Protection of Human Subjects in Research at CC

The U.S. Government requires that all research involving contact with human participants that it funds be reviewed by an Institutional Review Board (IRB) to assure that human participants will not be harmed by their participation in research. Colorado College requires that all research conducted by members of the College community, regardless of its funding source, undergo the same review.

The U.S. Government regulations that govern this review process are called “The Common Rule ” because the same set of regulations apply to 18 different federal agencies. According to “The Common Rule,”

“RESEARCH” is defined as: “[A] systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (46.102[d]).

Classroom exercises designed to facilitate students' comprehension of a concept do not ordinarily fall under the research rubric; the most obvious exception to this guideline are course exercises designed to teach about research processes themselves, or activities, the conclusions of which students might present at a public conference. Research activities that are conducted simply for institutional information (e.g., course evaluations) and not for public knowledge do not ordinarily fall under the research rubric. If you are uncertain whether your investigation falls under the research rubric, submit it to the IRB for clarification.

According to “The Common Rule,” a “HUMAN participant” is defined as: “[A] living individual about whom an investigator (whether professional or student) conducting research obtains:

(1) Data through intervention or interaction with the individual, or

(2) Identifiable private information” (46.102[f]).

In general, the following kinds of investigations must be reviewed before data collection begins:

1. Investigations in which the researcher creates or influences the situation in which the human participants find themselves for the purposes of collecting information about those participants. This includes naturalistic observational studies in which the presence of the observer may affect the situation, as well as ethnographic or participant observation studies and experimental manipulations whether in the field or the laboratory.

2. Investigations in which the researcher interacts with the human participants in order to obtain information from those participants. Biological research in which people are measured or fluids drawn or collected obviously fall under interaction. So do questionnaire and interview research, even when the interaction is an informal conversation, the content of which will be recorded in notes at a later time.

3. Investigations in which the research uses already existing data about human participants in which the identity of the participants is knowable from the data or the data are of such a personal nature that people might reasonably expect the data to be held in confidence. Obvious examples would be transcripts or medical records. Less clear cut examples might include email posts to a list-serve or letters written to a public person.

What need NOT be reviewed are investigations in which secondary data without personal identifications are used (e.g., other researchers’ survey data sets) or personally identifiable data that the participants themselves made publicly available (e.g., letters to the editor). If you are uncertain whether an investigation falls under the rubric covered by the federal regulations, contact the IRB Chair in the Office of Institutional Research and Planning. (In 2008-09, this is Amanda Udis-Kessler, 719-227-8177, audiskessler@coloradocollege.edu)

This page was last updated on June 4, 2008
for more information contact Amanda Udis-Kessler via email (audiskessler@coloradocollege.edu)

PROTECTION OF HUMAN PARTICIPANTS IN RESEARCH

IRB REPORT TO FACULTY 2006-2007

APPLYING FOR IRB APPROVAL