants on meeting the federal requirements.

However, the IRB cannot approve projects submitted after the fact (prior review is necessary to insure compliance with federally defined criteria for ethical treatment of human subjects, particularly when the intent is to contribute to generalizable knowledge: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.103). Thus research done without IRB approval MUST NOT BE USED IN ANY PRESENTATION OR PUBLICATION. Please be aware that IRB approval is critical for both Carleton related work (e.g. comps), as well as professional endeavors outside of Carleton. In fact, increasing restrictions are being placed on publication in professional journals of research conducted without IRB approval. Thus, we urge you to plan ahead and consider possible future uses of the data to be collected (e.g. class projects that do not require IRB approval would require IRB approval if used for comps and/or publication); and obtain necessary approval in advance. If you have collected data without IRB approval for a class project or other non-research purpose and later decide to pursue research that might build on or potentially use this data (for example, in a comps project), you must contact the Chair of the IRB to discuss restrictions and possible ramifications.

By teaching students about the ethical treatment of human subjects, working with them on the applications, and treating this matter as an opportunity for ethical reflection rather than an irksome requirement, faculty are helping to prepare students to understand obligations they may be expected to shoulder as adults.

If you have any questions, please contact:

Kim Smith
Chair, Carleton IRB
ksmith, x4123
One North College St.
Northfield, MN 55057

Learn More

For historical background on the development of this entire field, a videotape entitled "Protecting Human Subjects" was distributed to department chairs and program heads in the spring of 2002. Two copies are also available in the office of the Learning & Teaching Center in Willis Hall. This tape discusses the evolution of federal and professional standards and explains how IRBs generally work.

A variety of helpful materials may be found at:

• United States Department of Health & Human Services (DHHS) http://www.hhs.gov/ohrp/